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

Background & Aims: 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).

Methods: 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.

Results: 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.

Conclusions: 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).