ARTICLE IN PRESS

Phytomedicine 15 (2008) 153159

www.elsevier.de/phymed

Cholesterol reduction using psyllium husks Do gastrointestinal adverse

effects limit compliance? Results of a specic observational study$
B. Uehleke, M. Ortiz, R. Stange
Department for Natural Medicine, Charite Universitatsmedizin Berlin, Campus Benjamin Franklin, Immanuel Hospital,
Konigstr. 63, D-14109 Berlin, Germany

Abstract
Purpose: Despite known cholesterol lowering effects the use of psyllium husk (Plantaginis ovatae testa) in Germany
for hypercholesterolemia is limited compared to their use as a laxative. To investigate whether use in
hypercholesterolemia is limited due to adverse effects on the gastrointestinal system, a prospective observational
study was conducted.
Methods: Sixty-two outpatients with documented hypercholesterolemia and complaints of constipation were
identied from an academic clinical center. Treatment with 3.5 g psyllium husk preparation administered three times
daily was initiated and patients were monitored at weekly intervals. Gastrointestinal symptoms were quantied using a
validated Nepean Dyspepsia Index modied to identify both upper and lower abdominal symptoms. Diaries and study
medication records were used to evaluate compliance.
Results: Fifty-four of 62 patients enrolled in the study completed the study protocol with 4 subjects discontinuing
due to adverse reactions associated with psyllium husks. Total cholesterol was signicantly decreased from
252739 mg/dl before treatment to 239737 mg/dl after 3 weeks of treatment. Similarly, low density lipoprotein (LDL)cholesterol decreased from 174734 to 162731 mg/dl during the study. Triglycerides and high density lipoprotein
(HDL) were unchanged. Gastrointestinal symptoms were rated lower at the end than at the beginning of the study. In
week 1 most of the patients reported gastrointestinal symptoms and also gastrointestinal adverse reactions, which
however, showed a decrease from week 1 to weeks 2 and 3 in the diaries. Patient response to study medication was
positive for patients completing the study.
Conclusions: Psyllium husk preparations may be a therapeutic option for patients with mild to moderately elevated
cholesterol levels. Adverse gastrointestinal symptoms associated with the preparation appear to be transient in some of
the patients. Compliance may be optimized with adequate patient counseling.
r 2007 Elsevier GmbH. All rights reserved.
Keywords: Hypercholesterolemia; Soluble bers; Psyllium husks; Plantago ovata; Compliance; Gastrointestinal adverse effects

Introduction

This study has been supported by Kneipp-Werke, Wurzburg.

Corresponding author. Tel.: +49 30 80505 694;

fax: +49 30 80505 692.

E-mail address: b.uehleke@immanuel.de (B. Uehleke).
0944-7113/$ - see front matter r 2007 Elsevier GmbH. All rights reserved.
doi:10.1016/j.phymed.2007.11.024

Despite the known cholesterol reducing effect of

psyllium seed husks (PSH) that has been shown in a
number of studies (Garvin et al., 1965; Levin et al., 1990;
Chan and Schroeder, 1995; Anderson et al., 2000), their
use for therapy of mild or moderate hypercholesterolemia

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B. Uehleke et al. / Phytomedicine 15 (2008) 153159

in Germany is quite rare. One reason may be that until

now there were only a few registered herbal drug
products with this indication since PSH is mainly used
as a laxative. Although patients often express a
preference for herbal products over synthetically manufactured drug products, patients may be somewhat
reticent to use the PSH products due to unwanted
intestinal effects. It is known that ingesting PSH can
cause meteorism from bacterial fermentation in the
colon which is associated with gastrointestinal complaints of bloating, atulence and even painful cramps.
Although these unwanted effects are usually considered
minor compared with rare but severe adverse reactions
associated with commonly prescribed statins used to
lower cholesterol, it is possible that the side effects
associated with ingesting PSH limit patient compliance.
Therefore we designed a study to characterize the
incidence and tolerability of PSH treatment in an
outpatient population with mild to moderate hypercholesterolemia and a medical indication for laxative
treatment.
As an herbal product, PSH (Plantaginis ovatae testa,
Ispaghula husks) is differentiated from the unprocessed
psyllium (Plantaginis ovatae semen). PSH are processed
through fractional grinding of the outer layer of the seed
ESCOP (2003). Since the water-binding mucoid substances are located exclusively in the epidermis of the
husks (Jamal et al., 1987), PSH have a much higher
water-binding capacity swelling up to 40100 times of
their volume compared to unprocessed psyllium. The
mucoid polysaccharide fraction of Indian PSH contains
highly branched arabinoxylan with a xylose backbone
and arabinose- and xylose-containing side chains
(Sandhu et al., 1981; Marlett and Fischer, 2003). In
contrast to arabinoxylans in cereal grains that are
extensively fermented, PSH possesses a structural
feature that hinders its fermentation by typical colonic
microora. The increased concentration of gel forming
mucoids in PSH compared to unprocessed psyllium
correlates with recommended daily dosages of 420 g for
PSH and 1240 g for unprocessed psyllium. Clinical
observations also suggest the bloating effect is higher
for PSH.
The mechanism of action for PSH efcacy in lowering
cholesterol is thought to involve altered cholesterol
metabolism with increased hepatic cholesterol catabolism and increased fecal bile acid excretion (Vahouny
et al., 1980; Everson et al., 1992; Romero et al., 2002).
Most studies report a very high compliance with
psyllium or with PSH that ranges from 90% to 95%
(Levin et al., 1990; Anderson et al., 1991; Chan and
Schroeder, 1995). However, other investigators indicate
that unpleasant side-effects, including abdominal distention, atulence, and discomfort may limit adherence
to dosing regimens with PSH (Flannery and Raulerson,
2000). Studies may differ in evaluating gastrointestinal

adverse drug reactions (ADRs). Flatulence and bloating

may be considered as only minor expected complaints or
subjects might be reluctant to report unless tactfully
queried which may result in possible under-reporting.
Additionally study populations selected to investigate
the effects of PSH on cholesterol often exclude patients
with gastrointestinal disorders. Selected patient populations are likely to impact PSH tolerability outcomes. In
a double blinded crossover study, healthy volunteers
showed no increase in gas passage with psyllium, but
reported a signicant increase in bloating sensation
(Levitt et al., 1996). Dietary ber can trigger pain or
bloating in some patients among the 1015% of
population with irritable bowel syndrome (Talley,
1999) and large amounts of ber reaching the colon
has been suggested as a potential mechanism of irritable
bowel symptoms in patients with overeating disorder
(Dapoigny et al., 2003). Interestingly, psyllium was more
effective in lowering cholesterol in a population of
veterans less than 60 years old compared to older
patients undergoing evaluation at a Veterans Administration Medical Center lipid clinic. The study correlated
efcacy and compliance for several lipid lowering agents
(Schectman et al., 1993).
Flatulence is the gastrointestinal symptom most often
associated with PSH that is likely to impact compliance;
however, the effect has not been further characterized in
terms of dose response for incidence or severity. Reports
with healthy volunteers or patients with mild hypercholesterolemia often minimize gastrointestinal effects
compared to effects on lipid proles and emphasize high
compliance. We questioned whether high compliance
reported in study populations that excluded gastrointestinal disorders would be expected in patients with
mild to moderately elevated cholesterol and gastrointestinal disorders requiring laxative therapy. A prospective study in out-patients with mild to moderate
hypercholesterolemia and constipation was designed to
assess PSH tolerance and compliance. Evaluation
instruments included validated questionnaires and
patient diaries that were employed to capture in detail
all gastrointestinal symptoms over a 3-week treatment
period. Additionally, the motivation for PSH continuation and the manner in which PSH was administered
relative to meals and amount of liquid were specically
queried.

Methods
Study design and subjects
A prospective single-center, open label, observational
study was conducted in adult patients identied from
the ambulatory practice for natural healing at the

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B. Uehleke et al. / Phytomedicine 15 (2008) 153159

Benjamin Franklin Campus of Charite University

Clinics, Berlin, Germany. Inclusion criteria required
mild to moderate hypercholesterolemia and documented
indication for laxatives as well as stable medical history
with no change in diet or medication for at least 4 weeks
prior to study enrollment. Patients were excluded with
suspected bowel stenosis or if medication regimens
included cholestyramine, colestipol or ezetimib because
these medications are thought to have an overlapping
mode of action with PSH.
Subjects provided written, informed consent and the
study was conducted in accordance with the Declaration
of Helsinki, Good Clinical Practice guidelines and
German drug law.

Test material
The test drug1 was Indian PSH (husks of Plantago
ovata FORSSKAL, synonym: Plantago ispaghula
ROXBURGH; plantaginis ovatae testa) in a 100%
preparation without fat, sugar, aroma or other additives. PSH has been registered in Germany as an herbal
drug for many years as a laxative. The patients were
advised to take 1 level measuring spoon (3.5 g) full of the
test drug three times daily with foods such as yogurt or
in at least 100 ml of liquid without carbonic acid or
alcohol. Administration relative to meals and type of
liquid or food was determined by the subjects. To avoid
the possible binding of other drug substances, the test
product was to be taken 12 h before or after other
medications.

Study conduct
Complete medical histories and physical examinations
assured patient eligibility. Patients were instructed about
PSH administration, documenting dosage ingestion and
recording gastrointestinal symptoms and bowel function
in structured patient diaries. Study visits took place at
enrollment and at the end of the 3-week test period. A
structured telephone interview was conducted at 1 week.
At the last study visit, physical examinations and clinical
chemistry for plasma lipids was repeated. Patient
interviews monitored concomitant medications, adverse
reactions and drug tolerability. Remaining study medication was recorded to quantify compliance. At each
study visit values for total cholesterol, HDL, LDL and
triacylglycerides were determined from blood plasma
samples after 12 h of fasting and analyzed immediately
with routine lab diagnostics at the central laboratory of
Charite University Clinic facilities Benjamin Franklin
Campus, Berlin, Germany.
1
Now available as Kneipp Cholesterol Control by Kneipp-Werke
Wurzburg.

155

Part one of the validated Nepean Dyspepsia Index

(Talley et al., 1999) was used during clinic visits to
evaluate gastrointestinal symptoms. Fifteen questions
related to intensity, frequency and impact of upper
abdominal symptoms during the previous 2 weeks of
treatment. In order to record symptoms for the entire
abdomen, 10 additional questions with analogous
structure were included that queried function of the
lower abdomen. Total scores were calculated as the sum
of the single columns of the symptoms.
Patients were given a daily diary that was to be
completed each evening during the study. The diary
contained 17 questions relating to gastrointestinal
complaints including bloating, atulence, pain, nausea,
vomiting, heartburn and frequency and consistency of
the defecation. The daily ingestion of PSH was also
recorded.
After at least 7 days of study medication, a telephone
interview was conducted to evaluate ingestion preference and acceptance of the dosage form. Questions
included integration of study medication into the daily
routine, intake modalities (before, during or after a
meal; with food or mixed with liquid and type of liquid),
preference for the dose packaging, positivenegative side
effects and whether the patient would be likely to
continue PSH ingestion after the study.

Evaluation parameters and statistics

The primary evaluation parameter was the difference
of total cholesterol and LDL cholesterol before and
after the 3-week intake of PSH. Secondary parameters
examined plasma HDL cholesterol and triglycerides,
incidence and severity of gastrointestinal symptoms
including atulence, bloating upper and lower abdominal pain and bowel activity. Additionally, dosing form
preference and ingestion patterns relative to meals and
liquid or food was evaluated as part of patient diaries.
Paired, two-tailed t-tests were used to evaluate the
change in plasma lipid parameters at treatment initiation and after 3 weeks of treatment. Descriptive
statistics were used to evaluate secondary parameters.

Results
Of the 62 patients enrolled, 54 patients completed the
study according to protocol. For enrolled patients 66%
were women, mean age was 60 years (range 4074 years)
and mean body mass index was 27.7 kg/m2 (range
18.840.7 kg/m2). Combined hyperlipoproteinemia was
diagnosed for 37 patients, but only 14 showed elevated
triglycerides (4200 mg/dl). Four patients discontinued
after 610 days due to adverse drug reactions, 2 patients
had adverse events that were not considered related to

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study medication, 1 patient did not report a reason for

discontinuing and 1 patient violated study protocol by
stopping simvastatin therapy and was discontinued.
Of the 54 patients completing the study according to
the study protocol, 45 had total cholesterol values over
220 mg/dl. Indication for laxative treatment included 28
patients reporting constipation, 27 patients with hemorrhoids, 3 with anal disease and 4 patients with irritable
bowel syndrome. Additionally, 29 patients had medical
histories that included other diagnoses relating to the
gastrointestinal system, e.g. reux disease, cholecystectomy, ulcer disease, etc.
No consistent change in body weight was noted
during the study, including obese patients with body
mass index over 30. This result is consistent with patient
diaries and medical histories showing no change in diet
during the study.

over 220, with relative decrease during the study of 6.5%

for total cholesterol and 8.2% for LDL-cholesterol.

Secondary parameters
Total gastrointestinal symptom score decreased from
a mean value of 27.7729.8 at study initiation to
24.1732.2 after 3 weeks of PSH dosing. The score for
upper abdominal symptoms (calculated using 15 questions in the Nepean Dyspepsia Index for upper
abdominal symptoms) decreased from 18.0720.0 to
15.2720.7. Corresponding mean scores calculated for
the lower abdomen (irritable bowel symptoms) had a
smaller change from 9.7712.5 to 9.0712.8. Queries
during patient visits showed that fewer patients had high
complaint scores after 3 weeks PSH and 14 patients were
symptom free with a total score of zero (versus 9
patients at visit 1).
Evaluation of patient diaries showed that only 3 of 54
patients had no symptoms in the rst week. The number
of symptom free patients increased to 11 during week 3.
Consistently the frequency and intensity of gastrointestinal symptoms decreased from week 1 to week 3
(Table 2).
During the rst week, 13 patients reported cramps or
lower abdominal symptoms that were (n 10) or were

Primary endpoint
Total plasma cholesterol and LDL-cholesterol levels
showed a clear and statistically signicant reduction
after 3 weeks of administering PSH (Table 1). HDL and
fatty acids showed only slight changes during the study
that were not signicant. Mean reduction was higher in
the 45 patients with initial values of total cholesterol
Table 1.

Change in primary lipid parameters, total cholesterol and LDL

Parameter (n 54)

Initial score
(mg/dl)

End score
(mg/dl)

Absolute reduction
(mg/dl)

Relative reduction
(%)

Signicance (paired
t-test, 1-tailed)

Total cholesterol
LDL

252739
174734

239737
162731

13
12

5.2
6.9

o0.00002
o0.00001

Mean7SD.

Table 2.

Gastrointestinal symptoms according patients diaries

Symptom frequency per patient per week

Days with atulency (affected patients)
Frequency of painful atulence (affected patients)
Days with the feeling of a swollen lower abdomen (affected
patients)
Score of lower abdominal complaints (affected patients)
Frequency of cramp-like lower abdominal pain in
association with defecation/without association (affected
patients)
Pain in the upper abdomen (affected patients)
Appearance of bloating after minimal food intake
(affected patients)
Heartburn (affected patients)
Nausea (affected patients)
Stomach cramps (affected patients)
Vomiting (affected patients)
Mean score (patients with symptoms from 54).

1 week

2 weeks

3 weeks

4.6 (46)
8.1 (18)
3.6 (39)

5.6 (41)
5.2 (15)
4.3 (25)

5.2 (37)
5.4 (11)
4.0 (24)

8.2 (25)
4.4/6.0 (10/9)

5.8 (23)
4.1/4.3 (7/11)

5.9 (14)
3.0/3.6 (7/10)

7.6 (15)
11.0 (25)
5.5
4.0
5.6
2.0

(19
(13)
(6)
(1)

10.0 (11)
7.4 (25)
5.8
4.3
5.0
2.0

(18)
(8)
(4)
(1)

6.3 (12)
8.1 (22)
5.2
6.9
4.0
3.0

(25)
(5)
(5)
(1)

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not (n 9; some patients reported both types) associated with defecation. Eleven patients reported these
symptoms during the second week while 10 patients
reported the same symptoms during week three. Cramplike lower abdominal symptoms were persistently
reported in 6 patients over the coarse of the study. Only
one of these patients suffered from a chronic irritable
bowel syndrome. None of the others had any chronic
gastrointestinal disorders. With exception of a few cases
all those patients with cramp-like lower abdominal pain
also reported painful atulence.
The total number of recorded defecations increased
slightly from 571 in the rst week to 611 in the second
and 606 in the third week, their distribution per day is
shown in Table 3.
Days without bowel movements, indicating constipation, decreased only during the second week. Individual
patients show some increase of diarrhea-like frequent
defecations.
The stool consistency was scored with medians of 2.4,
2.6 and 2.5 during week 1, 2 and 3, respectively (with
2 soft/formed and 3 normal). Mucous discharge in
fecal stools was reported 6 or fewer patients each week.
Blood with the defecation was reported by 4 patients in
the rst week with a mean frequency of 4.3 times and
in the second and third week only 2 patients with mean
frequency of 2.5 and 5 times, respectively.
Compliance was veried through diary examinations
indicating a mean dosing frequency of 2.6 measuring
spoons, equal to 9.1 g PSH/day which corresponded
with returned study medication that revealed a mean
dosage of 9.3 g PSH/day. At the end of week one, 49
patients conrmed regular intake of the test drug from
the telephone interview and 1 patient reported reduced
the dosage to once daily (3.5 g/day) due to unacceptable
atulence.
Queries on dosing preferences showed that 51 of 54
patients were able to integrate PSH dosing into their
daily life. Thirty-two patients took PSH before their
meals, 10 during and 29 after their meals. At the end of
the study there was a slight change: 36 patients took
PSH before the meal, 12 during and 24 after their meals.
The vast majority of patients (51 of 54) ingested PSH
mixed in water, 14 also reported other modes of intake
including mixed with yogurt (8), granola (3), curd cheese
Table 3.

Days
Days
Days
Days
Days

157

(1), milk (1) and tea (1). Twenty-six patients would

prefer a daily dosage sachet.
Queries related to probability for compliance found
that 28 patients mentioned positive effects that included
a feeling of satiation (5), easier/softer feces (6), increased
feces volume (1), formed stool (1), cleaner defecation
(saving toilette paper) (2), weight reduction (2), a
relieved feeling (2). In contrast, 23 patients reported
unfavorable effects like bloating (9), stomach discomfort
(1), atulence (16), regurgitation, resp. heartburn (2),
nausea (1), abdominal cramps and abdominal pain
(2), awkward intake of drug at noon (4), constipation
(2), disturbing moist expansion (1). A total of 31
patients had no complaints regarding the product. At
the end of the study, only 16 patients still reported
adverse effects.
At study initiation 45 of 54 patients expressed their
wish to continue PSH assuming that the expected
cholesterol reducing effect was shown. Synthetic drugs
to reduce the cholesterol were viewed as acceptable in
only 18 patients. Queries on attitude toward the product
at the end of the study found 43 patients positive
regarding long-term intake of PSH and only 3 patients
would accept synthetic drugs as a therapeutic alternative. Positive product properties were recognized by
nearly each patient and negative responses correlated
with adverse effects.

Safety
Of all the 62 enrolled patients, 34 reported 41 adverse
events with most of events (25 patients) occurring during
the rst week. In 26 incidences, a causal relation was
considered as possible or probable with all events
involving gastrointestinal symptoms. No cause between
study medication and event was determined for 15
adverse events. Four subjects discontinued the study due
to adverse events considered possibly or probably
related to study medication. Adverse events considered
related to study medication included 12 cases of atulence, 11 cases of stomach pain, 8 incidents of bloating,
4 changes in bowel function, 2 incidents of nausea, one
report of heartburn and one report of burping. Most
symptoms disappeared after a few days but 4 persisted
for the coarse of the study and 10 of 26 adverse events

Frequencies of defecations

without defecation (affected patients)

with 1 defecation (affected patients)
with 2 defecations (affected patients)
with 3 defecations (affected patients)
with more that 3 defecations (affected patients)

Incidence reported (number of patients from 54 total).

Week 1

Week 2

Week 3

36
170
118
47
6

17
154
122
56
10

32
147
137
47
10

(16)
(45)
(41)
(21)
(4)

(9)
(41)
(41)
(24)
(6)

(17)
(38)
(37)
(17)
(8)

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lasted longer than a week. No adverse events required

additional treatment.
Of the 16 patients with known gastrointestinal
disorders (reux, irritable colon, irritable stomach,
gastritis) only 8 reported gastrointestinal adverse events
and only one patient discontinued study medication.
This patients diary indicated symptoms which were
consistent with an underlying gastrointestinal disease.

Discussion
Results from this prospective study showed clearly
decreased levels of total cholesterol and LDL cholesterol
in patients with mild to moderate hypercholesterolemia
and confounding gastrointestinal disorders. The effects
on cholesterol are consistent with previously reported
studies conducted in patients without medical indication
for concomitant medication. The study found rapid
onset of effects with highly signicant decreases in
cholesterol within 3 weeks of treatment initiation.
Results of this study are consistent with previous
studies showing efcacy of PHS in reducing total
cholesterol (discussed in 2003). Doses of 10.2 g PHS/day
administered for 816 weeks decreased total cholesterol
(515%) and LDL-cholesterol (820%) without changing triglycerol and HDL (Bell et al., 1989; Levin et al.,
1990) Similarly, a meta-analysis of 8 randomized
placebo-controlled studies investigating cholesterol-lowering effects of psyllium enriched cereals adjunctive to
diet therapy included a collective of a total of 384 active
and 272 placebo patients with mild to moderate
hypercholesterolemia showed similar results. After 12
weeks of treatments with 10.2 g PSH/day there was a
highly signicant reduction of total cholesterol by 4%
and of LDL-cholesterol by 7% without a signicant
inuence to HDL (Anderson et al., 2000). In 3-week
randomized, double-blind, placebo-controlled clinical
study we investigated the effects of PSH in granulate
form in 161 patients with hypercholesterolemia during a
rehabilitation program. Total cholesterol was reduced
signicantly in the test treatment group in comparison
to the placebo group and LDL-cholesterol and apolipoprotein B were also reduced (Brock et al., 2001). For
patients requiring higher cholesterol reduction, a randomized, double-blind, three-arm clinical study in 68
patients investigated the efcacy of PSH in combination
with simvastatin over a period of 12 weeks. The authors
conclude that combination of 10 mg simvastatin and
15 g psyllium supplement show a cholesterol-reducing
effect comparable to 20 mg simvastatin alone (Moreyra
et al., 2005).
In this study of mild to moderate hypercholesterolemia, there was no signicant difference between the
intention to treat population that included subjects with

total cholesterol levels under 220 mg/dl and the per

protocol population, indicating the robustness of the
results. There was no dependence between cholesterol
initial levels and effect and similarly, the study showed
no dose dependence between recorded daily dose
ingested and magnitude of cholesterol change. However,
the study was not designed to explore dose response in
patients with differing severity of hypercholesterolemia.
Signicantly, this study identied a 5% decrease in total
cholesterol and a 7% decrease in LDL-cholesterol which
is nearly identical to previous studies involving placebo
controlled blinded designs.
After validating efcacy of PSH on cholesterol in a
patient population with gastrointestinal disorders that
are consistent with laxative therapy, the study queried
parameters likely to impact compliance using the
validated Nepean Dyspepsia Index (Talley et al.,
1999). Results conrmed that symptoms are transient.
Previous studies in otherwise healthy subjects with
hypercholesterolemia identied a high compliance with
rates higher than 85% (Levin et al., 1990; Anderson
et al., 1991; Chan and Schroeder, 1995). The discontinuation rate due to PSH effects was less than 7% in the
current study indicating that patients with gastrointestinal dysfunction including irritable bowel syndrome can
be expected to have a high compliance with PSH dosing
regimens.
These results are consistent with the mild to moderate
and transient nature of reported adverse effects shown
from diary analysis. An exception was the symptom of
heartburn which appeared in more patients at the end of
the study than in the beginning (25 versus 18). A cause
for this nding remains unexplained. The high incidence
of initial symptoms is expected for a group that included
16 of 54 patients with underlying gastrointestinal
disorders. Interestingly patients who reported few
symptoms at the beginning rarely reported additional
symptoms with the exception of atulence throughout
the study.
The recorded ADRs correspond mainly to the
gastrointestinal complaints as recorded in the diaries.
It is noticeable that of the 16 patients with known
gastrointestinal disorders like reux, irritable bowel
syndrome, gastritis only 8 reported gastrointestinal
adverse events (in sum 24 patients) and only one patient
discontinued from the study. In their diaries these
patients showed symptoms, which could also be
explained through their gastrointestinal disease. However 10% of all patients showed pronounced and
persisting complaints without a known gastrointestinal
disease. It is possible that some patients enrolled in the
study without diagnosed gastrointestinal disease report
newly surfacing gastrointestinal symptoms as adverse
events even if they are not very severe.
Our queries regarding acceptance show that nearly all
patients were interested in an inexpensive natural

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B. Uehleke et al. / Phytomedicine 15 (2008) 153159

product to reduce cholesterol. At the end of the study

only 3 of 54 patients expressed a preference for synthetic
drug products compared to herbal PSH. PSH was most
commonly ingested after mixing with water and was
reported as easily integrated into patients daily routine.
The disadvantages of PSH herbal product use center on
initial adverse gastrointestinal reactions should be
communicated openly and explicitly in order to avoid
an early termination of the therapy. Many of our
patients wanted to continue taking the medication after
the study under the expectation that their cholesterol
levels were indeed reduced and consequent risks of heart
attack and stroke were decreased.

Conclusion
PSH provides a suitable appropriate herbal medication to reduce slight to moderate hypercholesterolemia,
despite the incidence of impressive intestinal symptoms
that are associated with the initiation of the therapy.
Patients with a sensitive gastrointestinal system and
particularly those with constipation can expect positive
gastrointestinal effects after some weeks of PSH therapy
that are consistent with the agents laxative effects.
Good compliance and patient acceptability can be
expected with PSH compared to synthetic drug alternative treatment regimens that include rare, but severe
adverse events. Dose adjustment is easily accomplished
with granular PSH. Patients should be informed about
the incidence and transient duration of adverse gastrointestinal effects observed with PSH ingestion and
dosage may be titrated to minimize adverse symptoms
during the rst days of therapy.

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