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针刺治疗原发性失眠:随机对照试验的最新系统评价

Acupuncture for Primary Insomnia: An Updated Systematic Review of Randomized Controlled Trials.

作者信息

Cao Hui-Juan, Yu Mei-Li, Wang Li-Qiong, Fei Yu-Tong, Xu Hao, Liu Jian-Ping

机构信息

1 Beijing University of Chinese Medicine, Beijing, China.

2 Beijing First Hospital of Integrated Chinese and Western Medicine, Beijing, China.

出版信息

J Altern Complement Med. 2019 May;25(5):451-474. doi: 10.1089/acm.2018.0046. Epub 2019 Apr 23.

Abstract

Acupuncture as one of the alternative therapies for insomnia is widely used in Asia and increasingly employed in western countries. To provide updated evidence from randomized controlled trials (RCTs) on the effectiveness and safety of acupuncture for primary insomnia. A comprehensive literature search in 11 databases was conducted from January 2008 to October 2017. Two authors independently extracted data and assessed risk of bias independently. Statistical analysis was performed using RevMan 5.3 software. According to predefined protocol, we combined data in meta-analysis and performed trial sequential analysis when appropriate. Grading of Recommendations Assessment, Development, and Evaluation was also conducted to assess the quality of evidence. A total of 73 RCTs involving 5533 participants were analyzed. The pooled results showed better effect from real acupuncture than no treatment (mean difference [MD] -5.58, 95% confidence interval [CI] -6.85 to -4.31,  = 0%,  < 0.00001, 2 trials, fixed effect model, 105 participants) on reducing Pittsburgh Sleep Quality Index (PSQI) scores with "very low quality" evidence. Acupuncture plus drugs showed better improvement than drugs alone on decreasing the PSQI total scores (MD -3.17, 95% CI -4.74 to -1.61,  = 72%, 4 trials, random-effects model (REM),  < 0.0001, 253 participants, low quality). Similar benefit favored acupuncture compared with no treatment (MD -8.46, 95% CI -9.59 to -7.33,  = 0%,  < 0.00001, 2 trials, 65 participants). Acupuncture showed more benefit than estazolam on PSQI (with enough statistical power). Athens Insomnia Scale (MD -1.64, 95% CI -2.40 to -0.89,  = 0%,  < 0.0001, 3 trials, fixed-effects model, 180 participants) or SPIEGEL (MD -2.86, 95% CI -3.54 to -2.18,  < 0.00001,  = 0%, 5 trials, fixed-effects model, 326 participants) with "very low-quality" evidence. Furthermore, low-quality evidence showed less adverse events from acupuncture than western medications (risk ratio 0.23, 95% CI 0.11-0.48,  = 56%,  < 0.0001, 11 trials, REM, 914 participants). Publication bias was likely present based on the PSQI total scores. The summary estimates indicate that acupuncture might result in improvement than no treatment on PSQI scores and appears safe. However, the quality of the evidence is varied from very low to low due to the potential risk of bias and inconsistency among included trials. Further large sample size and rigorously designed RCTs are still needed.

摘要

针灸作为治疗失眠的替代疗法之一,在亚洲被广泛使用,在西方国家也越来越多地被采用。旨在提供来自随机对照试验(RCT)的最新证据,以证明针灸治疗原发性失眠的有效性和安全性。于2008年1月至2017年10月在11个数据库中进行了全面的文献检索。两位作者独立提取数据并独立评估偏倚风险。使用RevMan 5.3软件进行统计分析。根据预定义方案,我们在荟萃分析中合并数据,并在适当的时候进行试验序贯分析。还进行了推荐评估、制定和评价分级以评估证据质量。共分析了73项涉及5533名参与者的随机对照试验。汇总结果显示,与不治疗相比,真针灸在降低匹兹堡睡眠质量指数(PSQI)评分方面效果更好(平均差[MD] -5.58,95%置信区间[CI] -6.85至-4.31,I² = 0%,P < 0.00001,2项试验,固定效应模型,105名参与者),证据质量为“极低质量”。针灸联合药物在降低PSQI总分方面比单纯药物治疗改善更明显(MD -3.17,95% CI -4.74至-1.61,I² = 72%,4项试验,随机效应模型(REM),P < 0.0001,253名参与者,低质量)。与不治疗相比,针灸也有类似的益处(MD -8.46,9:5% CI -9.59至-7.33,I² = 0%,P < 0.00001,2项试验,65名参与者)。在PSQI方面,针灸比艾司唑仑更有益(具有足够的统计效力)。在雅典失眠量表(MD -1.64,95% CI -2.40至-0.89,I² = 0%,P < 0.0001,3项试验,固定效应模型,180名参与者)或SPIEGEL量表(MD -2.86,95% CI -3.54至-2.18,P < 0.00001,I² = 0%,5项试验,固定效应模型,326名参与者)上,证据质量为“极低质量”。此外,低质量证据表明,与西药相比,针灸的不良事件更少(风险比0.23,95% CI 0.11 - 0.48,I² = 56%,P < 0.0001,11项试验,随机效应模型,914名参与者)。基于PSQI总分可能存在发表偏倚情况。汇总估计表明,针灸在PSQI评分方面可能比不治疗有改善,且似乎是安全的。然而,由于纳入试验中存在潜在的偏倚风险和不一致性,证据质量从极低到低不等。仍需要进一步的大样本量和严格设计的随机对照试验。

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