Efficacy of ACupuncTure in Irritable bOwel syNdrome (ACTION): A Multicenter Randomized Controlled Trial.

Abstract

Irritable bowel syndrome (IBS) affects 4.1% of the adult population, with many reporting ongoing symptoms despite first-line therapies. Acupuncture is widely used for IBS, but without sufficient evidence. We aimed to assess the efficacy of acupuncture in patients with diarrhea-predominant IBS (IBS-D). This was a multicenter randomized controlled trial in 6 hospitals in China. Patients aged 18 to 75 years with IBS-D per Rome IV diagnostic criteria were randomly allocated (1:1) to receive 15 sessions of acupuncture or sham acupuncture (blunt-tipped needle at non-acupoints) over 6 weeks with a 12-week follow-up. The primary outcome was the composite response rate at week 6, defined as at least a 30% improvement in the mean worst abdominal pain and a 50% or more reduction in the number of days with diarrhea from baseline during week 6. Between May 2021 and August 2022, 584 patients were assessed for eligibility, of whom 280 were randomly allocated. The primary outcome was reached by 71 (57.9%) patients in the acupuncture group compared with 47 (41.4%) patients in the sham acupuncture group (risk ratio 1.40; P = .008). The between-group difference became significant from week 3 and maintained throughout the study except week 16. No severe adverse event was reported. Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks. The results of this trial suggest that acupuncture may serve as an alternative treatment for IBS-D. (ACTION Chinese Clinical Trial Registry number, ChiCTR2100044762).