归脾汤加减治疗抑郁伴失眠的疗效及异质性研究——随机对照试验的Meta分析

Efficacy of Modified Guipi Decoction for Depression with Insomnia and Heterogeneity Evaluation—A Meta-Analysis of Randomized Controlled Trials

摘要: 目的：抑郁伴失眠作为临床常见心理障碍，对患者睡眠功能、情绪状态及日常生活质量均造成显著负面影响，已成为亟待关注的健康问题之一。而中药归脾汤加减治疗抑郁和失眠显示出一定疗效，但现有研究结果呈现不一致性。本研究旨在通过Meta分析方法，对归脾汤加减治疗抑郁伴失眠的临床疗效展开系统性评价。方法：系统检索PubMed，中国知网，万方数据库，维普数据库中截止2025年5月1日的相关随机对照试验(RCTs)。主要结局评价指标确定为匹兹堡睡眠质量指数(PSQI)与汉密尔顿抑郁量表(HAMD)，数据的合成分析通过RevMan5.4软件实施。结果：最终纳入14项随机对照试验(RCTs)，总涉及患者1115位，其中实验组557位患者接受归脾汤加减治疗干预。有558位患者作为对照组。Meta分析显示，归脾汤加减治疗的实验组在降低PSQI评分(SMD = −1.46, 95% CI: (−1.61, −1.31), P < 0.001)和HAMD评分(SMD = −1.32, 95% CI: (−1.49, −1.15), P < 0.001)显著均优于对照组。然而，在纳入的研究中存在高异质性(PSQI: I² = 93%, HAMD: I² = 97%)，表明实验结果存在显著差异。因此本研究进行了敏感性分析和亚组分析，实验结果表明干预的种类(单纯采用归脾汤进行治疗和联合治疗)的确导致了高异质性但并非唯一原因。结论：采用归脾汤加减方案治疗，能够有效改善抑郁伴失眠患者的睡眠质量，同时对其抑郁症状具有显著缓解作用。本研究为抑郁症和失眠的联合治疗提供了来自中医临床视角的证据支持。鉴于存在高异质性和潜在发表偏倚，未来仍需开展更多高质量、大样本量的随机对照实验(RCTs)加以验证。

Abstract: Objective: Depression with insomnia is a common mental disorder that severely affects patients’ sleep function, emotional state, and quality of daily life. It has become one of the health issues that require urgent attention. Modified Guipi Decoction, a traditional Chinese herbal formula, has been found to have certain therapeutic effects on depression with insomnia, but the results have been inconsistent. This study aims to systematically evaluate the clinical efficacy of Modified Guipi Decoction in treating depression with insomnia through a meta-analysis. Methods: A systematic search was conducted across PubMed, the China National Knowledge Infrastructure (CNKI), Wanfang Database and VIP Database for relevant randomized controlled trials (RCTs) up to May 1, 2025. The primary assessment indicators were the Pittsburgh Sleep Quality Index (PSQI) and the Hamilton Depression Scale (HAMD). Data synthesis and analysis were performed using RevMan 5.4. Results: The meta-analysis included a total of 1115 participants from 14 randomized controlled trials, with 557 patients receiving Modified Guipi Decoction (experimental group) and 558 patients serving as controls. Meta-analysis results showed that the Modified Guipi Decoction treatment group significantly outperformed the control group in both PSQI scores (SMD = −1.46, 95% CI: −1.61 to −1.31, P < 0.001) and HAMD scores (SMD = −1.32, 95% CI: −1.49 to −1.15, P < 0.001). However, high heterogeneity was observed between the included studies (PSQI: I² = 93%, HAMD: I² = 97%), indicating significant variability in the results. Sensitivity analysis and subgroup analysis suggested that the type of intervention (pure vs. combined) contributes to heterogeneity but is not the sole cause. Conclusion: Modified Guipi Decoction has certain therapeutic effects in improving the sleep quality of patients with depression and insomnia, and significantly alleviates their depressive symptoms. This study provides evidence support from the perspective of traditional Chinese medicine for the combined treatment of depression and insomnia. However, high heterogeneity and possible publication bias suggest that more high-quality, large-sample RCTs are needed to verify these findings.