Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial

Jun Zhao, Min Chen, Xin Wang, Kun Ye, Suhua Shi, Huixia Li, Jianfang Wang, Xiaowei Chen, Jinxia Ni, Qingshuang Wei, Yunzhou Shi, Yu Hu, Jingwen Sun, Da Li, Siyuan Liu, Zhigang Li, Hui Zheng, Shu-Guang Yu, Jun Zhao, Min Chen, Xin Wang, Kun Ye, Suhua Shi, Huixia Li, Jianfang Wang, Xiaowei Chen, Jinxia Ni, Qingshuang Wei, Yunzhou Shi, Yu Hu, Jingwen Sun, Da Li, Siyuan Liu, Zhigang Li, Hui Zheng, Shu-Guang Yu

Abstract

Introduction: Irritable bowel syndrome (IBS) is a common chronic functional gastrointestinal disorder that presents with abdominal pain/discomfort and altered bowel patterns. IBS has multiple potential causes for which conventional medicines have had limited success, resulting in a significant number of patients who do not sensitively respond to pharmacotherapy for a period of 12 months and who develop a continuing symptom profile (described as refractory IBS) and seek help through (non)pharmacological treatments. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for refractory IBS on the basis of conventional treatments.

Methods and analysis: A total of 170 eligible patients who meet the Rome IV criteria for refractory IBS will be randomly allocated to receive acupuncture or sham acupuncture. Each patient will receive 12 sessions of acupuncture over 4 weeks and a 4-week follow-up. The primary outcome will be the IBS Symptom Severity Score. Secondary outcomes will include the proportion of participants experiencing adequate relief of global IBS symptoms, the weekly frequency of defecation, the stool properties assessed by the Bristol Grading Scale, the Work and Social Adjustment Scale, the IBS-Quality of Life score, and the Self-Rating Depression Scale and Self-Rating Anxiety Scale anxiety and depression scores. Outcome measures will be collected at baseline, 2 and 4 weeks of the intervention, and 6 and 8 weeks after the intervention. Categorical variables will be compared with Fisher's exact test or the Wilcoxon rank-sum test, and continuous variables will be compared using Student's t-test or the Wilcoxon rank-sum test.

Ethics and dissemination: The entire project has been approved by the ethics committees of Beijing University of Chinese Medicine (2020BZYLL0507) and Sichuan Province Regional Institution for Conducting Research on Traditional Chinese Medicine (2020KL-025). The outcomes of the trial will be disseminated through peer-reviewed publications.

Trial registration number: NCT04276961.

Keywords: complementary medicine; gastroenterology; protocols & guidelines.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.

Figures

Figure 1
Figure 1
Trial flow diagram. IBS, irritable bowel syndrome.
Figure 2
Figure 2
Schedule of enrolment, intervention and assessments of this study protocol. IBS, irritable bowel syndrome; SAS, Self-Rating Anxiety Scale; SDS, Self-Rating Depression Scale; TAU, treatment as usual.
Figure 3
Figure 3
Locations of acupoints and non-acupoints.

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Source: PubMed

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