Abstract | BACKGROUND: METHODS: This was a randomized double-blinded placebo-controlled trial. Chinese IBS patients with predominant diarrhea symptoms that fulfilled Rome II criteria were recruited. The diagnosis was verified by a TCM herbalist using TCM criteria. Eligible patients were randomized to receive a standard preparation of TCM extracts that contained 11 herbs or placebo with similar appearance and taste for 8 wk after a 2-wk run-in period. Patients were followed up for an additional 8 wk post-treatment. Primary outcome was patient's global symptom assessment. Other outcome measures included individual IBS symptom scores and health-related quality of life (short form 36). RESULTS: One hundred nineteen patients were randomized: 60 to receive TCM and 59 to receive placebo. There was no significant difference in the proportion of patients with global symptom improvement between the TCM and placebo groups at week 8 (35% vs 44.1%, p = 0.38) and at week 16 (31.7% vs 33.9%, p = 0.62). Moreover, there was no difference in individual symptom scores and the quality-of-life assessment between the two groups at all time points. BACKGROUND: The use of this herbal formulation for diarrhea-predominant IBS did not lead to global symptom improvement. Further controlled clinical studies may be necessary to characterize the role of TCM in the management of IBS.
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Authors | Wai K Leung, Justin C Y Wu, S M Liang, L S Chan, Francis K L Chan, He Xie, Sara S L Fung, Aric J Hui, Vincent W S Wong, Chun-Tao Che, Joseph J Y Sung |
Journal | The American journal of gastroenterology
(Am J Gastroenterol)
Vol. 101
Issue 7
Pg. 1574-80
(Jul 2006)
ISSN: 0002-9270 [Print] United States |
PMID | 16863563
(Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Drugs, Chinese Herbal
- Placebos
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Topics |
- Adolescent
- Adult
- Aged
- Chi-Square Distribution
- Diarrhea
(drug therapy)
- Double-Blind Method
- Drugs, Chinese Herbal
- Female
- Humans
- Irritable Bowel Syndrome
(drug therapy)
- Male
- Medicine, Chinese Traditional
- Middle Aged
- Placebos
- Prospective Studies
- Quality of Life
- Regression Analysis
- Statistics, Nonparametric
- Treatment Outcome
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