School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, 3083, Australia; Department of Nursing, School of International Medical Technology, Shanghai Sanda University, Shanghai, China.
Yangpu Hospital, Tongji University School of Medicine, Shanghai, China.
Sleep Med. 2021 Apr;80:244-259. doi: 10.1016/j.sleep.2021.01.053. Epub 2021 Feb 2.
The efficacy of acupuncture for treating primary insomnia (PI) has been explored in several meta-analyses where the outcomes measures were based on subjective self-reported sleep rating scales. Sleep state misperception is common in PI and self-reports underestimate sleep duration and quality. No systematic reviews or meta-analyses have investigated the efficacy of acupuncture in improving objective sleep measures in PI.
To perform a systematic review to determine whether objective sleep parameters are improved by acupuncture in patients with PI.
Randomized controlled trials treating PI via verum-acupuncture versus sham-/placebo-acupuncture or waitlist control were searched for in English [MEDLINE (via PubMed), Sciverse ScienceDirect, Cochrane Central Register of Controlled Trials (CENTRAL), AMED, Springer, EMBASE (Elsevier), Ebsco Medline, and PsycINFO (ProQuest)] and Chinese (SinoMed, CNKI, Wanfang and CQVIP) databases, from the dates of the databases' inception to January 2020. The parameters of polysomnography (PSG), actigraphy, or micromovement sensitive mattress/pillow sleep monitoring systems were considered as the primary outcome measures. Revman 5.3 and Stata 16.0 software were used to conduct the meta-analysis. Heterogeneity was examined by using I statistics and publication bias was assessed via Egger's test.
Eleven studies involving 775 patients met the inclusion criteria. The results of meta-analysis suggested that acupuncture can increase total sleep time [MD = 55.29, 95%CI (29.16, 81.42), p < 0.01], increase sleep efficiency [MD = 8.96, 95%CI (3.97, 13.95), p < 0.01], decrease wake after sleep onset [MD = -49.54, 95%CI (-82.98, -16.09), p < 0.01], and reduce number of awakening times [MD = -6.29, 95%CI (-10.75, -1.82), p < 0.01] compared with either sham-/placebo-acupuncture or waitlist control. Subsequent analysis indicated a superior effect for verum-acupuncture in comparison with sham-/placebo-acupuncture or waitlist-control when the recommended lowest threshold dosage (12 sessions) was met. Despite positive outcomes, most studies reviewed were heterogeneous and at risk of bias due to methodological issues.
Despite limited evidence, acupuncture was significantly associated with improvements in several objective sleep parameters (increases in total sleep time and sleep efficiency, and reductions in wake after sleep onset and number of awakening times) as well as subjective sleep quantity and quality in patients with PI. A minimum therapeutic threshold dosage (≥12 sessions) is recommended. Well-designed RCTs using PSG are required to clarify the influence of acupuncture on sleep architecture/structure and to promote better application of acupuncture as a treatment for PI.
多项荟萃分析探讨了针灸治疗原发性失眠（PI）的疗效，其结局指标基于主观自我报告的睡眠评分量表。PI 患者中常存在睡眠状态感知错误，自我报告会低估睡眠时间和质量。目前尚无系统评价或荟萃分析研究针灸对改善 PI 患者客观睡眠指标的疗效。
进行系统评价，以确定针灸是否能改善 PI 患者的客观睡眠参数。
检索了英文数据库[MEDLINE（通过 PubMed）、Sciverse ScienceDirect、Cochrane 中央对照试验注册库（CENTRAL）、AMED、Springer、EMBASE（Elsevier）、Ebsco Medline 和 PsycINFO（ProQuest）]和中文数据库[中国生物医学文献数据库（SinoMed）、中国知网（CNKI）、万方数据知识服务平台（Wanfang）和维普期刊资源整合服务平台（CQVIP）]中治疗 PI 的真针灸与假针灸/安慰剂针灸或空白对照的随机对照试验，检索时间截至 2020 年 1 月。多导睡眠图（PSG）、活动记录仪或微运动敏感床垫/枕头睡眠监测系统的参数被视为主要结局指标。Revman 5.3 和 Stata 16.0 软件用于进行荟萃分析。使用 I ²统计量评估异质性，Egger 检验评估发表偏倚。
11 项研究共纳入 775 名患者符合纳入标准。荟萃分析结果表明，针灸可增加总睡眠时间[MD=55.29，95%CI（29.16，81.42），p<0.01]、增加睡眠效率[MD=8.96，95%CI（3.97，13.95），p<0.01]、减少睡眠潜伏期后觉醒[MD=-49.54，95%CI（-82.98，-16.09），p<0.01]和减少觉醒次数[MD=-6.29，95%CI（-10.75，-1.82），p<0.01]，与假针灸/安慰剂针灸或空白对照相比。后续分析表明，当达到推荐的最低治疗阈值剂量（12 次）时，真针灸与假针灸/安慰剂针灸或空白对照相比，效果更为显著。尽管有积极的结果，但由于方法学问题，大多数综述研究存在异质性和偏倚风险。
尽管证据有限，但针灸与 PI 患者的多项客观睡眠参数（总睡眠时间和睡眠效率增加，睡眠潜伏期后觉醒和觉醒次数减少）以及主观睡眠量和质量的改善显著相关。建议采用最低治疗阈值剂量（≥12 次）。需要设计良好的随机对照试验使用 PSG 来阐明针灸对睡眠结构/结构的影响，以促进针灸作为 PI 治疗方法的更好应用。
