PDF(Pubmed)
Abstract：
Background: Natural products are widely used for primary insomnia (PI). This systematic review with trial sequential analysis (TSA) aimed to summarize evidence pertaining to the effectiveness and safety of Zao Ren An Shen (ZRAS) prescription, a commercial Chinese polyherbal preparation, for treating PI. Methods: Controlled clinical trials appraising ZRAS compared to controls or as an add-on treatment were systematically searched across seven databases until January 2024. Cochrane ROB 2.0 and ROBINS-I tools were adopted to determine risk of bias. Quality of evidence was assessed using the GRADE framework. Results: We analyzed 22 studies, involving 2,142 participants. The effect of ZRAS in reducing Pittsburgh Sleep Quality Index scores was found to be comparable to benzodiazepines [MD = 0.39, 95%CI (-0.12, 0.91), p = 0.13] and superior to Z-drugs [MD = -1.31, 95%CI (-2.37, -0.24), p = 0.02]. The addition of ZRAS to hypnotics more significantly reduced polysomnographically-recorded sleep onset latency [MD = -4.44 min, 95%CI (-7.98, -0.91), p = 0.01] and number of awakenings [MD = -0.89 times, 95%CI (-1.67, -0.10), p = 0.03], and increased total sleep time [MD = 40.72 min, 95%CI (25.14, 56.30), p < 0.01], with fewer adverse events than hypnotics alone. TSA validated the robustness of these quantitative synthesis results. However, the quality of evidence ranged from very low to low. The limited data available for follow-up did not support meta-synthesis. Conclusion: While ZRAS prescription shows promising effectiveness in treating PI, the overall quality of evidence is limited. Rigorously-designed randomized control trials are warranted to confirm the short-term efficacy of ZRAS and explore its medium-to-long-term efficacy. Systematic Review Registration: (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=471497), identifier (CRD42023471497).
摘要：
背景：天然产物广泛用于原发性失眠（PI）。这项带有试验序贯分析（TSA）的系统评价旨在总结有关枣仁安神（ZRAS）处方的有效性和安全性的证据，一种商业中草药制剂，用于治疗PI。方法：在2024年1月之前，在七个数据库中系统地搜索了评估ZRAS与对照或作为附加治疗的对照临床试验。采用CochraneROB2.0和ROBINS-I工具来确定偏倚风险。使用GRADE框架评估证据质量。结果：我们分析了22项研究，涉及2142名参与者。发现ZRAS在降低匹兹堡睡眠质量指数评分方面的效果与苯二氮卓类药物相当[MD=0.39，95CI（-0.12，0.91），p=0.13]，优于Z-药物[MD=-1.31，95CI（-2.37，-0.24），p=0.02]。在催眠药中添加ZRAS可显着降低多导睡眠记录的睡眠发作潜伏期[MD=-4.44分钟，95CI（-7.98，-0.91），p=0.01]和觉醒次数[MD=-0.89次，95CI（-1.67，-0.10），p=0.03],总睡眠时间增加[MD=40.72分钟，95CI（25.14，56.30），p<0.01],与单独使用催眠药相比，不良事件更少。TSA验证了这些定量合成结果的稳健性。然而,证据质量从非常低到低不等。可用于随访的有限数据不支持荟萃合成。结论:虽然ZRAS方剂治疗PI具有良好的疗效,证据的整体质量是有限的。严格设计的随机对照试验有必要证实ZRAS的短期疗效，并探讨其中长期疗效。系统审查注册：（https：//www。crd.约克。AC.uk/prospro/display_record.php?RecordID=471497),标识符(CRD42023471497)。
