Efficacy of acupuncture based on acupoint combination theory for irritable bowel syndrome: study protocol for a multicenter randomized controlled trial

Background: Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease has been found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients based on conventional treatments. We also want to explore the optimal acupoint combination recommended for IBS and clarify the clinical advantage of "multi-acupoint co-effect and synergistic effect". Methods and analysis: A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly allocated to receive different acupuncture. Each patient will receive 12 acupuncture treatments over four weeks and will be followed up for four weeks. The primary outcome is the IBS-symptom severity score (IBS-SSS). The secondary outcomes include the Bristol stool form scale(BSFS), the work and social adjustment score (WSAS), the IBS-quality of life (IBS-QOL), self-rating anxiety scale (SAS), and the self-rating depression scale (SDS). Both the primary outcome and the secondary outcomes measures are collected at baseline, 2 weeks, and 4 weeks of the intervention, 6 weeks, and 8 weeks after the intervention. Ethics and dissemination: The entire project has been approved by the ethics committee of Beijing University of Chinese Medicine ( 2020BZYLL0903 ) . Discussion: This is a multicenter randomized controlled trial for IBS in China. This may shed light on the efficacy of acupuncture as an alternative to IBS. The results of the trial will be disseminated in peer-reviewed publications. Trial registration : Chinese Clinical Trials Register, ID: ChiCTR2000041215.First registered on 12 December 2020. http://www.chictr.org.cn/.