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|Date: November 15, 2004||HC# 070243-268|
Re: Herbal Combination for Irritable Bowel Syndrome: A Positive Clinical Trial
Madisch A, Holtmann G, Plein K, Hotz J. Treatment of irritable bowel syndrome with herbal preparations: results of a double-blind, randomized, placebo-controlled, multi-centre trial. Aliment Pharmacol Ther. 2004;19:271-279.
Irritable bowel syndrome is one of the most common gastrointestinal disorders. The disorder is characterized by abdominal pain or discomfort for at least 12 weeks, which is relieved by defecation. It is associated with a change in stool frequency (constipation) and/or stool consistency (diarrhea). The pathophysiology of irritable bowel syndrome is not well understood. There is no cure and treatment is targeted at symptom relief. Available treatments are helpful in a small proportion of patients. Herbal medicines have been used in many countries, but controlled data is lacking. The objective of this study was to evaluate the efficacy and safety of the commercially available herbal preparation STW 5 (sold under the name Iberogast™, Steingerwald Arzneimittelwerk GmbH, Darmstadt, Germany; distributed in the U.S. by Enzymatic Therapy, Green Bay, WI [independent health food stores] and PhytoPharmica, Green Bay, WI [pharmacies and healthcare professionals]).
Men and women (N = 203) with persistent irritable bowel syndrome participated in this randomized, placebo-controlled, double-blind, multi-center study based in Germany. The patients discontinued taking their current medications prescribed for irritable bowel syndrome one week prior to randomization. The patients were assigned to 1 of 4 treatment groups: STW 5, a research preparation called STW 5-II, bitter candytuft monoextract (BCT), or placebo. The trial medications were taken 3 times daily (20 drops) for 4 weeks. STW 5 contains bitter candytuft (a.k.a. clowns mustard; Iberis amara), German chamomile flower (Matricaria recutita), peppermint leaves (Mentha x piperita), caraway fruit (Carum carvi), licorice root (Glycyrrhiza glabra), lemon balm leaves (Melissa officinalis), celandine aerial part (Chelidonium majus), angelica root and rhizome (Angelica archangelica), and milk thistle fruit (Silybum marianum). STW 5-II contained bitter candytuft, German chamomile flower, peppermint leaves, caraway fruit, licorice root, and lemon balm leaves. BCT contained bitter candytuft. The quantity of each component and the manufacturer were not mentioned in the article. (Editor's Note: Manufactures information was obtained online.) Symptoms were evaluated.
There were no significant demographic or baseline differences between groups. Compared to placebo, treatment with STW 5 and STW 5-II significantly improved abdominal pain (P < 0.01) and irritable bowel syndrome symptoms (flatulence, sensation of tension or fullness, sensation of incomplete evacuation, constipation, diarrhea) (P < 0.001). Treatment with BCT did not significantly differ from placebo. Physicians judged the efficacy to be 'very good' or 'good' in 65% of the patients treated with STW 5 and 73% of the patients treated with STW 5-II. STW 5 and STW 5-II had 'very good' or 'good' tolerability. There were no serious adverse events and only 2 minor adverse events were noted.
Pharmaceuticals used to treat irritable bowl syndrome are effective for either diarrhea-predominant or constipation-predominant irritable bowel syndrome, but not for both. STW 5 and 5-II appear to be effective regardless of the predominance of the symptoms. The effect of STW 5 and 5-II may be mediated via an influence on gastrointestinal motility. Clinical trials of patients with irritable bowel syndrome have a high placebo response (40-70%) in short-term trials. Despite this high placebo response, STW 5 and 5-II performed remarkably well compared to placebo. The authors conclude that STW 5 and 5-II are highly effective for the treatment of patients with irritable bowel syndrome. Considering the excellent study design and statistics, the results of this study appear convincing.
—Heather S. Oliff, Ph.D.