I.

Background Study

Herbal medicine is the use of medicinal plants for prevention and treatment of diseases: it

ranges from traditional and popular medicines of every country to the use of standardized and

tritated herbal extracts. Generally cultural rootedness enduring and widespread use in a

Traditional Medical System may indicate safety, but not efficacy of treatments, especially in

herbal medicine where tradition is almost completely based on remedies containing active

principles at very low and ultralow concentrations, or relying on magical-energetic principles.

In the age of globalization and of the so-called ‘plate world’, assessing the ‘transferability’ of

treatments between different cultures is not a relevant goal for clinical research, while are the

assessment of efficacy and safety that should be based on the regular patterns of mainstream

clinical medicine. The other black box of herbal-based treatments is the lack of definite and

complete information about the composition of extracts. Herbal derived remedies need a

powerful and deep assessment of their pharmacological qualities and safety that actually can be

realized by new biologic technologies like pharmacogenomic, metabolomic and microarray

methology. Because of the large and growing use of natural derived substances in all over the

world, it is not wise to rely also on the tradition or supposed millenarian beliefs; explanatory

and pragmatic studies are useful and should be considered complementary in the acquisition of

reliable data both for health caregiver and patients (Fabio Firenzuoli, 2007).

Traditional Chinese medicine (TCM) has a long history of human use in China and

other Asian countries, such as Korea and Japan, for treating and preventing disease, and is part

of main stream medicine in these countries. Main components of TCM include herbal therapy,

acupuncture, acupressure/massage, mind-body therapy and dietary therapy. Since TCM is part

of Asian mainstream medicine, the cost is covered by insurance in these countries. TCM is also
beginning to play a role in the health care system in the US. Acupuncture needles have been

approved by the FDA as medical device; Herbal medicines are viewed as dietary supplements

and their cost is not covered by insurance. In recent years the US FDA has provided guidance

for investigating botanical drug products, including complex formulas containing several herbs,

focusing on efficacy, safety and consistency. The National Institutes of Health (NIH)/ NCCAM

defines TCM as Whole Medical Systems. The NCCAM/NIH provides grants to support clinical

and basic research on CAM. Several publications including ours indicate that TCM has

potential for treating asthma, managing allergic rhinitis and improving quality of life of atopic

dermatitis patients (Hon KL, 2007). Therefore, in the near future, some TCM remedies may

become botanical drugs i.e. prescription drug via clinical investigation. Since 2005, several

controlled clinical studies of “anti-asthma” herbal remedies including anti-asthma herbal

medicine intervention (ASHMI), DCT,(17) and AST-1 have been published (Wen MC,2005).

Of these ASHMI is the only anti-TCM herbal product that received US FDA IND approval and

entered clinical trial in the US. Research into ASHMI’s active compounds is actively being

pursued. Research on TCM herbal therapy for food allergy is limited. The food allergy herbal

formula-2 (FAHF-2) also received US FDA IND approval and is undergoing clinical trials for

multiple food allergies. Thus, this review is not a systematic review or meta analysis, but rather

a focus on up-to-date translational studies of safety, efficacy and mechanisms of action of the

herbal interventions, ASHMI and FAHF-2 for asthma and food allergy respectively in murine

models and clinical trials. In addition, potential effects of TCM on food allergy-associated

recalcitrant eczema, based on case review, have also been included.

Ulcerative colitis (UC) and Crohn's disease, collectively known as inflammatory

bowel disease (IBD), are chronic inflammatory conditions of the gastrointestinal (GI) tract.
 Although the etiology remains largely unknown, it has been suggested that a combination of

genetic susceptibility factors and the activation of the mucosal immune system in response to

luminal commensal bacterial antigens along with persistent pathologic cytokine production

contributes to the initiation and chronification of IBD ( Podolsky DK, 2002). To date, several

medicines have been used in the treatment of UC, such as 5-aminosalicylate, azathioprine, 6-

mecaptopurine, cyclosporine, and antitumor necrosis factor monoclonal antibody. The primary

aims of medical therapy for patients with UC are directed at inducing and then maintaining

remission of symptoms and mucosal inflammation to provide an improved quality of life with

the least amount of steroid exposure (Yadav PK, 2009). In recent years, herbal medicines have

been used in the treatment of UC and shown to be effective in the clinic. In this review, we

survey the current knowledge of the herbal therapy or traditional Chinese medicine (TCM) for

the treatment of patients with UC, and discuss recent progress in their role in disease

prevention.

II. OBJECTIVES

The objective of the study is to:

1. Be able to advise and educate effectively to create a comprehensive wellness plan

incorporating herbal, dietary and lifestyle recommendation integrating self-awareness and

lessons of nature possess knowledge of traditional herbal systems as well as an understanding of

the principles and practices of modern Western herbalism. Have a foundational understanding of

biomedicine, pharmacology, Materia Medica, herbal preparations, history, clinical assessment,

safety, and plant identification and wild crafting have the skills to understand, design and

perform GMP compliance measurements. Demonstrate the ability to critically analyze herbal

research and contribute to the current body of herbal literature. Know how to integrate
knowledge of raw materials, formulation, and hebal pharmacy for product development

perposes. Know how to effectively educate individuals and group about herbs.

Specifically aims to:

1. Protect the right of the public to choose herbal medicines ensuring that they are manufactured

to a high standard of quality and safety by the use of modern techniques and scientific research.

2. Investigate herbal medicines commonly used for the treatment and management of human

diseases.