Objective

The aim of this meta-analysis was to evaluate the efficacy and safety of modified Sini San (MSS) for poststroke depression (PSD).

Methods

Randomized controlled trials of MSS for PSD were identified in the Web of science, PsycINFO, World Cat, CNKI, VIP, Wanfang, DuXiu, and Embase databases according to the inclusion and exclusion criteria.

Results

In total, 7 trials with 548 patients were included in the review. The meta-analysis showed that MSS had superior effects to fluoxetine hydrochloride in terms of response rate in patients with PSD (relative risk (RR): 1.19, 95% confidence interval (CI) [1.10, 1.28], Z = 4.31, P < 0.0001). MSS may be more effective at reducing Hamilton depression rating scale (HAMD) scores and modified Edinburgh-Scandinavia stroke scale (SSS) scores than fluoxetine hydrochloride after 4 and 8 weeks of treatment.

Conclusions

: Our meta-analysis demonstrated that MSS appears to have excellent therapeutic effects on PSD and no serious adverse effects. However, due to the small sample sizes and low quality of the literature, studies with higher methodological quality, larger sample sizes, and placebo controls are recommended in future research on MSS in patients with PSD to enhance the strength of the evidence. Therefore, clinicians should be cautious in using this evidence to make clinical decisions.

中文翻译：

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改良四逆散治疗卒中后抑郁症的疗效和安全性：随机对照试验的荟萃分析

客观的

本荟萃分析的目的是评估改良四逆散（MSS）治疗卒中后抑郁症（PSD）的疗效和安全性。

方法

根据纳入和排除标准在 Web of science、PsycINFO、World Cat、CNKI、VIP、万方、独秀和 Embase 数据库中确定了 MSS 治疗 PSD 的随机对照试验。

结果

该评价总共纳入了 7 项试验，涉及 548 名患者。荟萃分析表明，MSS 在 PSD 患者的缓解率方面优于盐酸氟西汀（相对风险 (RR)：1.19，95% 置信区间 (CI) [1.10, 1.28]，Z  = 4.31，P < 0.0001）。在治疗 4 周和 8 周后，MSS 可能比盐酸氟西汀更有效地降低汉密尔顿抑郁量表 (HAMD) 评分和改良的爱丁堡-斯堪的纳维亚卒中量表 (SSS) 评分。

结论

：我们的荟萃分析表明，MSS 似乎对 PSD 具有出色的治疗效果，并且没有严重的副作用。然而，由于样本量小、文献质量低，在未来关于 PSD 患者 MSS 的研究中，建议采用更高方法学质量、更大样本量和安慰剂对照的研究，以增强证据的强度。因此，临床医生在使用这些证据做出临床决策时应谨慎。