Effect of Acupuncture for Diarrhea-Predominant Irritable Bowel Syndrome: Study Protocol for a Randomized Clinical Trial

Abstract Background Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common subtype of IBS. Acupuncture is commonly used to treat IBS-D, but its effect is uncertain because of the poor quality of prior studies. Therefore, we designed this trial to evaluate the effect and safety of acupuncture for the treatment of IBS-D through comparisons with sham acupuncture. Methods/design: This is a large-scale, multi-center, randomized, two-arm interventional clinical trial. Participant will take part in a total of 20 weeks, which contained 3 phases that 2-weeks screening, 6-weeks treatment, 12-week follow-up. Based on the composite response rate of primary endpoint in our pilot study (a sham acupuncture response rate of 27% and a true acupuncture of approximately 45%), 280 randomly allocated participants were planned. Eligible participants will be randomly assigned to true acupuncture group and sham acupuncture group according to the ratio of 1:1, and a total of 15 sessions of treatment overall 6-week treatment period will be brought. The primary endpoint is a composite response rate at week 6, and the responder is defined as who responses in both abdominal pain intensity and stool consistency. Furthermore, composite response rates at other weeks, IBS Symptom Severity Scale, IBS Quality of Life, Adequate Relief scale and individual IBS symptoms (abdominal pain, bloating, stool frequency) are chosen as secondary endpoints. Discussion This trial may provide high-quality evidence for the efficacy and safety of acupuncture in the treatment of IBS-D. The results of this study will be published in peer-reviewed journals. Trial registration: ClinicalTrials.gov, ChiCTR2100044762. Registered on 26 March 2021.