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 ALTERNATIVE THERAPIES
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A peer-reviewed journal • jan/feb 2009 • VOL. 15, NO. 1 • $6.95

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jan/feb 2009, VOL. 15, NO. 1

TABLE OF CONTENTS
editorial

10 Change
David Riley, MD

guest editorial

16 Improving the Science for Botanical and Dietary Supplements

Stacie E. Geller, PhD

column

20 The Map: Integrating Integrative Medicine

Mark A. Hyman

original research

24 Confirmation of the Efficacy of ERr 731 in Perimenopausal Women With

Menopausal Symptoms
Marietta Kaszkin-Bettag, PhD; Boris M. Ventskovskiy, MD, PhD; Sergey Solskyy, MD, PhD;
Sabine Beck, PhD; Ilona Hasper, MD; Andrei Kravchenko, MD, PhD; Reinhard Rettenberger, PhD;
Andy Richardson, PhD; Peter W. Heger

36 Clinical Observations and Seven-and-One-Half-Year Follow-up of Patients Using an

Integrative Holistic Approach for Treating Chronic Sinusitis
Robert S. Ivker, DO; William S. Silvers, MD; Robert A. Anderson, MD

44 Diets Based on Ayurvedic Constitution—Potential for Weight Management

Shikha Sharma, MBBS, MD; Seema Puri, PhD; Taru Agarwal, MSc; Vinita Sharma, BAMS

case study
50 Delivery of a Full-term Pregnancy After TCM Treatment in a Previously Infertile
Patient Diagnosed With Polycystic Ovary Syndrome
Jennifer A. M. Stone, LAc; Karmen K. Yoder, PhD; Elizabeth A. Case, MD

review articles

54 The Use of Botanicals During Pregnancy and Lactation

Tieraona Low Dog, MD

60 A Possible Central Mechanism in Autism Spectrum Disorders, Part 2: Immunoexcitotoxicity

Russell L. Blaylock, MD

2 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Table of Contents

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68 Frank Lipman, MD: Where Eastern Medicine Meets Western Medicine

special feature

78 American Holistic Medical Association January Newsletter

departments

14 Letters to the Editor

14 Erratum
82 Resources
84 Classifieds/Conference Calendar
84 Advertisers Index

in future issues

• Metabolic Cardiology: The Missing Link in Cardiovascular Disease

• Understanding Diagnostic Reasoning in TCM Practice: Tongue Diagnosis
• Cranberry Constituents Affect Fructosyltransferase Expression in Streptococcus mutans
• The Effects of Distant Healing Performed by a Spiritual Healer on Chronic Pain
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• Efficacy of Dried Cruciferous Powder for Raising 2/16 Hydroxyestrogen Ratios in Premenopausal Women

about It is generally known that Picasso’s paintings have exerted a great influence on the modern world, as have Oriental
the paintings. Ting Shao Kuang, a prominent contemporary Chinese painter in America, has produced works characterized
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4 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Table of Contents

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 w w w. a lt e r n at i v e - t h e r a p i e s . c o m

EDITOR in chief
David Riley, MD

EDITORs
Christine L. Girard, ND • Jason Hao, DOM • Michele Mittelman, RN, MPH

CONTRIBUTING EDITORs
Michael Balick, PhD Mark A. Hyman, MD
Jeffrey Bland, MD Roberta Lee, MD
Marc David Melvyn R. Werbach, MD

Sidney MacDonald Baker, MD
Co-Chairman of the DAN! Advisory Board
Elizabeth Ann Manhart Barrett, RN, PhD, FAAN
Hunter College of CUNY
Harriet Beinfield, LAc
Chinese Medicine Works
William Benda, MD
University of California San Francisco
Mark Blumenthal
American Botanical Council
Ian Coulter, PhD
RAND; UCLA; Samueli Institute;
Southern University of Health Sciences
Harley Goldberg, DO
Kaiser Permanente
Ellen Kamhi, PhD, RN
Stony Brook University
Institute for the Advancement of Complementary
Ted Kaptchuk, OMD
Harvard Medical School
Editorial Board
Stanley Krippner, PhD Dean Ornish, MD
Saybrook Graduate School and Research Center Preventive Medicine Research Institute,
University of California, San Francisco
George Lewith, MD, FRCP
University of Southampton Joseph E. Pizzorno, ND
President Emeritus, Bastyr University and
Peter Libby, MD President, SaluGenecists, Inc
Brigham and Women’s Hospital
Harvard Medical School Anthony L. Rosner, PhD, LLD (Hon)
Parker College of Chiropractic
Tieraona Low Dog, MD
University of Arizona Robert B. Saper, MD, MPH
Boston University Medical Center
Victoria Maizes, MD
University of Arizona Betsy B. Singh, PhD
Medicus Research, LLC
Bill Manahan, MD
American Holistic Medical Association Leanna Standish, ND, PhD, LAc
Bastyr University
Woodson C. Merrell, MD
Continuum Center for Health and Healing, Eugene Taylor, PhD
Beth Israel Medical Center Saybrook Graduate School
Harvard University
Pamela Miles, Reiki master
Roeland van Wijk, PhD
Therapies (I*ACT) International Institute of Biophysics, Germany

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6 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Masthead

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Alternative Therapies in Health and Medicine is recognized as the premier journal in the field of complementary and alternative medicine.
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are due in large part to the dedication of the peer reviewers and other contributors who have joined us in our efforts to advance the field
of CAM these last few years. Thank you.
Lise Alschuler, ND, FABNO
Midwestern Regional Medical Center,
Cancer Treatment Centers of America
Belinda J. Anderson, PhD, LAc
Pacific College of Oriental Medicine
Robert Anderson, MD
Bastyr University
American Board of Holistic Medicine
Maira Bes-Rastrollo, PharmD, PhD
University of Navarra, Spain
Clement Bezold, PhD
Institute for Alternative Futures
Felicity L. Bishop, MA, MSc, PhD, CPsychol
University of Southampton School of
Medicine, UK
Jeffrey Bland, PhD, FACN, FACB
Synthesis
Jeffrey B. Blumberg, PhD, FACN, CNS
Tufts University
Michelle Bowman, BSN, RNC, DiplAc
Health Center of Integrated Therapies,
A Service of Longmont United Hospital
William Braud, PhD
Institute of Transpersonal Psychology
Sarah Brien, PhD
University of Southampton, UK
Jane Buckle, RN, PhD
Thames Valley University, London, UK
Margaret Burkhardt, RN, PhD
West Virginia University School of Nursing
Etzel Cardeña, PhD
University of Lund, Sweden
Michael Carlston, MD
University of California, San Francisco
Lisa Conboy, MA, MS, ScD
Osher Institute, Harvard Medical School
J. K. Crellin, MD, PhD
Newfoundland, Canada
Jonathan Davidson, MD
Duke University
Robert M. Duggan, MA, MAc
Tai Sophia Institute
8 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
thank you
Charles Elder, MD, MPH, FACP
Kaiser Permanente NW
Henry Emmons, MD
Abbott Northwestern Hospital
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University of Texas Health Science
Center at Houston
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Albert Einstein College of Medicine
Tiffany Field, PhD
University of Miami
Peter Fisher, FRCP, FFHom
Royal London Homeopathic Hospital
Paula Gardiner, MD, PhD
Boston University
Tracy Gaudet, MD
Duke Integrative Medicine
Nicholas J. Gonzalez, MD
New York, New York
Gloria Andrea Gronowicz, PhD
University of Connecticut Health Center
Aviad Haramati, PhD
Georgetown University School of Medicine
Bethany Hays, MD
True North
Charles Nelson Ross Henderson
Palmer Center for Chiropractic Research
Martha R. Herbert, MD, PhD
TRANSCEND
Mark L. Hoch, MD
Partners in Healing of Minneapolis
Michael F. Holick, PhD, MD
Boston University Medical Center
Linda L. Isaacs, MD
New York, New York
Randy A. Jones, PhD
University of Virginia School of Nursing
Lynn Keegan, RN, PhD, AHN-BC, FAAN
Holistic Nursing Consultants
Raheleh Khorsan, MA
Samueli Institute
Barry Krakow, MD
Sleep & Human Health Institute
James D. Lane, PhD
Duke University Medical Center
Lixing Lao, PhD, LAc
University of Maryland
Dana J. Lawrence, DC, MMedEd
Palmer Center for Chiropractic Research
Larry LeShan, PhD
New York, New York
Karen Lesniak, PhD
Loma Linda University
Jacob Liberman, OD, PhD
Exercise Your Eyes, Inc
DeAnn Liska, PhD
Ocean Spray Cranberries, Inc
Patrick B. Massey, MD, PhD
Alexian Brothers Hospital Network
Robert S. McCaleb
Herb Research Foundation
Melany A. Meier, DC
Southern California University of
Health Sciences
Woodson Merrell, MD
Beth Israel Medical Center
Deanna Minich, PhD, CN
Metagenics
Ralph W. Moss, PhD
The Cancer Chronicles
Barry S. Oken, MD
Oregon Health and Science University
Michael M. Patterson, PhD, DO(HON)
Nova Southeastern University
Daryl S. Paulson, PhD
BioScience Laboratories, Inc.
Joanne L. Perron, MD, FACOG
Pebble Beach, California
Janice Post-White, RN, PhD, FAAN
University of Minnesota
Satya P. Rao, PhD, CHES
New Mexico State University
Keith Rayburn, MD
Castroville, California
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University of Arizona
Susan W. Ryan, DO
Rose Medical Center
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AIBMR Life Sciences, Inc
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Beatrice, Nebraska
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Dartmouth-Hitchcock Medical Center
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Woodbury, Connecticut
Leonard Zegans, MD
University of California, San Francisco
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 This article is protected by copyright. To share or copy this article, please visit copyright.com. Use ISSN#10786791. To subscribe, visit alternative-therapies.com.
editorial
CHANGE
David Riley,
David Riley, MD, is the editor in chief of Alternative Therapies in
Health and Medicine. (Altern Ther Health Med. 2009;15(1):10-11).
hange—and the images of transformation and
C charting a different course—has certainly been a
powerful and motivating force for many during the
past year. In healthcare, what can we change? Can
we chart a course of healthcare reform that includes
health promotion and wellness and creates an integrative health-
care delivery system? Healthcare in the United States costs sub-
stantially more than anywhere else in the world. Shouldn’t we
consider our existing assumptions and strategies and contem-
plate including other approaches? The difficulties we face in
healthcare require us to expand our thinking in order to find the
solutions that are inevitably hidden within our current challeng-
es. One key ingredient to consider is using a multidisciplinary
approach integrating a broader spectrum of healthcare provid-
ers. In our challenge to seek change, I am honored to introduce
our readers to 3 new editors of Alternative Therapies in Health and
Medicine who, through the diversity of their backgrounds, reflect
elements of transformation.
Christine L. Girard, ND, is executive vice president of aca-
demic and clinical affairs for the Southwest College of
Naturopathic Medicine in Tempe, Arizona. Dr Girard complet-
ed her undergraduate degree at Goddard College, Plainfield,
Vermont, and received her doctorate in naturopathic medicine
from the National College of Naturopathic Medicine, Portland,
Oregon. She participated in and completed the first hospital-
based residency for naturopathic physicians at Griffin Hospital
in Derby, Connecticut. Dr Girard’s career has focused on hospi-
tal-based integrative medicine and leadership in undergraduate
and postgraduate naturopathic medical education. She is the
cofounder and past codirector of the Integrative Medicine
Center at Griffin Hospital, where she created, in conjunction
with the University of Bridgeport College of Naturopathic
Medicine, an integrative medicine residency program for natur-
opathic physicians. Dr Girard served as a clinical research spe-
cialist at the Yale-Griffin Prevention Research Center and is
former director of naturopathic medicine at Southwestern
Regional Medical Center in Tulsa, Oklahoma, a Cancer
Treatment Centers of America hospital. Christine is a past board
member of the American Association of Naturopathic Medicine
10 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD
and the Council on Naturopathic Medical Education. Her volun-
teer work includes support of the Sojourner Center, a domestic
violence shelter in the Greater Phoenix area, and the Leukemia
and Lymphoma Society.
Jason Hao, DOM, received his bachelor’s and master’s
degrees from the Heilongjiang University of Chinese Medicine in
China in 1982 and 1987 and received his master’s of business
administration in 2004 from the University of Phoenix. He is
president of the International Academy of Scalp Acupuncture,
chairman of the Acupuncture Committee at the National
Certification Commission for Acupuncture and Oriental
Medicine, and vice president of the Southwest Acupuncture
College Board in Santa Fe, New Mexico. Dr Hao is a well-known
professor and has been teaching, practicing, and researching
acupuncture and treatment with Chinese herbs for 26 years at
academic centers in both the United States and China. In 2006,
Dr Hao was invited to the Walter Reed Army Medical Center in
Washington, DC, where he achieved remarkable results using
scalp acupuncture to treat amputee veterans suffering from
phantom pain. Dr Hao has published numerous articles and cur-
rently serves as an editor of Chinese Acupuncture and Moxibustion,
a leading acupuncture journal in China. He is committed to using
his knowledge and experience to enhance the high professional
standards already set by Alternative Therapies in Health and
Medicine and pledges his highest level of service toward further-
ing its global mission.
Michele Mittelman, RN, MPH, has a background in nursing
from the University of Pennsylvania Hospital School of Nursing,
Rutgers University, and is a member of nursing’s national honor
society, Sigma Theta Tau International. She has worked as a reg-
istered nurse in intensive care, obtained a graduate degree in
public health from Columbia University, and worked as a health-
care consultant with Ernst & Young. After a hiatus from health-
care, Michele has been increasingly drawn to her roots in nursing
and is an advocate for the nursing profession, focusing on inte-
grative care. She has worked nationally to advance integrative
medicine through strategic philanthropic initiatives and is also
involved with the Dana Farber Cancer Institute in Boston.
Michele has worked in her local community, serving The
Catalogue for Philanthropy and Tenacre Country Day School,
and has been a trustee, docent, and active volunteer with the
New England Wildflower Society.
As evidence that our healthcare system as currently structured
Change
TK
is financially untenable continues to accumulate, we need inno-
vative and expansive thinkers who are committed to change—
like these 3 editors. If we “got what we paid for,” we would be the
healthiest nation in the world. Unfortunately, if we look at the
top 30 developed economies in the world, we rank at or near the
bottom in virtually every category, from infant mortality to life
expectancy. In 2006, the American College of Physicians warned
that “primary care, the backbone of the nation’s healthcare sys-
tem, [was in] grave risk of collapse.”1(p6) Nearly 50 million people
have no health insurance and limited access to care2; those who
do have insurance often face ever-shortening office visits that
allow no time for comprehensive care for complex diagnoses,
much less health and wellness.
Today we fall short in prevention and instead focus on early
detection as an inadequate substitute. Access to services is limit-
ed, we have a shortage of a variety of healthcare providers, and
we offer little support or acknowledgement of the contributions
made by nurses, chiropractors, naturopaths, oriental medicine
practitioners, and other holistic healthcare providers. Nor have
we historically invested much energy envisioning on a policy
level what an integrative and holistic model of healthcare could
look like, how it might be designed, or how to track outcomes.
In fact, the actuarial data that track outcomes today and are
used to determine reimbursements from the insurance industry
are based on the CPT (Current Procedural Terminology) codes—
a proprietary product of the American Medical Association
(AMA) from which they earn millions of dollars every year.3 The
CPT codes ignore most of the services offered by the overwhelm-
ing majority of licensed healthcare providers, from nurses to
acupuncturists to naturopaths to chiropractors, making it virtu-
ally impossible to accurately track the outcomes associated with
their care. To make matters worse, the Centers for Medicare and
Medicaid Services has stifled innovation by basing its coding
policies almost exclusively on the AMA coding conventions.
Paul Krugman, a Princeton economist and Nobel laureate,
recently said,
Institute, along with a move toward broader healthcare coverage.
Emerging research methods for evaluating more individualized
therapeutic approaches, ranging from bioregulatory medicine to
intercessory prayer to a systems biology approach, will help cre-
ate an evidence mosaic that can be incorporated into the health-
care roadmap for change. It appears that the forces that have
stymied the move toward innovations in healthcare for more
than 20 years may be shifting.
Meaningful healthcare delivery must support and track pre-
vention and health and value as one of its key principles the med-
ical narratives at the core of the partnership between patient and
provider. As participants in our healthcare system, we strive to
be a part of the transformation that will enhance health and
move us beyond our current disease-management model.
REFERENCES
1. American College of Physicians. Reform of the Dysfunctional Healthcare Payment and
Delivery System: A Position Paper. Philadelphia, PA: American College of Physicians;
2006. Available at: acponline.org/advocacy/where_we_stand/policy/dysfunctional_
payment.pdf. Accessed December 2, 2008.
2. DeNavas-Walt C, Proctor BD, Smith JC, US Census Bureau. Income, Poverty, and Health
Insurance Coverage in the United States: 2007. Washington, DC: US Government Printing
Office; 2008. Current Population Reports, P60-235. Available at: http://www.census.
gov/hhes/www/hlthins/hlthin07.html. Accessed December 2, 2008.
3. American Medical Association. Helping Doctors Help Patients. 2007 Annual Report.
Chicago, IL: American Medical Association; 2008. Available at: http://www.ama-assn.
org/ama/pub/category/12528.html. Accessed December 2, 2008.
4. Rovner J. Is the government responsible for health care? NPR. September 24, 2008.
Available at: http://www.npr.org/templates/story/story.php?storyId=94812584&ft=1
&f=1027. Accessed December 2, 2008.

Our health care system is wildly inefficient, largely

because we have an insurance industry that devotes
enormous resources to try to identify who really needs
health insurance, so as not to give it to them. And we
have health care providers devoting enormous resources,
fighting with the insurance companies to actually get
paid. . . . It would be cheaper by far to just cover every-
body. We pay this huge price because we’ve managed to
convince ourselves or be convinced that somehow, some-
thing that every other advanced country does, and that
we do ourselves for the elderly, is impossible.4

The implicit assumption seems to be that we just need to do

more of what we are already doing, as if that will magically pro-
duce different results.
Other, more sustainable healthcare models are emerging,
such as the Wellness Initiative for the Nation from the Samueli

TK
Change ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 11
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 This article is protected by copyright. To share or copy this article, please visit copyright.com. Use ISSN#10786791. To subscribe, visit alternative-therapies.com.

letters to the editor

PREGNANCY AND LABOR ALTERNATIVE THERAPY Author Response

RESEARCH Many medical groups and professionals do not consider
In a recent literature review in Alternative Therapies in Health chiropractic an alternative therapy at this point. That is the rea-
and Medicine, Tiffany Field reviews the most popular comple- son I did not include chiropractic in the review.
mentary and alternative (CAM) therapies research (from the last
5 years) used during pregnancy and labor and potential underly- Tiffany Field, PhD
ing biological bases for their effects.1 We commend Dr Field on Touch Research Institute
her efforts. We are surprised and concerned, however, that the University of Miami Medical School
literature review published by Field fails to discuss spinal manip- Florida
ulative therapy (SMT) used by chiropractors, osteopaths, and Fielding Graduate University
physical therapists. Santa Barbara, California
The advantage of any systematic or narrative review is that it
provides a transparent, replicable approach to the subject area
through current and relevant references and an unbiased and ERRATUM
comprehensive view. This transparency is reflected through a In his guest editorial in the Nov/Dec 2008 issue (“Autism:
thorough methods section, possibly the most important aspect of Asking the Right Questions to Find the Right Answers,”
any research paper. It provides the information by which a study’s 2008;14(6):20-21), Dr Jeffrey Bland referred to a piece on autism
validity is judged. It therefore requires a clear and precise descrip- he wrote in what he called Autism Advances. The correct name of
tion of how a study was done and the rationale for why specific the publication is Autism Advocate, published by the Autism
procedures were chosen.2 Like other study designs, the methods Society of America. Alternative Therapies in Health and Medicine
section of a review paper (1) describes what was done to answer regrets the error.
the research question, (2) describes how it was done (eg, search
strategy, inclusion and exclusion criteria), (3) justifies the design,
and (4) explains how the results were analyzed and interpreted.
Field states that “the most common alternative therapies rec-
ommended during pregnancy were massage therapy (61%), acu- 17 CMEs – TWO DAY SEMINAR.
puncture (45%), relaxation (43%), yoga (41%), and chiropractic Environmental Endocrinology
(37%). Of the 5 therapies she references above, Field reviews 4
(massage therapy, acupuncture, yoga, and relaxation) as the most
341&$5*7&
0
frequently researched alternative therapies for pregnancy and
labor. Additionally, she also reviews exercise, hypnosis, music 1& /

"(
"
/&8

therapy, and aromatherapy. It is not clear why she excluded chiro-

practic from her review and included other therapies. The lack of
a clear rationale for her inclusion and exclusion criteria presents a */(
bias in her review.

Raheleh Khorsan, MA
Research Associate
Military Medical Program and Integrative Medicine
Samueli Institute
Corona del Mar, California
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REFERENCES of aging and quality of life. Refer a colleague and get 50% off your
1. Field T. Pregnancy and labor alternative therapy research. Altern Ther Health Med.
2008;14(5):28-34. registration. For more information and registration visit the
2. Kallet RH. How to write the methods section of a research paper. Respir Care. Physicians section at: www.thewileyprotocol.com.
2004;49(10):1229-1232.
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14 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Letters to the Editor/Erratum
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 This article is protected by copyright. To share or copy this article, please visit copyright.com. Use ISSN#10786791. To subscribe, visit alternative-therapies.com.
guest editorial
IMPROVING THE SCIENCE FOR BOTANICAL
AND DIETARY SUPPLEMENTS
Stacie E. Geller,
Stacie E. Geller, PhD, is the G. William Arends Professor of
Obstetrics and Gynecology, College of Medicine; director of
the Center for Research on Women and Gender; and director
of the National Center of Excellence in Women’s Health at
the University of Illinois, Chicago. (Altern Ther Health Med.
2009;15(1):16-17.)
illions of menopausal women use herbal medi-
M cines and botanical dietary supplements (BDS)
on a regular basis to treat a variety of symp-
toms related to menopause and for other
aging-related issues. Despite their widespread
use, the regulatory framework of the Dietary Supplements Health
Education Act (DSHEA) allows most herbal medication to be
marketed (albeit without indications) without going through the
extensive testing and rigorous clinical trials required of pharma-
ceutical products. This is not the case in Germany, for example,
where herbal medicinal products are held to more rigorous stan-
dards and registered as pharmaceutical products. The absence of
rigorous scientific evidence for herbal products in this country
often makes it difficult for consumers to be fully informed about
the efficacy and safety of the products they are using. I am pleased
to see a series of randomized controlled clinical trials on an herbal
extract of Rheum rhaponticum (Siberian rhubarb),1,2 reporting on
both efficacy and safety. To date, however, all of these trials have
been carried out by one contract research organization, Health
Research Services (HRS), for the manufacturer of the product. It is
important for confirmatory studies to be conducted as indepen-
dent clinical trials so that health consumers can be confident they
are receiving the most unbiased information on the safety and
efficacy of herbal products, independent from organizations that
will profit from their use.
How should this testing be done, and what sorts of issues
should be raised in menopause research? We already know that
60% to 75% of women report that they do not tell their providers
about these supplements, and providers seldom ask patients
about their use. What sorts of herb-drug interactions may be
going unreported? This means that scientists designing and con-
ducting clinical trials for BDS must be ever rigorous in their con-
duct of research, especially related to safety.
We also know from data of clinical trials in menopause that
there is a high placebo effect, ranging from 30% to 60%, especially
in studies of vasomotor symptoms in menopause. Exaggeration
16 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
PhD
of effectiveness can commonly occur if a clinical trial does not
have a placebo group and does not compare symptoms at entry
into the study to symptoms at the end of the study. Although it
was not the case in the trial reported by Kaszkin-Bettag,2 many
trials report only within-group comparisons and not between-
group comparisons.
Many trials are also designed with insufficient power to
address the outcome that is usually of greatest interest to wom-
en—reduction in hot flashes. For example, there have been at
least 8 clinical trials that have examined the efficacy of black
cohosh for relief of menopausal symptoms, and 6 of 8 have
shown a significant reduction in vasomotor symptoms. It should
be noted, however, that 5 of these studies reported improvement
in menopause rating scales (MRS) where subjects report their
symptoms in diaries, noting the change in frequency and intensi-
ty of vasomotor symptoms. Even though the use of MRS is inter-
nationally validated and used in most conventional research on
menopause, the specific symptom of the reduction in hot flashes
may be lost in the final analysis unless the reduction in hot flash-
es compared to placebo is calculated separately.
Additionally, there is very little understanding of the mecha-
nism of action of most botanicals. It is thought that the reduction
in hot flashes with treatment is due primarily to the binding of
medications with estrogen receptors in reproductive tissue. It
also has been known for more than a decade that some of these
effects are mediated via estrogen receptor (ER)–α and ER-β sys-
tems. Recent basic science studies with ER-α and ER-β have
shown that the activation of both receptors alleviates hot flashes.3
ER-β receptor activation seems to act as a negative regulator of
the ER-α receptors and probably protects against ER-α–mediated
breast cancer. And perhaps most interesting, it was shown by
Möller et al in Dresden that ERr 731—the special extract of
Siberian rhubarb—activates ER-β with high selectivity for this
estrogen receptor.4,5 It appears likely that ERr 731 may have bene-
ficial effects on menopausal symptoms through its ER-β selective
properties without the negative risks associated with hormone
replacement therapy, which activates both receptors.
It is not common in herbal medicine to find mechanism-of-
action studies for an herbal extract so consistent with known
physiological mechanisms of action. In fact, many clinical stud-
ies of plant extracts lack sufficient detail as to the material being
evaluated, including how the extract was chemically and biologi-
cally standardized, as well as stability studies of the product over
the course of the study.
Improving the Science for Botanical and Dietary Supplements
 Studies of traditional hormonal therapies in menopause are
held to high standards, in part because of the reported risk of
adverse events associated with the Women’s Health Initiative (an
independent clinical trial), which came as a surprise to the medi-
cal community when it was first reported in 2002.6 Clinical trials
of BDS—herbal medications—should be held to the same stan-
dards. We need not only randomized, placebo-controlled studies
to prove the efficacy of these treatments for menopausal symp-
toms but also mechanism-of-action and safety studies, as well as
more detailed information on standardization so that reasonable
comparisons can be made among the many therapies from
which women can choose.

REFERENCES
1. Heger M, Ventskovskiy BM, Borzenko I, et al. Efficacy and safety of a special extract of
Rheum rhaponticum (ERr 731) in perimenopausal women with climacteric complaints:
a 12-week randomized, double-blind, placebo-controlled trial. Menopause.
2006;13(5):744-759.
2. Kaszkin-Bettag M, Ventskovskiy BM, Kravchenko A, et al. The special extract ERr 731
of the roots of Rheum rhaponticum decreases anxiety and improves health state and
general well-being in perimenopausal women. Menopause. 2007;14(2):270-283.
3. Bowe J, Li XF, Kinsey-Jones J, et al. The hop phytoestrogen, 8-prenylnaringenin, revers-
es the ovariectomy-induced rise in skin temperature in an animal model of menopausal
hot flushes. J Endocrinol. 2006;191(2):399-405.
4. Wober J, Möller F, Richter T, et al. Activation of estrogen receptor-beta by a special
extract of Rheum rhaponticum (ERr 731®), its aglycones and structurally related com-
pounds. J Steroid Biochem Mol Biol. 2007;107(3-5):191-201.
5. Möller F, Zierau M, Jandausch A, Rettenberger R, Kaszkin-Bettag M, Vollmer G.
Subtype-specific activation of estrogen receptors by a special extract of Rheum rhapon-
ticum (ERr 731®), its aglycones and structurally related compounds in U2OS human
osteosarcoma cells. Phytomedicine. 2007;14(11):716-726.
6. Riley D, Moher D. When to disbelieve the believable. Altern Ther Health Med.
2002;8(5):36-37.

Alternative Therapies in Health and Medicine

wants to hear from YOU!

Send your comments, questions, or ideas to:

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Or by post to:
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 This article is protected by copyright. To share or copy this article, please visit copyright.com. Use ISSN#10786791. To subscribe, visit alternative-therapies.com.
column
THE MAP: INTEGRATING INTEGRATIVE MEDICINE
Mark A. Hyman,
Mark A. Hyman, MD, is a contributing editor of Alternative
Therapies in Health and Medicine. He recently launched the
Functional Medicine Foundation, based in New York, New
York, to promote awareness of, fund research on, and educate
the public about functional medicine. (Altern Ther Health Med.
2009;15(1):20-21.)
Everything should be made as simple as possible, but not simpler.
—Albert Einstein
he paradox and irony of integrative medicine is that
T it is not integrated. A coherent scientific map for fil-
tering a patient’s story into a personalized care plan
does not exist in clinical medicine, whether conven-
tional or “integrative”—at least not a science-based
method that enables us to decipher the causes of illness rather
than simply suppress symptoms. This leaves physicians frustrat-
ed and patients suffering unnecessarily. But a map does exist,
and contrary to prevailing notions, it is not integrating the best
of alternative and conventional medicine, which leads to mixed
metaphors, overlapping cosmologies, and a smorgasbord of
options without a menu.
The current approach of appending alternative therapies
onto conventional diagnoses leaves the patient with treatment
indigestion and the practitioner without a model of understand-
ing how to choose from many potentially beneficial therapeutic
options—both alternative and conventional. At times this
approach will succeed but often in spite of itself, like a foreigner
in a strange city happening upon a particular restaurant for
which he or she was searching without a street map. Applying
wholly integrated therapeutic systems, such as traditional
Chinese medicine, Ayurvedic medicine, osteopathy, or homeopa-
thy, to conventional medical ICD-9 diagnoses mixes different
worlds without a common language.
A language does exist for a new medicine based on emerg-
ing scientific laws and biological principles, however. It provides
a framework and architecture for interpreting all the data held
within a patient’s story and biology, one that is patient-centered,
not paradigm-centered. This framework provides a clear direc-
tion and a distinct understanding that guides the practitioner to
choose the appropriate tool for the task of healing, whether it is a
drug, a nutrient, an herb, an acupuncture needle, a cranial
manipulation, a shamanic ritual, or a breathing technique.
20 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD
Let us take a journey of the one and the many. One disease
with numerous potential causes and 29 “diseases” triggered by one
underlying precipitating cause. How might we assess them through
the lenses of “integrative medicine,” conventional medicine, and
the new “map”—a way of “integrating” integrative medicine?
Imagine a patient with a DSM-IV diagnosis of depression
entering an integrative healing center. This patient has a myriad
of emotional, cognitive, and physical symptoms. He also has a
number of “comorbid” and seemingly unrelated conditions.
After a thorough evaluation, a team of collaborative practitioners
reviews the case at a clinical case conference. Practitioners make
a diagnosis based on their perspective and worldview.
The psychopharmacologist diagnoses a serotonin deficiency
and prescribes a serotonin reuptake inhibitor. The traditional
Chinese medical physician diagnoses spleen chi deficiency and rec-
ommend herbs and acupuncture. The Ayurvedic physician diagno-
ses a pitta-kapha imbalance and recommends herbs and
Panchakarma. The homeopath determines the best remedy for
depression that is associated with the need to be hugged is
Pulsatilla. The energy healer believes the patient has a blocked
heart chakra from an old emotional trauma and recommends heal-
ing touch. The nutritionist diagnoses a folate or vitamin D deficien-
cy and prescribes nutrients. The psychotherapist believes the
depression may be the result of deep childhood trauma that
requires psychoanalysis. The yoga therapist sees it as a result of
chronic stress and prescribes meditation and yoga. The spiritual
healer suggests unresolved past life experiences and rebirthing. The
herbalist recommends St John’s wort. The biomedically inclined
psychiatrist recommends transcranial magnetic stimulation. The
toxicologist suggests mercury poisoning and recommends chela-
tion. The virologist diagnoses a viral limbic system infection with
Bornavirus and prescribes 4 months of antiviral therapy.
Integrative medicine has become a way for conventionally
trained healthcare providers to incorporate alternative world-
views into their treatment plans. Though they often are trained
in some other healing modalities, most integrative physicians use
scientific lenses to assess and treat their patients. How then can a
primary care doctor of integrative medicine proceed, confused,
bewildered, searching through a broad collection of tools, to find
the one or two that may help the patient “treat” his or her depres-
sion? What if it does not, as it often does not? What can he do
next? This presents a thoroughly disintegrating experience for
both doctor and patient.
So the question arises, is there a map that can serve as a
guide, is there a GPS to navigate the complex world of chronic
Integrating Integrative Medicine
disease and apply the many tools beyond drugs and surgery we
have welcomed to medicine and healing?
Among the greatest discoveries of our lifetime are the new
laws of systems biology and the ways in which they help us
understand that a few common underlying causes result in the Envisioning a Healthier World
more than 12 000 ICD-9 diagnoses that we have classified and through Herbal Medicine
named over the last 100 years of scientific medicine. As we can
see from the case of “depression” presented at an integrative
medicine case conference, however, the name of the disease has
nothing to do with the diagnosis. It describes symptoms, not eti-
ology. And the same symptoms may arise from a host of causes,
making the name of the disease increasingly meaningless. In a The Healthcare Professional’s
recent JAMA editorial called “Shifts in Thinking About
Dementia,” the author says, “The concept of dementia is obso- Source for Herbal Information
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original research
CONFIRMATION OF THE EFFICACY OF ERr 731
IN PERIMENOPAUSAL WOMEN WITH
Marietta Kaszkin-Bettag,
MENOPAUSAL
; Boris M. Ventskovskiy,
PhD
SYMPTOMS
; Sergey Solskyy, ; Sabine Beck,
MD, PhD ; Ilona Hasper, ;
Andrei Kravchenko, MD, PhD; Reinhard Rettenberger, PhD; Andy Richardson, PhD; Peter W. Heger
Objective • In a previous study, the special extract ERr 731 of
Rheum rhaponticum significantly reduced vasomotor and other
menopausal symptoms associated with perimenopause. This
trial was conducted to confirm the efficacy of ERr 731.
Design • A multicenter, randomized, placebo-controlled, clini-
cal trial with 112 perimenopausal women with menopausal
symptoms receiving either 1 enteric-coated tablet of ERr 731
(n=56) or placebo (n=56) daily for 12 weeks. Primary outcome
criterion for efficacy of ERr 731 compared to placebo was the
change of the Menopause Rating Scale (MRS) total score from
day 0 to day 84. Other efficacy assessments analyzed included
the number and severity of hot flushes, individual symptoms of
the MRS, treatment outcome, and various safety parameters.
Results • By 12 weeks, ERr 731 caused a highly significant
Marietta Kaszkin-Bettag, PhD, is professor of Pharmacology,
Toxicology, and Phytotherapy, University of Frankfurt Medical
School, Germany (mkbrhubarb@yahoo.de). Sabine Beck, PhD,
is a medical writer, Ilona Hasper, MD, is a medical writer, and
Peter W. Heger is director, all at Health Research Services Ltd,
St Leon-Rot, Germany. Boris M. Ventskovskiy, MD, PhD, is
chair of obstetrics and gynecology N1 and Sergey Solskyy, MD,
PhD, is chair of obstetrics and gynecology N2 at National
Medical University A.A. Bogomolets, Kiev, Ukraine. Andrei
Kravchenko, MD, PhD, is head of office at Health Research
Services Ltd, Kiev, Ukraine. Reinhard Rettenberger, PhD, is
director of Chemisch-Pharmazeutische Fabrik Göppingen, Carl
Müller, Apotheker, GmbH & Co KG, Göppingen, Germany.
Andy Richardson, PhD, is director of Health Research Services
Ltd, Hungerford, Berkshire, UK.
Corresponding author: Peter W. Heger, peter.heger@h-r-s.biz.
he conventional therapy for the relief of moderate to
T severe menopausal symptoms is hormone therapy
(HT). In March 2007, the North American Menopause
Society (NAMS) recommended HT as the preferred
therapy but with the caveat that it should be weighed
carefully against the potential risk of breast cancer and thromboem-
24 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD, PhD PhD MD
reduction of the MRS total score from 27.0 ± 4.7 points to 12.4
± 5.3 points when compared to the placebo-induced decrease
from 27.0 ± 5.3 points to 24.0 ± 6.2 points (P<.0001). A signifi-
cant reduction in each individual MRS item score, in hot
flushes and the hot flush weekly weighted score, together with
a marked improvement in treatment outcome were also
observed (P<.0001). These results confirm the efficacy of ERr
731 in alleviating menopausal symptoms in perimenopausal
women. Fourteen adverse events were reported in total: 11 by 5
women receiving ERr 731 and 3 by 3 women receiving placebo.
ERr 731 was well tolerated by the majority of the women.
Conclusion • ERr 731 was confirmed to be effective for the
treatment of menopausal symptoms in perimenopause. (Altern
Ther Health Med. 2009;15(1):24-34.)
bolism.1 A recent comment on the NAMS statement recommended
that postmenopausal HT should be used only for bothersome
symptoms, using the lowest effective HT dose for the shortest possi-
ble time and should not be used to prevent disease (eg, osteoporo-
sis).2 Lower HT doses or even ultra-low doses appear to be better
tolerated than standard doses and may have a better safety profile.3,4
The risks of the long-term use of low-dose HT over extended peri-
ods (ie, several years), however, has not been clarified. The European
Medicines Agency (EMEA) guidance for HT recommends the use of
HT only for the treatment of menopausal symptoms in postmeno-
pausal women,5 and the risks of breast cancer, coronary heart dis-
ease, stroke, and thromboembolism in perimenopausal women
with moderate to severe menopausal symptoms taking HT have not
been established in randomized controlled trials (RCTs).
The problems with HT therefore limit the spectrum of effective
measures available for women in perimenopause suffering from
menopausal symptoms, and often their only option is to use herbal
preparations. The special extract ERr 731 from the roots of rhapon-
tic rhubarb (Rheum rhaponticum) (trade name Phytoestrol N,
rebranded since September 1, 2007, Phyto-Strol and Phyto-Strol
Loges, Chemisch-Pharmazeutische Fabrik Göppingen, Carl Müller,
Apotheker, GmbH & Co KG, Göppingen, Germany) has been used
in Germany since 1993 for the treatment of women with menopau-
sal symptoms in both perimenopause and postmenopause.6 The
extract ERr 731 contains rhaponticin, desoxyrhaponticin, and their
Efficacy of ERr 731 in Perimenopause
aglycones, rhapontigenin and desoxyrhapontigenin.6 Neither
rhapontic rhubarb nor the special extract ERr 731 contains any of
the anthraquinones such as emodin or rhein that are found in
other rhubarb species.7 Thus, this extract has no laxative effect.
The absence of anthraquinones, of which some are known to be
potent activators of estrogen receptors (ERs) and therefore may
increase the risk of unwanted side effects in the endometrium and
breast,8 supports the use of ERr 731 in menopausal women.
It is thought that part of the reduction of menopausal com-
plaints by HT is due to the replacement of estradiol levels, and this
is consistent with the known role of estrogens in the development
and functioning of the female reproductive system and their
important role in the maintenance of structure and function in
nonreproductive tissues and systems (eg, vasculature, smooth
muscle, central nervous system, immune system).9 It is also known
that some of these effects are mediated with high specificity via the
structurally and functionally different estrogen receptor-α (ERα)
and ERβ systems. A recent study with ERα- and ERβ-specific acti-
vators has shown that both ERs need to be activated to alleviate
hot flushes.10 Additionally, through the use of ERβ-deficient mice,
an involvement of this receptor subtype in the etiology of anxiety
and depression has been demonstrated.11 Most importantly, ERβ
seems to act as a negative regulator of ERα and, where the recep-
tors are coexpressed, protect against ERα-mediated tissue hyper-
proliferation and carcinogenesis.12-15
Recent investigations with ERr 731 and its hydroxystilbene
constituents have shown that they bind and activate the ERβ with
high specificity in a variety of cell lines.16,17 In contrast, neither ERr
731 nor its aglycones rhapontigenin and desoxyrhapontigenin nor
the structurally related compounds resveratrol and piceatannol acti-
vate the ERα in Ishikawa cells naturally expressing ERα. Similarly,
ERr 731 showed no agonist activity when tested in the HEC-1B
endometrial cancer cells transfected with ERα.16 On ERβ, the activi-
ty of ERr 731 is comparable to that of 10-8 M E2, and thus, it appears
likely that ERr 731 mediates its beneficial effects on menopausal
symptoms such as hot flushes, depression, and anxiety at least in
part via its ERβ-selective properties. Preliminary results from an
uterotrophic assay in ovariectomized rats have shown that ERr 731
up to 100 mg per kg body weight per day did not display any prolif-
erative and uterotrophic effects (submitted for publication).
In 4-week and 13-week toxicity studies in male and female
dogs with continuing intake of 100 mg, 300 mg, and 1000 mg ERr
731 per kg body weight per day, it was demonstrated that even at
the highest doses, ERr 731 (1000 mg per kg body weight per day)
did not affect viability, induce any signs of toxicity or significant
pathological changes in any organs in either male or female ani-
mals which might be related to the intake of the extract.18 Of par-
ticular importance is the observation that the uterine weight was
not changed when compared to the control animals, indicating
that ERr 731 even in these high dosages given continuously had
no uterus-stimulating effect. Also, no other abnormalities in the
genital tracts of either female or male dogs were detected macro-
scopically or microscopically. Based on the animal study reports,
the no-observed-adverse-effect-level has been determined to be
Efficacy of ERr 731 in Perimenopause
1000 mg per kg body weight per day.
The recommended therapeutic dose of ERr 731 for menopau-
sal women is 4 mg extract per day (taken as 1 tablet once daily).
This dose has been demonstrated to be effective in reducing meno-
pausal symptoms in a 12-week RCT in 109 perimenopausal
women6,19 and in a 6-month postmarketing surveillance study with
252 perimenopausal and postmenopausal women.20
In these and other long-term (48-week and 96-week) observa-
tional studies with continuous intake of ERr 731, no clinically rele-
vant changes due to ERr 731 in endometrial biopsies, bleeding,
weight, blood pressure, pulse, and laboratory parameters were
seen, whilst sustained alleviation of the menopausal symptoms
was present, and there were no adverse events associated with the
intake of the extract.21 The results have confirmed that ERr 731 is a
safe and effective alternative to HT in perimenopausal women for
the alleviation of menopause symptoms.
In order to provide confidence to physicians, consumers, and
regulatory authorities that ERr 731 is of value in alleviating the cardi-
nal menopausal complaints such as vasomotor, psychological, and
physical symptoms, the efficacy and safety of ERr 731 has been fur-
ther examined using an extended battery of symptom scores and
including additional safety parameters. These results are reported
here. The primary outcome criterion for efficacy used was the change
of the Menopause Rating Scale (MRS) total score under ERr 731
when compared with placebo after 12 weeks of treatment.
Menopausal symptoms were assessed using an international version
of the validated MRS score, with the subjects reporting their experi-
ences directly using subject diaries to record the MRS, hot flushes,
and other efficacy parameters independently of the investigators.22
METHODS
Trial Design, Participants, and Treatment
This was a 12-week, multicenter, prospective, randomized,
double-blind, parallel-group, placebo-controlled, phase III clinical
trial using a multistage adaptive-sequential design with 2 interim
analyses to compare the efficacy and safety of ERr 731 with placebo
in women with menopausal complaints in perimenopause. The
trial and the subsequent 52-week observational study were con-
ducted at 8 gynecological outpatient departments with a Russian-
speaking trial population in the Ukraine from February 2004 to
April 2007. Trial and study were conducted in accordance with the
ethical requirements of the Declaration of Helsinki, ICH GCP guide-
line, and the legal provisions of the Ukraine. Approval by the Ethics
Committee, Kiev, Ukraine, and the State Pharmacological
Committee of the Ministry of Health, Kiev, Ukraine, was obtained
in December 2003.
Inclusion and Exclusion Criteria
Inclusion criteria were (1) females aged 45 to 55 years; (2)
perimenopause defined as a break in cycle regularity during the
past 12 months or last menstruation at least 3 but no longer than
12 months ago; (3) MRS total score ≥18 points, reflecting moder-
ate to severe menopausal symptoms23; (4) capability of providing
written informed consent; (5) accessibility by telephone; and (6)
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 25
willingness and ability to comply with all procedures of the trial
and attend all scheduled contacts at the investigational site.
Exclusion criteria included abnormalities in the endometrium
and breast, presence of concomitant diseases, the concomitant use
of predefined medications, pretreatment of menopausal symptoms
with hormone therapies, semi-luxuries (alcohol, smoking, caf-
feine), and a body mass index <18kg/m2 or >30kg/m2.
Women who met all inclusion and no exclusion criteria and
gave informed consent were enrolled into the trial and allocated to
one of the treatment groups.
Trial Conduct
Baseline and all assessment parameters were recorded by the
investigator in electronic case report forms. In addition, every
woman was required to keep a diary during the course of the trial
recording her hot flushes, menstrual bleeding, MRS, and the con-
sumption of investigational medication. Other assessments
including anxiety, depression, state of health, and quality of life
also were recorded (not reported here; they will be the subject of a
separate publication).
Subjects visited the investigator on days 28, 56, and 84, where
the clinical status was checked, the diary reviewed, and blood and
urine samples taken for laboratory analyses. The intake of investi-
gational medication was also documented, as were any changes in
concomitant medications and the appearance of any adverse
events (AEs).
On day 84 (and also in the case of premature withdrawal
from the trial), each participant underwent a final investigation
including determination of laboratory blood and urine parame-
ters, a tobacco test, a clinical breast examination, breast tender-
ness assessment, mammography, PAP and vaginal smears, a
transvaginal ultrasound examination, a pelvic examination, and
endometrial biopsy. Women were free to discontinue their partici-
pation in the trial at any time without any prejudice to their fur-
ther treatment. In contrast to a previous RCT,6 the protocol for the
present trial did not permit nonresponders to withdraw from the
trial or cross over to open active treatment during the 12-week
period of the double-blind phase due to lack of efficacy of the
investigational medication.
Investigational Medication
The investigational medication was administered as enteric
coated tablets (400 mg) containing 4 mg Rheum rhaponticum dry
extract as the only active ingredient (drug:extract ratio 16-26:1,
extraction solvent calciumoxide:water, 1:38 [m/m]). Placebo was
matched to a formulation of ERr 731 with regard to color, smell
and taste, and viscosity. The medication was manufactured by
Chemisch-Pharmazeutische Fabrik Göppingen, Carl Müller,
Apotheker, GmbH & Co KG, Göppingen, Germany. On day 0, day
28, and day 56, women received 30 enteric coated tablets of either
ERr 731 or placebo over a maximum time period of 12 weeks,
according to their treatment group. Tablet intake started on day 1.
Participants documented the consumption of investigational med-
ication every day in their diaries.
26 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
Outcome Criteria
Primary outcome criterion for the efficacy of ERr 731 com-
pared to placebo was the change of the MRS total score from day 0
to day 84:
ΔMRSday 84 = MRSday 0 – MRSday 84.
The Menopause Rating Scale (MRS) consists of 11 symptoms
typically associated with the menopausal transition.22 The individ-
ual MRS items recorded were (1) hot flushes, sweating; (2) heart
complaints; (3) sleep problems; (4) depressive mood; (5) irritabili-
ty; (6) anxiety; (7) physical and mental exhaustion; (8) sexual prob-
lems; (9) bladder problems; (10) vaginal dryness; and (11) joint
and muscular discomfort.
These items were further categorized for analysis as “psycho-
logical,” “somatic,” and “urogenital.” Subscales were calculated
from the following item groups23:
• Psychological subscale: symptoms number 4, 5, 6, and 7;
• Somatic subscale: symptoms number 1, 2, 3, and 11; and
• Urogenital subscale: symptoms number 8, 9, and 10.
The MRS was recorded by both the investigators (in the
eCRFs at each visit on day 0, day 28, day 56, day 84) and by the trial
subjects in their diaries every week, using the following rating
scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe. The
value of the total MRS score is between 0 and 44 points, with lower
scores indicative of less severe menopausal symptoms.
Secondary outcome criteria used to determine efficacy were
(1) the individual symptoms of the MRS, (2) the number and
severity of hot flushes, (3) the Hot Flush Weekly Weighted Score
(HFWWS), (4) the time until onset of treatment effect, and (5)
treatment outcome according to Integrative Medicine Outcomes
Scale (IMOS).24
The HFWWS was calculated from the daily assessment of the
number and severity of hot flushes during the last week as follows:
total number of slight hot flushes per week multiplied by 1, plus
total number of moderate hot flushes per week multiplied by 2,
plus total number of severe hot flushes per week multiplied by 3.25
Outcome criteria for safety were endometrial biopsy findings,
transvaginal ultrasound, PAP smear, vaginal smear, mammography,
breast tenderness, vital parameters, tolerability of investigational
medication, adverse events, and laboratory safety parameters.
Response Criteria
The following 3 response criteria were used to determine
which subjects had responded to treatment:
1. MRS total score < 24 points by the end of the trial (day 84);
2. Decrease of ≥10 points in MRS total score from baseline
(day 0) to the end of the trial (day 84); and
3. Women fulfilling criterion number 1 and criterion number 2.
Trial Objective
This was a confirmatory trial to prove the superiority of ERr 731
when compared to placebo as determined using the primary outcome
variable “change of the MRS from day 0 to day 84 (ΔMRSday 84 =
MRSday 0 – MRSday 84).” For women who discontinued the trial, the
Efficacy of ERr 731 in Perimenopause
clinical findings at the time of discontinuation were used for the groups was performed using a 2-factorial analysis of covariance
analysis of the primary outcome variable using the last observation with the 2 factors treatment and study site, and the baseline value
carried forward (LOCF) method. as covariate. Study sites with less than 6 women (4 of 7 study sites)
The null hypothesis was as follows: were pooled. Descriptive statistical methods were used to analyze
H0: Decrease of the MRS in the ERr 731 group is less than or baseline, secondary efficacy, and safety variables. Explorative P val-
equal to the decrease in the placebo group. ues were calculated for the comparison of ERr 731 with placebo on
The alternative hypothesis was as follows: day 0 and day 84 (LOCF) using the 2-sample t-test. The data are pre-
H1: Decrease of the MRS in the ERr 731 group is larger than sented as mean and standard deviation (SD) and [median] if not
the decrease in the placebo group. otherwise indicated.

Statistical Methods RESULTS

The trial was conducted according to a 3-stage group sequen-
tial design with adaptive sample size adjustments at the 2 interim
analyses.26 The adjusted 1-sided significance limits for the first, sec-
ond, and third stages were αi=0.00026, 0.00710, and 0.02253 (i=1,
2, 3) with the corresponding critical values 3.471, 2.454, and 2.004
and the information rates 0.333, 0.667, and 1, respectively.
The statistical evaluation was performed using the statistical
software package SAS (release SAS 9.1.3, SAS Institute Inc, Cary,
North Carolina). The primary efficacy comparison of the treatment
Baseline Characteristics
In this trial, 171 women were screened for participation;
112 women were enrolled in the trial at 7 of 8 investigational sites (1
site failed to recruit any trial subjects). All enrolled trial subjects
were randomized to treatment with ERr 731 (56 women) or placebo
(56 women). All women in the ERr 731 and the placebo group were
included in the intention-to-treat (ITT) analysis (Figure 1). Three
(5.4%) women in the ERr 731 group and 2 (3.6%) women in the pla-
cebo group were excluded from the per-protocol (PP) analysis due

Screened (N=171) Screening failures (n=59)

• inclusion criteria not met/
exclusion criteria present
• other reasons
Randomized (n=112)

Allocated to ERr731 (n=56) Allocated to placebo (n=56)

• received ERr731 as randomized (n=56) • received placebo as randomized (n=56)

Trial termination/withdrawal (n=9) Trial termination/withdrawal (n=10)

• Adverse events (n=1) • Adverse events (n=1)
• Noncompliance (n=5) • Noncompliance (n=7)
• Other reasons and noncompliance (n=1) Follow-up on Follow-up on • Other reasons and noncompliance (n=1)
• Withdrawal of informed consent (n=1) • Day 28 (n=56) • Day 28 (n=55) • Violation of inclusion/exclusion criteria (n=1)
• Noncompliance and withdrawal of • Day 56 (n=55) • Day 56 (n=54)
informed consent (n=1)

Termination as planned Termination as planned

at FAI (n=47)* at FAI (n=46)*

ITT analysis: n=56 ITT analysis: n=56

Excluded Excluded
• no regular intake of medication (n=3) • no regular intake of medication (n=2)

PP analysis: n=53 PP analysis: n=54

FIGURE 1 Participant Flow Chart
Individuals may have discontinued for more than one reason. For these trial subjects, all examinations and assessments were available at the Final Assessment I (FA I). Eighty-
nine women who terminated the double-blind phase of the trial entered into a 52-week observational study with ERr 731. ITT indicates intention to treat.

Efficacy of ERr 731 in Perimenopause ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 27
to major protocol deviations. All planned examinations and assess- cological diseases and surgeries were distributed similarly among
ments were available for 93 of 112 women at the end of the double- the treatment groups (Table 1). The most frequently reported dis-
blind trial (FA I, Figure 1). eases and surgeries were salpingitis, uterine leiomyoma, and cer-
None of the baseline characteristics differed markedly vical diathermy.
between the treatment groups (Table 1). All women were peri-
menopausal when included in the trial, with their serum hormone Duration of Treatment
levels showing large variations as expected during perimeno- The duration of treatment was comparable between the 2 treat-
pause. All women reported menstrual cycle irregularities during ment groups (ERr 731: 81.5 ± 9.7 [84.0] days, placebo 81.3 ±
the previous 12 months. The time since last menstrual bleeding 12.4 [84.0] days).
was slightly longer in the ERr 731 group (4.1 ± 3.6 [3.0] months)
than in the placebo group (3.6 ± 3.5 [2.0] months). Previous gyne- Primary Outcome Criterion
At baseline (day 0), the MRS total score was 27.0 ± 4.7 [26.0]
TABLE 1 Demographic Data and Gynecological Findings at Screening* points in the ERr 731 group (n=56) and 27.0 ± 5.3 [26.0] points in
ERr 731 Placebo the placebo group (n=56) (not significant, P=1.00, 2-sided t-test).
Screening (n=56) (n=56) From baseline to day 84 (LOCF), the MRS total score decreased
Age, yrs
by -14.6 ± 5.1 [-15.0] points in the ERr 731 group (n=56) and -2.9 ±
(mean ± SD [median]) 49.4 ± 3.6 [49.0] 49.6 ± 3.0 [49.0] 4.3 [-2.0] points in the placebo group (n=56). The difference in the
Height, cm MRS total score between the 2 treatment groups on day 84 was high-
(mean ± SD [median]) 163.7 ± 5.3 [164.0] 164.0 ± 5.5 [165.0] ly significant (P<.0001; 95% confidence interval [-13.8 to -9.5],
Weight, kg LOCF). The results from the PP analysis were consistent with the ITT
(mean ± SD [median]) 68.9 ± 9.3 [70.0] 71.3 ± 8.9 [72.0] analysis (data not shown). Figure 2 shows the change in the MRS
Body mass index, kg/m2 total score in the ERr 731 group compared with the placebo group
(mean ± SD [median]) 25.7 ± 3.2 [26.0] 26.4 ± 2.7 [27.5] from day 0 to day 84 for those trial subjects for whom MRS assess-
Serum hormone levels ments were available on day 84 (n=105, no LOCF).
(mean ± SD [median])
17β-Estradiol, ng/L 110.3 ± 127.9 [49.4] 138.6 ± 159.2 [76.0] Response Criteria
FSH, IU/L 44.5 ± 36.7 [42.5] 36.2 ± 32.6 [19.3] Using the response criteria defined earlier, the number of
Polymenorrhea, n (%) 6 (10.7) 8 (14.3) responders in the ERr 731 group (n=56, LOCF) was higher than in
Oligomenorrhea, n (%) 20 (35.7) 23 (41.1) the placebo group (n=56, LOCF) in each category:
Amenorrhea, n (%) 30 (53.6) 25 (44.6) • response criterion 1: 54 (96.4%) women with ERr 731 vs 27
Intermenstrual bleeding, n (%) (48.2%) women with placebo;
yes 0 (0) 1 (1.8) • response criterion 2: 47 (83.9%) women with ERr 731 vs 2
no 56 (100.0) 55 (98.2) (3.6%) women with placebo; and
Spotting, n (%) 44
yes 0 (0) 1 (1.8)
40
no 56 (100.0) 55 (98.2)
Dysmenorrhea, n (%) 36
yes 6 (10.7) 7 (12.5) 32
n=56
MRS Points

no 50 (89.3) 49 (87.5) 28 n=55 n=54 n=53

Complications concerning 24 n=56
pregnancies, births, or
20
abortions, n (%) *
16 n=56
yes 25 (44.6) 20 (35.7)
no 31 (55.4) 36 (64.3) 12 **
n=55
Previous gynecological 8 **
ERr731 n=52
diseases and surgeries, n (%) 4 Placebo
yes 38 (67.9) 39 (69.6) 0
no 18 (32.1) 17 (30.4) 0 28 56 84
Pretreatment of menopaus- Days
al symptoms (during the FIGURE 2 Change in the MRS Total Score
past 6 months), n (%) Presented is the decrease in the Menopause Rating Scale (MRS) total score from
yes 1 (1.8) 1 (1.8) baseline to the third follow-up contact on day 84. The number of trial subjects, for
no 55 (98.2) 55 (98.2) whom MRS assessments in the electronic case report forms were available, is
indicated for each time point. The significances were calculated for the differences
*Intention-to-treat population (N=112); FSH indicates follicle-stimulating hormone. between the treatment groups: *P<.001, **P<.0001.

28 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Efficacy of ERr 731 in Perimenopause
 • response criterion 3: 46 (82.1%) women with ERr 731 vs 2
(3.6%) women with placebo.
Diary-reported MRS
The diary-reported MRS total score in the ERr 731 group
decreased continuously over the 84-day period, whereas the scores in
the placebo group displayed a small decrease during the first week
and then remained constant. This decrease (a mean of -2.4 points)
was observed over the first week; scores then remained generally
constant but returned to their original value before the next follow-
up contact. This pattern was repeated over the next assessment peri-
ods (decreases of -1.5 points after day 28, -1.3 points after day 56,
respectively [Figure 3]). The treatment success reported by the
women in their diaries was consistent with that reported by the phy-
sicians at the follow-up contacts (Figure 2).
At the end of the RCT, the severity of the menopausal symp-
toms was significantly different in the 2 groups. The majority of the
ERr 731 women reported to have no/mild (0-8 points) or moderate
(9-16 points) symptoms on Day 84, while more than 80% of the pla-
cebo women still had severe (>17 points) symptoms (Figure 3).
Individual Symptoms of MRS
Analysis of the individual MRS symptoms showed that the
majority of women in both treatment groups had moderate to very
severe symptoms at baseline (Table 2). After 12 weeks, ERr 731 was
effective in reducing symptoms, whereas the placebo group contin-
ued to report high incidences of each symptom. The difference
between the groups on day 84 is highly significant for all MRS items.
The analysis of the combined MRS items into the “psychologi-
cal,” “somatic,” and “urogenital” subgroups showed that ERr 731

MRS Total Score

44 100
Severe > 17
MRS Points (Mean ± 95% CI)

40
36 Moderate 9-16
1. FU 2. FU 80 Mild 5-8
32 FA I
Subjects (%)
No/little 0-4
28
60
24
20
16 40
12 ERr731
8 Placebo 20
4
0 0
0 7 14 21 28 35 42 49 56 63 70 77 84 Day 0 Day 84 Day 0 Day 84
Days
ERr 731 Placebo
FIGURE 3 Change in the MRS Total Score as Assessed by the Women in Diary I
The Menopause Rating Scale (MRS) total score was assessed weekly by the women in diary I. Presented is the change from baseline to the third follow-up contact on day 84. The
arrows indicate the time point of the scheduled visits of the women at their gynecological centers on day 28, day 56, and day 84. FU indicates follow-up contact; FA I, final assessment I.

TABLE 2 Changes in the Individual Menopause Rating Scale (MRS) Items*

ERr 731 Placebo
(n=56) (n=56)
MRS Item mean ± SD [median] mean ± SD [median]
Day 0 Day 84 Δ Day 0 to Day 84 Day 0 Day 84 Δ Day 0 to Day 84
1. Hot flushes/sweating‡ 2.8 ± 0.9 [3.0] 1.0 ± 0.7 [1.0] -1.7 ± 0.8 [-2.0] 2.9 ± 0.8 [3.0] 2.5 ± 1.1 [3.0] -0.4 ± 0.9 [0.0]
2. Heart complaints‡ 2.3 ± 0.9 [2.0] 1.2 ± 0.9 [1.0] -1.1 ± 0.9 [-1.0] 2.4 ± 0.9 [2.0] 2.2 ± 0.9 [2.0] -0.2 ± 0.9 [0.0]
3. Sleep problems‡ 2.5 ± 1.1 [3.0] 1.0 ± 0.8 [1.0] -1.5 ± 0.9 [-2.0] 2.4 ± 1.0 [2.0] 2.1 ± 0.8 [2.0] -0.4 ± 0.9 [0.0]
4. Depressive mood‡ 2.5 ± 1.1 [3.0] 0.8 ± 0.9 [1.0] -1.8 ± 1.2 [-2.0] 2.7 ± 0.8 [3.0] 2.1 ± 0.8 [2.0] -0.5 ± 0.7 [0.0]
5. Irritability‡ 2.7 ± 0.8 [3.0] 1.1 ± 0.7 [1.0] -1.6 ± 1.1 [-2.0] 2.9 ± 0.8 [3.0] 2.2 ± 0.7 [2.0] -0.6 ± 0.8 [-1.0]
6. Anxiety‡ 2.7 ± 1.0 [3.0] 1.1 ± 0.7 [1.0] -1.6 ± 1.0 [-2.0] 2.7 ± 0.9 [3.0] 2.3 ± 0.9 [2.0] -0.4 ± 0.9 [0.0]
7. Physical and mental exhaustion‡ 2.7 ± 0.9 [3.0] 1.4 ± 0.6 [1.0] -1.3 ± 0.9 [-1.0] 2.6 ± 0.9 [3.0] 2.5 ± 0.9 [3.0] -0.1 ± 0.7 [0.0]
8. Sexual problems‡ 2.4 ± 0.9 [2.0] 1.5 ± 0.7 [1.5] -0.9 ± 1.0 [-1.0] 2.4 ± 1.0 [2.0] 2.3 ± 1.1 [2.0] -0.1 ± 0.7 [0.0]
9. Bladder problems‡ 1.9 ± 1.1 [2.0] 0.9 ± 0.8 [1.0] -1.0 ± 0.9 [-1.0] 1.9 ± 1.0 [2.0] 1.7 ± 1.0 [2.0] -0.2 ± 0.8 [0.0]
10. Vaginal dryness† 1.8 ± 1.2 [2.0] 1.1 ± 0.7 [1.0] -0.7 ± 1.1 [-0.5] 1.7 ± 0.7 [2.0] 1.6 ± 0.8 [2.0] -0.1 ± 0.6 [0.0]
11. Joint and muscular discomfort‡ 2.8 ± 0.9 [3.0] 1.5 ± 0.9 [1.0] -1.3 ± 1.1 [-1.0] 2.5 ± 0.8 [3.0] 2.6 ± 0.8 [3.0] 0.1 ± 0.6 [0.0]
*Intention-to-treat population (n=112). The significances were calculated for the difference between both treatment groups on Day 84: †P<.001, ‡P<.0001 (t-test,
2-sided, last observation carried forward).

Efficacy of ERr 731 in Perimenopause ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 29
 14 ERr 731 14 Placebo
12 Day 0 12 Day 0
Day 84 Day 84
10 10
MRS Points

MRS Points
8 8

6 6

4 4

2 2

0 0
Psychological Somatic Urogenital Psychological Somatic Urogenital
MRS Subscales MRS Subscales
FIGURE 4 Decrease of the MRS Subscales
Presented is the decrease of the Menopause Rating Scale (MRS) subscales “psychological,” “somatic,” and “urogenital” with ERr 731 compared to placebo from baseline to
the third follow-up contact on day 84.

was most effective in reducing symptoms in the “psychological”
and “somatic” subscales (Figure 4).
Hot Flushes
On entry to the study, all women were experiencing an aver-
age of 12 hot flushes per day (Figure 5), and there was no differ-
ence between the treatment groups (ERr 731: 11.4 ± 5.8 [12.0] hot
flushes, placebo: 12.1 ± 6.0 [12.0] hot flushes, Table 3).
By day 84, a significant reduction in the number of hot flush-
es was observed in women in the ERr 731 group when compared
to placebo (Figure 5). Moderate and severe hot flushes decreased
to a larger extent with ERr 731 than with placebo (Table 3). One
woman did report an increase in hot flushes following ERr 731
intake, but on average, women taking ERr 731 were experiencing
2.8 ± 2.8 [2.0] hot flushes per day after 12 weeks.
ERr 731
35
Total Number of Hot Flushes per Day
In contrast, women in the placebo group experienced vari-
able changes in hot flushes: some reduction, some not changing,
and some deterioration (Figure 5). By 12 weeks, the women in the
placebo group still had an average of 11.4 ± 6.8 [13.0] hot flushes
per day, most of them being moderate to severe (Table 3).
On entry to the trial, women had an average of 84 hot flush-
es per week, with most of the trial subjects reporting >60 moder-
ate to severe hot flushes in this period. Thus, the HFWWS on
entry was 121.83 ± 75.9 [120.5] points in the ERr 731 group and
144.96 ± 81.6 [158.0] points in the placebo group. The difference
between the groups is not significant (P=.13, 2-sided t-test).
In the ERr 731 group, the HFWWS decreased to 23.9 ± 27.5
[13.0] points from day 1 to day 84, but it remained high in the
placebo group (137.6 ± 95.9 [147.0] points, LOCF). The 95% CI
for the differences in HFWWS between the 2 treatment groups
(ERr 731 minus placebo) on day 84 (LOCF) was calculated as
Placebo [-140.3 to -87.0] (P<.0001, 2-sided t-test).
35

30 30 Treatment Outcome
25 25 On day 84 (LOCF), 44 (78.6%) women in the ERr 731 group
but only 2 (3.6%) women in the placebo group reported a major
20 20
improvement. Ten (17.9%) women in the ERr 731 group and
15 15 5 (8.9%) women in the placebo group reported slight to moderate
10 10 improvement, and the majority of women in the placebo group
(47 of 56 [83.9%]) reported no change. In the ERr 731 group, 2 of
5 5
56 (3.6%) women reported no change following treatment. One
0 0 woman in the placebo group (1.8%) and no women from the ERr
731 group reported a deterioration of their condition. The investi-
Day 0 Day 84 Day 0 Day 84 gator-reported changes of treatment outcome confirmed the rat-
Hot flushes [mean] ings given by the women themselves (data not shown).

FIGURE 5 Change in the Total Number of Hot Flushes Adverse Events

The total number of hot flushes during the last 24 hours on day 0 and day 84 was
plotted for each individual patient in the ERr 731group (n=46) and the placebo
group (n=43) of the double-blind trial ERr 004-DB. The thick lines represent the
change in the mean values of hot flushes per day from day 0 to day 84.
Fourteen adverse events and no serious AEs were reported
during the study. Eleven AEs were reported by women in the ERr
731 group (all assessed as “moderate”) and 3 by women in the pla-
cebo group (2 mild and 1 moderate, Table 4). Three AEs in the ERr

30 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Efficacy of ERr 731 in Perimenopause
 TABLE 3 Decrease in the Number and Severity of Hot Flushes from Day 0 to Day 84*
Number and ERr 731 Placebo
Severity mean ± SD [median] mean ± SD [median]
of Hot Flushes
Day 0 n† Day 84 n† ∆ Day 0 to Day 84 Day 0 n† Day 84 n† ∆ Day 0 to Day 84

Total 11.4 ± 5.8 53 2.8 ± 2.8 48 -9.3 ± 5.2 12.1 ± 6.0 50 11.4 ± 6.8 49 -0.7 ± 4.6
[12.0] [2.0] [-9.0] [12.0] [13.0] [-1.0]
Mild 5.4 ± 2.3 49 2.5 ± 2.1 44 -2.8 ± 2.8 5.3 ± 2.6 47 4.8 ± 3.0 48 -0.3 ± 2.6
[5.0] [2.0] [-2.5] [5.0] [5.0] [0.0]
Moderate 4.3 ± 1.7 48 0.7 ± 1.2 27 -3.8 ± 1.8 4.7 ± 2.6 47 4.6 ± 4.4 45 -0.2 ± 3.2
[4.0] [0.0] [-4.0] [5.0] [4.0] [0.0]
Severe 4.3 ± 1.7 32 0.4 ± 0.8 7 -5.2 ± 1.1 4.3 ± 1.1 32 3.5 ± 2.2 35 -0.3 ± 2.2
[4.5] [0.0] [-5.0] [5.0] [3.0] [0.0]

*Intention-to-treat population (N=112).

†Number of women who reported their hot flushes in their diaries.

731 group (vertigo, asthenia, and headache) were assessed as hav-
ing a possible causal relationship to the intake of ERr 731. These
AEs all occurred in the same woman and were reported 6 weeks
after starting intake of ERr 731. They disappeared the day after the
woman discontinued the intake of ERr 731. All other reported AEs
were assessed as not being related to the study medication. None
of the AEs in women in the ERr 731 group were associated with
gynecological organs or tissues.
Liver and Hematology Parameters
Serum levels for liver and hematology parameters were
measured at baseline and again at the end of the trial. The
majority of women in both treatment groups had liver enzyme
serum levels within the normal range, and no differences in
these parameters between the groups were seen. Values outside
the normal range were assessed by the investigators as not being
clinically relevant (Table 5). No clinically relevant deviations
from the normal range were observed for the hematological
parameters (data not shown).
The results of endometrial biopsies, mammography, vaginal
cytology, and other safety parameters will be reported separately,
together with the results of the open observational study with
ERr 731 intake for 52 weeks that followed this study (results cur-
rently being analyzed).

TABLE 4 Details on Adverse Events*

Adverse Events (AEs) ERr 731 (n=56) Placebo (n=56)
per Subject 5 women with AEs 3 women with AEs
n Intensity Relation to study medication (cause) n Intensity Relation to study medication (cause)

Vertigo Moderate No (other known cause)

Headache Moderate No (other known cause)
Depression 1 Moderate No (other known cause)
Sleep disorder Moderate No (other known cause)
Asthenia Moderate Possibile
Vertigo 1 Moderate Possibile
Headache Moderate Possible
Pneumonia (chlamydial) 1 Moderate No (concomitant illness)
Respiratory tract infection (viral) 1 Moderate No (unknown)
Hypoaesthesia Moderate No (other known cause)
Sleep disorder 1 Moderate No (other known cause)
Facial swelling 1 Mild No (unknown)
Increase in blood pressure 1 Moderate No (unknown)
Endometrial polyp 1 Mild Unlikely

*Safety population n=112, “no” indicates no causal relationship to the investigational medication.

Efficacy of ERr 731 in Perimenopause ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 31
 TABLE 5 Liver Parameters*
Parameter ERr 731 Placebo
mean ± SD [median] mean ± SD [median]

Day 0 Day 84 Δ Day 84 to Day 0 Day 0 Day 84 Δ Day 84 to Day 0

ALT [IU/L] 21.8 ± 16.2 [16.7] 24.4 ± 25.1 [14.9] 1.9 ± 19.6 [-1.2] 17.6 ± 6.8 [16.4] 19.7 ± 7.6 [19.4] 1.7 ± 6.3 [2.0]
n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
AST [IU/L] 21.9 ± 13.3 [18.2] 23.1 ± 14.0 [19.8] 0.7 ± 9.0 [0.5] 20.1 ± 4.1 [19.8] 21.9 ± 6.3 [21.4] 1.6 ± 5.8 [-0.1]
n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
γ-GT [IU/L] 25.1 ± 28.5 [16.6] 30.8 ± 40.5 [18.9] 4.6 ± 29.7 [0.7] 20.6 ± 11.0 [17.6] 23.9 ± 17.7 [18.8] 3.1 ± 14.0 [0.3]
n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
Total bilirubin 0.58 ± 0.23 [0.53] 0.67 ± 0.63 [0.56] 0.10 ± 0.62 [0.02] 0.51 ± 0.20 [0.49] 0.55 ± 0.23 [0.54] 0.04 ± 0.24 [0.00]
[mg/dL] n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
Direct bilirubin 0.11 ± 0.07 [0.11] 0.14 ± 0.06 [0.13] 0.03 ± 0.07 [0.02] 0.11 ± 0.07 [0.11] 0.13 ± 0.09 [0.13] 0.02 ± 0.10 [0.00]
[mg/dL] n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
Indirect bilirubin 0.47 ± 0.19 [0.42] 0.46 ± 0.17 [0.44] -0.00 ± 0.22 [-0.01] 0.40 ± 0.17 [0.38] 0.43 ± 0.18 [0.44] 0.03 ± 0.21 [0.00]
[mg/dL] n = 56 n = 50 n = 50 n = 55 n = 52 n = 52
*Intention-to-treat population (N=112). Indicated is the number of trial subjects for which blood samples were taken on day 84. AST indicates aspartate aminotrans-
ferase; ALT, alanine aminotransferase; γ-GT, γ-glutamyltransferase.

Tolerability MRS items) had decreased significantly from day 1 to day 84 in

The medication was well tolerated by the majority of women
from both treatment groups. On Day 84 (LOCF), tolerability was
reported to be “very good” in 25 (44.6%) and “good” in 28 (50%)
women in the ERr 731 group, compared to 11 (19.6%) and 44
(78.6%) women, respectively, in the placebo group. In the ERr
731 group, 2 (3.6%) women assessed the tolerability as “moder-
ate” and 1 (1.8%) woman as “bad.”
DISCUSSION
The study was undertaken to confirm the superiority of ERr
731 when compared to placebo for the treatment of menopausal
symptoms using a clinical trial design that repeated and strength-
ened the results of previous studies.6,19 The data obtained has
confirmed these results and the experience of practitioners over
many years recommending ERr 731 for the treatment of meno-
pausal symptoms.
The trial included only those perimenopausal women with
an MRS total score of ≥18 points (≥17 is indicative of moderate
to severe menopausal symptoms22) and thus, with a mean MRS
total score of 27.0 ± 5.0 points at baseline, all the women were
experiencing moderate to severe menopausal symptoms on
entry. This population was selected to introduce sufficient power
in the trial design to be able to (1) clearly detect any differences
between the ERr 731 and placebo groups, (2) to examine the
effects on the individual as well as the total MRS item scores, and
(3) to investigate the effects of ERr 731 compared to placebo on
hot flushes and the HFWWS as a predictor of treatment success.
The effectiveness of ERr 731 in reducing both the frequency
and severity of menopausal symptoms was confirmed by all mea-
sures studied. The MRS total score (which provides a better over-
all measure of well-being in these women than the individual
the ERr 731 group, unlike the placebo group. The difference in
scores at this time (ERr 731 minus placebo) was also highly sig-
nificant, confirming the superiority of ERr 731 in alleviating
menopausal symptoms.
These results also support the use of the total MRS score for
comparing menopausal symptoms between perimenopausal
and/or postmenopausal women, as this scale dampens the large
variations seen in the individual parameters between individual
women. This is perhaps not unexpected, since perimenopausal
women are known to experience strong fluctuations in their
endogenous estradiol and follicle-stimulating hormone (FSH)
levels, and thus, hot flushes and other individual menopausal
symptoms may undergo significant swings during these changes,
unlike in postmenopausal women, where the hormonal fluctua-
tions are less pronounced.
This may also explain in part the statistically weak placebo
effects observed in the current study, despite the fact that indi-
vidual placebo subjects experienced reductions, increases, or no
change in their MRS scores (Figure 5). It is also likely that the
severity of the symptoms (~84 hot flushes per week, of which up
to 70% were classified as moderate or severe) would contribute to
a lack of placebo effect, since this group of women are clearly
experiencing predominately physiologically induced symptoms.
This is in contrast to other trials reporting placebo effects where
much lower baseline levels are reported (eg, 50 moderate to
severe hot flushes per week3; 21 to ≥42 per week27-29).
The MRS subscales provide a valuable insight into the pri-
mary reasons for these improvements with ERr 731. The effec-
tiveness of ERr 731 on vasomotor and psychological symptoms
was already reported in the first published clinical trial6,19 and is
confirmed here. This study also collected data using different

32 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Efficacy of ERr 731 in Perimenopause
assessment scales for quality of life, anxiety, and depression, and
the preliminary results from these instruments also support the
effectiveness of ERr 731 in reducing psychological and vasomo-
tor symptoms (manuscript in preparation). It is also clear that
similar effects are present in some individual MRS scores.
Hot flushes are significantly decreased, both in frequency
and severity, by ERr 731.
After 12 weeks’ treatment, women taking ERr 731 had on
average 2.8 hot flushes per day, compared to 11.4 hot flushes per
day in the placebo group. The reduction in frequency was pro-
portional to the baseline frequency: women with a higher num-
ber of hot flushes (≥10 per day) experienced a more pronounced
alleviation of symptoms than women with less than 10 hot flush-
es per day. In contrast, several women in the placebo group with
baseline frequencies of ≥10 hot flushes per day reported increases
in the number of hot flushes over the course of the study. This
group displayed many different individual trends, however, as
shown by the individual hot flush records in Figure 5. These
results are similar to those observed in a previous study, where it
also was reported that moderate to severe hot flushes did not
change significantly following a 12-week intake of placebo.6
Similar results are also seen from the calculation of the
HFWWS. Whereas the placebo group continued to have scores
of about 135 points over the 12-week trial period, the scores for
the ERr 731 treated group decreased to about 25 points, due pre-
dominately to the reduction in severe hot flushes because the
HFWWS is more sensitive to changes in severe hot flushes.
The HFWWS has been used successfully to assess the effica-
cy of HT products and also a black cohosh extract.25,30 This offers
the possibility to compare the efficacy of ERr 731 seen here with
that of HT from other trials. For example, a recent RCT investi-
gating the effect of ultra-low-dose oral hormone therapy in post-
menopausal women reported a decrease of the mean HFWWS to
35.8 points in the group receiving 0.5 mg 17β-estradiol plus 0.1
mg norethisterone acetate (NETA) and to 26.6 points in the
group receiving 0.5 mg 17β-estradiol plus 0.25 mg NETA after 12
weeks.3 These values are similar to those reported here for ERr
731 and suggest that ERr 731 may be an effective alternative to
ultra-low-dose HT, particularly in perimenopausal women for
whom HT is not recommended.
No gynecological AEs were reported in this RCT in any
women taking ERr 731, and all of the reported AEs were classified
as mild or moderate. These results are similar to those reported
for ERr 731 previously.6 Three AEs (all experienced by the same
woman) were considered to have been possibly related to the
intake of ERr 731, but it could not be determined how the extract
may have caused these effects. The good safety profile was con-
firmed by the laboratory safety parameters that showed no chang-
es of any clinically relevance, with most values remaining within
the normal range throughout the trial. In contrast, the values of
FSH and 17β-estradiol levels displayed large individual varia-
tions, which are expected to be found in perimenopausal women
and present no safety issues. None of the participants reported
problems with tolerating the product over this study period.
Efficacy of ERr 731 in Perimenopause ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
CONCLUSION
The results of this double-blind, placebo-controlled clinical
replication trial confirm that ERr 731 is superior in efficacy when
compared to placebo for the treatment of menopausal symptoms
and is particularly effective at alleviating the vasomotor and psy-
chological symptoms of menopause.
Acknowledgments
Health Research Services Ltd, St Leon-Rot, Germany, conducted this trial on behalf of
Chemisch-Pharmazeutische Fabrik Göppingen, Carl Müller, Apotheker, GmbH & Co KG,
Göppingen, Germany. We thank Vitaly Solskyy, MD, PhD (Health Research Services Ltd, Kiev,
Ukraine), for his support in the conduct of this trial. Chemisch-Pharmazeutische Fabrik
Göppingen, Carl Müller, Apotheker, GmbH & Co KG, Göppingen, Germany, kindly provided
the supplements. Chemisch-Pharmazeutische Fabrik Göppingen neither controlled nor influ-
enced the contents of the research of this paper.
Marianne Heger passed away on August 24, 2005, before the results of her medical and scien-
tific contributions to this paper could be realized. Her fellow authors pay tribute to the leader-
ship, guidance, and enthusiasm she contributed that were critical to the successful comple-
tion of these studies.
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 Research Training Opportunity for Complementary and Alternative Medicine Practitioners

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original research
CLINICAL OBSERVATIONS AND SEVEN-AND-
ONE-HALF-YEAR FOLLOW-UP OF PATIENTS
USING AN INTEGRATIVE HOLISTIC APPROACH
FOR TREATING CHRONIC SINUSITIS
Robert S. Ivker, ; William S. Silvers, ; Robert A. Anderson,
DO
Context • Despite the widespread popularity of alternative
medical approaches to respiratory and allergic disorders, there is
a lack of scientific substantiation of their benefits.
Objective • Assessment of the therapeutic benefit of an integra-
tive holistic approach to the treatment of chronic sinusitis.
Design • Patients began a 5-month program consisting of 5 eve-
ning sessions of 2 hours each in October of 1999.
Setting • The program was held in the offices of one of the
authors (WSS).
Patients • Ten patients of an allergist-immunologist specialist
(WSS), symptomatic despite aggressive conventional treatment
for their chronic sinusitis, were recruited to participate in an
integrative holistic medical education and treatment program
consisting of 5 sessions and evaluated at a 1-year follow-up.
Sessions consisted of education in lifestyle and indoor-air modifi-
Robert S. Ivker, DO, is a clinical instructor in the Department of
Otolaryngology at the University of Colorado Health Sciences
Center, Denver, Colorado. William S. Silvers, MD, is a clinical pro-
fessor of medicine in the Division of Allergy and Immunology at the
University of Colorado Health Sciences Center and director of the
Allergy, Asthma and Immunology Clinic of Colorado in Englewood,
Colorado. Robert A. Anderson, MD, is an adjunct instructor in
family medicine at Bastyr University in Kenmore, Washington.
ccording to estimates from the 1995 National Health
A Interview Survey by the National Center for Health
Statistics and the Centers for Disease Control,1 chronic
sinusitis was America’s most common chronic condi-
tion at the time this study was conducted, from
October 1999 through March 2001. Continuing to increase in inci-
dence, chronic sinusitis afflicts about 40 000 000 people in the United
States and is the most prevalent respiratory condition in the United
States.1,2 Treatment and cure of chronic sinusitis and the prevention of
recurrences by conventional medical and surgical approaches have
met with increasingly limited success.3-5 As a result, alternative medical
approaches to chronic sinusitis as well as to many other chronic diseas-
es are increasingly popular.6-8
36 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD MD
cation, nasal hygiene, and treatment with fluconazole. Eight of 9
subjects were located and provided feedback 7 years and 6
months later, in June 2007.
Main Outcome Measures • Health-related quality of life (QOL)
was assessed using the short-form QOL survey (SF-12) and rhini-
tis QOL by the Rhinitis Quality of Life Questionnaire (RQLQ ).
Results • No significant differences emerged in the SF-12 or
mini-RQLQ scores comparing visit 2 with visit 1. Statistically
significant improvement for physical and mental subscales of the
SF-12 emerged comparing the results of visit 4 with visit 2 after
the addition of fluconazole treatment to the regimen, persisting
through an additional year of follow-up. Feedback at 7.5 years
confirmed marked long-term improvement in chronic sinusitis
symptoms compared to their pre-study condition. (Altern Ther
Health Med. 2009;15(1):36-43.)
Given the popularity of alternative medicine in today’s society,
patients in a private practice of a board certified allergist (WSS) were
surveyed to determine their interest in alternative medicine. Data from
113 returned questionnaires found that alternative medicine approach-
es had been discussed by 18% of the primary care providers or aller-
gists previously seen. Sixty-five percent of the 113 patients, however,
had wanted to discuss alternative options. Sixteen percent had seen
alternative practitioners for general health issues, and 4% for their
allergies. Ten percent of their primary care physicians regularly pre-
scribed alternative medicine approaches. Of alternative providers
mentioned, the greatest number had seen a chiropractor (36%). The
most commonly chosen alternative treatments included vitamin/min-
eral therapy (28%), deep tissue massage (19%), and herbal remedies
(19%). Patients selected alternative medicine approaches based on
advice from a friend (39%), health food store (15%), physician (14%),
magazine (8%), herbalist (6%), newspaper (1%), or other (13%).
Concomitant substantiation of the potential benefits of the
addition of alternative approaches in the management of chronic
sinusitis has been lacking. An observational study was undertaken to
assess the potential benefit of an integrative holistic medical
approach to the treatment of chronic sinusitis based on the methods
described in the book Sinus Survival,9 involving this population of
patients with established chronic sinusitis who continued to experi-
An Integrative Holistic Approach for Treating Chronic Sinusitis
ence moderate to severe symptoms despite aggressive conventional
medical and surgical treatment under the care of a board-certified
allergist-immunologist (WSS).
OBJECTIVES
Objectives of the study included (1) evaluation of the potential
independent improvement in chronic sinusitis symptoms with anti-
fungal medication as part of an integrative holistic medical approach;
(2) evaluation of changes in health-related quality of life (QOL) by the
SF-12 short form (SF-12) and the wellness self-test10; and (3) evaluation
of changes in rhinitis-related quality of life by the Full and Mini
Rhinitis Quality of Life Questionnaire short form (RQLQ).11
MATERIALS AND METHODS
This study is longitudinal with observations at the intervals
described below. A single-group design was chosen because the group
was small and consisted entirely of patients of a board-certified allergist
and clinical immunologist, with all members attending group sessions
together. This allowed the investigators to monitor and evaluate the clini-
cal status of patients for any exacerbations between group sessions.
Participants
Fifteen patients, aged 30 to 70 years with at least 2 consecutive
years of chronic sinusitis were accepted for the treatment program.
Chronic sinusitis was defined as persistent or recurrent episodes of
infection and/or inflammation of 1 or more sinus cavities producing
most or all of the following symptoms: headache, facial pain, head
congestion, purulent postnasal drainage or rhinorrhea, and fatigue.9,12
The patients were selected from the practice population of a board-
certified allergist-immunologist during patient visits over a span of 4
months, representing those most resistant to conventional treatment.
Design
Ten patients completed the program with 5 evening Sinus
Survival classes of 2 hours each at monthly intervals. There was no fee
for the classes. Five patients dropped out following visit 1 due to their
inability to commit to the treatment program. There was no further
follow-up with these patients. The book Sinus Survival9 was recom-
mended to participants. Patients were expected to implement the ther-
apeutic recommendations and lifestyle suggestions offered in the class.
All subjects kept and completed a symptom chart with weekly entries.
They also completed baseline measurements including subjective
assessment of their health status for the 2 years prior to enrollment
and at baseline using the SF-1210; patients’ subjective assessment of
sinusitis-related symptoms for 2 years prior to enrollment (RQLQ) 11;
completion of the Wellness Self Test13; completion of a Symptom
Chart9; and completion of the Candida Questionnaire and Score Sheet
created by William G. Crook, MD14 and reprinted with permission in
Sinus Survival.
Physical examination at baseline and at study completion empha-
sized the chest and upper respiratory tract. Analysis reflects data on 9
patients finishing the 1-year follow-up at visit 6, with 1 patient failing to
complete all the required data.
Patients served as their own controls based on their 2-year history
An Integrative Holistic Approach for Treating Chronic Sinusitis ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
prior to enrollment. During the study, broad-spectrum antibiotics
were prescribed for any patient with an exacerbation of acute sinusitis16
whose purulent rhinorrhea and/or purulent postnasal drainage did
not significantly diminish within 10 days of treatment with the study
protocol for acute sinusitis (see Visit 1: Nutritional and Botanical
Supplements, below). Any patient choosing to be treated with conven-
tional measures including antibiotics and corticosteroids or who
wished to be removed from the study for any reason was free to do so
at any time while continuing to receive full support and medical care of
the attending allergist-immunologist.
Outcome Measures
The study’s outcome measures were (1) evaluation of changes in
health-related quality of life (QOL) indicated by the SF-12 and (2) eval-
uation of changes indicated by the RQLQ.
Study Visits and Therapeutic Management
Visit 1 measured the outcomes of conventional treatment and
the possible diagnosis of fungal sinusitis as measured by the Candida
Questionnaire and Score Sheet, visit 2 measured the outcomes of the
integrative holistic treatment without fluconazole, and visit 3 mea-
sured the outcomes after the addition of fluconazole to the integrative
holistic program.
Visit 1: Physical and Environmental Health
All of the following were recommended at the first visit:
Modification of indoor air17
1. Negative air ion generator (Sinus Survival Air Vitalizer, Sinus
Survival, Denver, Colorado)18,19
2. Warm mist humidifier (Bionaire, Milford, Massachusetts)
with weekly cleaning instructions20
3. Air duct cleaning with Monster Vac (Glenwood Springs,
Colorado)21
Nasal hygiene program
1. Steam inhaler (Vicks Steam Inhaler, Procter & Gamble,
Cincinnati, Ohio) or other respiratory steam therapy/personal
steam inhaler22—3 times daily for 20 minutes with a medicinal
eucalyptus oil (Sinus Survival)—1 to 2 sprays every 5 minutes
2. Nasal irrigation (SinuCleanse, Med-Systems Inc, Madison,
Wisconsin)23,24,25—3 times daily following steam inhaler.
3. Botanical nasal spray with aloe vera,26 goldenseal,27 and grape-
fruit seed extract28 included (Sinus Survival Spray)—1 to 2
sprays in each nostril every 2 to 3 hours
Dietary modifications
1. Elimination of dairy products29,30,31
2. Elimination of processed sugar32
3. Elimination of fruit (sugar)
4. Elimination of alcohol33
5. Elimination of wheat products34
6. Determination of intake of filtered or bottled water, at least .5
oz daily per lb of body weight35
37
Nutritional and botanical supplements
1. Antioxidants:
a) Vitamin C36 as Ester C or polyascorbate—2000 mg 3 times
daily; for acute sinusitis, 4000 mg 3 times daily
b) Vitamin E37—400 IU twice daily
2. Multivitamin38,39—1 twice daily
3. Proanthocyanidins40 (Masquelier’s Original OPC Grape
Seed)—100 mg 3 times daily; for acute sinusitis, 200 mg 3
times daily
4. Garlic41,42—600 mg 3 times daily; for acute sinusitis, 1200 mg 3
times daily
5. Flaxseed oil43—1 tablespoon twice daily
For acute sinusitis, the following was added:
6. Echinacea44—200 mg 3 times daily for 3 weeks; omit for 1 week
then resume
7. Grapefruit seed extract28—100 mg 3 times daily
In addition to the nutritional and botanical supplements, mild
aerobic exercise was prescribed—a minimum of 3 times per week,
achieving a maximum heart rate (220 minus age times 0.6) for a dura-
tion of at least 20 minutes.45
Also at the first visit, a physical examination with special atten-
tion to eyes, ears, nose, throat, and chest was conducted.
Completing the first visit also involved the following:
1. Evaluation of the Chronic Sinusitis Questionnaire
2. Completion of starting point symptom chart
3. Scoring of the SF-12 and Wellness Self-Test
4. Completion of the RQLQ and the mini-RQLQ
5. Completion of the Candida Questionnaire and Score Sheet
Visit 2, at 5 Weeks After Visit 1
1. Symptom charts were reviewed, copied, and returned to patients
2. Progress reviewed, with discussion, questions and answers,
encouragement and reinforcement of patient commitment
3. Continuation of all visit 1 therapies
4. Completion of the SF-12 and mini-RQLQ
5. For those not experiencing any significant improvement (all
study participants did not improve, and all scored above 120
on the Candida Score Sheet, indicating “probably yeast-con-
nected”), prescription of fluconazole 200 mg daily for 5 weeks
and every other day for another 3 weeks46,47
Visit 3, at 10 Weeks After Visit 1: Mental and Emotional Health
1. Symptom charts were reviewed, copied, and returned to
patients
2. Follow-up review of progress: questions and answers, encour-
agement, and reinforcement of patient commitment
3. Continuation of all visit 1 and 2 therapies except the following:
a) Resume fruit and minimally increase complex carbohydrates
b) Reduce fluconazole 200 mg to every other day for another
3 weeks
c) Reduction of vitamins and botanicals to initial dosage for
patients with chronic sinusitis who no longer have an exac-
38 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
erbation with purulent rhinorrhea and/or purulent postna-
sal drainage
4. Addition of supplementary therapies:
a) Prescription for the writing and daily recitation and visualiza-
tion of a list of 10 to 12 affirmations.48 This list encompassed
the patient’s primary objectives for his/her own life: physical,
environmental, mental, emotional, spiritual, and social
b) Instruction in and prescription for practicing 1 anger-
release technique daily for 1 to 15 minutes; options included
punching, screaming, stomping, and journaling49
c) Prescription of acidophilus and bifidus supplements, 2 cap-
sules 3 times daily for all patients taking fluconzaole
Visit 4, at 14 Weeks After Visit 1
1. Symptom charts were reviewed, copied, and returned to
patients
2. Follow-up review of progress: questions and answers, encour-
agement and reinforcement of patient commitment
3. Continuation of all visit 1, 2, and 3 therapies
4. Completion of the SF-12, RQLQ and mini-RQLQ
5. Addition of the following therapies:
a) Prescription for meditation,50 beginning with at least 5 min-
utes twice daily
b) Prescription of a listening exercise, spending at least 20 to
40 minutes weekly with spouse or partner; each person
expressing feelings without partner response, followed by
role reversal as the speaker becomes the listener51
c) Prescription for a date night—scheduling at least 1 evening or
a portion of the day each week reserved for recreation alone
with spouse or partner without children or friends present52—
or with a friend (for patients without significant others).
d) Prescription to attend the Sinus Survival support group
meetings of 10 enrolled patients.53
Visit 5, at 18 Weeks After Visit 1: Focus on Review, Support, and
Outcome Measurements
1. Symptom charts were reviewed, copied, and returned to
patients
2. Follow-up review of progress: questions and answers, encour-
agement and reinforcement of patient commitment
3. Completion of objective measurements:
(a) Physical examination
(b) Completion of final mini RQLQ
(c) Completion of repeat SF-12 and Wellness Self-test
Visit 6 (1 Year After Visit 5), at 70 Weeks After Visit 1
Completion of final RQLQ. Nine of the 10 subjects completed
this visit, and the tenth was lost to follow-up. Seven-and-one-half-year
follow-up obtained data from 8 of the 9 patients who could be located.
RESULTS
Comparisons were tested using a 2-sided paired t-test. No adjust-
ments for multiple comparisons were made. Statistical significance is
assumed for P<.05.
An Integrative Holistic Approach for Treating Chronic Sinusitis
 Table 1 displays the observed mean values and descriptive statistics
for the SF-12 and the full RQLQ dimensions and total for each study
visit. Statistical data compares the full RQLQ difference between visits
1 and 4, the mini-RQLQ difference between visits 1 and 4 and visits 2
and 4, and the SF-12 difference between visits 1 and 4 and visits 2 and
4. For the full and mini-RQLQ, a difference greater than 0.50 per
dimension or total corresponds to the minimally important difference.
No statistically significant differences emerged for the physical and
mental subscales of the SF-12 or for any scale of the mini-RQLQ
between visits 1 and 2.
The SF-12 showed no statistically significant difference for either
the physical or mental subscales comparing visits 1 and 4. A higher
SF-12 score implies better health. The full RQLQ showed statistically
significant improvements for sleep, non–hay fever symptoms, and
overall score. A lower RQLQ score implies improving symptoms. The
mini-RQLQ showed significant improvements for activities, nasal
symptoms, eye symptoms, and overall score.
Table 2 shows the changes for the SF-12 and the full RQLQ
between visit 1 and visit 6 (1-year follow-up). For the SF-12, the mean
physical and mental scores showed significant improvement to 7.6 and
10.3, respectively, at 1 year compared to visit 1. All of the RQLQ out-
comes except eye condition showed significant improvement of about
2.0 scale points at 1 year compared to visit 1.
Table 3 displays the comparison of visits 2 and 4. The physical
and mental subscale scores of the SF-12 showed significant gains.
Gains were also seen with significant differences in the RQLQ scales for
non–hay fever symptoms, eye symptoms, and overall score.
Table 4 shows the differences between the 1-year follow-up and
visit 4 at 14 weeks (ie, follow-up minus visit 4) for the SF-12 and the full
RQLQ. For the SF-12, the 2 measures were improved somewhat at the
1-year follow-up but did not reach statistical significance. All of the full
RQLQ outcomes measures were improved somewhat at 1-year follow-
up, but these also did not reach statistical significance.
The Figure shows the patient feedback at 7.5 years’ follow-up.
The positive evaluations demonstrate the continuing benefit of the
entire program.
DISCUSSION
Integrative holistic medicine can be defined as the art and science
of healing that addresses care of the whole person—body, mind, and
spirit. The practice of holistic medicine integrates conventional and
complementary therapies to promote optimal health and to prevent
and treat disease by mitigating causes. The extensive use of alternative,
complementary, integrative, or holistic options in medical care was
first described by Eisenberg et al in 1993.6 A follow-up by these authors
in 1998 found 46% of the population seeking treatment by an “alterna-
tive practitioner” in the previous year, primarily for chronic condi-
tions.7 Astin found that a major motivation involved appeared to
include a desire on the part of the patient to work with a practitioner
with a “holistic orientation to health, consistent with having had a
transformational experience which shifted their worldview.”8(p1548)
Seeking conventional treatment for allergies and asthma is much
more common than pursuing alternative medical advice. This is large-
ly a result of the effectiveness of medication in managing the symp-
An Integrative Holistic Approach for Treating Chronic Sinusitis ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
toms of both of these conditions. However, chronic sinusitis has
become increasingly less responsive to conventional treatment.
Clinical allergists may be well served to be aware of and discuss the
possible role of alternative or integrative holistic approaches with
patients who indicate interest in this arena.
The widespread popularity of books dedicated to the causes and
treatment of chronic sinusitis gives testimony to the interest of the lay
public in being better informed about alternative treatments for
chronic sinusitis. In this observational study the integrative holistic
medical treatment program for chronic sinusitis without the addition
of fluconazole appeared to be associated with little or no improvement
or a nonsignificant worsening of symptoms. This result is compatible
with the clinical experience of lead author RSI. Before committing to
an integrative holistic treatment program, the vast majority of chronic
sinusitis patients have been conventionally treated with multiple
courses of broad-spectrum antibiotics. It has been observed by lead
author RSI that these patients are therefore far more susceptible to
fungal sinusitis and as a result pose a far greater therapeutic challenge.
For this reason, the lead author’s integrative holistic medical approach
for treating patients with severe chronic sinusitis typically includes
antifungal medication (in addition to antifungal supplements and
adherence to an “anti-Candida diet” that is even more restricting than
that recommended in the study) on the first visit, in addition to the
entire regimen offered to the patients in this study.
In order to isolate and evaluate the therapeutic benefit of flucon-
azole alone, however, this medication was withheld until the second
session. The data clearly demonstrate a statistically significant
improvement compared to baseline and the first visit following the
introduction of fluconazole. Although this study documents the bene-
fit of treating severe chronic/fungal sinusitis with fluconazole, it is the
lead author’s experience that the entire integrative holistic medical
approach is necessary in order to address each of the primary causes of
chronic sinusitis—chronic inflammation of the mucous membranes,
immune dysfunction, and fungal infection/yeast overgrowth—and
obtain long-term relief from and a cure for this chronic condition. The
patients continued to apply most of the recommended therapies for
nearly 18 months, whereas the fluconazole was a short-term therapy.
The improvement seen during the first 5 months and especially at the
1-year follow-up (Table 4) may well be seen as a result of the patients’
ongoing implementation of some portion of the entire program
(including lifestyle changes), not simply the 8-week course of flucon-
azole. The nasal hygiene measures helped to reduce the inflamed
mucous membranes; the antioxidants, vitamins, herbs, and supple-
ments assisted in strengthening and restoring balance to the immune
system; and the recommended diet and probiotics kept the fungal
sinusitis in check following the course of fluconazole.
This improvement is consistent with results of the 1999 Mayo
Clinic sinusitis study47 in which allergic responses to fungal organisms
were thought to play a prominent role in chronic sinusitis. A non-IgE-
mediated immunological mechanism has been described to explain
common airborne fungi reactivity in patients with chronic sinusitis.54
Further work appears to confirm the significance and importance of
these findings.55 There have been very few studies on the treatment for
chronic sinusitis, however, and all have been of short duration. Our
39
 TABLE 1 Mean Values for the SF-12 and the Full RQLQ Survey by Visit*
Variable N Mean SD Minimum Maximum
Physical subscale (SF-12) 9 43.05 7.20 30.59 51.71
Mental subscale (SF-12) 9 42.82 10.05 28.88 57.47
Activities (full RQLQ ) 10 3.05 1.32 1.00 5.00
Sleep (full RQLQ ) 10 2.93 1.56 0.33 6.00
Non–hay fever (full RQLQ ) 10 3.07 1.10 1.00 5.47
Practical problems (full RQLQ ) 10 2.97 1.24 1.00 5.00
Nasal (full RQLQ ) 10 3.40 1.57 0.25 5.75
Eyes (full RQLQ ) 10 1.53 1.47 0.00 5.00
Emotion (full RQLQ ) 10 3.25 1.57 0.00 5.25
Overall (total) 10 2.89 1.01 0.71 3.86
Visit 2†
Physical subscale (SF-12) 10 38.99 9.35 24.00 51.12
Mental subscale (SF-12) 10 39.37 10.21 19.06 54.23
Visit 4†
Physical subscale (SF-12) 9 46.04 9.14 32.75 56.90
Mental subscale (SF-12) 9 48.63 9.93 32.04 60.29
Activities (full RQLQ ) 9 2.04 1.74 0.00 4.00
Sleep (full RQLQ ) 9 1.48 1.02 0.00 3.00
Non–hay fever (full RQLQ ) 9 1.60 1.01 0.00 3.00
Practical problems (full RQLQ ) 9 2.70 2.21 0.00 5.67
Nasal (full RQLQ ) 9 2.17 1.46 0.25 4.25
Eyes (full RQLQ ) 9 0.86 1.32 0.00 3.75
Emotion (full RQLQ ) 9 2.11 1.48 0.00 4.00
Overall (total) 9 1.80 1.23 0.11 3.68
Visit 5†
Physical subscale (SF-12) 5 48.18 11.11 34.08 57.94
Mental subscale (SF-12) 5 45.64 14.55 26.20 56.66
Activities (full RQLQ ) 6 1.61 1.88 0.00 4.00
Sleep (full RQLQ ) 6 1.44 1.56 0.00 3.67
Non–hay fever (full RQLQ ) 6 1.57 1.47 0.14 3.71
Practical problems (full RQLQ ) 6 2.11 2.30 0.00 5.33
Nasal (full RQLQ ) 6 1.83 1.86 0.00 4.75
Eyes (full RQLQ ) 6 1.13 1.46 0.00 3.50
Emotion (full RQLQ ) 6 2.25 1.77 0.75 4.75
Overall (total) 6 1.69 1.59 0.39 3.75
Visit 6†
Physical subscale (SF-12) 9 50.69 10.37 32.46 57.26
Mental subscale (SF-12) 9 53.12 7.01 41.19 62.13
Activities (full RQLQ ) 9 1.22 1.41 0.00 3.67
Sleep (full RQLQ ) 9 1.11 1.52 0.00 3.67
Non–hay fever (full RQLQ ) 9 1.02 1.25 0.00 3.29
Practical problems (full RQLQ ) 9 1.22 1.11 0.00 3.00
Nasal (full RQLQ ) 9 1.17 1.27 0.00 3.25
Eyes (full RQLQ ) 9 0.42 0.85 0.00 2.25
Emotion (full RQLQ ) 9 0.94 1.12 0.00 2.50
Overall (total) 9 1.00 1.10 0.00 2.86

*Displays the observed mean values and descriptive statistics for the short-form QOL survey (SF-12) and the full Rhinitis Quality of Life Questionnaire (RQLQ )
dimensions and total for each study visit. Statistical data compare the full RQLQ difference between visits 1 and 4; the mini-RQLQ difference between visits 1 and 4
and visits 2 and 4; and the SF-12 difference between visits 1 and 4 and visits 2 and 4.
†Data analyzed using the MEANS Procedure.

40 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 An Integrative Holistic Approach for Treating Chronic Sinusitis
 TABLE 2 Comparison of 1-Year Follow-up With Visit 1 SF-12 and TABLE 4 Comparison of 1-Year Follow-up With Visit 4 Based on
Full RQLQ Survey*† Results of the SF-12 and Full RQLQ Survey*†
t-test t-test
Variable N Mean SD Minimum Maximum P Value Variable N Mean SD Minimum Maximum P Value
Physical subscale Physical sub-
(SF-12) 9 7.64 6.58 -3.25 17.52 .0083 scale (SF-12) 9 4.65 12.11 -20.49 23.32 .2827
Mental subscale
Mental subscale
(SF-12) 9 10.31 9.68 -4.84 23.80 .0127
(SF-12) 9 4.50 14.18 -13.29 30.09 .3692
Activities (full
RQLQ ) 9 -1.94 2.03 -5.00 1.33 .0209 Activities (full
RQLQ) 9 -0.81 1.99 -4.00 2.00 .2535
Sleep (full
RQLQ ) 9 -1.93 1.54 -4.33 0.67 .0057 Sleep (full
RQLQ) 9 -0.37 1.80 -3.00 2.00 .5539
Non–hay fever
(full RQLQ ) 9 -1.94 1.17 -3.71 0.14 .0011 Non–hay fever
Practical prob- (full RQLQ) 9 -0.59 1.65 -3.00 2.00 .3163
lems (full RQLQ ) 9 -1.63 1.71 -5.00 0.00 .0213 Practical prob-
Nasal (full lems (full
RQLQ ) 9 -1.97 1.95 -5.25 1.25 .0164 RQLQ) 9 -1.48 2.40 -5.33 1.33 .1017
Eyes (full RQLQ ) 9 -1.06 1.59 -5.00 0.25 .0816 Nasal (full
Emotion (full RQLQ) 9 -1.00 1.85 -4.00 1.50 .1435
RQLQ ) 9 -2.31 2.02 -5.25 0.00 .0091 Eyes (full RQLQ) 9 -0.44 1.32 -3.75 0.75 .3405
Overall (total) 9 -1.83 1.42 -3.79 0.43 .0047
Emotion (full
*Displays the changes for the short-form QOL survey (SF-12) and the full RQLQ) 9 -1.17 1.95 -4.00 0.75 .1108
Rhinitis Quality of Life Questionnaire (RQLQ ) between visit 1 and visit 6
(1-year follow-up).
Overall (total) 9 -0.81 1.70 -3.64 1.25 .1925
†All differences are in the order of “1-year follow-up minus visit 1.” *Displays the differences between the 1-year follow-up and Visit 4 at 14 weeks
(ie, follow-up minus visit 4) for the short-form QOL survey (SF-12) and the
TABLE 3 Comparison of 1-Year Follow-up With Visit 2 Based on full Rhinitis Quality of Life Questionnaire (RQLQ ).
†All differences are in the order of “1-year follow-up minus visit 4.”
Results of SF-12 and Full RQLQ Survey*†
t-test commitment compared to that of patients with moderate-to-severe
chronic and fungal sinusitis typically treated by this study’s lead
Variable N Mean SD Minimum Maximum P Value
author. The patients in this study were still confident in the care they
Physical sub- were receiving from a conventional allergist. They had neither sought
scale (SF-12) 9 11.69 12.87 -11.14 28.52 .0260 alternative care nor did they pay a fee for the treatment provided
Mental sub- throughout the course of the study. Most significantly, they were not as
scale (SF-12) 9 13.42 13.49 -3.96 43.06 .0175 desperate, had not read Sinus Survival before participating in the study,
*Displays the comparison of visits 2 and 4; SF-12 indicates short-form QOL and they were not as inspired, motivated, and hopeful as many of the
survey; RQLQ, Rhinitis Quality of Life Questionnaire. lead author’s private patients have been after reading the book. This
†All differences are in the order of “1-year follow-up minus visit 2.” latter group of patients usually demonstrate a greater willingness to
make lifestyle changes and to do whatever is necessary to get well.
study involved antifungal treatment of relatively short duration (8 Alternative approaches to allergic respiratory conditions56 often
weeks) with long-term benefits. The authors believe that this consis- involve botanical therapy (Western and Asiatic herbs),57,58 psychologi-
tent improvement over a period approaching 8 years is a reflection of cal interventions,49,59 hypnosis,60 and homeopathy.61 There is growing
the total integrative holistic approach addressing all of the underlying evidence that stress plays a role in asthma and allergic responses.62 It
causes of chronic sinusitis. has been the clinical experience of the lead author that repressed anger
In mild to moderate cases of sinus disease in which fungal infec- and unshed tears (a sense of loss/grief ) in response to an underlying
tion is not suspected, one author (RSI) has found that the integrative perceived loss of love (often from oneself ) are the primary emotional
holistic treatment program without fluconazole is highly effective. All factors causing chronic and fungal sinusitis.
of the patients included in this study were thought to have fungal Food allergy occurs frequently enough to be an etiological consid-
sinusitis and were candidates for fluconazole therapy. eration in the allergy symptoms of many children and adults63; respira-
It should be noted that the long-term improvement demonstrat- tory allergic symptoms can clearly be the result of ingestant exposure.64
ed in the 1- and 7.5-year follow-ups (Tables 4 and 5, respectively) is also The role of probiotics in primary prevention of atopic disease and
remarkable given the study participants’ significantly lesser degree of the effect on cytokines involved in allergic immune responses continue

TK Integrative Holistic Approach for Treating Chronic Sinusitis

An ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 41
 FIGURE Follow-up Questionnaire and Responses From 8 of 9 Study Participants at 7.5 Years’ Follow-up
1. Compared to prior to October 1999, my sinus condition today is better, 7. I had sinus surgery:
worse, or the same? Better: 8 of 8 Prior to October 1999 Since March 2000
No 2 6
2. Rate your sinus condition on a scale of 1 to 10 (1= worst, 10=optimum)
Yes: 1 surgery 3 2
Prior to October 1999 Currently
3 surgeries 2 0
2 9 (2 participants)
5 surgeries 1 0
3 9 (1 participant)
3 8 (1 participant) 8. During the past 7 years, which therapies that you learned during the
3.5 7.5 (1 participant) Sinus Survival Study have you continued or found to be most benefi-
4 7 (1 participant) cial in caring for your sinuses?
4 6 (1 participant) Nasal irrigation: 8
6 7.5 (1 participant) Eliminate or reduce sugar: 4
Steaming: 3 (with eucalyptus oil: 1; with tea tree oil: 1)
3. Compared to prior to October 1999, my overall health today is gener-
Eliminate or reduce
ally: better, worse, or about the same? Better: 8 of 8
wheat: 2 dairy: 2 alcohol: 2
4. Rate your energy level on a scale of 1 to 10 (1=extreme fatigue, General dietary improvement: 2
10=unlimited energy) Supplements: 2
Prior to October 1999 Currently vitamin C: 1 fish oil: 1
3 7 Saline spray: 1
3 9 Ionizer: 1
3.5 7.5 Humidifier: 1
4 6.5 Affirmations: 1
4 8 Anger release: 1
5 9 Avoid antibiotics: 1
6 8 The program “helped my asthma”: 2
7 8
9. During the past 7 years, have there been any significant changes in
5. I averaged the following number of sinus infections/year: your life that have impacted your overall health and sinus condition?
Prior to October 1999 Since March 2000 No significant changes: 2
0-1 0 1 “I have gotten into mind-body medicine and meditate.”
2-3 0 6 “More aware of stress and diet and how that affects sinuses.”
4-5 3 0 “Diagnosed with lupus (2002) and sinus polyps which cause the loss of
>5 5 1 smell and taste.”
“Thanks for giving me my life back.”
6. I averaged the following number of courses of antibiotics/year:
“Sinus surgery to remove polyps, and removal of abscessed upper
Prior to October 1999 Since March 2000
wisdom teeth.”
0-1 0 3
2-3 0 5
4-5 3 0
>5 5 0

to be an area of evolving understanding regarding the gut microflora’s
role in altered immune responses.65 The preventive effect of probiotics
appears to extend well beyond the previously shown benefits in the
first 2 years of life.66
The evidence for benefit with acupuncture67 and various manual
therapies is mixed. Many integrative interventions have not been sub-
jected to controlled studies, although patients often have favorable
opinions about their effects.56 The growing interest from practitioners
and patients alike has been well documented.57
In their extensive review, Heimal and Bielory point out that
potential side effects are not limited to conventional drug treatments of
allergic conditions but are seen with integrative and alternative
approaches as well.68 A second extensive review by Miller includes data
on immunological and clinical issues in allergy, including potential
benefits from yoga and biofeedback.69
After participating in this study and being impressed with the
process, patient engagement and satisfaction, and therapeutic out-
comes, the “conventional” allergist (coauthor WSS) modified his sum-
mary consultation to be an “Integrative Summary Consultation,”
including discussion of the mental, emotional, social, and spiritual
approaches to the patient’s health per the patient’s desires.
The relationships among conventional and integrative holistic
approaches to the management of sinusitis clearly are evolving.
Conventional practitioners need to be in ongoing communication with
their patients, including awareness of their interest in alternative prac-
tices, in order to design therapeutic programs that integrate a mix of
conventional and integrative therapies meeting reasonable standards
for evidence-based care.
CONCLUSION
Our 14-month observational study of patients with intractable
chronic sinusitis suggested that the integrative holistic medical treat-
ment program including antifungal drug treatment resulted in distinct
improvement from baseline to visits 4 and 5 (14 and 18 weeks). This
statistically significant benefit persisted through the additional year,
further improving nonsignificantly by the final 1-year follow-up visit.
Additionally, the 7.5-year follow-up in 8 of 9 subjects indicated contin-
ued and marked benefit of the program.

42 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 An Integrative Holistic Approach for Treating Chronic Sinusitis
Acknowledgments
The 5 tables were prepared by Howard Shapiro, PhD, biostatistician for the University of Colorado
Health Sciences Center.
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original research
DIETS BASED ON AYURVEDIC CONSTITUTION—
POTENTIAL
Shikha Sharma,
FOR WEIGHT
; Seema Puri,
MANAGEMENT
; Taru Agarwal, ; Vinita Sharma,
MBBS, MD
Context • Ayurveda, the traditional Indian medical system, is
receiving increasing attention worldwide.
Objective • A retrospective study was conducted to determine the
effectiveness of Ayurvedic constitution–based diets on weight loss
patterns of obese adults.
Design, setting, subjects, and intervention • Records of 200
obese adults, both male and female, who had completed 3 months
of the diet therapy at Ayurvedic clinics, were examined and data
collated. Techniques used included a checklist of personality traits,
physical signs, and food likes and dislikes to determine the dosha.
Based on the predominant doshas, diets were prescribed and
closely monitored for a period of 3 months.
Outcome measures • Records of height and weight and chest,
Shikha Sharma, MBBS, MD, is managing director of NutriHealth
Systems, New Delhi, India. Seema Puri, PhD, is a reader,
Department of Nutrition, Institute of Home Economics,
University of Delhi. Taru Agarwal, MSc, is a nutritionist, and
Vinita Sharma, BAMS, is an Ayurvedic consultant, Clinique De
Rejuvenation, New Delhi.
e are in the midst of a global paradigm shift
W in healthcare. At the center of this change is
Ayurvedic medicine, a healing system that
promotes health using natural, nontoxic
substances and recognizes the important
role of the mind and emotions. It employs a variety of natural
means to bring harmony to the physiology, including diets,
herbs, spices, minerals, exercise, meditation, yoga, mental
hygiene, sounds, smells, and mechano-procedure to eliminate
toxic substances from the body.1
Physiology or constitution of the body is a central concept
of Ayurveda. It considers that the universe is made up of combi-
nations of the 5 elements (pancha mahabhutas): akasha (ether),
vayu (air), teja (fire), aap (water), and prithvi (earth). The 5 ele-
ments can be seen to exist in the material universe at all scales of
life and in both organic and inorganic things. In biological sys-
tems, such as humans, elements are coded into 3 forces, which
govern all life processes. These 3 forces (vatta, pitta, and kapha)
are known as the 3 doshas or simply the tridosha. Each of the
doshas is composed of 1 or 2 elements. Vatta is composed of
44 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
PhD MSc BAMS
abdominal, waist, arm, and thigh circumferences noted initially
and after each month for the period of 3 months were obtained.
Results • Among the 200 subjects, 55 (27.5%) were vatta-, 83
(41.5%) were pitta-, and 62 (31.0%) were kapha-predominant. At
the beginning, kapha and pitta people were heavier than vatta peo-
ple. After the 3 months of therapy, the pitta group lost the most
weight (9.84%). The decrease in all the anthropometric measure-
ments was higher in pitta and kapha people than in vatta individu-
als. Hence, diets based on Ayurvedic constitution may prove useful
in promoting weight loss. Though these promising findings sup-
port traditional Indian Ayurvedic scriptures, more closely con-
trolled trials are needed to substantiate these findings. (Altern Ther
Health Med. 2009;15(1):44-47.)
space and air, pitta of fire, and kapha of water and earth. Vatta
dosha has the mobility and quickness of space and air, pitta dosha
the metabolic qualities of fire, kapha dosha the stability and solid-
ity of water and earth. The tridosha regulates every physiological
and psychological process in the living organism. The interplay
among them determines the qualities and conditions of the indi-
vidual. A harmonious state of the 3 doshas creates balance and
health; an imbalance, which might be an excess (vriddhi) or defi-
ciency (kshaya), manifests as a sign or symptom of disease.2,3
Therefore, the purpose of treatment of any disease including
obesity is to bring this altered state of doshas back to the basal
state of normalcy. Hence, if a person indulges in a right food pat-
tern according to his/her body constitution, he/she not only
loses weight but also remains healthy and is less prone to diseas-
es that might be due to an imbalance of doshas.
Changes in dietary patterns, physical activity levels, and
lifestyles associated with affluence and migration to urban areas
are related to increasing obesity in adults as well as children.
Apart from dietary excesses and easy availability of ready-to-eat
foods, the lack of physical exercise among affluent people with
sedentary lifestyle patterns is a major contributor to obesity.
Weight loss has hence become a significant concern among
them. In India the weight loss industry is booming, with weight
loss being promoted through fad diets, machines, liposuction,
surgery, medications, etc. Although these measures show short-
term results, they often do not target holistic well-being.
Ayurveda promotes sustainable weight loss along with allevia-
tion of disease states, thereby ensuring good health.
Diets Based on Ayurvedic Constitution and Weight Management
 Weight loss based on body constitution is well documented
in Ayurveda. Obesity is generally due to aggravation of kapha
dosha—that is, the vitiated kapha targets body tissues and causes
water retention and fat accumulation; therefore, weight loss
strategies target balancing kapha with the other 2 doshas.4
Several Ayurvedic practitioners have been counseling individ-
uals on weight loss based on the principle of body constitution.
They have reported significant weight loss among their clients.
This retrospective study was planned to determine the effective-
ness of dosha-based diets on weight loss pattern of obese adults.
METHODS
Seven centers in Delhi where weight loss techniques based
on the principle of Ayurveda were being used were identified. At
these centers, Ayurvedic consultants analyzed the body constitu-
tion of the individuals, and nutritionists prescribed diets based on
body constitution. Three centers in South Delhi were selected for
the study based on their willingness to cooperate, accessibility,
and large client base. Records of obese adults (body mass index
[BMI] >25kg/m2), both male and female, who had visited the
weight loss clinics over the past 3 years (2004-2007) were exam-
ined and data collected. Only subjects who had completed 3
months of the therapy were included in the study. Subjects whose
records for 3 months were incomplete or who had not adhered to
the program were excluded. Subjects with medical problems like
metabolic syndrome, diabetes, polycystic ovary syndrome, and
renal disorders were excluded. The total number of subjects for
whom complete data was available was 200 (24 males, 176
females); these subjects constituted the sample for the study.
Records available at these weight loss clinics were analyzed
and the following information collected:
• Body constitution based on Ayurveda was determined
according to a checklist of personality traits, physical
signs, and food likes and dislikes against which the sub-
jects were evaluated. Based on the responses, the subjects
were classified as predominantly vatta, pitta, or kapha.

TABLE 1 Mean ± SD and Range of Mean Weight (kg) and Mean Body Mass Index (kg/m2) According to Prakriti

Weight Mean weight (kg) ±SD

Vatta (n=55) Pitta (n=83) Kapha (n=62) Total (n=200)

At entry 81.14±19.23 83.78±18.52 84.65±16.29 83.33±18.03
(Range) (52.7-138.8) (59.3-161.6) (55.4-151.8) (52.7-161.6)
After 1 month 77.08±18.11 79.65±17.65 80.37±15.46 79.17±17.10*
(Range) (50.60-130.0) (55.9-153.6) (52.9-143.1) (50.6-153.6)
After 2 months 74.99±17.77 77.31±17.33* 78.39±14.77* 77.01±16.68‡
(Range) (50.20-127.0) (53.5-149.4) (52.0-135.7) (50.2-149.4)
After 3 months 73.41±17.65* 75.54±16.96† 76.53±13.71† 75.26±16.19‡
(Range) (49.0-125.0) (51.7-144.0) (51.0-117.6) (49.0-144.0)

BMI Mean± SD BMI (kg)

Vatta (n=55) Pitta (n=83) Kapha (n=62) Total (n=200)
At entry 30.97±5.32 31.98±5.21 31.63±4.95 31.50±5.15
(Range) (22.69-45.16) (23.55-53.14) (23.63-52.53) (22.69-53.14)
After 1 month 29.43±5.09 30.41±4.96* 30.04±4.78 30.02±4.93†
(Range) (21.79-43.56) (21.8751.92) (21.93-49.52) (21.79-51.92)
After 2 months 28.63±5.03* 29.51±4.89† 29.32±4.67† 29.21±4.85‡
(Range) (21.61-42.74) (21.09-50.37) (20.54-46.96) (21.09-50.37)
After 3 months 28.01±4.98† 28.83±4.50‡ 28.63±4.33‡ 28.54±4.70‡
(Range) (21.09-42.08) (20.19-48.67) (20.88-40.76) (20.19-48.67)

Weight in loss kg (%)

Vatta (n=55) Pitta (n=83) Kapha (n=62) Total (n=200)

Entry to month 1 3.06 (5.00) 4.13 (4.93) 4.28 (5.06) 4.16 (4.99)

Entry to month 2 6.15 (7.58) 6.47 (7.72) 6.26 (7.40) 6.32 (7.58)
Entry to month 3 7.73 (9.53) 8.24 (9.84) 8.12 (9.59) 8.07 (9.68)

*P≤.05, †P≤.01, ‡P≤.001 as tested by t-test.

Diets Based on Ayurvedic Constitution and Weight Management ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 45
 • Anthropometric profiles included records of height and
weight and chest, abdominal, waist, arm, and thigh cir-
cumference noted initially and after each month for 3
months. Standard tools and techniques had been used to
determine the anthropometric measurements. Weight
was recorded to the nearest 100 g, height to the nearest 1
cm, and circumferences to the nearest 0.5 cm. BMI was
calculated using this formula:
was significant, though it was more so in the subjects of pitta-
and kapha-dominant dosha. Kapha-predominant people lost
more weight initially, presumably due to a decrease in water
retention, as kapha dosha tends to retain more water, the major
liquid component of the body. 17
The trend in reduction in BMI was similar to that of weight,
the significance level being even higher than that with weight
loss. Pitta subjects lost the maximum weight (9.84%) over the

Weight (kg) TABLE 2 Mean± SD of Anthropometric Measurement According to

Height2 (m2) Prakriti Group
Anthro-
• Diet intervention was based on the Ayurvedic constitu-
pometric At After After After
tion, and the nutritionist counseled the individuals on the parameters entry month 1 month 2 month 3
diets to be followed. These diets were administered based
on the predominant doshas. Arm circumference (cm)
1. For people of vatta constitution, the diets were based Vatta 34.19±4.35 32.44±4.03 31.50±3.61 30.78±3.41†
mainly on wheat, potato, rice, 5 black gram, besan
(gram flour),6 and fish.7 Pitta 35.13±6.02 33.21±5.42 32.13±5.19 31.51±5.14†
2. For people of pitta constitution, the diets were based on Kapha 35.74±10.55 34.08±10.24 33.10±10.24 32.39±10.07
barley, besan (gram flour),8,9 dairy (paneer), animal foods Total 35.05±7.81 33.27±8.15 32.26±6.14 31.58±6.24†
like chicken or egg, rice, amla,10 soya, and green gram.11,12
Chest circumference (cm)
3. For people of kapha constitution, the diets were based
mainly on wheat bran, barley,13,14 soy nuggets, besan Vatta 104.44±10.94 100.95±10.54 99.63±10.27 98.22±9.98*
(gram flour), green gram, and garlic.15 Pitta 105.40±9.79 101.89±9.09 99.58±13.35 98.36±8.75†
Kapha 106.62±9.63 102.98±8.84 101.18±8.62 100.08±8.66†
Adherence to the diets had been ensured by weekly monitor-
Total 105.52±10.01 101.97±9.98 100.10±10.81 98.87±9.01†
ing. The respondents visited the clinics twice a week and interact-
ed with the nutritionists. The emphasis on compliance was on Abdominal circumference (cm)
inclusion of certain foods based on suitability to body constitution Vatta 103.54±16.34 98.06±15.14 96.75±14.86 95.40±14.86*
and not the calorie content. Subjects who reported any deviations Pitta 105.49±12.31 100.29±11.95 97.06±11.08 94.58±15.31†
from the diets prescribed were excluded; only those who complied
Kapha 105.70±12.60 100.38±12.10 97.78±11.11 94.97±14.84†
with the diets prescribed have been included in the study.
Total 105.02±14.18 99.70±13.19 47.21±12.18 94.93±14.88†
RESULTS Thigh circumference (cm)
The total number of subjects for whom complete data were Vatta 64.50±7.37 62.68±7.18 60.89±6.26 59.94±6.58*
available was 200 (24 males, 176 females). All of the subjects
Pitta 64.61±8.12 61.51±8.13 59.62±7.85 58.71±7.76†
were obese, with a BMI >25kg/m2, and their ages ranged from 20
Kapha 63.47±7.53 61.28±7.19 59.63±7.38 58.54±7.47†
to 60 years. The subjects were classified according to 3 predomi-
nant doshas: vatta-predominant, pitta-predominant, and kapha- Total 64.22±7.93 61.77±7.08 59.99±7.85 59.01±7.58†
predominant (henceforth written as vatta, pitta, and kapha). Of Hip circumference (cm)
the 200 subjects, 55 (27.5%) were vatta-, 83 (41.5%) were pitta-, Vatta 113.45±11.62 108.64±10.80 107.06±10.28 106.11±10.29†
and 62 (31.0%) were kapha-predominant. Among obese subjects Pitta 115.61±8.91 111.12±8.57 108.64±8.66 107.08±8.88†
of the study, the dominant constitution of the subjects was pitta
Kapha 114.08±9.92 109.50±9.75 107.31±9.62 106.15±9.65†
followed by kapha and vatta. According to Ayurvedic text, obesity
is caused by vitiation of body tissues with kapha16; hence, most Total 114.51±10.11 109.90±10.01 107.77±9.88 106.51±9.85†
kapha-predominant people are prone to obesity, whereas vatta Waist circumference (cm)
people have the least tendency to gain weight. Vatta 92.74±14.80 87.34±14.05 86.47±13.89 85.24±13.93*
Table 1 shows that at the beginning of the study, kapha and
Pitta 93.50±13.97 88.92±13.44 86.65±13.00 84.45±13.17†
pitta subjects were heavier that vatta subjects. All groups lost weight
at the end of the first month. After 2 months of therapy, there was a Kapha 93.15±10.09 89.18±9.52 86.70±9.53 85.72±9.81†
significant weight loss in the pitta- and kapha-dominant subjects Total 93.17±13.81 88.53±14.01 86.61±12.48 85.06±12.18†
(P<.05) but not in the vatta group. After 3 months of diet thera- *P≤.01, †P≤.001 as tested by t-test.
py, however, weight loss in the subjects of the vatta group also

46 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Diets Based on Ayurvedic Constitution and Weight Management
3-month period. Pitta people are reported to have intense meta- the vatta (8.1%) and kapha (8%) groups after 3 months of dietary
bolic fire (pitta) and therefore a higher fat metabolism, contribut- intervention. The percentage decrease in chest circumference,
ing to a greater weight loss over time.2 abdominal circumference, thigh circumference, and hip circum-
All the anthropometric parameters measured at entry for ference was highest in the pitta group, followed by kapha and
the 3 doshas decreased after the third month of therapy at a high- vatta individuals after 3 months of dietary intervention. As
ly significant level, either at 1% or 0.1% (Table 2). The percentage shown in Table 3, the change in circumference measurements
of decrease in arm circumference was highest in pitta individuals across all locations was highest in the pitta group. This finding is
(10.3%), followed by vatta (10%) and kapha (9.4%), and the supported by the fact that the maximum weight loss was also
decrease in waist circumference was higher in pitta (9.7%) than in reported among the pitta group. Not much difference was seen in
the percentage loss among the kapha and vatta groups.
TABLE 3 Percentage Decrease in Anthropometric Measurements Classic Ayurvedic texts such as Charak Samhita, Charak
Sutra Sthanam, and Ashtanga Hridayam have documented the
Arm
circumference (cm) After month 1 After month 2 After month 3
role of diet in achieving weight loss without any side effects.
This retrospective study has shown that diets based on
Vatta -5.1 -7.9 -10.0
Ayurvedic constitution are useful in promoting weight loss.
Pitta -5.5 -8.5 -10.3 Though these promising findings support traditional Indian
Kapha -4.6 -7.4 -9.4 Ayurvedic scriptures, more closely controlled trials are needed
Total -5.1 -8.0 -9.9 to substantiate these findings.
Chest REFERENCES
circumference (cm) After month 1 After month 2 After month 3 1. Frawley D. Ayurvedic Healing: A Comprehensive Guide. Delhi, India: Motilal Banarsidass
Pvt Lmt; 2005.
Vatta -3.3 -4.6 -6.0 2. Hankey A. CAM modalities can stimulate advances in theoretical biology. Evid Based
Complement Alternat Med. 2005;2(1):5-12.
Pitta -3.3 -5.5 -6.7 3. Lad V. Ayurveda: The Science of Self-Healing. Silver Lake, WI: Lotus Press; 1984.
Kapha -3.4 -5.1 -6.1 4. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 14/21. Delhi, India: Chaukhambha
Orientalia; 2007.
Total -3.4 -5.1 -6.1 5. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 6/26. Delhi, India: Chaukhambha
Orientalia; 2007.
Abdominal 6. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 6/21-22. Delhi, India: Chaukhambha
Orientalia; 2007.
circumference (cm) After month 1 After month 2 After month 3 7. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 6/67. Delhi, India: Chaukhambha
Vatta -5.3 -6.6 -7.9 Orientalia; 2007.
8. Sharma PV. Charak Samhita. Sutra Sthanam 27/273. Delhi, India: Chaukhambha
Pitta Orientalia; 2005.
-4.9 -8.0 -10.3 9. Sharma PV. Charak Samhita. Sutra Sthanam 27/28. Delhi, India: Chaukhambha
Kapha Orientalia; 2005.
-5.0 -7.5 -10.15 10. Sharma PV. Charak Samhita. Sutra Sthanam 27/147. Delhi, India: Chaukhambha
Total -5.1 -7.4 -9.6 Orientalia; 2005.
11. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 6/17. Delhi, India: Chaukhambha
Thigh Orientalia; 2007.
12. Sharma PV. Charak Samhita. Sutra Sthanam 27/65. Dehli, India: Chaukhambha
circumference (cm) After month 1 After month 2 After month 3 Orientalia; 2005.
13. Tripathi B. Ashtanga Hridaya. Sutra Sthanam 6/38-39. Delhi, India: Chaukhambha
Vatta -2.8 -5.6 -7.1 Orientalia; 2007.
Pitta -4.8 -7.7 -9.1 14. Sharma PV. Charak Samhita. Sutra Sthanam 27/19-20. Delhi, India: Chaukhambha
Orientalia; 2005.
Kapha -3.5 -6.1 -7.8 15. Sharma PV. Charak Samhita. Sutra Sthanam 27/23. Delhi, India: Chaukhambha
Orientalia; 2005.
Total -3.8 -6.6 -8.1 16. Sharma PV. Charak Samhita. Sutra Sthanam 21/4. Delhi, India: Chaukhambha
Orientalia; 2005.
Hip 17. Sharma PV. Charak Samhita. Sutra Sthanam 20/18. Delhi, India: Chaukhambha
circumference (cm) After month 1 After month 2 After month 3 Orientalia; 2005.

Vatta -4.2 -5.5 -6.5

Pitta -3.9 -6.0 -7.4
Kapha -4.0 -5.9 -7.0
Total -4.0 -5.9 -7.0
Waist
circumference (cm) After month 1 After month 2 After month 3
Vatta -5.8 -6.8 -8.1
Pitta -4.9 -7.3 -9.7
Kapha -4.3 -6.9 -8.0
Total -5.8 -7.0 -8.7

Diets Based on Ayurvedic Constitution and Weight Management ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 47
 Advancing integrative medicine to improve patient care.

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case study
DELIVERY OF A FULL-TERM PREGNANCY AFTER TCM
TREATMENT IN A PREVIOUSLY INFERTILE PATIENT
DIAGNOSEDJennifer
WITH POLYCYSTIC; Elizabeth
A. M. Stone, ; Karmen K. Yoder,
OVARY
A. Case,
SYNDROMELAc
There is a growing body of literature supporting the use of tra-
ditional Chinese medicine (TCM) for increasing the likelihood
of conception and carrying a pregnancy to term.1,2 The use of
TCM in fertility treatment is becoming more widely recognized,
and several clinical trials are being supported by the National
Center for Complementary and Alternative Medicine to assess
the efficacy of such treatments, as evidenced by the listings in
the National Institutes of Health’s Computer Retrieval of
Information on Scientific Projects (CRISP) database. In addi-
tion to subjecting TCM to the rigors of Western scientific stan-
dards, it is important that TCM and other CAM practitioners
Jennifer A. M. Stone, LAc, is an adjunct volunteer faculty
member at the Indiana University School of Medicine,
Indianapolis, Indiana. Karmen K. Yoder, PhD, is an assistant
professor in the Department of Radiology, Division of
Research, Section of Imaging Sciences, in the Department of
Obstetrics and Gynecology at the Indiana University School
of Medicine. Elizabeth A. Case, MD, is an adjunct faculty
member and practicing ob/gyn at Indiana University/Clarian
Medical Center, Indianapolis.
olycystic ovary syndrome (PCOS) affects 7% to 10% of
P premenopausal women.3 Research has shown that
women with PCOS develop many small cysts on the
periphery of their ovaries.4 Several of the symptoms
develop as a result of hormonal imbalance.3 PCOS is
characterized as hyperandrogenism (high levels of male hormones)
and chronic anovulation. Symptoms may include hirsutism (excess
hair growth), obesity, hypertension, dislipidemia, type 2 diabetes,
and coronary artery disease. Women with PCOS have profound
insulin resistance as well as pancreatic β-cell dysfunction.4
Recurrent miscarriage is defined as 3 consecutive miscar-
riages of pregnancies conceived with the same partner. The most
common cause of recurrent miscarriage is PCOS.5,6 Other causes
include parental chromosomal abnormality, antiphospholipid
antibody syndrome, structural abnormalities, bacterial vagino-
sis, and cervical incompetence.6
50 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
PhD MD
share their expertise and practical experiences through case
reports in the same spirit that their Western medical counter-
parts do. This dissemination of knowledge is critical in increas-
ing awareness about TCM within the broader scientific com-
munity. The clinical case report presented here describes the
course of TCM treatment that resulted in a successful preg-
nancy in a previously infertile woman who had been diagnosed
with polycystic ovary syndrome (PCOS). It also illustrates the
importance of the need for collaborative efforts between TCM
and Western medical practitioners. (Altern Ther Health Med.
2009;15(1):50-52.)
PCOS AND RECURRENT MISCARRIAGE FROM A
TRADITIONAL CHINESE MEDICINE PERSPECTIVE
Chinese medicine is an ancient whole-medicine system inde-
pendent of Western theory that heals by improving homeostasis
in the body. The term TCM refers to the ancient medical practice
that survives today and is systematically taught in modern colleg-
es and universities. TCM theory states that qi (vital energy, life
force, inner fire)7 courses through meridians (pathways) that are
associated with organs and systems and can be manipulated to
encourage homeostasis within the body. TCM theory attributes
fertility to the functions of kidney and spleen qi.
Ancient texts teach that the jing (seed of life, life essence) that
is stored in the kidney is responsible for fertility.8 Jing is said to be
the substance most closely associated with life itself as the source
of life and individual development. The entire body and all the
organs need jing to survive. The kidneys, because they store jing,
contain potential for life activity, and all of the organs and sys-
tems are dependent on the kidney to survive. The kidneys are
often called the “root of life.”9 The kidneys rule the ovaries. PCOS,
a disruption of the ovaries, is a result of kidney disharmony.
In TCM pathology, the spleen is the primary organ of diges-
tion. The spleen is the organ responsible for absorption of nutri-
ents from food and assimilation of nutrients to blood and
muscles. The spleen nourishes and governs the blood. The qi
that the spleen produces holds the blood within the body. Weak
spleen qi causes uterine bleeding and organ prolapse.
Miscarriage is a result of spleen qi vacuity/deficiency.
TCM Treatment for Polycystic Ovary Syndrome
Clinical Observation
S was a 32-year-old, 142-lb white female who presented to
the TCM clinic seeking treatment for infertility. S reported amen-
orrhea and a previous diagnosis of PCOS. Medical history was
significant for a blood clot at age 21 (attributed to birth control
pills prescribed for menstrual cycle regulation) and 3 miscarriag-
es (2 during the first trimester; 1 second-trimester loss from pre-
maturely ruptured membranes). At the time of presentation, she
was under the care of a reproductive endocrinologist. The prior
history of blood clot necessitated heparin treatment during hor-
monal treatment and/or pregnancy.
Physical examination revealed pale and lusterless skin, deep
and weak pulse, enlarged tongue with a slippery coating, and
tight and swollen abdomen. TCM diagnosis was spleen qi, kid-
ney qi, and lung qi deficiencies with liver qi stagnation. Kidney qi
deficiency causes poor fertility and poor embryo viability. Spleen
qi deficiency causes weakness of the muscles and membranes
that hold the placenta and embryo in the body. Lung qi deficien-
cy causes weak qi and poor circulation. Liver qi stagnation pre-
vents smooth coursing of qi and blood. In TCM theory, the lungs
breathe qi in from the air, and the kidneys “grasp the qi” from the
lung and “root” the qi in the body.10 Fertility is dependent on
both kidney and lung qi, and maintaining the pregnancy is
dependent on spleen qi.
Treatment Strategy
The treatment strategy was 3-fold: (1) acupuncture and
Chinese herbal preparations would be used to restore the men-
strual cycle, (2) acupuncture would be used immediately prior to
ovulation and menstruation to increase the probability of con-
ception, and (3) moxibustion treatments (stimulation of acu-
puncture points by burning of dried moxa, Artemisia vulgaris, on
or near the desired point) to prevent miscarriage.
The safety of the patient is always paramount. To protect S
from interactions of TCM and Western medical treatments, the
TCM treatments were adjusted in conjunction with any treat-
ments prescribed by the reproductive endocrinologist.
Herbal treatments were discontinued during any hormone
treatments given in preparation for intrauterine insemination
(IUI), and herbs were not used during postovulation if there was
the possibility of pregnancy. Acupuncture was used only when
there was no chance of pregnancy, as several acupuncture points
cause uterine contractions when needled. Instead, indirect moxi-
bustion (moxa near the actual point) was used to achieve the
desired effects of each acupuncture point (with the exception of
the Bai Hui point). In TCM theory, chronic miscarriage is the
result of weak spleen qi that causes weakening of the blood, ves-
sels, and uterine tissues that support and nurture the fetus. In
TCM, anticoagulants such as heparin are thought to exacerbate
these weaknesses and promote miscarriage. In this case, howev-
er, continuation of heparin treatments was necessary because of
the patient history of hormonally induced blood clots. To coun-
teract the negative effects of heparin, indirect moxibustion was
used to strengthen the uterine tissues and placenta.
TCM Treatment for Polycystic Ovary Syndrome ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
Herbal Treatment
Gu Zhi Tang (Cinnamon Twig Decoction tea pills), a Plum
Flower Classic Formula (Mayway Corp, Oakland, California), 8
pills, 3 times daily for 21 days, was used to warm the interior qi
and allow it flow to the surface. Ba Zhen Wan (Eight Treasure
Decoction tea pill, also called Women’s Precious Pill), Plum
Flower Classic Formula, 5 pills 3 times daily throughout the
course of therapy, was used to strengthen the spleen qi (to
increased tissue nourishment), the lung qi (to improve circula-
tion), and the blood (to improve the health of erythrocytes, leu-
cocytes, platelets, and balance the overall blood composition)
and to smooth liver qi that keeps the blood flowing in all direc-
tions, improving the blood supply to the organs. An in-house
preparation of Chinese dong quai, Dang Gui (Radix angelica sin-
ensis), was used to facilitate movement of blood and to strength-
en the uterus.10
Acupuncture
During the initial 12-month period of TCM treatment, a
total of 27 acupuncture treatments were given immediately before
ovulation and immediately before onset of menses. As stated
earlier, acupuncture was used only if there was no chance that the
patient was pregnant. Disposable acupuncture needles (Seirin
No.3 [0.20×30mm; Seirin Corporation, Shizuoka, Japan]) were
inserted approximately 1 cm into the skin and gently twisted for
1 to 3 seconds, until a light resistance against the needle was per-
ceived. Needles remained in place for 25 minutes. Different acu-
points along spleen (Sp) meridian (Leg Tai Yin) were selected for
acupuncture based on the physical condition of S at the beginning
of each visit. Tai Bai (Sp3) was used for extreme nutritive qi vacu-
ity. Xue Hai (Sp10) was used to help clean and detoxify the blood.
Yin Ling Quan (Sp9), San Yin Jiao (Sp6), and Zu San Li (Stomach
[St] 36) were used to aid in digestion, assimilation of nutrients,
and proper management of fluids. Tai Chong (Liver [Lv] 3) was
used in accordance with TCM theory to ensure smooth circula-
tion of qi and blood. Fu Liu (Kidney [K] 7) and Guan Yuan
(Conception Vessel [CV] 4) were used to strengthen kidney qi and
invigorate the yang qi (fierce, fiery qi), which together aid in fertil-
ity. Zhong Fu (Lung [Lu] 1), Lie Que (Lu7), Shencang (K25), and
Dan Zhong (CV17) were used to strengthen lung qi so the kidneys
can grasp the qi and pull it deep into the body. Indirect moxibus-
tion was used on Guan Yuan (CV4) to strengthen and warm the
kidney and the jing and to drive qi into the body.
Moxibustion
During times of pregnancy and possible pregnancy, weekly
moxa treatments were used instead of acupuncture. The purpose
of the moxibustion was to help drive qi into the body to assist in
sustaining the pregnancy. Indirect moxibustion was used on Tai
Bai (Sp3), San Yin Jiao (Sp6), Zu San Li (St36), Gong Sun (Sp4),
Nie Guan (Pericardium [P] 6) and Guan Yuan (CV4). In particu-
lar, Guan Yuan (CV4) was heated until a pink circle approximate-
ly 4 cm in diameter was noted. A single needle in Baihui was
inserted during moxa treatments to raise qi within the body and
51
to tighten the perineum (direct needling in this point presented
no danger to the fetus). The timing and frequency of moxa treat-
ments is described below.
Clinical Course and Outcome
One week after the onset of TCM treatment, menses
resumed and were maintained on a 28-day to 32-day cycle.
Natural pregnancy occurred after 2 months of treatment; at this
time, medical treatment with progesterone, human chorionic
gonadotropin, and heparin was initiated. TCM herbs and acu-
puncture were discontinued, and moxibustion treatments were
started. Natural miscarriage occurred during the third month of
TCM treatment. IUI was attempted during the ninth and elev-
enth months of TCM treatment without success. Twelve months
after initiation of TCM treatment, S conceived naturally. Heparin
treatment was started, and weekly moxibustion treatments were
resumed. Recommendations to avoid standing and excessive
movement were followed. Occasional spotting was noted starting
in gestational week 3 and continued until the end of the first tri-
mester. Moxa treatments were continued during this time.
Nausea and fatigue (symptoms typically associated with preg-
nancy) began in gestational week 8 and continued to worsen
throughout the first trimester. A cervical cerclage was performed
in week 9 to help prevent miscarriage. S was gradually weaned
off moxa treatments, receiving 2 treatments in month 4 and 1
treatment in months 5 and 6. TCM treatments were then discon-
tinued. The second and third trimesters were uneventful and
ended with successful delivery of a full-term baby.
REFERENCES
1. Paulus WE, Zhang M, Strehler E, El-Danasouri I, Sterzik K, Influence of acupuncture
on the pregnancy rate in patients who undergo assisted reproduction therapy. Fertil
Steril. 2002;77(4):721-724.
2. White AR. A review of controlled trials of acupuncture for women’s reproductive
health care. J Fam Plann Reprod Health Care. 2003;29(4):233-236
3. No authors listed. What causes PCOS? PCOS Website at NorthWestern University
Feinberg School of Medicine. Available at: http://www.pcos.northWestern.edu/what_
causes_pcos.htm. Accessed September 22, 2008.
4. Azziz R, Woods KS, Reyna R, Key TJ, Knochenhauer ES, Yildiz BO. The prevalence and
features of the polycystic ovary syndeome in an unselected population. J Clin Endocrinol
Metab. 2004;89(6):2745-2749.
5. Walling AD. Supportive care important with recurrent miscarriage. Am Fam Physician.
Available at: http://www.aafp.org/afp/20021001/tips/13.html. Accessed November,
24, 2008.
6. Rutherford AJ, Shillito J. The patient with recurrent miscarriage. Practitioner.
2002;246(1634):342-649.
7. Cohen KS. The Way of Qigong; The Art and Science of Chinese Energy Healing. New York,
NY: Ballantine Books; 1997.
8. Guan Dzu, 4th Century B.C.E. Vol. 16:1.
9. Kaptchuk T. The Web That Has No Weaver: Understanding Chinese Medicine. New York,
NY: Congdon & Weed; 1983.
10. Bensky D, Gamble A, Kaptchuk T. Chinese Herbal Medicine: Materia Medica. Seattle,
WA: Eastland Press, 1986.

CONCLUSION
TCM involves the complex use of many
therapeutic modalities to achieve and main-
tain health. This case report documents how
the synergy of 3 TCM modalities likely facili-
tated a successful pregnancy in a previously
infertile woman; the TCM strategy was also
carefully integrated with conventional
Western treatments to maximize patient safe-
ty. This latter point is extremely important, as
it emphasizes the need for CAM and Western
medicine practitioners to be aware of and have
a healthy respect for the potentially dangerous
consequences of treatment interactions.
Although this report demonstrates how acu-
puncture, herbal preparations, and moxibus-
tion together contributed to a successful
outcome, it is impossible to parse the individ-
ual contributions of each therapy. The com-
plex nature of TCM creates difficulties in the
design of clinical efficacy studies; however, the
complementary and alternative medicine
community needs to continue pursuing well-
designed clinical trials to document the effica-
cy of TCM and other CAM treatments.

52 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 TCM Treatment for Polycystic Ovary Syndrome
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review article
THE USE OF BOTANICALS DURING
PREGNANCY AND LACTATION
Tieraona Low Dog,
Women are the largest consumers of healthcare, and this
extends to their utilization of complementary and alternative
medicine (CAM). Researchers have attempted to uncover the
reasons why women turn to CAM in general and to botanical
medicine in particular. Desire to have personal control over
their health has been cited as the strongest motive for women
to use herbal medicine. Second was dissatisfaction with con-
ventional treatment and its disregard for a holistic approach, as
well as concerns about the side effects of medications.1 These
concerns may explain, in part, the fact that many women use
herbal remedies during pregnancy. A survey of 578 pregnant
women in the eastern United States reported that 45% of
respondents had used herbal medicines,2 and a survey of 588
women in Australia revealed that 36% had used at least 1 herbal
product during pregnancy.2 Women probably feel comfortable
using herbal remedies because of their perceived safety, easy
access, and the widespread availability of information about
them (ie, Internet, magazines, books).
While it is true that many botanicals are mild in both
treatment effects and side effects, the data regarding safety
during pregnancy are very limited. Given the small sample
Tieraona Low Dog, MD, is director of the fellowship at
Arizona Center for Integrative Medicine, University of
Arizona Health Sciences Center, Tucson.
Editor’s note: The following article is excerpted from a chapter of
The H.E.R.B.A.L. Guide: Evidence-Based Dietary Supplement
Resources for the Clinician, edited by Robert Bonakdar, MD, who works
at the Scripps Center for Integrative Medicine. The book is in press and
will be available from Lippincott Williams & Wilkins later in 2009.
he topic of herb use during pregnancy or breastfeed-
T ing is very large and clearly cannot be extensively
covered in this article. What follows is a review of
several botanicals that are either commonly used or
have documented evidence of benefit for some of the
common problems women encounter during these times.
NAUSEA AND VOMITING OF PREGNANCY
Nausea and vomiting of pregnancy (NVP) is a common
54 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD
sizes in clinical trials studying botanicals in pregnant women,
only large differences in measures of pregnancy outcomes
would likely be detected. For example, if an herb were thought
to increase the rate of spontaneous abortion from 6% to 7%, a
sample size of more than 19 000 women would be needed. It is
highly unlikely that there will be any studies of a botanical (or
drug) with this large a sample size. So when addressing the
safety of an herb during pregnancy, we must look at the totality
of the evidence, which includes traditional and contemporary
use, animal studies, pharmacological studies, and clinical trial
data, when available.
Survey data tell us that women often do not share their use
of herbal remedies with their healthcare providers due to fear of
offending providers or to the belief that clinicians will be igno-
rant about their use. Practitioners should maintain an open and
respectful demeanor when counseling pregnant and nursing
women about the use of botanical medicines, and they should
know how to access unbiased and authoritative information
sources, so they may reliably answer questions on inadvertent
exposures and provide guidance on herbal products that might
be beneficial. (Altern Ther Health Med. 2009;15(1):54-58.)
experience for many women (33%-50%), usually beginning by 4
to 8 weeks’ gestation and disappearing by the 16th week. The eti-
ology is not known. Mild cases of morning sickness generally
pose no significant risk to mother or baby and can be safely
treated at home with self-care measures. The diagnosis of hyper-
emesis gravidarum is made when NVP is serious enough to cause
a weight loss of at least 5% of the prepregnancy weight, dehydra-
tion, electrolyte imbalance, and ketosis. This condition necessi-
tates hospitalization.3
Case
Kathy is in the first trimester of her second pregnancy. She had a
terrible time with nausea and vomiting during her first pregnancy and
was hospitalized for dehydration. She is experiencing nausea and
occasional vomiting and is routinely late for work, as she feels too sick
to drive. Kathy says that her employer and husband are sympathetic
and supportive. She has no health problems and does not take any
prescription or over-the-counter medications except for her prenatal
vitamin. She recently read that ginger was helpful for morning sick-
ness. Kathy mentioned it to her obstetrician, who told her that ginger
was not safe during pregnancy and that the FDA does not regulate
The Use of Botanicals During Pregnancy and Lactation
dietary supplements, making them risky to use. He told her to try soda
crackers and small frequent meals, which have not helped.
In addition to its long history of use as a spice, ginger
(Zingiber officinale) is also highly regarded as an antiemetic, an
antiinflammatory, a digestive aid, a diaphoretic, and a warming
agent. It is also the most extensively studied botanical for NVP. A
systematic review of 6 published clinical trials found that ginger,
at doses of 1.0 to 1.5 g, is effective for reducing NVP.4 Four of the
6 randomized controlled trials (RCTs) (n=246) showed superiori-
ty of ginger over placebo; the other 2 RCTs (n=429) found ginger
as effective as vitamin B6 in relieving the severity of nausea and
vomiting episodes.
There has been some concern about the use of ginger during
pregnancy, largely due to the publication of The Complete German
Commission E Monographs in English, which state that ginger is
contraindicated during pregnancy.5 In a controlled experimental
rat study, however, ginger failed to demonstrate maternal or
developmental toxicity at doses up to 1000 mg/kg per day of
body weight.6 When pregnant Sprague-Dawley rats were admin-
istered 20 g/L or 50 g/L ginger tea via their drinking water from
gestation day 6 to day 15 and then sacrificed at day 20, no mater-
nal toxicity was observed; however, embryonic loss in the treat-
ment groups was double that of the controls (P<.05).7
Researchers at the Hospital for Sick Children in Toronto,
Canada, conducted a prospective observational study in which
they followed 187 pregnant women who used some form of gin-
ger in the first trimester. The risk of these mothers having a baby
with a congenital malformation was no higher than that of
women in a control group.8 The follow-up of RCTs consistently
shows that there are no significant side effects or adverse effects
on pregnancy outcomes.4
In summary, based upon traditional use, modern use in the
population as a spice, animal data, as well as clinical trials, we
can assume with some degree of assurance that ginger at doses of
1.0 to 1.5 g per day is a safe and effective remedy for NVP.
Vitamin B6, or vitamin B6 plus doxylamine, is safe and effec-
tive and should be considered first-line pharmacotherapy. A single
25-mg dose of the antihistamine doxylamine (Unisom) tablet
taken at night can be used in combination with vitamin B6 (10-25
mg 3 times daily).9 Acupressure was found in 6 of 7 randomized
trials to be effective for relieving morning sickness.10 Acupressure
wristbands are readily available over the counter, and many
women find them a less expensive alternative to acupuncture.
URINARY TRACT INFECTION
Urinary tract infections (UTIs) are common in pregnancy;
up to 90% are due to the gram-negative bacteria Escherichia coli.
Pregnancy increases the risk of UTI because increased bladder
volume and decreased bladder and ureteral tone increase urinary
stasis and ureterovesical reflux.11 Up to 70% of pregnant women
develop glycosuria, which encourages bacterial growth in the
urine.12 Untreated asymptomatic bacteriuria can lead to the
development of pyelonephritis in up to 50% of cases and is asso-
ciated with an increased risk of intrauterine growth retardation
The Use of Botanicals During Pregnancy and Lactation ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
and low-birth-weight infants. Thus, routine screening is advocat-
ed. The US Preventative Services Task Force recommends a urine
culture be obtained between 12 and 16 weeks of gestation.13
Case
Shelly is a G3P2 and is being seen for her first prenatal visit at 9
weeks. She has had 2 healthy children, born vaginally at term, and is
excited about her current pregnancy. Her exam is normal except for the
presence of bacteria in her urine. She denies any dysuria, frequency, or
urgency. Shelly is frustrated at the prospect of taking antibiotics, as she
ended up on suppressive therapy during her last pregnancy because of
recurrent asymptomatic bacteriuria. She wants to know if there is any-
thing else she can try.
Cranberry (Vacccinium macrocarpon) reduces the frequency
of UTI by preventing the adherence of pathogenic E coli and other
fimbriated bacteria to the urinary epithelium. A Cochrane review
reported that cranberry significantly reduces the incidence of
UTIs at 12 months (RR 0.65, 95% CI 0.46-0.90) as compared to
placebo/control.14 Cranberry extracts in tablet form also reduce
the risk of UTI and are often more convenient and better tolerat-
ed. There are no significant safety concerns for cranberry prod-
ucts during pregnancy and given the significant morbidity that
can occur, it seems common sense to recommend it for preven-
tion. Though not studied to the same degree as cranberry, blue-
berries and blueberry juice appear to exhibit similar activity.15 The
typical dose is 4 oz cranberry juice 2 times per day or 400 mg
cranberry extract twice daily.
Uva ursi (Arctostaphylos uva-ursi), also known as bearberry, is
endorsed by the European Scientific Cooperative on Phytotherapy
and the German Commission E for minor infection/inflammato-
ry disorders of the lower urinary tract. Arbutin, an active com-
pound in uva ursi leaf, has antibacterial activity against E coli,
Pseudomonas aeruginosa, Proteus mirabilis, and Staphylococcus
aureus.16 Uva ursi reduced the risk of recurrent UTI in a 12-month
study of 57 women who had at least 3 documented UTIs in the
previous year when compared to placebo.17 Unfortunately for
Shelly, both the German Commission E and the American Herbal
Products Association18 contraindicate the use of uva ursi during
pregnancy, likely due to the potential for hydroquinone toxicity in
the fetus. Exposure of human lymphocytes and cell lines to hydro-
quinone has been shown to cause various forms of genetic dam-
age.19 Uva ursi is also contraindicated during lactation.5
The use of cornsilk (Zea mays) for afflictions of the kidney
and bladder can be traced back to the Incas. Parke-Davis intro-
duced a cornsilk product in the 1880s for the treatment of urinary
pain and spasm. The British Herbal Compendium lists cornsilk as a
mild diuretic and urinary demulcent. Cornsilk is quite safe and
often included in herbal formulas designed to ease the pain of cys-
titis. No contraindications are found in the literature.
PARTUS PREPARATORS AND LABOR AIDS
Case
Kathy responded to the combination of an acupressure bracelet
and ginger capsules for the nausea and vomiting she experienced during
55
her first trimester. She has had an easy pregnancy and is now in her
34th week. She returns to your office with an herbal product her friend
used during her last pregnancy. The label says it contains blue cohosh
(Caulophyllum thalictroides), black cohosh (Actaea racemosa),
and raspberry (Rubus spp). Kathy’s friend said that it was “simply
amazing” and that if a woman takes the product 6 weeks before her
due date, it will “essentially guarantee a timely and painless birth.”
Kathy’s first pregnancy ended in an induction when she went 2 weeks
past her due date, and though she had prepared for natural childbirth,
she had an epidural for the pain. She is feeling a little anxious and
wants to know if these herbs are safe and if they can really help ensure
a timely and less painful birth.
Since ancient times, pregnant women have used and mid-
wives have recommended herbs to facilitate labor. These prepa-
rations are often referred to as partus preparators. Depending
upon the herb, these labor aids were taken anywhere from a few
days to a month before the suspected due date. Indigenous North
American women used blue cohosh to induce labor or stimulate
sluggish, ineffective contractions. It was official in the USP as a
labor-inducing agent from 1882 to 1905 and the NF from 1916 to
1950. There has been little contemporary data to explore its
effectiveness as a labor aid.
Blue cohosh is found in many formulations marketed to
women as partus preparators. Many obstetricians are unfamiliar
with its use, but a survey of nurse midwives in 1999 found that
64% used blue cohosh, often in combination with black cohosh,
to augment labor during delivery.20 While many used blue cohosh,
they also reported having the least comfort with its use during
pregnancy as compared to other herbs. A significant number
reported observing an increased rate of meconium, tachycardia,
and need for resuscitation in association with its use.
There have been a small number of case reports implicating
blue cohosh, often in combination with black cohosh and/or
other herbs, with myocardial infarction,21 multiorgan failure,
congestive heart failure,22 and perinatal stroke23 in infants born
to mothers taking the herb several weeks before birth. While the
published case reports are not conclusive, blue cohosh contains
some potentially dangerous compounds that should give clini-
cians pause. Blue cohosh contains caulosaponin, a glycoside that
has been shown to constrict coronary vessels and likely accounts
for its oxytocic effects.24 It also contains N-methylcytisine, an
alkaloid with action similar to nicotine, known to cause coronary
vasoconstriction, tachycardia, hypotension, and respiratory
depression.25 In vitro studies show that extracts of blue cohosh
rhizome or pure N-methylcytisine (at 20 ppm) induce major mal-
formations in cultured rat embryos. 26 The concentration of
N-methylcytisine in dietary supplements containing blue cohosh
ranges from 5 to 850 ppm.27
The question immediately before the healthcare profession-
al is what to say to a woman regarding the safety and use of blue
cohosh during pregnancy. Despite the shortcomings of pub-
lished case reports, the chemistry and pharmacology of the plant
are reasonably well known. The human case reports, as incom-
plete as they are, paint a picture that is consistent with the evi-
56 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
dence provided by in vitro and animal studies. At this time, it is
wise to err on the side of caution and counsel against its use dur-
ing pregnancy.
Black cohosh (Actaea racemosa, Cimicifuga racemosa) is prob-
ably best known for its use in menopause, though it was tradi-
tionally used for rheumatic pain and uterine cramping and to
ease melancholy. The German health authorities also recognize
its use for dysmenorrhea. It is unrelated to blue cohosh, but the
two herbs are often used in combination to induce labor or as a
partus preparator. Studies on other Cimicifuga species failed to
show teratogenicity in female rats at doses up to 2000 mg/kg per
day28; however, similar studies in Actaea racemosa have not been
published. Both the British Herbal Pharmacopoeia 29 and
American Herbal Products Association contraindicate the use of
black cohosh during pregnancy.18 Reproductive toxicology stud-
ies are definitely needed for this herb.
Raspberry leaf (Rubus idaeus, R occidentalis) can be found in
many popular “pregnancy teas.” It is often promoted to prevent
miscarriage, ease morning sickness, and ensure a quick birth. A
survey of 172 certified nurse midwives found that 63% of midwives
using herbal preparations recommended red raspberry leaf.20
A retrospective study of women taking raspberry leaf from
30 to 35 weeks onward failed to find any significant adverse out-
comes in mother or infant compared to controls.30 A double-
blind, placebo-controlled study randomized 192 low-risk,
nulliparous women to receive raspberry leaf tablets (2 tablets of
1.2 g per day) or placebo from 32 weeks’ gestation until delivery.31
Raspberry leaf was not associated with any adverse effects in
mother or baby but contrary to popular belief did not shorten the
first stage of labor. Clinically significant findings were a shorten-
ing of the second stage of labor (mean difference, 9.59 minutes)
and a lower rate of forceps deliveries between the treatment group
and the control group (19.3% vs 30.4%). No contraindications for
use in pregnancy or lactation are found in the literature.
LACTATION
Although the benefits of breastfeeding may be self-evident,
they are also increasingly demonstrated by science. Benefits
include the superior nutritional composition of breast milk,32
reduced incidence of feeding intolerance and necrotizing entero-
colitis in preterm infants,33 and enhanced resistance to infectious
disease.34 There is also a significant psychological benefit for both
mother and infant. It is beyond the scope of this brief article to
explore the myriad of ways botanical medicine could be safely
used by breastfeeding women for conditions such as sore nip-
ples, engorgement, early mastitis, nipple thrush, postpartum
depression, etc. Instead, this article will be limited to a discus-
sion of lactagogues.
Lactagogues, or galactagogues, are substances that aid in
the initiation, maintenance, or augmentation of milk production.
Common indications include increasing milk production after
maternal or infant illness or separation, reestablishment of milk
supply after weaning, or induction of lactation in a woman who
did not give birth to the infant (eg, adoption). Maternal milk
The Use of Botanicals During Pregnancy and Lactation
production is a complex process. Dopamine agonists inhibit,
whereas dopamine antagonists increase, prolactin and milk pro-
duction. Although some lactagogues act as dopamine antago-
nists, the mechanism of action for most is simply not known.
Case
Anna is a 27-year-old single mother of a 9-week healthy son born
at term. Anna has recently started back to work part-time and is con-
cerned that her milk supply is faltering. She is trying to pump, but “it
isn’t going very well.” Anna had been successfully breastfeeding prior
to returning to her job. The baby appears healthy and hydrated. You
observe Anna using the breast pump and make appropriate recom-
mendations. Anna returns 6 weeks later for the baby’s immunizations,
and you ask how the breastfeeding is going. Anna tells you that her
mother gave her a tea of fenugreek and shatavari and laughingly
reports that she is making enough milk to feed the neighborhood.
Around the world and throughout history, women have
used herbs and foods to enhance their milk supply. In spite of
formal scientific evaluation, many are widely recommended.
Herbs commonly mentioned in the literature include fenugreek,
goat’s rue, milk thistle, blessed thistle, shatavari, aniseed, cara-
way seed, dill, borage, and comfrey.
Fenugreek (Trigonella foenum-graecum) has been valued as a
spice and medicine throughout India and the Middle East for
millenia. The seeds are used to relieve intestinal gas and respira-
tory congestion, and in larger doses, it can reduce serum choles-
terol and glucose levels. Fenugreek has a substantial reputation
for increasing breast-milk production in nursing mothers. A case
report summarized the anecdotal use of fenugreek in at least
1200 women who reported an increase in milk supply within 24
to 72 hours.35 Two small preliminary reports also suggest effec-
tiveness,36,37 yet in spite of its widespread use, there are no rigor-
ous trials for review. Well-tolerated, ingestion of fenugreek can
impart a maple-like odor to sweat, milk, and urine, which could
lead a practitioner to mistakenly consider the diagnosis of maple
syrup–urine disease (branched-chain hyperaminoaciduria), a
rare inherited metabolic disorder, in a breastfed infant whose
mother is taking the herb. There is crossreactivity in those with
chickpea allergy. There are numerous cautionary statements in
the literature regarding hypoglycemia with fenugreek use, though
blood sugar–lowering activity is mild and seen only at doses
exceeding 25 g per day. The usual dose for lactagogue effect is 1
to 2 g of the dried powdered seeds taken 3 times per day.
Fenugreek can also be prepared as tea, steeping a quarter tea-
spoon of seeds in 8 oz of water for 10 minutes.
The roots of wild asparagus (Asparagus racemosus), also
known as shatavari, have been widely recommended in the
Ayurvedic tradition to increase milk production in lactating
women. The herb is considered to be a nourishing herb and is
also recommended for those who are debilitated or convalescing.
Nursing mothers often consume a combination of wild aspara-
gus root and cardamom called Shatavari Kalpa. There are a
handful of animal and human studies that support the lactogenic
effect of wild asparagus, given either alone or in combination
The Use of Botanicals During Pregnancy and Lactation
with other herbs38; however, a randomized controlled study of A
racemosus in women with lactational inadequacy failed to find
any effect on milk production or prolactin levels.39 The dose is 1 g
powdered root per day taken in milk or juice.
The lactagogue effect of goat’s rue (Galega officinalis) leaf was
first scientifically reported to the French Academy in 1873 after
observing that it increased milk production in cows by 35% to
50%. These findings were later independently confirmed in 1913.40
There are no modern studies for review. Goat’s rue is found in
numerous products, typically in combination with other herbs.
The tea is generally prepared by steeping 1 teaspoon of dried
leaves in 8 oz of water for 10 minutes, with 1 cup taken 2 or 3
times a day. One adverse event in the literature links the maternal
ingestion of a lactation tea containing extracts of licorice
(Glycyrrhiza glabra), fennel (Foeniculum vulgare), anise (Pimpinella
anisum), and goat’s rue with drowsiness, hypotonia, lethargy,
emesis, and poor suckling in 2 breastfed neonates. An evaluation
for infection yielded negative results, and symptoms and signs
resolved after discontinuation of the tea and a 2-day break from
breastfeeding.41 The tea was not tested for contaminants or adul-
terants, and there are no other published adverse events.
Milk thistle (Silybum marianum), best known for its liver-
protecting effects, has been used as a lactagogue for centuries.
Early Christian lore holds that the white leaf veins are a symbolic
representation of the Virgin Mary’s breast milk, hence the com-
mon names of milk thistle and St Mary’s thistle. There are no
human studies evaluating its purported lactagogue effect. There
are no known safety concerns with the seed. The tea is prepared
by simmering 1 teaspoon crushed seeds in 8 oz of water for 10
minutes. The dose is 1 to 3 cups daily or 1 to 3 g of the ground
seeds in capsule form. Note that this is not the standardized
extract typically used for liver disorders but rather crude prepa-
rations of the seeds.
Aniseed, caraway seed, cinnamon, dill, and fennel seed are
all aromatic spices that can easily and safely be added to the diet:
dill to a tuna salad, cinnamon in applesauce, a cup of anise tea,
or candied fennel after a meal. Raspberry and nettle can be easily
consumed in tea. Of the herbs commonly recommended in lay
literature, only comfrey and borage should be avoided as they
contain pyrrolizidine alkaloids, which pass readily into breast
milk and have the potential to cause severe liver damage.42
CONCLUSION
Women have been the recipients, as well as the primary
keepers, of botanical medicines for millennia. Women herbalists
and midwives observed the effects that particular plants had on
female reproduction, pregnancy, and breastfeeding, handing
down their knowledge across the generations. While their exper-
tise and wisdom can still be felt in various folk traditions, much
of the wise woman knowledge was shared through oral, not writ-
ten, traditions; thus, some of the finer nuances of herbal minis-
trations have been lost. The lack of formal herbal training
programs in Western countries over the past century has contrib-
uted to our gap in knowledge. While scientific research has
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 57
exploded in the field of natural products, there has been shame- 26. Kennelly EJ, Flynn TJ, Mazzola EP, et al. Detecting potential teratogenic alkaloids from
blue cohosh rhizomes using an in vitro rat embryo culture. J Nat Prod.
fully little research aimed at assessing the safety and effectiveness 1999;62(10):1385-1389.
of botanical remedies during pregnancy and lactation. When 27. Betz JM, Andrzejewski D, Troy A, et al. Gas chromatographic determination of toxic
quinolizidine alkaloids in blue cohosh Caulophyllum thalictroides (L.) Michx. Phytochem
coupled with a marketplace filled with hundreds of products tar- Anal. 1998;9(5):232-236.
geting women, including a considerable number with dubious 28. Liske E. Gerhard I, Wustenberg P. Menopause: herbal combination product for psy-
chovegetative complaints. TW Gynakol. 1997;10:172-175.
efficacy and questionable quality, it becomes clear that there is a 29. Bradley PR. British Herbal Compendium: Volume 1: A Handbook of Scientific Information
strong need for a rigorous approach for assessing which herbs on Widely Used Plant Drugs. Dorset, UK: British Herbal Medicine Association; 1992.
30. Parsons M, Simpson M, Ponton T. Raspberry leaf and its effect on labour: safety and
are of benefit and under what circumstances. Hopefully clini- efficacy. Aust Coll Midwives Inc J. 1999;12(3):20-25.
cians, researchers, and herbal manufacturers can work together 31. Simpson M, Parsons M, Greenwood J, Wade K. Raspberry leaf in pregnancy: its safety
and efficacy in labor. J Midwifery Womens Health. 2001;46(2):51-59.
to conduct rigorous scientific studies, both at the basic science 32. Wagner CL, Anderson DM, Pittard WB 3rd. Special properties of human milk. Clin
level and in clinical trials; create reasonable practice guidelines Pediatr (Phila). 1996;35(6):283-293.
33. Lucas A, Cole TJ. Breast milk and neonatal necrotizing enterocolitis. Lancet.
for the use of botanical remedies during pregnancy and lactation; 1990;336(8730):1519-1523.
and design high-quality products that are based on sound formu- 34. Wright AL, Bauer M, Naylor A, Sutcliffe E, Clark L. Increasing breastfeeding rates to
reduce infant illness at the community level. Pediatrics. 1998;101(5):837-844.
lation, scientific principles, and clinical need. 35. Huggins KE. Fenugreek: One Remedy for Low Milk Production. Available at: http://www.
breastfeedingonline.com/fenuhugg.shtml. Accessed December 2, 2008.
REFERENCES 36. Swafford S, Berens P. Effect of fenugreek on breast milk volume. Abstract presented at:
1. Vickers KA, Jolly KB, Greenfield SM. Herbal medicine: women’s views, knowledge and 5th International Meeting of the Academy of Breastfeeding Medicine; September
interaction with doctors: a qualitative study. BMC Complement Altern Med. 2006 Dec 7;6:40. 11-13, 2000, Tucson, Arizona.
2. Glover DD, Amonkar M, Rybeck BF, Tracy TS. Prescription, over-the-counter, and 37. Co MM, Hernandez EA, Co BG. A comparative study on the efficacy of the different
herbal medicine use in a rural, obstetric population. Am J Obstet Gynecol. galactogogues among mothers with lactational insufficiency. Abstract presented at:
2003;188(4):1039-1045. AAP Section on Breastfeeding, 2002 NCE; October 21, 2002.
3. Cashion C. Endocrine and metabolic disorders. In: Lowdermilk DL, Perry SE, Bobak 38. Goyal RK, Singh J, Lai H. Asparagus racemosus—an update. Indian J Med Sci.
IM, eds. Maternity and Women’s Health Care. 7th ed. St. Louis, MO: Mosby; 2003;57(9):408-414.
2000:861-886. 39. Sharma S, Ramji S, Kumari S, Bapna JS. Randomized controlled trial of Asparagus rac-
4. Borrelli F, Capasso R, Aviello G, Pittler MH, Izzo AA. Effectiveness and safety of ginger emosus (Shatavari) as a lactogogue in lactational inadequacy. Indian Pediatr.
in the treatment of pregnancy induced nausea and vomiting. Obstet Gynecol. 1996;33(8):675-677.
2005;105(4):849-856. 40. Remington JP, ed. The Dispensatory of the United States of America. 20th ed. Philadelphia,
5. Blumenthal M, Busse W, Goldberg A, et al, eds. The Complete German Commission E PA: Lippincott-Raven; 1918.
Monographs: Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical 41. Rosti L, Nardini A, Bettinelli ME, Rosti D. Toxic effects of a herbal tea mixture in two
Council; 1998. newborns. Acta Paediatr. 1994;83(6):683.
6. Weidner MS, Sigwart K. The safety of ginger extract in the rat. J Ethnopharmacol. 42. Panter KE, James LF. Natural plant toxicants in milk: a review. J Anim Sci.
2000;73(3):513-520. 1990;68(3):892-904.
7. Wilkinson JM. Effect of ginger tea on the fetal development of Sprague-Dawley rats.
Reprod Toxicol. 2000;14(6):507-512.
8. Portnoi G, Chng LA, Karimi-Tabesh L, Koren G, Tan MP, Einarson A. Prospective com-
parative study of the safety and effectiveness of ginger for the treatment of nausea and
vomiting in pregnancy. Am J Obstet Gynecol. 2003;189(5):1374-1377.
9. Atanackovic G, Navioz Y, Moretti ME, Koren G. The safety of higher than standard
dose of doxylamine-pyridoxine (Diclectin) for nausea and vomiting of pregnancy. J Clin
Pharmacol. 2001;41(8):842-845.
10. Fugh-Berman A. Acupressure for nausea and vomiting of pregnancy. Alt Ther Women’s
Health. 1999;1(2):9-16.
11. Patterson TF, Andriole VT. Bacteriuria in pregnancy. Infect Dis Clin North Am.
1987;1(4):807-822.
12. Lucas MJ, Cunningham FG. Urinary infection in pregnancy. Clin Obstet Gynecol.
1993;36(4):855-868.
13. US Preventive Services Task Force. Guide to Clinical Preventive Services: Report of the U.S.
Preventive Services Task Force. 2d ed. Baltimore, MD: Lippincott Williams & Wilkins; 1996.
14. Jepson RG, Craig JC. Cranberries for preventing urinary tract infections. Cochrane
Database Syst Rev. 2008 Jan 23;(1):CD001321.
15. Jepson RG, Craig JC. A systematic review of the evidence for cranberries and blueber-
ries in UTI prevention. Mol Nutr Food Res. 2007;51(6):738-745.
16. European Scientific Cooperative on Phytotherapy Monographs on the Medicinal Uses
of Plant Drugs. Fascicule 5. Exeter, United Kingdom: ESCOP, 1997.
17. Larsson B, Jonasson A, Fianu S. Prophylactic effect of UVA E in women with recurrent
cystitis: A preliminary report. Curr Ther Res Clin Exp. 1993;53(4):441-443.
18. McGuffin M, Hobbs C, Upton R, Goldberg A. American Herbal Products Association’s
Botanical Safety Handbook. Boca Raton, FL: CRC Press; 1998.
19. Smith MT, Zhang L, Jeng M, et al. Hydroquinone, a benzene metabolite, increases the
level of aneusomy of chromosomes 7 and 8 in human CD34-positive blood progenitor
cells. Carcinogenesis. 2000;21(8):1485-1490.
20. McFarlin BL, Gibson MH, O’Rear J, Harman P. A national survey of herbal preparation
use by nurse-midwives for labor stimulation. Review of the literature and recommenda-
tions for practice. J Nurse Midwifery. 1999;44(3):205-216.
21. Gunn TR, Wright IM. The use of black and blue cohosh in labour. N Z Med J.
1996;109(1032):410-411.
22. Jones TK, Lawson BM. Profound neonatal congestive heart failure caused by maternal
consumption of blue cohosh herbal medication. J Pediatr. 1998;132(3 Pt 1):550-552.
23. Finkel RS, Zarlengo KM. Blue cohosh and perinatal stroke. N Engl J Med.
2004;351(3):302-303.
24. de Smet PA, Hansel R, Keller K. Adverse Effects of Herbal Drugs. Berlin, Germany:
Springer Verlag; 1993:348.
25. Scott C, Chin K. The pharmacologic action of N-methylcytisine. Therapeutics.
1943;79:334.

58 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 The Use of Botanicals During Pregnancy and Lactation
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review article
A POSSIBLE CENTRAL MECHANISM IN
AUTISM SPECTRUM DISORDERS, PART 2:
IMMUNOEXCITOTOXICITY
Russell L. Blaylock,
In this section, I explore the effects of mercury and inflamma-
tion on transsulfuration reactions, which can lead to elevations
in androgens, and how this might relate to the male preponder-
ance of autism spectrum disorders (ASD). It is known that
mercury interferes with these biochemical reactions and that
chronically elevated androgen levels also enhance the neurode-
velopmental effects of excitotoxins. Both androgens and gluta-
mate alter neuronal and glial calcium oscillations, which are
known to regulate cell migration, maturation, and final brain
cytoarchitectural structure. Studies have also shown high levels
of DHEA and low levels of DHEA-S in ASD, which can result
from both mercury toxicity and chronic inflammation.
Chronic microglial activation appears to be a hallmark of
Russell L. Blaylock, MD, is a retired neurosurgeon and profes-
sor of biology at Belhaven College, Jackson, Mississippi.
Editor’s note: The following is part 2 of a 3-part series. Part 3
will appear in the Mar/Apr 2009 issue of Alternative Therapies in
Health and Medicine.
EXCESSIVE ANDROGENS AND AUTISM
There is strong evidence that mercury exposure in humans
increases androgen levels. For example, Barregård et al reported
that there was a significant correlation between increasing con-
centration of mercury in chloralkali workers and testosterone lev-
els.1 Animal studies also show a link between sex steroid
production and mercury dosing.2 Studies have also shown a link
between elevated prenatal testosterone,3 postnatal serum testos-
terone,4 and autism spectrum disorders.
As to the mechanism of testosterone elevation by mercury
exposure, it has been suggested that Hg2+ directly causes a defect
in adrenal steroid biosynthesis by inhibiting the activity of 21
alpha-hydroxylase,5 while others have suggested inactivation of
hydroxysteroid steroid sulfotransferase either directly6 or by way
of inflammation.7 It has also been shown that DHEA-S, the pro-
posed storage form of active DHEA, is also significantly lowered
in autistic disorders.8
Kim et al have shown that even very small doses of LPS
60 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
MD
ASD. Peripheral immune stimulation, mercury, and elevated
levels of androgens can all stimulate microglial activation.
Linked to both transsulfuration problems and chronic mercury
toxicity are elevations in homocysteine levels in ASD patients.
Homocysteine and especially its metabolic products are power-
ful excitotoxins.
Intimately linked to elevations in DHEA, excitotoxicity
and mercury toxicity are abnormalities in mitochondrial func-
tion. A number of studies have shown that reduced energy pro-
duction by mitochondria greatly enhances excitotoxicity.
Finally, I discuss the effects of chronic inflammation and elevat-
ed mercury levels on glutathione and metallothionein. (Altern
Ther Health Med. 2009;15(1):60-67.)
(1 nmoL) can dramatically decrease the levels of mRNA for
SULT2A1 and PAPSS2, which are responsible for sulfonation of a
number of endogenous hydroxysteroids, bile acid, and xenobiot-
ics as well as sulfonation of DHEA to DHEA-S.7 Normally, DHEA-S
plasma levels are 300- to 500-fold higher than DHEA levels. Kim
et al found that TNF-α and IL-1ß were responsible for the
decrease. Unlike in autistic patients, DHEA levels were not
increased in LPS-exposed animals, which can occur with mercury
toxicity. Reductions in DHEA-S are common with other chronic
inflammatory disorders, such as rheumatoid arthritis.9
In keeping with the finding of a defect in transsulfuration,
one frequently sees associated elevations in androgens and eleva-
tions in homocysteine. For instance, several workers have found
elevated levels of homocysteine in cases of polycystic ovary syn-
drome.10,11 Normally, men have higher homocysteine levels than
women, thought to be secondary to higher androgen levels.12
Androgen excess interferes with the conversion of homo-
cysteine to cysthathionine, which by conversion to cysteine
becomes a major source of glutathione.13 Thus androgen excess
can not only raise homocysteine levels, it can lower glutathione,
a major antioxidant in brain. Other pathways in the methionine
cycle are also affected, which may partially explain the significant
reduction in methionine seen in autistic children, as well as
s-adenosyl methionine levels.4,14
James et al found not only low total glutathione levels in
autistic subjects but also oxidized glutathione levels that were
2-fold higher, which strongly indicate oxidative stress.14 Several of
A Possible Central Mechanism in ASD, Part 2
the enzymes utilized in the methionine cycle, such as methionine
synthase, betaine-homocysteine methyltransferase, and methion-
ine adenosyltransferases, are known to be redox-sensitive
enzymes.15,16 With the chronic elevation of ROS, RNS, and lipid
peroxidation products in the autistic brain, one would not be sur-
prised by suppression of these enzymes.
Vitamin B12 and folate interplay in generating methyl groups
during the methionine cycle. A recent study found an increased
frequency in mutations of the C677T allele of methylenetetrahy-
drofolate reductase enzyme in autistic children.17 The same genetic
mutation causes elevations in homocysteine.18 In addition, studies
have shown abnormal absorption of vitamin B12 from the ileum
of autistic children.19
It is accepted that there is a dimorphic influence of sex steroids
on both external male/female morphology as well as brain structure
and behavior.20 In addition, it has been suggested that autism repre-
sents a form of “extreme male brain,” with normal male behaviors,
such as a reduced ability to read nonverbal skills, different language
skills, and low theory of mind function, being accentuated.21,22
Support for this theory arises from studies of children with
congenital adrenal hyperplasia (CAH), which is characterized by
high levels of circulating androgens in both afflicted males and
females. For example, in one such study, Knickmeyer et al found
that females affected with high androgen levels scored higher on
the Autism Spectrum Quotient test than normal females.23
While this is suggestive of a link, despite high levels of testos-
terone in children with CAH, few are fully autistic, even though
they may share some behavioral symptoms. In addition, many
have other metabolic disorders that could contribute to symp-
tomatology, such as electrolyte disorders.
This is not to say that these studies on CAH didn’t show
behavior effects; it’s just that the serious defects in social cognitive
function seen with autism are not observed. This indicates that
more is involved with autism than elevated androgen levels early
in development. For example, elevated androgen levels do not
explain the chronic extensive immune activation seen in the autis-
tic brain or the prolonged, widespread activation of microglia and
astrocytes. It also doesn’t completely explain the extensive neuro-
pathological findings and abnormal pathway development found
in the autistic brain.
A number of studies have shown abnormalities in both mor-
phology and function in the amygdala and prefrontal cortex of
autistic children, something not accounted for with androgen
excess alone.24-26 Estrada el al have shown that supraphysiologic
levels of testosterone (micromolar ranges) can initiate apoptosis
of neuronal cells in culture, which should affect neural develop-
ment.27 Likewise, Geier and Geier found rather dramatic and
rapid improvement in 11 consecutively treated autistic children
using both mercury chelation and leuprolide acetate, a drug that
lowers androgen levels.28 The children experience a 2-fold drop in
serum testosterone levels over 3 months. Improvements were
seen in sociability, cognitive awareness, and aggressive behavior,
due mostly to lowered androgen levels, as the effects of mercury
chelation usually take longer to manifest.
A Possible Central Mechanism in ASD, Part 2 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
It should be noted that children fasting for blood test have
been noted to show similar rapid improvements in behavior. The
combination of elevated androgens, reduced glutathione protec-
tion against oxidative stress, and elevated levels of homocysteine
would be of considerable concern during brain development.
The Role of Androgens and Estrogens on Microglial
Activation and Excitotoxicity
The question to be answered is by what mechanism does
androgen excess affect neurodevelopment and neurologic func-
tion? There are several possibilities, yet they may be interrelated.
It is known that both testosterone and estrogen, at basal
levels, are neuroprotective and play a significant role in neu-
ronal development, migration, dendritic outgrowth, and synap-
togenesis.29,30 Central to the effect of androgen excess appears to
be generation of calcium oscillations by androgens, which have
been shown to regulate not only neurite outgrowth but also neu-
ron migration.31 These oscillations of calcium are not caused by
stimulation of nuclear gene androgen receptors but rather by
rapidly acting cell membrane G-protein-regulated receptors that
activate endoplasmic reticulum calcium release by inositol
1,4,5-triphosphate and diacylglycerol signal transduction.32 It
was also shown that the calcium oscillations were not secondary
to conversion of testosterone to estrogens by brain aromatase.
These oscillations of intracellular calcium also code for cell dif-
ferentiation in the CNS.33
The recent finding by Balthazart et al that the glutamatergic
system, primarily acting through the AMPA/kainate receptors,
rapidly inhibits brain aromatase activity demonstrates another
mechanism by which brain testosterone levels remain elevated in
the autistic child.34 Brain aromatase, as an inducible enzyme, con-
verts testosterone into 17ß-estradiol as an inducible enzyme.35
Studies have shown that both NMDA receptors and andro-
gen receptors play a role in neuronal differentiation, migration,
and dendritic outgrowth by regulating calcium oscillations.36,37
Calcium waves have also been shown to regulate growth cone
function.38 Of particular interest was the finding by Estrada et al
that low concentrations of testosterone induced calcium oscilla-
tions, but high concentrations produced sustained dose/depen-
dent elevations in intraneuronal calcium levels, something that
would be expected to produce abnormal neuronal migration and
neurotoxicity.27 In their study, they indeed found that higher
doses of testosterone triggered apoptosis human neuroblastoma
cells. The effect was dose-dependent, with 1 μmol measured in
inducing significant cell death and 10 μmol being significantly
more lethal. It is also of note that the recent finding of region
specific 5α-reductase, which converts testosterone to the more
potent dihydrotestosterone, can result in specific regions of the
CNS having testosterone levels higher than plasma levels.39
Others have noticed that there is a sex difference in terms
of the outcome of neurological injury, with females making bet-
ter neurological recoveries than males.40,41 Experimentally, Hawk
et al found that chronic testosterone replacement increased
stroke damage, and 17ß-estradiol treatment decreased damage
61
in castrated male rats.42 This is in keeping with the demonstrat-
ed protective effects of estrogens on brain, at least when in
physiological ranges.
While androgen receptors have been demonstrated in the
hypothalamus, hippocampus, preoptic area, amygdala, and
medial hypothalamus, they have also been demonstrated
throughout frontal lobe areas as well and influence frontal lobe
GABAA receptor regulation.43-48 This finding demonstrates a
more expanded behavioral effect of androgens than merely
reproductive behavioral effects.
In another study, Yang et al using both a murine hippocam-
pal culture and an in vivo study using Sprague-Dawley rats found
that 10 μmol of testosterone in vitro significantly increased gluta-
mate toxicity.49 Likewise, 10 μmol of estradiol significantly ame-
liorated glutamate toxicity. In the in vivo study, they used an
implanted testosterone pellet for slow release of the hormone to
minimize the stress of repeated injections. Using a middle cere-
bral artery stroke model, they found that the testosterone-
implanted animals had a significantly larger volume of stroke
damage than did controls.
Androgens, like excitotoxins, have been shown to enhance
the inflammatory mediator NF-kB and thereby increase COX-2
and iNOS activation, leading to free radical generation, lipid per-
oxidation, and increased secretion of glutamate from microglia.50,51
Using both an excitotoxic and stab wound injury to hippocampus,
García-Ovejero et al demonstrated that both lesions could induce
androgen and estrogen receptors on glia.51 Estrogen receptor
alpha (ERalpha) was expressed on astrocytes, and androgen
receptors (AR) were expressed on microglial membranes.
Both receptors were observed to appear 3 days after the
injury, with the maximum of ERalpha and AR immunoreacting
glia appearing at day 7 and returning to baseline at 28 days.
Taken together, these studies indicate that chronic elevation of
testosterone activates microglia, triggering the release of a num-
ber of neurotoxic elements including the excitotoxins glutamate
and quinolinic acid. Indeed, DonCarlos et al have shown that of
the glial cells only activated microglia express androgen recep-
tors, whereas activated astrocytes express estrogen receptors.52
They also found that AR immunostaining was heavier in frontal
cortex than the hypothalamic-limbic structures. In addition, the
demonstration that microglia direct neuronal precursor cell
migration and differentiation and that activated microglia can
increase neuronal numbers significantly may explain the hyper-
cellularity seen in certain areas of the autistic brain, particularly
the amygdala.53
When androgen levels are chronically elevated, microglial
activation would not only be enhanced, but toxicity of secreted
glutamate and inflammatory cytokines would be exaggerated.
Unlike the adult brain, this combination of inflammatory cytok-
ines, androgens, and excitotory neurotransmitters would not
only precipitate chronic neurodegeneration but also alter pro-
genitor cell differentiation and maturation, dendrite outgrowth
and arborization, synaptic development and stabilization, and
neuronal migration.
62 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
HOMEOCYSTEINE, EXCITOTOXICITY, AND THE
DEVELOPING CENTRAL NERVOUS SYSTEM
Homocysteine, which is elevated in many autistic children, is
involved in various transsulfuration reactions, such as cysteine
synthesis, remethylation for methionine synthesis and trans-
methylation of DNA, proteins, and lipids, and the biosynthesis of
neurotransmitters and some hormones. While cysteine itself is
known to be a powerful excitotoxin,54 especially in an alkaline
environment, in the autistic low cysteine levels are seen.55
Elevated homocysteine, even to moderate levels, is associated
with Alzheimer’s disease,56 age-related memory loss,57 schizophre-
nia,58 neural tube defects,59 seizures,60 and neurobehavioral toxicity
of chemotherapeutic agents.61 Homocysteine oxidizes to a number
of L-glutamate analogues (L-homocysteine sulfinic acid [L-HCSA]
and L-homocysteic acid [L-HCA]) and L-aspartate analogues
(L-cysteine sulfinic acid [L-CSA] and L-cysteic acid [L-CA]) with
significantly greater excitotoxic effects than homocysteine itself.62
Recent studies have shown that oxidized homocysteine
metabolites activate NMDA receptors as well as metabotropic
receptors and that in cerebellar granule cells, neurotoxicity
involves a co-stimulation of NMDA receptors and Group I
metabotropic receptors.63 Others have confirmed potent stimula-
tion of excitatory metabotropic glutamate receptors by homo-
cysteine metabolites.64,65
Lockhart et al found that hippocampal neurons were espe-
cially sensitive to excitotoxicity induced by the homocysteine oxi-
dative product, L-homocysteic acid.66 There is growing evidence
that L-homocysteic acid may be a glial transmitter, acting through
astrocytic NMDA receptors.67 One sees a powerful amplification of
the excitotoxic cascade with the metabotropic receptors of group
I, as well as NMDA receptors, being activated by homocysteic acid
and homocysteine sulfinic acid, especially when in combination
with high levels of extraneuronal glutamate.
There is also evidence that Purkinje cells have unique receptor
properties in that they have few NMDA receptors and greater
expression of non-NMDA receptors.68 Homocysteic acid has been
shown, as an excitotoxin, to act through NMDA receptors in hip-
pocampal neurons and via non-NMDA receptors in Purkinje cells.
With proinflammatory cytokines, ROS/RNS, lipid peroxidation
products, and mitochondrial depression-caused amplification of
excitotoxicity, one can better understand the widespread loss of
Purkinje cells seen in the cerebella of autistic cases. In essence, this is
less of a direct autoimmune injury and more characteristic of
bystander injury described by McGeer and McGeer as autotoxicity.69
Because both inotropic and metabotropic glutamate recep-
tors, as well as androgens, act through excess intracellular calcium
accumulation, one can readily understand the critical role played
by each in the process, as explained in the next section.
Homocysteine oxidation products, such as homocysteic acid,
homocysteine sulfinic acid, and cysteic acid, along with gluta-
mate, inflammatory cytokines, chemokines, and inflammatory
prostaglandins, trigger the autotoxic injury to a widespread area
surrounding the immune reaction, thus explaining the autopsy
picture seen in the autistic brain.
A Possible Central Mechanism in ASD, Part 2
THE ROLE OF MERCURY IN AUTISM
Both mercury and aluminum are considered neurotoxic met-
als, with mercury being significantly more toxic. Autistic children
are exposed to a number of sources of mercury and aluminum.
Mercury exposure can be from atmospheric sources, dental amal-
gam, fish consumption, certain pesticides and herbicides, and vac-
cines. In most cases, children are exposed a number of such
sources. Of particular concern to the child’s developing brain is in
utero exposure to mercury from the mother’s dental amalgam, sea-
food consumption, or vaccinations during pregnancy or immedi-
ately before conception. Because of the human brain’s extensive
postnatal development, mercury exposure after birth is also of
major concern. Mercury has been shown to pass through the pla-
cental barriers rather easily, thus entering the fetus’s circulatory
system, and hence, brain.70,71 The leading sources of aluminum are
food and vaccines.
A number of studies have shown architectonic abnormalities
in the fetus following maternal exposure to mercury.72-75 This can
result in abnormalities in neuronal and glial proliferation, neu-
ronal migration, and the final cytoarchitecture of the brain, espe-
cially the cerebellum.
There is also evidence that ionic mercury is the most toxic
form of mercury within the CNS and that organic mercury is slowly
demethylated in the brain to form ionic mercury, which can then be
redistributed over time. Vahter et al, for example, studied demethy-
lation of methylmercury in Macaca fascicularis monkeys after oral
dosing with 50μg/kg of methylmercury for 6, 12, or 18 months and
found that the concentration of inorganic mercury slowly increased
in all brain sites but especially in the thalamus and pituitary.76
Recent studies have shown that there are toxicological and
pharmacokinetic differences between methylmercury from seafood
and ethylmercury from the vaccine preservative thimerosal. For
example, Burbacher et al, using monkeys exposed either to methyl-
mercury (MeHg) or vaccines with thimerosal at birth and then at 1,
2, and 3 weeks of age, found a significant difference in the blood
half-life, with thimerosal’s initial and terminal half-life being 2.1 and
8.6 days respectively and MeHg being 21.5 days.77 They also found
that ethylmercury’s brain concentration was 3-fold lower than
MeHg. Yet, of significant importance was the finding that 34% of
ethylmercury was converted to ionic mercury in the monkeys’
brains vs 7% for MeHg. Ionic mercury, besides being more toxic, is
much more difficult to remove from the CNS, even with chelation.
Two studies measured the mercury burden of children receiv-
ing the recommended childhood vaccines. Redwood et al found
that at birth an infant received 12.5 μg of mercury, 62.5 μg at 2
months, 50 μg at 4 months, 62.5 μg at 6 months, and 50 μg at 18
months, for a total mercury burden of 237.5 μg of ethylmercury
during the first 18 months of life, which exceed the environmental
protection agency safety guidelines for an adult.78 In the second
study, similar infant mercury exposures were seen.79
Effect of Mercury on Neurons, Microglia, and Astrocytes
One of the most obvious toxic effects of mercury is the gen-
eration of abundant free radicals and lipid peroxidation prod-
A Possible Central Mechanism in ASD, Part 2
ucts, with antioxidants providing considerable protection against
mercury-induced neurotoxicity.80 Yet a more complicated process
appears to be involved in the generation of these free radicals
since blocking the NMDA glutamate receptor also significantly
attenuates MeHg toxicity and reduces ROS generation as well.81,82
It has also been shown that free radicals dramatically increase the
toxic sensitivity of immature neurons to MeHg, so that previous-
ly nontoxic concentrations of MeHg became fully toxic,83 just as
in the case of excitotoxins.84
One of the most involved free radicals in both mercury neu-
rotoxicity and excitotoxicity is peroxynitrite, formed by an inter-
action between nitric oxide (NO) and superoxide. 83-85
Peroxynitrite is known to especially target the mitochondria,
which reduces energy production and enhances ROS formation.86
In addition, peroxynitrite, as a reactive nitrogen species, reacts
with cellular proteins, particularly L-tyrosine residues, producing
nitrotyrosine accumulation.
New evidence points to a strong connection between inflam-
mation in the brain, mitochondrial failure, and excitotoxicity
through calcium-activated inducible nitric oxide synthetase
(iNOS) and the formation of peroxynitrite.87 Activated microglia
are known to upregulate iNOS and generate large amounts of
peroxynitrite, which in turn not only triggers excitotoxicity but
reduces cellular energy levels.88,89 Reduction in cellular energy
enhances excitotoxicity to the degree that even physiological con-
centrations of extracellular glutamate can be excitotoxic.90 Recent
studies have shown that mitochondrial dysfunction is commonly
found in neurodegenerative diseases.91,92 Also of note, studies
have shown the mitochondria to have the highest intracellular
levels of mercury on exposure to ionic mercury.93
One of the major functions of mitochondria, besides energy
production, is calcium buffering. During excitotoxicity, much of
the cytosolic calcium is removed by either the smooth endoplas-
mic reticulum (SER) or mitochondria, and dysfunction of either
can result in exacerbation of intracellular signaling, with resulting
free radical generation, lipid peroxidation, and activation of cellu-
lar death signals. Mercury, by disrupting cellular calcium channels
and activating SER calcium signaling, further exacerbates the
problem, leading to abnormal neurogenesis and neurodegenera-
tion as well as microglial activation as described previously.94
Systemic stimulation of immunity utilizing LPS increases
brain oxidative stress, thus increasing sensitivity to excitotoxins
and mercury.95 In addition, as we have seen, systemic inoculation
with LPS also increases brain microglial activation, inflammatory
cytokine activation, and enhancement of excitotoxicity. Likewise,
these events are characterized by disruptions of calcium homeo-
stasis, mitochondrial dysfunction, and cellular energy loss—
again, all events that have been shown to disrupt neurogenesis
and induce neurodegeneration. The effect of overstimulation of
glutamate receptors, particularly NMDA and AMPA receptors, is
further enhanced by ROS, lipid peroxidation products, and
inflammatory cytokines, especially TNF-α.96,97 Aluminum, like
mercury, is a powerful inducer of brain ROS and LPO produc-
tion.98,99 Measures of oxidative stress and lipid peroxidation have
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 63
shown significant elevations in children with autism.100,101
It should also be noted that high levels of DHEA interfere
with mitochondrial energy production, and as we have seen,
DHEA levels are increased as much as 2-fold in some studies of
children with autism spectrum disorders.102 In this study, it was
found that high levels of DHEA suppressed complex I (NADH
quinone oxidoreductase) in primary cultures of cerebellar gran-
ule cells without affecting other mitochondrial electron transport
enzymes. In the in vivo part of the study, adult male mice were
fed a diet containing 0.6% DHEA for 10 weeks followed by a nor-
mal diet to exclude acute effects of DHEA. They found that the
neuron density was significantly lower in the primary motor cor-
tex and hippocampus. They also noted that under hypoglycemic
conditions, the toxic effect of DHEA was significantly more pro-
nounced. Because of the effects of complex I inhibition on neuro-
genesis, one would expect a different histological picture in
immature or fetal mice. With DHEA levels being significantly
elevated in autism spectrum disorders, it is reasonable to assume
depression of mitochondrial function would occur, especially in
the presence of other mitochondrial depressing factors such as
elevated levels of peroxynitrite and mercury toxicity.8
Charleston et al103 in their study of long-term exposure of
monkeys to methylmercury described extensive microglial, as
well as astrocytic activation throughout the brain as described in
the brains of autistics by Vargas et al.104 Of special importance,
they found continued microglial activation in the group of mon-
keys in which MeHg exposure was stopped for 6 months, dem-
onstrating that microglial activation persists long after exposure.
It should also be noted that with priming by mercury-induced
activation of microglia, further immune activation from any
cause, vaccinations, systemic infections, food allergies, etc, would
be expected to exaggerate brain excitotoxicity and inflammation.
While astrocytes are the major source of glutamate as well
as critical inflammatory cytokines, microglia act as the primary
mechanism of astrocyte activation, and they can also secrete exci-
totoxic levels of glutamate upon stimulation.105,106 This is especial-
ly so under conditions of mitochondrial dysfunction, magnesium
deficiency, and hypoxia/ischemia.
With astrocytes acting as the sink for mercury, concentra-
tions reach significantly higher, neurotoxic levels in this cell type.
Astrocytes also act as the primary site for glutamate uptake. A
large number of studies have shown that glutamate uptake can
be significantly altered by extracellular toxins, including TNF-α,
ROS, RNS, and lipid peroxidation products and that uptake is
sensitive to even small concentrations of mercury.107-111 In fact,
Brookes demonstrated that concentrations of mercuric chloride
as low as 0.5 μg inhibited glutamate transport into astrocytes by
50% and that no other metal tested—Al 2+, Pb 2+, Cu 2+, Co 2+, Sr 2+,
Cd 2+, or Zn 2+—inhibited glutamate transport.112 At this concen-
tration, mercury is considered not to be directly cytotoxic.
Glutamate uptake is not the only neurotransmitter affected.
Dave et al found that methylmercury not only inhibited gluta-
mate uptake in primary astrocyte cultures but that it also inhibit-
ed Na+-dependent and fluoxetine-sensitive [3H] 5-HT uptake as
64 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
well.113 This could in part explain the elevated serotonin levels
seen in autism.114 Of concern with chronically elevated levels of
serotonin is the fact that one of its metabolic products, quinolin-
ic acid, is also an excitotoxin secreted from activated microglia.115
Effect of Mercury on Glutamate Transporters
Glutamate regulation occurs through 4 primary mechanisms:
the XAC- transporters (excitatory amino acid transporters—
EAAT1-5), the Xc- cystine/glutamate antiporter, conversion of
glutamate into glutamine by glutamine synthetase, and metabol-
ic diversion into Kreb’s cycle. Inhibition of the EAAT glutamate
transporters may be primarily through oxidation, since antioxi-
dants can reverse the inhibition.116,117 The transporters contain
sulphydryl groups, which would make them vulnerable to mer-
cury as well as oxidation.118 It is also known that the transporters
are dependent on protein kinase C and that mercury inhibits its
function.119,120 One of the mechanisms for estrogen protection
against excitotoxicity is its ability to enhance glutamate transport
into the astrocyte.121
Not only do the glutamate transporters play a vital role in
preventing excitotoxicity, they also play a major role in brain
development, as there is a programmed rise and fall in the differ-
ent transporters during brain development.122 In one study,
Kugler and Schleyer found that the glutamate transporter GLAST
(EAAT1) was expressed in higher levels earlier in development
than GLT-1 (EAAT2) in the rat hippocampus and that both the
glutamate transporters and glutamate dehydrogenase were
increased at birth and rose to adult levels between P20 and P30,
indicating an important control system over glutamate levels
during postnatal development.123 Mercury has also been shown
to suppress glutamate dehydrogenase activity as well.124
It has also been shown that Purkinje cells are very depen-
dent on GLAST and EAAT4 for resistance against excitotoxicity
induced by hypoxia/ischemia. 125 GLAST is expressed in
Bergmann glia and EAAT4 in the perisynaptic region of Purkinje
cell spines.126 This could also explain the dramatic loss of Purkinje
cells in autism, since mercury toxicity alone usually spares the
Purkinje cells and targets cerebellar granule cells.127 A combina-
tion of inflammatory bystander injury, ROS-RNS/LPO accumu-
lation, androgen excess, and excitotoxicity dramatically increase
the damage, mainly because of hyperexcitability of NMDA and
AMPA receptors and chronic microglial activation with release of
neurotoxic elements.
Juárez et al demonstrated a dramatic increase in extracellu-
lar glutamate following methylmercury instillation in the frontal
cortex of 15 freely moving awake rats using a microdialysis
probe.128 They found a 9.8-fold rise in extracellular glutamate fol-
lowing a MeHg dose of 10 μmol and 2.4-fold rise using a 100
μmol dose. It is known that a dose of 10 μmol of MeHg produces
a 50% inhibition of glutamate uptake into astrocytes.129 Brain
trauma in rats has been shown to produce a 2.8-fold rise in extra-
cellular glutamate.130
Mercury is also known to be a potent inhibitor of glutamine
synthetase activity, which when inhibited, causes a buildup of
A Possible Central Mechanism in ASD, Part 2
extracellular glutamate.131 This can lead to excitotoxicity and an
alteration in neuronal migration and progenitor cell differentiation.
Mercury’s Effect on Glutathione, Metallothionein,
Excitotoxicity, and Autism
Another frequent finding in autism is lower glutathione lev-
els, which is also common with mercury toxicity and excitotoxici-
ty.132-134 As one of the principal intracellular antioxidants,
glutathione scavenges a number of reactive oxygen and nitrogen
species, including peroxynitrite. It has also been shown to have a
neurotransmitter function, binding to its own synaptic receptors,
and in addition has been shown to modulate glutamatergic excit-
atory neurotransmission by displacing glutamate from ionic recep-
tors.135,136 At high extracellular concentrations glutathione enhances
NMDA receptor activity, increasing the risk of excitotoxicity.135
Astrocytes are the sole source of glutathione for neurons,
making glutathione particularly susceptible to mercury inactiva-
tion, since astrocytes are also the principle site of mercury accumu-
lation in the CNS.137 Mercury has been shown to lower glutathione
levels in embryonic neuronal cells as well as adult neurons.138,139
Low glutathione levels have been associated with a number of neu-
rodegenerative conditions, especially Parkinson’s disease, as an
early event.140-142
Glutathione production by astrocytes is dependent on the
sodium-independent Xc- cystine/glutamate antiporter, which
exchanges intracellular glutamate for extracellular cystine utilized
by the astrocyte to produce glutathione.143 High levels of glutamate
inhibit cystine entry into astrocytes, resulting in low glutathione
levels, as we would expect with the elevated glutamate levels seen
in autistics and those exposed to mercury.144
Another protective system impacted by mercury is metalloth-
ionein. Rising et al have shown that exposure of rat neonatal pri-
mary astrocytes to methylmercury constitutively increase the
production of metallothionein-1 (MT-1) and MT-2.145 Aschner et al
demonstrated a 14-fold increase in MT-1 mRNA upregulation in
full-term fetal rats exposed in utero to elemental mercury vapor.146
Beside their role in heavy metal detoxification, metallothion-
eins function to control inflammation and oxidative stress and to
promote brain repair.147 They have also been found to play a signifi-
cant role in protection against excitotoxicity.148 MT-1 and MT-2 play
the most significant role in protection against neuroinflammation
and have been shown to reduce the number of activated microglia
during injury.149 With a significant number of metallothionein
molecules bound with mercury, they would be less able to carry
out their antiinflammatory and antioxidant functions.
There is abundant evidence that mercury, particularly in its
ionic form, is toxic to neurons and less so glial cells and that organ-
ic forms of mercury are demethylated slowly to form ionic mercu-
ry, with accompanying redistribution in the CNS. Because of
mercury’s effects on a number of enzymes, mitochondrial func-
tion, gene function, microglial activation, inflammatory cytokine
release, antioxidant systems, and glutamate metabolism, it
becomes a major player in abnormal brain development as well as
neurodegenerative-associated excitotoxicity. Most of these effects
A Possible Central Mechanism in ASD, Part 2 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
occur at very low micromolar or submicromolar concentrations.
Because few studies have looked at total accumulated con-
centrations from multiple sources, such as atmospheric mercury,
seafood sources, thimerosal-containing vaccines, and dental
amalgam, the impact of mercury has been grossly underestimat-
ed by many experts in autism spectrum disorders.
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68 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Conversations: Frank Lipman, MD
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FRANK LIPMAN, MD: WHERE EASTERN MEDICINE
MEETS WESTERN MEDICINE
Interview by Frank Lampe and Suzanne Snyder • Photography by Karol DuClos Photography
Frank Lipman, MD, is the founder and director of the Eleven Eleven
Wellness Center in New York, New York, where he practices integrative
medicine, combining the best of the many alternative practices he has
studied with Western medicine. Trained as a medical doctor in South
Africa, he became board certified in internal medicine after immigrating
to the United States in 1984.
Recognized as a leader in his field, he has been profiled in O Magazine,
Time Out New York, and Donna Karan’s Women to Women Magazine.
He has appeared as a medical expert on CBS’s Morning Show, Fox’s Good
Day New York and Ten O’clock News, and NBC’s Today in New York. He
has been on the cover of New York Magazine as one of the “in” doctors in
New York and named one of the healers for the new millennium by Country
Living’s Healthy Living. He has also been featured in many magazines,
including Marie Claire, Self, Harpers Bazaar, Elle, Spa Finders, Natural
Health, and New Age Journal.
Dr Lipman lectures and teaches frequently on various health topics.
He is the author of Total Renewal: 7 Key Steps to Resilience, Vitality
and Long-Term Health (Tarcher-Putnam, 2003) and Spent: End
Exhaustion and Feel Great Again (Fireside-Simon and Schuster, 2009)
and the editor of the website www.SPENTMD.com. He lives in White
Plains, New York.
Alternative Therapies in Health and Medicine (ATHM): How and
when did you first become interested in practicing medicine?
Dr Lipman: I grew up in South Africa in the ’50s, ’60s, and ’70s,
and those days it was sort of automatic: the smart kids went into
medicine. I was never really interested in medicine per se, but it
was what my brother did and what I was expected to do. I sort of
automatically went into medical school. I only got interested in
medicine when I qualified and I started practicing.
ATHM: Were your parents or anyone else in your family involved
in medicine?
Dr Lipman: My father was a frustrated pharmacist who wanted
Opposite: Frank Lipman, MD, shown here at his clinic in New York,
New York, believes that people feel spent as a result of systemic imbal-
ances and that getting back to nature—eating well and restoring the
body’s rhythms—is key to becoming healthy again.
Conversations: Frank Lipman, MD
CONVERSATIONS
to be a doctor, but because of financial limitations, he had to go
into pharmacy because that allowed him to work and go to
school at the time.
ATHM: Was there anything around the household as you were
growing up that also directed you that way?
Dr Lipman: My memories of how I grew up are more of a politi-
cal nature because I grew up in South Africa during apartheid
with politically active parents. What is right and what is wrong
and how disgusting and inhuman the apartheid system is was
imprinted on me more than medicine was. That was the topic of
conversation at the table, much more so than medicine.
ATHM: How did you form your sense of social justice, which
seems to have been very important in the formation of your
medical practice?
Dr Lipman: Growing up in South Africa during the apartheid
era, it was obvious that the system was morally and ethically
wrong and unjust. The apartheid government tried to brainwash
the white population in order to perpetuate their regime.
Consequently, I learned to question everything and to not accept
the status quo. I automatically learned to mistrust the system.
This questioning transferred itself to how I feel about the conven-
tional medical system where I believe that many if not most regu-
lar doctors are also brainwashed. As a result of their convictions
being so limited and narrow, they are skeptical of alternatives,
and this creates an unfortunate separateness in the medical sys-
tem. In the same way I was considered an outsider in South Africa
for questioning the system, I am considered “alternative” or a
“quack” for questioning the conventional medical system. I have
the same feeling about the medical establishment as I did about
the political establishment in South Africa then—I am separate
and other for not believing in their dogma and not toeing the
party line. In both cases, it is so obvious that this is harmful, that
the establishment is misguided. I call it medical apartheid.
ATHM: Can you expand on what you mean by “medical apartheid”?
Dr Lipman: Growing up in South Africa, I always struggled with
how most white people viewed the apartheid system. It was obvi-
ously so cruel, so rotten, so wrong, and yet the vast majority of
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 69
whites accepted it as something normal. You find yourself feeling
crazy for being the one to say, “This is not right; it shouldn’t be
like this.” Not that I was the only one, but I was in the minority
of my peers. I get a similar sense of uneasiness about our current
medical system, and once again I am part of a small minority. I
am not saying Western medicine itself is wrong, but I am critical
of a system that I feel is conservative and dogmatic. Some doc-
tors look at people like me and think that we are the crazy ones
for thinking differently, for telling patients that perhaps they
don’t have to rely upon conventional drugs for the rest of their
lives, that maybe there are other options. There is a separateness
between the two belief systems and an ignorance and hubris on
the part of the “powers that be” to be open to a more expansive
way of thinking. Change came to South Africa, and so will our
medical system have to change.
ATHM: Are there any specific examples of something that creat-
ed a turning point for you in terms of understanding the issues
around social justice in South Africa?
Dr Lipman: I don’t think there was one specific episode. The
social and legal injustices were pervasive and affected every
aspect of life in South Africa during the apartheid era. From the
Group Areas Act, which legally determined where the different
racial groups lived or were prevented from living, to the inferior
education system, it was everywhere. The brutality of the police
force was widespread and scary. Blacks and anyone who opposed
the system were especially targeted. Police raids were frequent
and notorious in their randomness. Even my parents’ home in
suburban white Johannesburg was raided a few times when the
police discovered that our maid was running a shebeen at our
home. A shebeen is like a local bar, a meeting place where friends
could gather and have a drink. It is a part of the local culture in
South Africa. The police would come with their sticks and beat
the people. You would see this type of episode fairly often grow-
ing up in that society. So for me, the older I grew, the more I
understood and the angrier and more frustrated I became.
ATHM: Was there anybody that you saw as a hero in fighting
apartheid?
Dr Lipman: Since the apartheid government banned all materi-
als relating to leaders of the freedom movement like Nelson
Mandela and Steven Biko, we did not know much about them
except that they were either imprisoned or died for their opposi-
tion to the system. Most details about their philosophies and
their beliefs were completely suppressed. Now I know that
Nelson Mandela is the most unbelievable man, but in those days
I did not really know that. We were forcibly kept ignorant.
ATHM: Who were your mentors as you were entering into medicine?
Dr Lipman: I had 2 really great mentors in South Africa. One
was Dr Bloomson, with whom I worked as a student at
70 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
Baragwanath Hospital, the biggest hospital in Africa. The hospi-
tal was so large and impersonal, and yet he managed to convey a
real warmth and sense of caring toward all his patients. He
taught me the importance of a good bedside manner. The other
big influence was Dr Paul Davis, a general practitioner I worked
with when I graduated. Paul’s leftist politics and mine were com-
pletely aligned. His practice drew many from both the leftist
political community and the art community. These associations
often resulted in the police raiding his practice to obtain the
medical records of detainees whom they had beaten up and who
consequently were treated by Paul. From Paul I learned the
importance of the doctor-patient relationship and became
increasingly aware of the human connection in the healing pro-
cess. He would always put his hands on the patient. He used to
say, “People get better in spite of the medicines that we give
them, and your job is to be there and to listen to them.” It was
while I was working at this practice that I was first exposed to
homeopathy, which was fairly popular in South Africa, and also
to acupuncture. This was where I began my journey in exploring
the many different alternative healing traditions, and when I left
South Afica, he gave me the Barefoot Doctor’s Manual as a farewell
present. It was also at Paul’s practice that I started noticing the
shortcomings of my training in western medicine.
ATHM: In your book Total Renewal, you write that it was at
Baragwanath Hospital that you had your first exposure to non-
Western medical traditions through seeing a sangoma, a tradi-
tional African healer. How did this affect your view of medicine
and healing?
Dr Lipman: At the hospital, there were times when a patient was
not getting better and the family called in a sangoma, or local
healer, to help. As crazy as it seemed to me, in many cases, the
patient would get better. I did not really understand the value of
the cultural context of the patient. This only developed after my
internship at Baragwanath. I spent 18 months working in a hos-
pital in Kwandebele, a tribal “homeland.” One of my duties was
to visit the outlying clinics, many of them accessible only by dirt
road. Next to one of the clinics lived a sangoma whom I noticed
helping some of the patients that I could not help in the hospital.
Initially my interest was only in taking photographs of her
“throwing the bones,” but over time, seeing that she did indeed
help her patients, I started to believe that there must be some-
thing more to this than I understood. When I came out of medi-
cal school, I arrogantly believed that I knew everything. However,
exposure to patients who got better using modalities that I
thought were nonsense led me to start questioning the limita-
tions of my training. Western medicine is hospital-based medi-
cine, which is great for acute care and critical care. However,
once I finished medical school and was working in Paul Davis’s
practice or at the clinics in Kwandebele, I began to see a different
type of patient—people suffering from headaches, fatigue,
insomnia, digestive problems. There was not much that my hos-
pital training could do to help those types of problems. I began
Conversations: Frank Lipman, MD
TK
to understand that there were other valuable healing traditions
that could significantly impact the health of patients, and it was
the role of the sangoma that first planted those seeds.
That is how I started questioning my training. I came out of
medical school a real believer in Western medicine. My father
was a pharmacist; my brother is an intensive care specialist. It is
not that I got brought up questioning the medical system. I got
brought up questioning the political system. As I got older I real-
ized that I should question both, that because of their exclusion-
ary nature, neither is particularly good for society.
ATHM: In one of your books, you discuss the South African con-
cept called ubuntu. Can you explain
what that is?
I
saw that
Dr Lipman: Ubuntu is an African
expression that means, “What
makes us human is the humanity we
the future
show each other.” I experienced this
when I was working in Kwandebele.
of medicine
There I was, a white boy driving
around in a jeep with a black transla-
would be to
tor and driver, and I felt I may be
perceived as a representative of a combine Western
detestable system. However, wherev-
er we went, people would ask us into medicine and
their homes and share their meals
with us. I was fascinated with the Chinese medicine.
culture. People were extremely poor
and hardly had any food, yet they
would always invite us in to sit down and share whatever they
had with them. That was pretty moving.
What is important to remember is that I only realized all of
this much later in life. I was in my early 20s when these things
were happening, and I did not really put it all together then. It
took me many years of thinking about medicine and thinking
about life. Nobody spoke about ubuntu back then. I discovered
the term much later when I recognized that this was just part of
their culture; their behaviors, their warmth, their invitations
were all a testament to how they saw the world.
ATHM: Did you have an “aha” moment at some point, when all
of this made sense to you?
Dr Lipman: Yes, after getting interested in Buddhism, I came to
realize that the concept of ubuntu and the Buddhist tenets of
compassion, respect, and connectedness are so similar. So when
I became familiar with the term ubuntu, it really resonated with
me because to me it is the same as the Buddhists talking about
compassion. When I realized what ubuntu was, it was definitely
an “aha moment” because it was putting a name to what I had
experienced in Kwandebele. This led me to find a way to give
back to South Africa, to help make a difference to a country that
had given me so much and to which I still feel very connected.
Conversations: Frank Lipman, MD ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
ATHM: You offer a unique blend of musculoskeletal medicine,
Chinese medicine, and functional medicine as part of your prac-
tice. How did you come to this?
Dr Lipman: When I came to the United States, I had to do 3 years
in a residency program to get a license in New York. I got into an
internal medicine program at Lincoln Hospital in the South
Bronx. Once again, I was working with acutely ill patients and see-
ing where Western medicine is really effective. But I realized after
a week or two of my residency that this is not the type of medicine
that I wanted to practice. Test results replaced the doctor-patient
relationship, it was too impersonal, and I was not happy.
Luckily, before I started my resi-
dency, a Hispanic woman who
worked at the hospital took a liking
to me and said, “Let me take you for
a drive through the South Bronx to
areas that you are never going to see
as a white person.” She took me first
to an organic garden, then to an acu-
puncture clinic—a detox clinic,
which was about 10 blocks from the
hospital and actually part of the psy-
chiatry department. It was fascinat-
ing because we walked into this
burnt-out building in the South
Bronx, and there were about 100
hardcore heroin addicts sitting qui-
etly with needles in their ears. That
was quite an experience.
When I realized that hospital-based medicine was not the
type of medicine I wanted to practice, I took a walk over to the
acupuncture clinic and introduced myself to Mike Smith, who
ran the clinic. I told him my story, and he was fascinated with
South Africa. We got to talking about politics, and he said,
“Whenever you want, you can always come and work here. You
can study here. It would be a pleasure to expose you to Chinese
medicine.” He was a psychiatrist who got turned onto Chinese
medicine. So whenever I had free time in the afternoon and
sometimes on weekends, I would go to the acupuncture clinic,
and I started learning acupuncture. I was fascinated with acu-
puncture because the philosophy of Chinese medicine is all
about balance and improving function. It made a lot of sense to
me. The philosophy resonated with me, so I kept going back.
So there I was in the hospital practicing Western medicine
and going to the acupuncture clinic and learning Chinese medi-
cine. What was interesting is that I would often see the same
patients who would come into each clinic for different problems.
I would see a patient in the hospital being treated for one prob-
lem, and then maybe a couple of weeks later, I would see the
same patient getting acupuncture for something else. It became
very clear that although they were completely different worlds,
two systems that saw the body so differently, they complemented
each other perfectly. It was an easy lesson for me to learn because
71
each was particularly good for treating certain conditions and
poor at others; they balanced each other’s weaknesses. I saw that
the future of medicine would be to combine Western medicine
and Chinese medicine. During the last year of my internship
there, they asked me to be chief resident. I said I would be chief
resident if I could do some rotations in psychiatry. The acupunc-
ture clinic was part of the psychiatry department. I ended up
spending 2 months at the acupuncture clinic.
By the end of my residency, I had completed almost all of the
required hours to get an acupuncture license in New York. I con-
tinued working at the clinic after I finished my residency. It was
not until a couple of years later that I came across the work of Jeff
Bland, who articulated so well the concepts of Chinese medicine
to improve function and balance, with Western physiology and
anatomy and biochemistry. Talk about an “aha” experience. That
was a major “aha” experience because there was Jeff Bland articu-
lating what I learned in Chinese medicine from a Western per-
spective. Getting introduced to Jeff and his work really put it all
together for me. Acupuncture is functional medicine. Acupuncture
is a way of improving function. That is the way I see it. It is just
another tool in my functional medicine tool bag.
ATHM: How is acupuncture integrated into your practice?
“In the same way I was considered an outsider in South Africa for question-
ing the [political] system, I am considered ‘alternative’ or a ‘quack’ for ques-
tioning the conventional medical system.”
72 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
Dr Lipman: When I finished my Chinese medicine training there
was this frustration that I always had about how to integrate it
with Western medicine. I was always wondering, how do I explain
this from a Western perspective? What is energy? What is chi?
What are meridians? I had been obsessed when I finished my
Chinese medicine training with how to integrate it. What is really
going on from a Western perspective when you stick in a needle?
Jeff Bland was great at explaining the internal medicine aspect of
Chinese medicine, but there was no one talking about what this
“energy” was, what were the meridians. Then I discovered the
importance of the fascia and became obsessed with it.
Acupuncture is a very hands-on, touchy-feely experience, so my
questions were, “What are these tender points I was feeling? Why
do these tender points occur? Why, when you needle a tender
point, do people get better? Even in areas away from the tender
point?” I started exploring osteopathy and the whole fascial sys-
tem. I started believing that the meridians are actual fascial path-
ways and what acupuncture is doing is releasing blocked fascia or
improving the flow through the fascia. As the meridian system is
connected from head to toe, so is the fascial system.
I started to become convinced that when we talked about
meridians in Chinese medicine or fascia in Western medicine, we
were talking about the same system, but I never found anyone else
“I began to understand that there were other valuable healing traditions
that could significantly impact the health of patients, and it was the role
of the sangoma that first planted those seeds.”
Conversations: Frank Lipman, MD
who articulated this until fairly recently, when I found some stud-
ies by Helen Langevin confirming that meridians are probably
fascial pathways.
Her studies showed that cells communicate via these integ-
rins, which are mini-projections on the cells. The integrins get
deformed and distorted through overuse, through misuse,
through age, and the distortion impedes cellular communication.
The act of needling the area or doing some deep tissue work to
the area actually improves the integrin function and improves cel-
lular function. That confirms what I see clinically all the time—
that acupuncture is a way of improving function.
I have been lucky to have studied with some great acupunc-
ture teachers. Mark Seem in New York was a big influence on me.
Harriet Beinfield and Efrem Korngold, who wrote the book
Between Heaven and Earth, have been my teachers for many, many
years and have been helpful in terms of giving me clarity on my
philosophy. They have been instrumental in making me think a
certain way. And recently I met an acupuncture teacher who I
think goes way beyond anyone else in terms of mixing the West
and the East. His name is Dr Alejandro Elorriaga Claraco, and he
teaches at the McMaster University in Canada. He has taken acu-
puncture to a whole other level. To me he is the Jeff Bland of the
acupuncture world. Unfortunately, not many people know about
“Rhythms of nature have become imprinted in our genes. In our genes and
biology, we still are our ancient ancestors, but we are living at a pace and
rhythm that are completely foreign to us. We have outpaced our biology.”
Conversations: Frank Lipman, MD
him. Anyone who really wants to understand acupuncture or to
learn to do acupuncture at a sophisticated level should take his
courses. And I have been blessed to have a yoga master, Lindsey
Clennell, personally guide me and show me the importance of
yoga and how I can integrate it into the way I practice.
So I basically practice my brand of functional medicine,
which includes my knowledge of Chinese medicine, acupunc-
ture, and yoga, which expands that model. When a patient
comes to see me, I give them acupuncture, and at the same time,
I change their diets, give them supplements, and encourage them
to do yoga or to mediate. It all works so well together.
Acupuncture is interesting because you get very close to your
patients. It is a very intimate experience. You are touching them
in a nonsexual way because acupuncture is such a hands-on
approach. This trusting environment enhances the relationship
between doctor and patient.
ATHM: How do you integrate your background in internal medi-
cine into your practice?
Dr Lipman: I don’t usually do much internal medicine. I think
where I integrate it is that I know who is sick and who is not sick.
For instance, a young woman came in to see me the other day. She
had chest pain and was coughing. I listened to her chest, and I
thought she might have pneumonia. I sent her straight out to get
an x-ray and get treated.
If someone is possibly having a heart attack or an acute asth-
ma attack or like the woman with pneumonia, I know they need
Western medicine. But for the most part, I would say almost all of
the patients that come to see me don’t need drugs or surgery.
Because of my training in Western medicine, I know who does
and who does not. I see Western medicine as one part of a more
comprehensive approach, which I call good medicine. Take the
woman with pneumonia, for example—I am not going to treat
her with acupuncture and herbs. She needed antibiotics.
ATHM: Please explain the concept of the “worried well.”
Dr Lipman: When you work in a hospital, you see acutely ill
patients who most of the time need antibiotics, drugs, or Western
medical management. The “worried well,” the people who come
in with headaches, fatigue, and back pain, are the patients whom
I am seeing in private practice in New York City or whom I saw in
Johannesburg. They are not sick enough to go to the hospital, but
there is enough going on that they know they need to do some-
thing. It is for these people that functional medicine, acupunc-
ture, and Chinese medicine work so well. They respond really well
with changing their diets, taking some supplements, doing a bit
of yoga, changing the way they think, changing when they eat and
how they eat.
ATHM: It seems you are focusing on the “worried well” as
opposed to the acute care patients. Is there a reason that you
chose to go in that direction?
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 73
Dr Lipman: I think it just happened. When I began my residency
here, there was no emphasis placed on the connection with the
patient. The patients used to come up to the ward. I would look at
the x-ray, look at the EKG, look at the blood results, and then
would have to go study up on the disease and present the case the
next day. I really did not have the time to spend taking a good his-
tory, examining a patient well, and getting to know him. There
was not much emphasis put on the doctor-patient relationship.
That is why I felt I needed to find a more rewarding way of prac-
ticing medicine. I have always loved the relationship aspect. I
think what really turns me on about medicine is developing bonds
with people. I think it is hard to do that in a hospital setting,
whereas in private practice, you can spend more time with
patients, and the “worried well” are the patients that I attract. It
all happened naturally.
ATHM: How did the Eleven Eleven Wellness Center in New York
come about, and what is its focus?
Dr Lipman: After my residency, I was working at a community
clinic downtown and part-time at the acupuncture clinic at the
hospital. An orthopedic surgeon came in for acupuncture to try to
control his blood pressure. He said, “By the way, I have tennis
elbow. Can you help me?” I put some needles in, and he came
back the next week and said, “My elbow is better, but my shoulder
is a bit sore. Can you help that?” I put some needles in, and he
came back the next week and said, “Now my shoulder is better. I
have a sports clinic downtown. Do you want to come work in my
sports clinic?” So I started working at the sports clinic. I was there
for about 2 years, but I wanted to explore health and healing
more. In 1992, I decided to open the Eleven Eleven Wellness
Center, where I could have other practitioners working with me.
There was an Alexander teacher, a yoga teacher, another acupunc-
turist, and a nutritionist. I wanted to expand on what I could offer
my patients. It is has been going strong ever since.
ATHM: What does the center focus on?
Dr Lipman: We focus on healthcare as opposed to disease care. The
focus is on education and prevention. How do we keep people healthy?
I am really big on trying to educate people to take care of themselves.
At the moment I have another great doctor, Alejandro Junger, who
works with me, who focuses on detox. There is also a physical thera-
pist, a chiropractor, a healer, and a nutritionist. The whole idea of the
clinic is to create a warm, trusting, and relaxing environment for peo-
ple, rather than a typical run-of-the-mill doctor’s office.
It is hard for me to put myself in any box in terms of how I
practice. I have developed a mixed bag of tricks that I use, and I
have always been my own biggest guinea pig. I am not one who
necessarily follows research that closely. If I see something is
working, I will explore it further, and that is really how I have
developed my practice. I am a good observer and implement what
I notice helping patients. I have a very practical approach; I am
not attached to any one system.
74 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
ATHM: Is there anything in particular that you are most proud of
at the center?
Dr Lipman: I think I am a great facilitator of helping people get
healthy. I motivate them to make changes to their lifestyles, to
their diets, to start yoga or an exercise program. The challenge is
that everyone is different and unique. The person sitting in front
of you one day is completely different from the person you see
the next day. How you develop a person’s treatment plan is very
personalized. I get a sense of how far I can push the limit. When I
am sitting with a patient, I keep saying to myself, “How far will
he go?” If I tell a patient he needs to give up sugar, caffeine, soy,
gluten, and dairy all at once, is he going to do it? Is it easier if we
do it slowly? A lot of it is getting a feel for what the patient can
and will do.
An advantage of acupuncture is that I see people once a
week initially. And the intimacy of acupuncture makes a big dif-
ference because of the trust that’s established. It is much easier
for me to develop a relationship with someone and get them to
trust me if they are getting help from the acupuncture. If they
come back the next week and they are feeling better, and I say,
“Why don’t you make all of these changes now?” they are more
likely to make them if they see that the acupuncture is helping. I
get great results for the most part.
ATHM: Let’s talk about another concept that you mention in
your work: the role of rhythm of nature.
Dr Lipman: I first realized the importance of rhythms and
health while working in Kwandebele, where there was no elec-
tricity. People lived in tune with the cycles of nature. They went
to sleep when it was dark and woke up when it was light. They
lived with the seasons, in sync with nature. We humans evolved
as people who lived in harmony with the seasons and with day
and night. As a result, these cycles and rhythms became imprint-
ed in our genes. We talk about nutrigenomics, eating for your
genes. I believe the same applies to rhythms; these rhythms of
nature have become imprinted in our genes. In our genes and
biology, we still are our ancient ancestors, but we are living at a
pace and rhythm that are completely foreign to us. We have out-
paced our biology.
Over the years, I have come to realize that rhythm is a key to
health and that working with body rhythms is essential. My job
is to help patients get their “groove” back. I have always been a
music fan. I love world music and in particular African music.
The beauty of world music is that you cannot really understand
the words; it is the rhythm that is important. Music and rhythm
are an integral part of my life.
My whole philosophy of healing is, how do we get back to
nature? How do we get back to the natural rhythms? My philoso-
phy on food is, eat as close to nature as possible. My philosophy
on exercise is, work with your body rhythms. When you watch
animals in nature, you’ll see they sprint and then stop. Even if you
watch a squirrel—the squirrel sprints, and then it stops or it slows
Conversations: Frank Lipman, MD
down. When kids play, they will run, run, run, and then they will
stop. In many of the yoga traditions, they will do strenuous yoga,
and then they will relax. With most Eastern exercises, it is not
push, push, push, like we often do in the way we train in the West.
There is a rhythm even to exercise. That is why I am a big believer
in variations of interval training where you sprint and then you
stop, so you are teaching your body to recover. Finding one’s
rhythm is really important to my philosophy on health.
For example, we know about circadian rhythms. We know
that there are different rhythms in our body, that these rhythms
govern all of our physiological processes, that we actually have
an internal body clock. Science is now showing that our body
clocks try to harmonize them-
selves with natural rhythms. I
W
believe many sleep disturbances
are from rhythm disorders. I
e are
believe being spent, which is what
I named my new book, this feel-
living
ing of exhaustion, is a result of us
being out of sync with our body too far
rhythms because we are continu-
ally giving our bodies the wrong removed from
cues. For instance, we do not give
it enough sunlight. We use artifi- the rhythms and
cial lights at night. We are eating
the wrong food at the wrong cycles of nature,
times. We are exercising way too
fast or not at all. We don’t spend and consequent-
enough time in nature. These all
upset the body rhythms. The par-
allel I use is animals in the zoo as
ly we are getting
opposed to animals in the wild.
Animals in the zoo have a much
chronic diseases.
shorter lifespan. They develop
chronic diseases, whereas animals
in the wild don’t. People living in this industrialized world are
much like animals living in a zoo. We are living too far removed
from the rhythms and cycles of nature, and consequently we are
getting chronic diseases.
ATHM: What led you to write Spent?
Dr Lipman: I noticed that most of the patients who came in to
see me were exhausted, even though many were not complaining
of feeling exhausted. They would come in with digestive prob-
lems or aches and pains. The feeling of exhaustion was just an
accepted norm. They thought, “Oh, I am just getting older.” This
is how everyone feels. At the same time, I started to understand
the value of rhythm and the beneficial effects of adjusting the
way you eat and the way you move or the way music can be used
to help people get back into rhythm. When I do acupuncture and
I put needles into people at the office, I use special CDs, and I
have them wear headphones. I get them to not only listen to but
to feel the music and the tones in these special CDs. I saw the
Conversations: Frank Lipman, MD
effects of rhythm helping people all the time. I saw how restor-
ative yoga helped. I saw how getting people to modify the way
they exercise helped. I saw how getting people to have a smoothie
in the morning that has protein and a green drink helped. I have
seen hundreds, thousands of patients, and I have seen what
works, and I thought, “Gee, I have all of this information that I
learned over the years; let me put it into a book as a program.”
What I try to do in the book is give daily tips. The name,
Spent, was suggested to me by one of my patients, and that is
such a perfect name because everyone feels spent.
“Spent” is really how you feel. “Spent” could mean your
adrenals are weak, your thyroid is not functioning properly, or
you are nutritionally depleted.
“Spent” is a catchall for many
types of problems or what I see as
systemic imbalances. I took a lot
of what I saw helping my patients
and put it all together in a book
and called it Spent: End Exhaustion
and Feel Great Again.
ATHM: And it is a 6-week pro-
gram that you ask people to go
through?
Dr Lipman: It is a 6-week pro-
gram, but that is because we had
to come up with a time period; the
publisher wanted a program. I see
it more as 50 to 60 tips on how to
get back in rhythm and then stay
healthy. The book sort of devel-
oped into a program that is a vari-
ation of what I do in my practice.
I see it more as, “These are
healthy tips to get you back in rhythm.” Some people may need
to work more on their diet, others on their exercise, others on
their minds. That is why I structured it into daily tips. The way I
practice is more of a freewheeling type of style that allows me to
pick and choose what I think will be most beneficial to the
patient. The book compiles all of the tips for good health in one
place. Six weeks may seem long for some people, so on the web-
site www.SPENTMD.com, we have a 1-week program.
ATHM: Based on your observations, do you feel that this issue of
exhaustion or being spent is an epidemic?
Dr Lipman: I do think it is an epidemic, in New York anyway.
When I speak to people from around the country, it seems like it
is an epidemic in most big cities. Most of us are overwhelmed
and overloaded. That is part of why people get spent. Another
aspect is that there is a lot of what I call “corporatitis.” The
whole corporate model is breaking down. I see it a lot in New
York: people are working much harder than they used to because
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 75
the corporations fired more workers, so the same person has to
do 2 people’s work.
People are working longer hours. They often feel powerless,
and I believe that contributes to feeling spent, too. This kind of
stress, combined with so many toxins in the environment, not
getting enough sun or nutrients in our diets, not taking supple-
ments, all of these things contribute to this epidemic. When I
speak to practitioners from around the country, they say the same
thing—they are seeing more and more people who are exhausted.
I have simplified it in terms of calling it “spent.” What I have tried
to do in my office is create a little haven for people. They come in;
they chill out for 45 minutes with
the acupuncture and the music.
Sometimes I put them in restor-
I
ative yoga positions while I am see Western
doing the acupuncture. They leave
the office feeling so much better. medicine as one
What is interesting is all you
need to do is change a couple of part of a more
things to improve your health. That
is the beauty. If you catch it early
and make a couple of changes, you
comprehensive
are going to feel much better.
approach, which I
ATHM: What are you working on
in the near future? call good medicine.
Dr Lipman: Spent comes out this
month. On the companion website, www.SPENTMD.com, I
want to expose people to a lot of different, interesting people and
wise elders. I want people to start thinking differently about the
way they see medicine. I want them to see music as medicine,
movement as medicine, ubuntu as medicine. I want to try to edu-
cate people about modalities or parts of their lives that they don’t
consider beneficial to their health. For instance, I think it is cru-
cial for one’s health to have meaning in our lives, so I want to
turn people onto various nonprofits that are doing important
work around the world. I work with 2 nonprofits in South Africa,
and this work has been so meaningful to me because I have been
able to make a difference in the country that I had to leave and
still love so much. When people have meaning in their lives, its
effects can be profound. I think that is where I am heading now.
Another project I am so excited about is a project I worked
on with Bill Laswell, a patient of mine and a brilliant musician
and cultural gem. We have brought out a CD, Spent: Beats to Bring
You Back, an amazing CD companion to the book, to help people
get back in rhythm. It takes you on a rhythm trip through Africa,
India, and Latin America.
ATHM: Is there anything you are particularly proud of?
Dr Lipman: Yes, the organic gardens I initiated in Port Elizabeth,
South Africa. I was inspired by Rancho la Puerta, a wonderful
spa near the United States-Mexico border where I have been
76 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
teaching for the last 9 years. They have a great organic garden
there. Depending on what time of the year you go, anywhere
from 40% to 80% of the food you eat comes from their gardens.
Then a few years ago, I started working with the Ubuntu
Education Fund (www.ubuntufund.org), a nonprofit group in
South Africa that works with impoverished kids, many of whom
have AIDS and are orphans. When we went back one year, I
noticed that many of the kids in the schools that we work in were
getting a piece of bread with jelly at school for lunch. For many,
this was their only meal of the day. I also noticed that next to
some of the schools there was some open, unused land. I thought,
“Why don’t we plant some
organic vegetable gardens, so we
can start feeding the kids nutri-
tious food rather than the bread
and jelly?” I saw how successful
it was at Rancho la Puerta. So I
got funding from a benefactor,
and we started organic vegetable
gardens at 3 schools, and they
have been a huge success. We are
now feeding more than 1100 kids
a day from the vegetables we
grow in our gardens, and as I
said, for many, this is their only
meal of the day. Many of these
children’s parents have died from
AIDS, so a lot of grandparents
are serving as housekeepers and homemakers. We get them to
help at the schools. They make a big stew from the vegetables
every day for the kids. I think by the end of the year, 6 or 7
schools will have gardens.
In the same community, we created a vegetable garden at an
AIDS clinic where the AIDS patients work in the gardens and are
fed from the gardens. We will be working with 2 or 3 more clinics
in the next couple months. The garden project has become a
huge success. Every time I go back, I see how much better the
kids are just from getting one nutritious meal a day. Not only are
the kids who have AIDS doing much better, but many of the kids
with ADD and learning problems are better too, now that they
are getting healthy nutrients. We are seeing what great improve-
ments in health we can get by just giving these kids basic nutri-
ents. That is one project that I am really proud of—using my
knowledge of nutrition and my connections in New York and
doing good with it. My mission is to do good. How do you spread
the word about this new medicine and spread the wealth? I want
to do good in society because too many people have too little,
and there is too much unnecessary suffering.
Conversations: Frank Lipman, MD
 s p e c i a l
AHMA JANUARY 2009 Newsletter
Healthcare and holistic medicine
are changing. The American
Holistic Medical Association is
in the midst of its internal trans-
formation and is serving as a
catalyst for positive change in
healthcare across the country.
Message from the President
We have more wonderful news as the
winter holiday season passes and the new
year begins. The board had its 2009 plan-
ning retreat in November in Cleveland,
Ohio. While there, we sponsored a recep-
tion for the local holistic community.
Approximately 60 people attended, some
from 3 hours away. The Board enjoyed
meeting our members and prospective
new members, and we hope to continue
these meetings in association with future
board meetings.
With the leadership change in this
country, it is likely that there will also be
changes in healthcare policy. The AHMA is
working to see that holistic medicine is on
the radar and agenda of those in our lead-
ership as healthcare policy is reexamined.
As our membership is growing, our
staff is slowly growing too, so that we can
continue to provide services for our mem-
bers and the public. We are once again
stepping forward as a healthcare leader,
78 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
f e a t u r e
this time with a focus on collaboration
and integration. I am grateful for the trust
you have placed in the Board for leader-
ship, and the support you have given us
during the past year as we have worked to
rebuild and redefine our organization.
In 2008 we accepted the invitation of
the AANP to join with their organization
for our yearly conference. Many of you
attended, and the conference was a won-
derful experience. We knew from our
membership meeting that it was impor-
tant to create an AHMA conference. The
board has responded and we are in the
process of planning two distinct confer-
ences for our members in 2009. One is a
return to an annual AHMA conference
and the other is a collaboration with
A.R.E. Both have a goal to enhance our
experience, and integrate our members
with other communities.
This spring we will have our first
“spring break” for personal enrichment
and community-building. It will take
place in Virginia Beach, May 1-3, in con-
junction with the A.R.E. workshop enti-
tled, “Your Body Speaks Your Mind”.
There will be sessions created specifically
for AHMA members.
Our annual scientific and educational
meeting is scheduled for November 5-7,
2009 in Cleveland, Ohio. Planning is
underway for an exciting experience in
cooperation with other organizations. We
will be working with some of the organiz-
ers of Pangea conference that was held in
New York City this past November and in
other locations around the United States
(San Francisco, New York) for the past
four years..
The winter holidays for me - from
Thanksgiving through the New Year - have
always been a time for giving thanks,
reconnecting with family and friends, and
appreciating the many good things we
have in our world. I consider it a privilege
to support the important work that the
American Holistic Medical Association is
doing, not only by paying my member-
ship dues but through personal contribu-
tions and work. Many of you demonstrate
your support in that same way, and for
that, I give you my personal thanks.
As 2009 begins, please consider join-
ing the Board and making a tax- deduct-
ible contribution to the AHMA for our
30/30/30 fund-raising campaign. We
have much to do in 2009, and your contin-
ued support through membership, partic-
ipation, and financial contribution, will
make it all possible.
I look forward to seeing you at our
meetings in 2009 this year and wish you
the best,
Hal Blatman, President
November Board Meeting Summary
Present: Pat Belisle, Hal Blatman, David
Forbes, John Laird, Paul Mittman, John
Neely, Donna Nowak, David Riley, Molly
Roberts, Henri Roca, Robert Wickiewicz
The November AHMA board meet-
ing was held in Cleveland, Ohio and
among the “good news” items reported
was that membership has stabilized and
for the last quarter the physician renewal
rate has steadily climbed.
The AHMA Board of Trustees voted
unanimously to further refine our
Physician member category (now called
“Doctor” members). Doctor members
shall be persons who have earned a rec-
ognized doctorate degree from an accred-
ited institution (DC, DDS, DMD, DMP,
DO, DOM, DSC, MD, ND, PharmD,
PhDNP, PhDPsych, and PsyD) and are
currently licensed to diagnose, treat, and
practice their profession by the applica-
ble licensing or examining board and
who have been accepted for membership
by such procedures as the Board of
Trustees may designate.
2009 AHMA Meeting & Conference
The AHMA is collaborating with the
A.R.E. May 1-3 in Virginia Beach at the
conference titled “Your Body Speaks Your
Mind: Learning the Language of Your
AHMA Newsletter
 s p e c i a l
Body/Mind Connection”. We’ll be join-
ing authors of “Your Body Your Mind”,
Deb & Ed Shapiro, Dr. Eric Mein and oth-
ers for three days of learning how to
decode the emotional, psychological and
spiritual message that underlies your
health and understand the intricate rela-
tionship between the mind and body.
You’ll also have a unique opportunity
for community building with AHMA col-
leagues, A.R.E. members and friends, and
time for spa treatments and tourist attrac-
tions. For more information on this and
other A.R.E. events, go to www.edgar-
cayce.org. We will soon share more details
regarding this AHMA activity.
2009 AHMA Annual Conferences
The AHMA will once again be hold-
ing an annual conference, November 5 - 7,
2009 in Cleveland, Ohio. The focus will
be The Future of Integrative Health. There
will be a pediatric track drawn from the
highly successful Pangea conferences in
integrative pediatrics that does not have a
conference scheduled in 2009. Invited
keynotes include Michael Roizen, Leland
Kaiser, and Tieraona Low Dog. More
details coming soon.
Newsletter
Information for the March 2009
newsletter should be sent electronically to
the AHMA by February 5th.
Executive Director Update
It’s hard for me to believe that 2008
is over. When I accepted the position as
AHMA’s Executive Director and CEO
nearly a year ago, I had little idea what I
was getting into. And between you and
me, that’s probably a very good thing.
In many respects, this has been the
most challenging business endeavor of my
nearly 57-year life. 2008 has come to a
close, and when I look back at what we
have accomplished together since
February 2008 (the membership, Board,
staff and so many important others work-
ing side-by-side), I get goose bumps. It is
exciting to consider the good things that
2009 holds for us.
AHMA Newsletter
f e a t u r e
The AHMA is blessed to have 815
members united around our shared mis-
sion of helping transform healthcare to a
more holistic model. For those who know
the organization’s recent financial histo-
ry, I am delighted to say that we will fin-
ish the year well in the black after having
lost nearly $34,000 in 2007. Yes, we must
continue to invest in our infrastructure to
ensure continued growth, but the prog-
nosis is good.
There is no doubt in my mind that
the AHMA’s greatest asset lies within the
rich diversity of our membership: We
range in age from our 20’s to 80’s. We
have MD’s, ND’s, DO’s, DC’s, DOM’s and
a host of other impressive and dedicated
doctors. Our membership also includes a
compassionate and committed group of
licensed healthcare professionals, e.g.,
acupuncturists, massage therapists, and
nurses, as well as those practitioners
whose helpful services are, as yet, unli-
censed (Reiki, for instance). We are also
thrilled to have students, residents, busi-
ness managers, interns, and a variety of
others coming together under the AHMA
umbrella. We are a wonderful eclectic
mix, united behind an important mis-
sion. It seems to me that the time we
spent in 2008 repairing relationships and
building bridges, and laying the bricks/
applying the mortar for a strong founda-
tion, has restored our own sense of well-
being and given us an incredible and
appropriate optimism for the future.
Best wishes for a healthy and happy
2009. May your involvement in the
American Holistic Medical Association -
whether as a member, friend, donor,
sponsor, or someone who benefits from
our services - bring you many blessings.
Staff News
The AHMA must have been very
good this year, because Santa delivered a
very special gift after the holidays.
Kathleen Alter, a creative professional
with expertise in business development,
corporate sales, event planning, public
relations and executive management has
joined us as Director of Business
Development.
Over the past couple of months,
Kathleen has volunteered her services in
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
various ways. That means we already
know how much she will contribute to our
growing organization’s needs. She has
served as Executive Director of three dif-
ferent nonprofits during the past decade,
and for five years prior, she was Director
of Convention Sales & Marketing for the
Ft. Wayne/Allen County Convention &
Visitor’s Bureau.
Kathleen will take the lead on corpo-
rate fund raising, grant writing, events
planning, and general management sup-
port. Please help us welcome her to the
AHMA team.
2009 Member Directory
A preliminary version of the 2009
member directory was posted on the
AHMA website in November. Thanks to
Heather El-Khoury and Shakirra Jones for
all of their efforts in publishing such a
helpful resource. In addition to listing
members alphabetically and providing
cross-references by both geographical area
and specialty, the directory includes a
glossary of CAM credentials, definitions
of many modalities, other national orga-
nizations that may be of interest, etc.
Members can access the directory by
going to www.holisticmedicine.org,
choosing the Members Only tab, and then
selecting “2009 Member Directory” from
the drop-down menu bar. If any of your
personal information needs to be updat-
ed, please make changes through the web-
site by February 15, 2009, or contact
Shakirra Jones for help by email at
Shakirra@holisticmedicine.org or by
phone at (216) 292-6644.
Communicate Your Message through
Advertising
If you would like to advertise your
products or services nationally, or simply
want to make it easier for AHMA mem-
bers and friends to understand more
about what you do, consider placing an ad
in our newsletter or member directory.
Bi-monthly Newsletter Advertising
The AHMA’s bi-monthly newsletter
is sent electronically to all AHMA mem-
bers and “tipped inside” the digital edi-
tion of Alternative Therapies in Health and
Medicine.
79
 s p e c i a l
Ad Sizes: Member /Non-Member
2-1/8” w x 2” h - $100/$150
2-1/8” w x 3” h - $150/$200
4-3/8” w x 4” h - $200/$300
2009 Member Directory Advertising
Ad Sizes: Member /Non-Member
3-1/2” w x 4-3/4” h - $150/$250
7-1/2” w x 4-3/4” h - $350/$450
Full page 7-1/2” w x 10” h - $500/$650
Full page inside front - $725/$850
Full page inside back - $625/$750
Full page center - $750/$875
Donna Nowak, Executive Director
Letters from AHMA Members
Conflict of Interest
Is there a conflict of interest when
holistic doctors sell nutraceuticals for a
profit?
I occasionally am asked by a medical
student how I feel about holistic physi-
cians prescribing nutraceuticals for
patients and then selling them for a profit.
I tell them that I believe that we are not
doing our patients or our profession a
favor by making a profit on anything we
prescribe for our patients. That includes
pharmaceuticals, nutraceuticals, laborato-
ry tests, x-rays, ultrasounds, CT scans,
and scores of other tests routinely done in
our offices.
A number of studies have validated
that when physicians make money off
procedures, they end up prescribing more
of them. The same is true for pharmaceu-
ticals and nutraceuticals.
The vision statement by the
American Medical Student Association
(AMSA) is as valid for nutraceuticals as it
is for pharmaceuticals. Vision: AMSA
envisions a day when pharmaceutical
companies are able to dedicate their
resources to creating drugs that physi-
cians choose to use because they are effec-
tive in treating disease, not because they
are effectively marketed. We envision a
day when every medical student and phy-
sician is aware of the professional, ethical
and practical complications of the cur-
rent relationship with pharmaceutical
company representatives. We envision a
day when physicians demand integrity,
80 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
f e a t u r e
honesty, and education (not biased infor-
mation) from members of their profes-
sion, for the sake of our patients and their
trust in us.
Of course, it is not just that we pre-
scribe and profit from nutraceuticals.
Some holistic physician colleagues have
the same kind of close relationships with
nutraceuticals companies and their rep-
resentatives that have plagued the doc-
tor/drug industry for many years. We
are offered free or reduced rate confer-
ences, free samples, free luncheons with
a speaker presentation, and free or dis-
counted products.
I believe there is a conflict of interest
when a holistic physician makes a profit
on something she or he has prescribed. I
would like to hear from those holistic phy-
sicians who are making a profit on what
they are prescribing. There may be some
excellent arguments as to why it is a good
idea, and a free exchange of ideas may be
beneficial to everyone.
Bill Manahan MD
AHMA Past President
billmanahan@msn.com
HARPS are Changing
Creating a sense of community–
nationally and locally – has always been of
utmost importance to the AHMA and
continues to be so. I’d like to thank every-
one who has ever served as a Holistic Area
Resource Person (HARP). Creating com-
munity will be important as we transition
into our future. As we move into the
broader landscape of advocacy and
healthcare transformation, we will devel-
op local communities that link compo-
nents of our new membership–doctors,
practitioners, and community members.
We are transitioning our local effort
to a more organized AHMA “chapter”
concept, that will be rolled out in 2009.
There will no longer be an individual
HARP. This transition will involve having
a core group of leaders who all must be
members of the AHMA (one of these core
group must be a doctor as newly defined
by the AHMA.
Locales that feel that their situation
warrants individual consideration can
contact me by e-mail at Henriroca@aol.
com, by phone 225-266-8051, and/or
Donna Nowak, Executive Director at
216-292-6644.
Henri Roca MD
AHMA Board, Community Liason
Upcoming Conferences and Events
February 19-21, 2009
Integrative Healthcare Symposium
Perhaps you remember this conference as
CAM Expo from the past. This year’s
event, entitled, “Advancing Integrative
Medicine to Improve Patient Care”, will be
held at the Hilton New York and Towers in
NYC. The AHMA will hold a member/
guest meeting at 5:45 pm on 2/19 in the
Clinton room
www.ihsymposium.com.
FEBRUARY 25-27, 2009
National Summit on Integrative
Medicine and Public Health
Convened by the Institute of Medicine
(IOM) of the National Academies and
building on their 2002 report the National
Summit on Integrative Medicine and the
Health of the Public will be held in
Washington, DC, on February 25-27,
2009. This National Summit will explore
the science and practice of integrative
medicine — health care that addresses the
need for improving the breadth and depth
of patient-centered care. www.iom.
edu/?ID=52555
May 1-3, 2009
A.R.E. Conference - Your Body Speaks
Your Mind: Learning the Language of
Your Body/Mind Connection
Decode the emotional, psychological, and
spiritual messages that underlie your
health, and understand the intricate rela-
tionship between the mind and body with
Deb Shapiro and Ed Shapiro; Dr. Eric
Mein, author of Keys to Health; and Istvan
Fazekas, author of Edgar Cayce and the
Yoga Sutras, revealing the Cayce body-
mind-spirit connection.
www.edgarcayce.org/edgar_cayce/
conferencesVaBeach.aspx
AHMA Newsletter
 s p e c i a l
May 12-15, 2009
Consortium of Academic Health
Centers for Integrative Medicine
The North American Research Conference
on Complementary & Integrative
Medicine will be held in Minneapolis,
MN. CAHCIM consists of 41 leading aca-
demic medical centers from across North
America. This conference is the third in a
series of international meetings and fol-
lows a 2007 conference in Alberta,
Canada. The AHMA is a participating
organization at this conference.
www.imconsortium-conference.org/
July 23-26, 2009
Yoga, Science, and Selfless Practice
Intensive
This retreat is an immersion into the prac-
tice and science of yoga asana practice and
meditation. There are five to six hours a
day of guided yoga practice with Richard
Freeman. Roshi Joan Halifax, Abbot of
Upaya Zen Center and longtime Zen prac-
titioner, explores the shared principles of
yoga and Buddhism. David Riley MD, a
researcher and yoga practitioner explores
the decades of biomedical research on the
health benefits of yoga.
October 4-9, 2009
ABIHM Review Course
10th Annual Integrative Holistic Medicine
Review Course and Exam will be held at
the Westfields Marriott in Chantilly, VA.
The site is about 6 miles from Dulles
Airport west of Washington, DC. Scripps
will again be partner to the American
Board of Integrative Holistic Medicine and
will arrange for CME credit.
www.holisticboard.org/
November 5-7, 2009
AHMA 2009 Conference: The Future of
Holistic Medicine
The American Holistic Medical
Association’s 2009 conference will be held
in Cleveland, Ohio at the Renaissance
Hotel in downtown Cleveland on the
future of Holistic Health. Invited keynote
speakers include Michael Roizen, Tieraona
Low Dog, and Leland Kaiser.
www.holisticmedicine.org/
AHMA Newsletter
f e a t u r e
Sponsor Highlights
InnoVision Health Media Inc
InnoVision is a health-media com-
pany that offers print publications and
professional education programs and
services for healthcare practitioners and
consumers interested in complementary
and alternative medicine (CAM).
Through a cooperative agreement
between the AHMA and InnoVision
Health Media, our members receive elec-
tronically copies of their various medical
journals as well as significant discounts
on printed publications with access to an
extensive library of articles in the field of
integrative and holistic medicine.
Monroe Products’ Hemi-Sync®
Nonprofit organizations like ours
rely on the generosity of those who sup-
port our mission of helping transform
healthcare to a more holistic model. The
AHMA is, therefore, very appreciative of
the generosity shown by Monroe
Products, located in Lovington, Virginia.
ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
Monroe’s Hemi-Sync® has 50+ years
of research and development behind their
product. Perhaps you have experienced
for yourself the enhanced physical and
emotional states possible with Hemi-
Sync®. Please visit www.hemi-sync.com
to learn more about this technology that
creates a focused, whole-brain state.
Ongoing experimentation, data col-
lection and analysis are conducted at The
Monroe Institute’s laboratory facilities to
demonstrate the correlation between sub-
jective experiential reports and objective
electronic measurements. Such research
is indispensable in revealing the influence
of specific Hemi-Sync® sound patterns on
consciousness. Over the years, these
efforts have resulted in the development
of scores of individual products for specif-
ic applications such as focused attention,
stress management, meditation, sleep
enhancement, and pain management.
Member Classifieds
HOLISTIC WELLNESS CENTER
OPENING APRIL 2009. Seeking holistic-
minded professionals to join clinic in Salem,
Oregon. Available positions: Acupuncture,
Chinese Medicine, Chiropractic,
Counseling, Massage Therapy, Naturopathy.
Interested parties should contact Judy
Auerbach, Ed.D., (503) 581-6059 or e-mail
Ahavahmassage@aol.com.
81
 Resources
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82 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1 Resources

 Esther M. Sternberg, MD

IS PROUD TO PRESENT

James Gordon, MD
“Illuminating the Path Forward:
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May 27–30, 2009
The Westin Diplomat Resort and Spa, Hollywood, Florida

The 16th Symposium on Functional Medicine will focus on common mood

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84 ALTERNATIVE THERAPIES, jan/feb 2009, VOL. 15, NO. 1
2009 conference calendar
Food As Medicine: Integrating Nutrition Into Clinical Practice, Medical
Education & Community Health
January 8-11, 2009—San Francisco Marriott Hotel, San Francisco,
California
June 11-14, 2009—Marriott Wardman Park Hotel, Washington, DC
Food As Medicine is the most comprehensive clinical nutrition training pro-
gram for healthcare professionals in the United States. Co-directed by James S.
Gordon, MD, founder and director of The Center for Mind-Body Medicine, and
Kathie Swift, MS, RD, one of the nation’s leading nutrition educators, this out-
standing program provides the latest in science-based nutrition education. It is
designed to give graduates the knowledge, confidence, compassion, and skills
required to integrate food as medicine into their clinical practices. Faculty
include Mark Hyman, MD; Jeffery Bland, PhD; and Cynthia Geyer, MD. The 4-day
intensive course includes delicious gourmet organic meals along with food and
culinary demonstrations, to nourish attendees and provide the tools they need
to practice clinical nutrition and teach healthy, whole-foods eating. For more
information, visit www.cmbm.org/fam or call (202) 966-7338.
Scripps Center for Integrative Medicine’s 6th Annual Natural
Supplements: An Evidence-Based Update
January 22-25, 2009—Paradise Point Resort, San Diego, California
Renowned faculty will present a clinically relevant overview of the latest infor-
mation on natural supplements and nutritional medicine with an emphasis on
disease states. This course provides practical information for healthcare profes-
sionals who make nutritional recommendations or manage dietary supplement
use. Comprehensive presentation topics will include supplement use, regula-
tion, resources, research and efficacy in commonly utilized areas such as pain
management, cardiovascular health and diabetes, women’s health, mental
health and neurology, etc. CME credits are available for physicians, nurse practi-
tioners, nurses, nurse midwives, acupuncturists, chiropractors, dietitians, phar-
macists, physician assistants, and psychologists. For more information, visit
www.scripps.org/naturalsupplementsCME or contact us by phone at
(858) 652-5400 or by e-mail at med.edu@scrippshealth.org.
Advancing Integrative Medicine to Improve Patient Care (Integrative
Healthcare Symposium)
February 19-21, 2009—Hilton New York and Towers, New York, New York
Get the most up-to-date scientific and clinical applications in integrative medi-
cine from top-notch industry experts at the Integrative Healthcare Symposium
conference and meet with pioneers in the industry, on top of the latest in inte-
grative medicine research and product innovation, at the exhibit hall. Keynote
speakers include Woodson Merrell, MD (conference chair); Jeffrey Bland, PhD;
Larry Dossey, MD; Frank Lipman, MD; Gabrielle Roth; and Barbara Dossey,
PhD, RN. Areas of focus will include environmental health; women’s health;
nutrition; spirituality and consciousness; and practice management with
PractiCAM workshops in rhythm and movement, mind-body medicine, and
traditional healing. For more information, visit http://www.ihsympo-
sium.com/08/public/enter.aspx or contact us by e-mail at info@
ihsymposium.com or by telephone at (207) 842-5412.
Successful Aging: Integrative Medicine Throughout a Lifetime
February 28-March 1, 2009—Hilton Irvine/Orange County Airport,
Irvine, California
Sponsored by the Susan Samueli Center for Integrative Medicine, this confer-
ence offers a great opportunity to hear from experienced national leaders in
the field and to share your thoughts and ideas with others who have similar
interests in successful and health aging. Presenters will address such topics as
traditional Chinese Medicine, chiropractic, naturopathy, spirituality, herb-drug
interactions, natural supplements, and many others. This educational activity
is designated for a maximum of 11.5 AMA PRA Category 1 Credits. For more
information, visit http://www.sscim.uci.edu/index_2col.asp?page=16.
Classifieds/Conference Calendar/Advertisers Index
 Remodeling the gut?
If our friendly gut bacteria
are so important…
Friendly bacteria create vitamins (A, B1, B2, B3,
B6, B12, K and Biotin); make essential fatty acids
that feed the gut lining; help digest food; pro-
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ous substances; help remove hormone excess;
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as produce bacteriocins and anti-fungals to
fight them; help maintain healthy cholesterol
and triglyceride levels; increase the number of
immune cells; help cells reproduce normally;
reduce inflammatory response and stimulate
cell repair mechanisms.
…isn’t it smart to support
all of the good guys, not
just a few strains?
A healthy gut contains hundreds of strains,
some of which are unique to the individual.
Flooding the gut with just a few supplemental
strains can worsen any imbalance and even
alarm the immune system.
Dr. Ohhira’s Probiotics 12 PLUS is the
only product that replenishes impor-
tant strains and creates a supportive
environment for all beneficial bacteria.
Dr. Ohhira’s Probiotics 12 PLUS is more than a
probiotic; it’s the only complete flora-balancing
system. The product contains Organic Acids
produced by the bacteria that improve the gut
pH for the benefit of other friendly flora.
Dr. Ohhira’s
Essential Formulas Incorporated • P.O. Box 166139 • Irving, TX 75016-6139
(972) 255-3918 (phone) • (972) 255-6648 (fax) • info@essentialformulas.com
Other significant advantages:
■ Live bacteria, not freeze-dried or centrifuged.
Viability and cohesion in digestive tract are
guaranteed.
■ The 12 strains were fermented together,
avoiding the territorial competition that
is a major downside of combining freeze-
dried strains.
■ The caps contain the rich culture medium
used in the fermentation process, so the
bacteria arrive with their ideal food supply.
■ Cultured 3-5 years, allowing the strongest
organisms to flourish.
■ Fermented using the proprietary and
extremely potent TH10.
■ No refrigeration is needed because the
fermentation was achieved at seasonal
temperatures, thereby acclimating the
bacteria to a normal temperature range.
■ Vegan soft capsule is blister-packed
for freshness.
■ Hypoallergenic- No dairy, soy or gluten.
■ Backed by 14 years of university-based
scientific research.
Don’t forget that if you use oregano
oil, Echinacea, goldenseal, colloidal
silver, fiber, grapefruit seed extract or
other yeast killers, you should replenish
the friendly flora damaged by those
natural agents.
Visit our web site to learn more about this
unique product. www.EssentialFormulas.com
 Douglas Laboratories® Presents...

Ultra Preventive X and Vita-Kids

® ™

raising the standard for overall health and wellness support.

Maintaining good health is a challenge for adults

More than 50% of U.S.
and children alike. Ultra Preventive® X is a
carefully balanced multivitamin formula that
children ages two to ten years
NutriSearch 5-Star GOLD Medal of Achievement Winner
N
Nut
contains more than 50 nutritional ingredients,
fail to get the recommended
and is rated the #1 multivitamin in the daily allowance (RDA)
professional healthcare market by the independent of vital nutrients.
Comparative Guide to Nutritional Supplements. —National Institutes of Health
TM
Vita-Kids multivitamin formula now contains
choline and added vitamin D in delicious teddy
bear-shaped chewable tablets. Each tablet provides
28 vitamins, minerals and trace elements to
support the unique nutritional needs of children.†

† These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Call today 1-888-DOUGLAB (1-888-368-4522) or 1-800-245-4440 www.douglaslabs.com

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