百乐眠胶囊治疗失眠症：荟萃分析的系统评价

IF 1.7 4区医学 Q3 INTEGRATIVE & COMPLEMENTARY MEDICINE

European Journal of Integrative Medicine Pub Date : 2025-08-07 DOI:10.1016/j.eujim.2025.102537

Yifan Yang , Qinghao Cai , Jiayu Huang , Runru Mai , Yuanyuan Hu , Lijun Ouyang , Zhimin Yang , Biyun Xu

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引用次数: 0

摘要

介绍：百乐眠胶囊是一种广泛用于治疗失眠的中成药。最近，许多新的随机对照试验（rct）被发表。我们的目的是评价百乐眠胶囊的有效性和安全性。方法：检索截至2024年2月24日的7个数据库（EMBASE、PubMed、Cochrane图书馆、Web of Science、中国国家知识基础设施、万方数据库和中国生物医学文献数据库），检索白莲面胶囊的rct。主要结果用匹兹堡睡眠质量指数（PSQI）进行评估。偏倚风险由Cochrane协作工具评估，meta分析使用Review Manager 5.3进行。该综述已在PROSPERO注册（CRD42024507706）。结果：共纳入15项rct， 1547名受试者。与单药治疗相比，百乐眠胶囊与镇静精神药物合用(MD = -3.74, 95% CI [-4.99, -2.48], Z = 5.85, P <；0.00001, I2= 87%)或非镇静性精神药物（MD = -2.84, 95% CI [-4.61, -1.08], Z = 3.16, P = 0.002, I2= 95%）显著降低失眠患者的PSQI评分。联用非镇静性精神药物也能显著改善焦虑性失眠患者的PSQI评分(MD = -1.28, 95% CI [-1.85, -0.72], Z = 3.16, P <；0.00001, I2 = 0%)和抑郁/焦虑性失眠(MD = -4.34, 95% CI [-4.91, -3.77], Z = 4.49, P <；0.00001, i2 = 0%)。与镇静精神药物相比，百乐眠胶囊对失眠患者PSQI评分的降低更大(MD = -3.55, 95% CI: [-5.09, - 2.50]；Z = 4.49, p = 0.0002, i2 = 92.9%)。此外，与镇静相比，联合用药显著降低了不良事件的发生率(RR = 0.29, 95% CI 0.17-0.50, Z = 4.47, P <；0.00001, I2 = 0%)和单独使用非镇静性精神药物（RR = 0.42, 95% CI 0.25 ~ 0.69, Z = 3.42, P = 0.0006, I2 = 0%）。结论：本荟萃分析为百乐眠胶囊治疗失眠症的有效性和安全性提供了证据。然而，由于纳入的研究具有高异质性和高偏倚风险，该结论的推荐仍然是谨慎的，需要通过高质量的临床研究进一步验证。

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Bailemian capsule for insomnia: a systematic review with meta-analysis

Introduction

: Bailemian capsule is a Chinese patent medicine widely used for insomnia. Recently, numerous new randomized controlled trials (RCTs) have been published. Our objective was to evaluate the efficacy and safety of Bailemian capsule.

Methods

: Seven databases (EMBASE, PubMed, the Cochrane library, Web of Science, Chinese National Knowledge Infrastructure, Wanfang database and China Biomedical Literature database) were searched for RCTs of Bailemian capsule as of 24 February 2024. Primary outcomes were assessed with the Pittsburgh Sleep Quality Index (PSQI). The risk of bias was assessed by the Cochrane Collaboration's tool, and meta- analysis was performed using Review Manager 5.3. The review was registered in PROSPERO (CRD42024507706).

Results

: A total of 15 RCTs involving 1547 participants were included. Compared with monotherapy, combining Bailemian capsules with sedating psychotropic drugs (MD = -3.74, 95 % CI [-4.99, -2.48], Z = 5.85, P < 0.00001, I²= 87 %) or non-sedating psychotropic drugs (MD = -2.84, 95 % CI [-4.61, -1.08], Z = 3.16, P = 0.002, I²= 95 %) significantly reduced PSQI scores in patients with insomnia. The combination with non-sedating psychotropic drugs also significantly improved PSQI scores in patients with anxiety insomnia (MD = -1.28, 95 % CI [-1.85, -0.72], Z = 3.16, P < 0.00001, I² = 0 %) and depressive/anxiety insomnia (MD = -4.34, 95 % CI [-4.91, -3.77], Z = 4.49, P < 0.00001, I² = 0 %). Compared with sedating psychotropic drugs, the combination with Bailemian capsules led to greater reductions in PSQI scores in patients with insomnia disorder (MD = -3.55, 95 % CI: [-5.09, -2.00]; Z = 4.49, P = 0.0002, I2=92.9 %). Furthermore, the combination significantly reduced the incidence of adverse events compared with sedating (RR = 0.29, 95 % CI 0.17–0.50, Z = 4.47, P < 0.00001, I² = 0 %) and non-sedating psychotropic drugs alone (RR = 0.42, 95 % CI 0.25–0.69, Z = 3.42, P = 0.0006, I² = 0 %).

Conclusion

: This meta-analysis provides evidence for the efficacy and safety of Bailemian capsule in treating insomnia. However, with high heterogeneity and high risk of bias of the included studies, the recommendation of this conclusion remains cautious and requires further validation by high-quality clinical studies.

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来源期刊

European Journal of Integrative Medicine INTEGRATIVE & COMPLEMENTARY MEDICINE-

CiteScore

4.70

自引率

4.00%

发文量

102

审稿时长

33 days

期刊介绍： The European Journal of Integrative Medicine (EuJIM) considers manuscripts from a wide range of complementary and integrative health care disciplines, with a particular focus on whole systems approaches, public health, self management and traditional medical systems. The journal strives to connect conventional medicine and evidence based complementary medicine. We encourage submissions reporting research with relevance for integrative clinical practice and interprofessional education. EuJIM aims to be of interest to both conventional and integrative audiences, including healthcare practitioners, researchers, health care organisations, educationalists, and all those who seek objective and critical information on integrative medicine. To achieve this aim EuJIM provides an innovative international and interdisciplinary platform linking researchers and clinicians. The journal focuses primarily on original research articles including systematic reviews, randomized controlled trials, other clinical studies, qualitative, observational and epidemiological studies. In addition we welcome short reviews, opinion articles and contributions relating to health services and policy, health economics and psychology.