Acupuncture & Tuina College/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Chinese Evidence-based Medicine Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, China.
Neurogastroenterol Motil. 2018 Jul;30(7):e13316. doi: 10.1111/nmo.13316. Epub 2018 Feb 28.
To test the efficacy of electroacupuncture for patients with refractory functional dyspepsia (FD).
A 24-week, 2-arm, single-blind, randomized controlled trial was conducted at three hospitals in China. Patients with refractory FD were randomly assigned to receive 20 sessions of authentic or sham electroacupuncture in a treatment duration of 4 weeks. The primary outcome was complete absence of dyspeptic symptoms at 16 weeks after initiation of acupuncture (week 16). The secondary outcomes included adequate relief of dyspeptic symptoms, Leeds Dyspepsia Questionnaire (LDQ), Nepean Dyspepsia Index (NDI), and adverse events. Intention-to-treat analysis was performed.
Two hundred patients were included, of which 196 (98%) completed follow-up data at week 24. At week 16, 17 (17%) patients in the authentic electroacupuncture group vs 6 (6%) patients in the sham group achieved the primary outcome (P = .014). Sixty-two (62%) patients had adequate relief in the authentic electroacupuncture group, as compared to 22 (22%) in the sham group (P = .001). The scores of LDQ and NDI were significantly improved in both groups at week 16, and patients in the authentic electroacupuncture group have more improvements (LDQ, mean difference, -2.2, 95% confidence interval, -2.3 to -2.1, P < .001; NDI, -7.3, -10.5 to -4.2, P < .001). Results were similar for all the outcomes assessed at week 24. No serious adverse events were reported in both groups.
Acupuncture efficaciously improves dyspeptic symptoms in patients with refractory FD.
为了测试电针对难治性功能性消化不良（FD）患者的疗效。
在中国的三家医院进行了一项为期 24 周、2 臂、单盲、随机对照试验。将难治性 FD 患者随机分为接受 20 次真实或假电针治疗，治疗持续 4 周。主要结局是在针刺开始后 16 周（第 16 周）完全没有消化不良症状。次要结局包括消化不良症状的充分缓解、Leeds 消化不良问卷（LDQ）、Nepean 消化不良指数（NDI）和不良事件。进行意向治疗分析。
共纳入 200 例患者，其中 196 例（98%）在第 24 周完成了随访数据。在第 16 周，真实电针组 17 例（17%）患者达到主要结局，而假电针组 6 例（6%）患者达到主要结局（P=0.014）。真实电针组 62%（62%）的患者有充分缓解，而假电针组为 22%（22%）（P=0.001）。两组患者在第 16 周时 LDQ 和 NDI 评分均显著改善，真实电针组患者的改善更为明显（LDQ，平均差异，-2.2，95%置信区间，-2.3 至-2.1，P<0.001；NDI，-7.3，-10.5 至-4.2，P<0.001）。在第 24 周评估的所有结局中，结果均相似。两组均未报告严重不良事件。
针刺有效地改善了难治性 FD 患者的消化不良症状。
