Yin Xuan, Gou Minghui, Xu Jian, Dong Bo, Yin Ping, Masquelin Fernand, Wu Junyi, Lao Lixing, Xu Shifen
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Beijing Fengtai Hospital of Traditional Chinese and Western Medicine, Beijing, China.
Sleep Med. 2017 Sep;37:193-200. doi: 10.1016/j.sleep.2017.02.012. Epub 2017 Mar 8.
The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primary insomnia.
We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventy-two patients with primary insomnia were randomly assigned into two groups - the acupuncture group, who received acupuncture treatment, and the control group, who received sham acupuncture treatment. The treatment was given three times a week for four weeks. Patients were asked to wear sleep monitors and complete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index (ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleep time (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-Rating Depression Scale (SDS).
Compared with pretreatment baseline, patients in both groups had varying degrees of improvements in their sleep conditions. Paired t-test showed that there was a significant difference in all indicators in the acupuncture group before and after acupuncture treatment. One-way analysis of covariance adjusted for baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks post-treatment (F = 11.3, p = 0.001), four weeks post-treatment (F = 33.6, p < 0.001), 2 weeks follow-up (F = 39.4, p < 0.001) and four weeks follow-up (F = 34.1, p < 0.001). Similar significant improvements can also be observed in the SE, TST and SDS scores. Although no differences in SA and SAS were shown between the two groups until the end of the treatment, remarkable decrements in SA and SAS were found in the acupuncture treatment group after the two-week and four-week follow-ups.
Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients' sleep quality and improving their psychological health.
Chinese Clinical Trial Registry: Chi CTR-TRC-14004859.
本研究旨在评估针刺治疗原发性失眠的疗效和安全性。
我们开展了一项单中心、单盲随机对照临床试验。72例原发性失眠患者被随机分为两组，针刺组接受针刺治疗，对照组接受假针刺治疗。治疗每周进行3次，共4周。要求患者佩戴睡眠监测仪，并每两周填写问卷，为期8周。主要结局指标为失眠严重程度指数（ISI）。次要结局指标为睡眠参数，包括通过活动记录仪记录的睡眠效率（SE）、睡眠觉醒次数（SA）和总睡眠时间（TST），以及自评焦虑量表（SAS）和自评抑郁量表（SDS）的得分。
与治疗前基线相比，两组患者的睡眠状况均有不同程度改善。配对t检验显示，针刺组针刺治疗前后各项指标均有显著差异。协方差分析经基线评分调整后表明，针刺组在治疗后2周（F = 11.3，p = 0.001）、4周（F = 33.6，p < 0.001）、随访2周（F = 39.4，p < 0.001）和随访4周（F = 34.1，p < 0.001）时ISI显著改善。在SE、TST和SDS评分方面也观察到类似的显著改善。虽然直到治疗结束两组间SA和SAS均无差异，但针刺治疗组在随访2周和4周后SA和SAS显著下降。
针刺治疗在提高失眠患者睡眠质量和改善心理健康方面比假针刺治疗更有效。
中国临床试验注册中心：Chi CTR-TRC-14004859。
