Ma Ning, Pan Bei, Yang Sihong, Lai Honghao, Ning Jinling, Li Ying, Liu Jianing, Huang Jiajie, Ma Yan, Hou Liangying, Li Dan, Deng Xiyuan, Wang Xiaoman, He Xin, Liu Xiaowei, Liu Yajie, Jin Jiayue, Tian Jinhui, Ge Long, Zhao Hui, Yang Kehu
Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou, 730000, China; Centre for Evidence-Based Social Science/Center for Health Technology Assessment, School of Public Health, Lanzhou University, 730000, Lanzhou, China; Gansu Key Laboratory of Evidence-Based Medicine, Lanzhou University, 730000, Lanzhou, China.
Institute of Basic Research of Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing, China; China Center for Evidence Based Traditional Chinese Medicine, China Academy of Chinese Medical Sciences, Beijing, 100700, China.
J Ethnopharmacol. 2025 Jan 31;340:119254. doi: 10.1016/j.jep.2024.119254. Epub 2024 Dec 18.
Chinese patent medicine (CPM) is formulated using Chinese herbal medicines as raw materials according to prescribed methods and preparation processes. It is one of the most commonly used complementary and alternative therapies for insomnia in China. Dozens of CPMs have been applied in clinical settings to treat primary insomnia, and ample evidence has proven the efficacy and safety of various CPMs.
We aimed to use the network meta-analysis method to simultaneously compare the efficacy and safety of Chinese patent medicines for primary insomnia.
We systematically searched eight databases from their inception to July 2022. The relevant randomized controlled trials (RCTs) were eligible if they compared one CPM or one CPM plus a Western drug with another CPM or with Western drug/placebo in adults with primary insomnia. Two reviewers independently performed literature screening, data extraction, and risk of bias assessment. We evaluated the certainty of evidence utilizing CINeMA (Confidence in Network Meta-Analysis) framework.
A total of 109 RCTs involved 11,488 patients (54.26% female) with a median age of 47.97 years. Forty-five CPMs were assessed in this study. Compared with placebo and Benzodiazepine drugs, Shugan Jieyu capsules, Shenqi Wuweizi tablets, and Tianmeng oral liquid/capsules combined with Benzodiazepine drugs significantly improved sleep quality. Compared to Benzodiazepine drugs, both Shenqi Wuweizi tablets and Anshen Bunao liquid/granules significantly prolonged subjective total sleep duration and reduced sleep onset latency. Considering safety, all CPMs showed an insignificant difference or lower risk of gastrointestinal and dizziness events compared to Western drugs or placebo. The certainty of evidences was rated as low or very low.
This meta-analysis demonstrated the efficacy and safety of CPMs for primary insomnia, especially several CPMs such as Shugan Jieyu capsules, Shenqi Wuweizi tablets and Tianmeng oral liquid, which have shown their potential benefits. However, the present conclusions are based on low quality trials. Well-designed trials, including rigorous methods and patient-important outcomes, are required to verify these results.
中成药是以中草药为原料，按照规定的方法和制备工艺制成的。它是中国治疗失眠最常用的补充和替代疗法之一。数十种中成药已应用于临床治疗原发性失眠，大量证据证明了各种中成药的有效性和安全性。
我们旨在使用网络荟萃分析方法同时比较治疗原发性失眠的中成药的疗效和安全性。
我们系统检索了8个数据库，检索时间从建库至2022年7月。纳入的相关随机对照试验需满足：在成年原发性失眠患者中，比较一种中成药或一种中成药加一种西药与另一种中成药或西药/安慰剂。两名评价员独立进行文献筛选、数据提取和偏倚风险评估。我们利用CINeMA（网络荟萃分析可信度）框架评估证据的确定性。
共纳入109项随机对照试验，涉及11488例患者（女性占54.26%），中位年龄为47.97岁。本研究评估了45种中成药。与安慰剂和苯二氮䓬类药物相比，疏肝解郁胶囊、参芪五味子片以及甜梦口服液/胶囊联合苯二氮䓬类药物能显著改善睡眠质量。与苯二氮䓬类药物相比，参芪五味子片和安神补脑液/颗粒均能显著延长主观总睡眠时间并缩短入睡潜伏期。在安全性方面，与西药或安慰剂相比，所有中成药的胃肠道和头晕事件差异均无统计学意义或风险更低。证据确定性等级为低或极低。
本荟萃分析证明了中成药治疗原发性失眠的有效性和安全性，尤其是疏肝解郁胶囊、参芪五味子片和甜梦口服液等几种中成药显示出了潜在益处。然而，目前的结论基于低质量试验。需要设计良好的试验，包括严谨的方法和对患者重要的结局指标，来验证这些结果。
