Efficacy of acupuncture in refractory irritable bowel syndrome patients: a randomized controlled trial

Abstract

Previous studies have confirmed that acupuncture for irritable bowel syndrome (IBS) provided an additional benefit over usual care alone. Therefore, we performed a multicenter, randomized, sham-controlled trial to assess the efficacy and safety of acupuncture versus sham acupuncture for refractory IBS in patients in the context of conventional treatments. Patients in the acupuncture and sham acupuncture groups received real or sham acupuncture treatment in 3 sessions per week for a total of 12 sessions. The primary outcome was a change in the IBS–Symptom Severity Scale (IBS-SSS) score from baseline to week 4. A total of 521 participants were screened, and 170 patients (85 patients per group) were enrolled and included in the intention-to-treat analysis. Baseline characteristics were comparable across the two groups. From baseline to 4 weeks, the IBS-SSS total score decreased by 140.0 (95% CI: 126.0 to 153.9) in the acupuncture group and 64.4 (95% CI: 50.4 to 78.3) in the sham acupuncture group. The between-group difference was 75.6 (95% CI: 55.8 to 95.4). Acupuncture efficacy was maintained during the 4-week follow-up period. There were no serious adverse events. In conclusion, acupuncture provided benefits when combined with treatment as usual, providing more options for the treatment of refractory IBS.

Keywords

acupuncture / functional gastrointestinal disorders / irritable bowel syndrome / clinical trial

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Acknowledgements

We thank the team of Evidence-Based Medicine Center, Beijing Institute of Traditional Chinese Medicine, and Yan Liu, MD (Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing, Dongzhimen Hospital) for assisting in statistical analysis. This study was supported by the National Key R&D Program of China (No. 2019YFC1709004).

Compliance with ethics guidelines

Conflicts of interest Jun Zhao, Hui Zheng, Xin Wang, Xuefei Wang, Yunzhou Shi, Chaorong Xie, Qingfeng Tao, Da Li, Jingwen Sun, Junjian Tian, Junxia Gao, Huimin Liu, Suhua Shi, Jinxia Ni, Rongdan Xue, Hui Hu, Min Chen, Shuguang Yu, and Zhigang Li declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article. Min Chen, ShuGuang Yu, and ZhiGang Li served as the reviewers of grant proposals for the National Natural Science Foundation of China.

Informed consent was obtained from all the patients, in which their identifying information is included in this article. Other ethical board approval is not applicable in this manuscript.

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Supplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-024-1073-7 and is accessible for authorized users.

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