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

Acupuncture is widely used for IBS, but without sufficient evidence.

针灸被广泛用于肠易激综合症的治疗，但缺乏足够的证据。

We aimed to assess the efficacy of acupuncture in patients with diarrhea-predominant IBS (IBS-D).

我们旨在评估针灸在腹泻型肠易激综合征(IBS-D)患者中的疗效。

Methods

This was a multicenter randomized controlled trialin 6 hospitals in China.

这是一项在中国六家医院进行的多中心随机对照试验。

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.

年龄在18至75岁之间，符合罗马IV诊断标准的IBS-D患者被随机分配（1:1）接受为期6周的15次针灸治疗或假针灸治疗（在非穴位使用钝头针），并进行12周的随访。

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.

主要结果是第6周的综合反应率，定义为在第6周期间，平均最严重的腹痛至少改善30%以及与基线相比，腹泻天数减少50%或以上。

Results

Between May 2021 and August 2022, 584 patients were assessed for eligibility, of whom 280 were randomly allocated.

在2021年5月至2022年8月期间，共有584名患者被评估以确定其是否符合入选标准，其中280名患者被随机分配。

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).

主要结果指标方面，针灸组有71名（57.9%）患者达到，而对照组（假针灸组）有47名（41.4%）患者达到（风险比1.40；P = .008）。

The between-group difference became significant from week 3 and maintained throughout the study except week 16.

从第3周开始，组间差异变得显著，并在整个研究期间保持显著，除了第16周。

No severe adverse eventwas reported.

未报告严重不良事件。

Conclusions

Acupuncture improved abdominal pain and stool consistency in patients with IBS-D, with sustained efficacy over 18 weeks.

针灸改善了肠易激综合症腹泻型患者的腹痛和大便性状，其疗效在18周内持续显现。

The results of this trial suggest that acupuncture may serve as an alternative treatment for IBS-D.

本试验的结果表明，针灸可能作为肠易激综合症腹泻型的一种替代治疗方法。

(ACTION Chinese Clinical Trial Registry number, ChiCTR2100044762).

（中国临床试验注册中心注册号，ChiCTR2100044762）。