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

• Published in: Current controlled trials in cardiovascular medicine Vol. 22; no. 1; p. 719
• Main Authors: Sun, Jing-Wen, Sun, Ming-Liang, Li, Da, Zhao, Jun, Shi, Su-Hua, Li, Hui-Xia, Liu, Hui-Min, Gao, Jun-Xia, Hu, Yu, Zheng, Hui, Wang, Xin, Xue, Rong-Dan, Feng, Xue, Yu, Shu-Guang, Li, Zhi-Gang
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 19.10.2021; BioMed Central; BMC
• Subjects: Abdomen; Acupoint combination; Acupuncture; Acupuncture Points; Acupuncture Therapy - adverse effects; Care and treatment; Chinese medicine; Clinical trials; Defecation; Diagnosis; Diarrhea; Hospitals; Humans; Irritable bowel syndrome; Irritable Bowel Syndrome - diagnosis; Irritable Bowel Syndrome - therapy; Methods; Multicenter Studies as Topic; Patients; Protocol; Quality of Life; Randomized controlled trial; Randomized Controlled Trials as Topic; Statistical analysis; Study Protocol; Testing; Treatment Outcome; China; Beijing China; Acupoint combination; Acupuncture; Protocol; Randomized controlled trial; Irritable bowel syndrome
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-021-05432-0

Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain, diarrhea or constipation, and changes in defecation patterns. No organic disease is found to explain these symptoms by routine clinical examination. This study aims to investigate the efficacy and safety of acupuncture therapy for IBS patients compared with those of conventional treatments. We also aim to identify the optimal acupoint combination recommended for IBS and to clarify the clinical advantage of the "multiacupoint co-effect and synergistic effect." A total of 204 eligible patients who meet the Rome IV criteria for IBS will be randomly stratified into acupuncture group A, acupuncture group B, or the control group in a 1:1:1 ratio with a central web-based randomization system. The prespecified acupoints used in the control group will include bilateral Tianshu (ST25), Shangjuxu (ST37), Neiguan (PC6), and Zusanli (ST36). The prespecified acupoints used in experimental group A will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Neiguan (PC6). The prespecified acupoints used in experimental group B will include bilateral Tianshu (ST25), Shangjuxu (ST37), and Zusanli (ST36). Each patient will receive 12 acupuncture treatments over 4 weeks and will be followed up for 4 weeks. The primary outcome is the IBS-Symptom Severity Scale (IBS-SSS) score. The secondary outcomes include the Bristol Stool Form Scale (BSFS), Work and Social Adjustment Score (WSAS), IBS-Quality of Life (IBS-QOL), Self-Rating Anxiety Scale (SAS), and Self-Rating Depression Scale (SDS) scores. Both the primary outcome and the secondary outcome measures will be collected at baseline, at 2 and 4 weeks during the intervention, and at 6 weeks and 8 weeks after the intervention. The entire project has been approved by the ethics committee of the Beijing University of Chinese Medicine (2020BZYLL0903). This is a multicenter randomized controlled trial for IBS in China. The findings may shed light on the efficacy of acupuncture as an alternative to conventional IBS treatment. The results of the trial will be disseminated in peer-reviewed publications. Chinese Clinical Trials Register ChiCTR2000041215 . First registered on 12 December 2020. http://www.chictr.org.cn/ .