Project 3 - A Dose-Ranging Study of Chinese Herbal Medicine in Treating Patients

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Irritable bowel syndrome (IBS), characterized by abdominal pain/discomfort and disturbed bowel frequency, is a common functional bowel disorder that accounts for a substantial proportion of patients seen in primary care and secondary referral centers. The impact on patients' quality of life and the economic burden on the community are considerable. However, the outcome of conventional Western medicine in reating IBS has been disappointing. Several potential new therapeutic agents have been withdrawn because of serious adverse events. Traditional Chinese medicine (TCM) has been used in the treatment of BS for centuries in Asian countries but scientific evaluation of its therapeutic function is scarce. Recently, a a methodologically strong trial of a 20-herb formula showing significant benefit for IBS patients. However, the herbal formulation is inadequately characterized and defined for repeated clinical studies. PROJECT SUMMARY: Subsequent to complete chemical characterization (Botanical Core), we will conduct a randomized, placebo-controlled, double-blind, phase II dose-escalation clinical trial to find an optimally safe and efficacious dosage of this standardized 20-herb preparation in 117 patients aged 18 to 75 with all types of IBS. At each of three dosage levels, 39 participants will be randomized to treatment for 8 weeks with the herbal formula or placebo in a 2:1 allocation ratio, and will be assessed at baseline, weeks 0, 2, 4, 8, and 12 for the clinically important and reliable outcome of patient reported global symptom improvement. At the conclusion of the 1st and 2nd dosage levels, safety will be assessed prior to using a higher dosage in a new cohort of participants. We also will assess individual IBS symptoms, nature, severity, duration, and frequencv of adverse events, quality of life, concurrent IBS medications and health care utilization, and will perform blood tests for safety purposes. Adherence to study medication will be verified by pill counts. Results of this dose-ranging study will help to identify the optimal dosage of the herbal formula to be used in future randomized placebo-controlled trials and in head-to-head comparisons with conventional Pharmaceuticals.