Abstract
INTRODUCTION: While recent research suggests that acupuncture may offer benefits to individuals with diarrhoea-predominant irritable bowel syndrome (IBS-D), high-quality studies are scarce in this area. We intend to investigate the efficacy and safety of individualised sensitised acupuncture in IBS-D. METHODS AND ANALYSIS: The study is designed as a large-scale, multicentre, two-arm, randomised clinical trial involving 326 patients diagnosed with IBS-D. Participants will be randomly allocated into the acupuncture or the sham acupuncture group in a 1:1 ratio. Both groups will undergo 15 sessions over 6 weeks. The primary outcome is the effective response rate at week 6, with secondary outcomes including the effective response rate at alternative time points, percentage of patients with 3 or more effective response weeks throughout the treatment duration, IBS Symptom Severity Scale, IBS-Quality of Life, Patient Health Questionnaire-9, Adequate Relief of IBS Symptoms Scale, Extraintestinal Symptoms Scale and other symptoms. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Ethics Committee of Beijing University of Chinese Medicine (project number: 2023BZYLL0102) and the ethics committees of other participating institutions. Each participant will be required to provide written consent before enrolment. The study results will be submitted for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: ChiCTR2300078321.