Efficacy of acupuncture at pain-sensitive acupoints for diarrhoea-predominant irritable bowel syndrome (IBS-D): protocol of a multicentre, randomised, sham-controlled trial.

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.