Kaiyue Huang
Mi Lv
*The final, formatted version of the article will be published soon.
SYSTEMATIC REVIEW article
Front. Pharmacol.
Sec. Ethnopharmacology
Volume 15 - 2024 |
doi: 10.3389/fphar.2024.1475366
This article is part of the Research Topic Herbal Medicines’ Safety and Clinical Application: New Strategies for Overcoming Therapeutic Challenges View all articles
Herbal placebo response in clinical trials on irritable bowel syndrome: A systematic review and meta-analysis
Provisionally accepted- Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Aim of the study: To systematically evaluate the herbal placebo response in randomized controlled trials (RCTs) of herbal medicine on irritable bowel syndrome (IBS). Materials and methods: We searched for RCTs with herbal placebo groups for IBS in PubMed, EMBASE, the Cochrane Library, the China National Knowledge Infrastructure (CNKI), the Wan Fang database and Sinomed database from January 31, 1994 to November 2023, and the quality of the literature was evaluated by the Cochrane risk of bias assessment criteria. The primary outcome indicators were response rate, abdominal pain and stool improvement rate, which were analyzed by single-group rate meta-analysis. Secondary outcomes were analyzed in subgroups based on diagnostic criteria, duration of treatment, subtype, research locations, placebo form, and presence of herbal ingredients to look for factors affecting respond rate. RESULTS: The study included 24 papers, involving a total of 2596 patients. Of these, 1151 IBS patients were treated with the herbal placebo. The placebo response rate in IBS patients in the herbal placebo group was 37% (P < 0.01,I 2 = 75%). A total of 287 patients in five studies were given the herbal placebo, and the improvement rate of abdominal pain was 29% (P = 0.83, I 2 = 0%). Four studies enrolled a total of 212 patients with IBS who received herbal placebo, and the stool improvement rate was 46% (P = 0.02<0.05, I 2 = 71%). The research locations and treatment duration were sources of heterogeneity (P < 0.05). Conclusions: There is a significant herbal placebo response in patients with IBS. Different research locations and treatment durations are major sources of heterogeneity that may affect IBS patient response rates. The addition of a low dose of herbal ingredients when simulating an herbal placebo does not exaggerate the therapeutic effect of the placebo. There is a lack of uniformity and standardization in the preparation and evaluation of herbal placebos.
Keywords: herbs, Complementary treatment, placebo, Irritable Bowel Syndrome, Meta-analysis
Received: 03 Aug 2024; Accepted: 11 Nov 2024.
Copyright: © 2024 Huang, Lv, Zheng, Wang, Tang and Lv. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Mi Lv, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Ting Zheng, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Fengyun Wang, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Xudong Tang, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Lin Lv, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.