Acupuncture for irritable bowel syndrome: Study protocol of a prospective, multicentre, registry study in real-world settings

Abstract

Acupuncture is a complex intervention influenced by many factors, and its effectiveness in treating irritable bowel syndrome (IBS) in the real world is unknown. Therefore, we will conduct a registry study to evaluate the effectiveness and safety of acupuncture alone or as adjunctive therapy for IBS in real-world settings. This is a prospective multicentre registry study. At least 788 patients will be recruited from 6 medical centres. Patients who are diagnosed with IBS, aged over 18 years, and voluntarily sign the informed consent form will be recruited. The interventions will include acupuncture or without acupuncture therapy for IBS. The primary outcome will be the IBS symptom severity score, and the secondary outcomes will include adequate relief of global IBS symptoms, the Bristol Stool Form Scale, the weekly frequency of defecation, the Self-Rating Anxiety Scale, and the Self-Rating Depression Scale. All information will be collected through the Epi Info™7 data platform. Propensity score matching will be used to control for potential confounding factors. The generalized additive mixed model will be used to analyse the curative effect. We posit that the treatment should not be less than 3 times, and 1 follow-up is an effective case. This study protocol describes the first large-scale, multicentre patient registry of acupuncture for IBS. The findings of the study will confirm the effectiveness and safety of acupuncture alone or as adjunctive therapy in treating IBS and provide the characteristics of acupuncture implementation, the conditions related to more acupuncture benefit, and identify the key factors affecting the clinical effectiveness of acupuncture treatment for IBS in the real world. Chinese Clinical Trial Registry, ChiCTR2100045329. Registered date on 12 April 2021.