Acupuncture For The Treatment of Diarrhoea-Predominant Irritable Bowel Syndrome (ATIBS-D): A Pilot Randomized Controlled Trial

Abstract Background: Diarrhoea-predominant irritable bowel syndrome (IBS-D) is a common disease without an established optimal treatment. Acupuncture has promising effects on IBS-D, but high-quality evidence is scarce.Methods: In this parallel, multicenter, randomized controlled trial, participants with IBS-D were assigned to three groups: specific acupoints (SA), non-specific acupoints (NSA) and non-acupoints (NA). Participants received 12 sessions (3 sessions per week) treatment over 4 weeks. The primary endpoint was a composite response rate at week 4 of treatment. An eligible composite responder was responded in both abdominal pain intensity and stool consistency, defined as at least 30% decrease in the weekly average of worst abdominal pain score and 50% or greater reduction in the number of Type 6 or 7 stool days weekly compared with baseline.Results: Of 201 screened patients with IBS-D, 90 (44.8%) patients were enrolled, and 88.9% patients completed this study (26 in NSA; 27 in SA and NA). The composite response rates at week 4 were 46.7%, 46.7% and 26.7% (P＞0.05) of the participants who received SA, NSA and NA acupuncture, respectively. Adverse events were reported in 2 (6.7%) patients in SA, 3 (10%) patients in NSA and NA. There were no serious adverse events.Conclusions: The present study suggests that acupuncture treatment is feasible and safe for IBS-D patients. The further adequately powered trials can be achieved by recruiting more patients, increasing treatment dose, prolonging follow-up, choosing specific acupoints, setting up sham-acupuncture control, or a combination thereof.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030670. Registered on 9 March 2020. https://www.chictr.org.cn/edit.aspx?pid=50167&htm=4