SYSTEMATIC REVIEW article

Front. Pharmacol.

Sec. Ethnopharmacology

Volume 16 - 2025 | doi: 10.3389/fphar.2025.1534904

Efficacy and safety of Chinese botanical drug Si Shen Wan in irritable bowel syndrome: A meta-analysis and trial sequential analysis of randomized controlled trials

Provisionally accepted
Qian  LiuQian Liu1Zongming  ShiZongming Shi2Yang  JiangYang Jiang1Zhang  TaoZhang Tao3Sijing  DuSijing Du3Yemei  GaoYemei Gao1*
  • 1Beijing Jishuitan Hospital, Capital Medical University, Beijing, China,, Beijing, China
  • 2First Hospital, Peking University, Beijing, Beijing Municipality, China
  • 3Wangjing Hospital, China Academy of Chinese Medical Sciences, Beijing, Beijing Municipality, China

The final, formatted version of the article will be published soon.

Background and Objectives: Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders (FGIDs), characterized by complex pathogenesis, prolonged disease duration, frequent recurrence, and a significant impact on patients' quality of life. Si-Shen-Wan (SSW), a renowned traditional Chinese medicine formula, is widely recognized for its efficacy in managing gastrointestinal symptoms, particularly diarrhea, and is commonly used to treat diarrhea-predominant IBS (IBS-D). This study utilized a meta-analysis to evaluate the efficacy and safety of SSW in the treatment of IBS-D.A comprehensive search for randomized controlled trials (RCTs) was conducted across seven databases from their inception to October 31, 2024. The analysis included outcomes such as efficacy rate, overall symptom score, abdominal pain score, diarrhea score, abdominal distension score, loss of appetite score, recurrence rate, and adverse events. Meta-analyses were performed using either a random-effects or fixed-effects model. Trial sequential analysis (TSA) was applied to estimate the sample size and validate the robustness of the meta-analysis.Results: A total of 34 RCTs involving 2,976 participants met the inclusion criteria.

Keywords: Si-Shen-Wan, Irritable Bowel Syndrome, Meta-analysis, Trial sequential analysis, Chinese botanical drug

Received: 26 Nov 2024; Accepted: 21 May 2025.

Copyright: © 2025 Liu, Shi, Jiang, Tao, Du and Gao. 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: Yemei Gao, Beijing Jishuitan Hospital, Capital Medical University, Beijing, China,, 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.