Efficacy and safety of modified Sini San for treating poststroke depression: A meta-analysis of randomized controlled trials.
patients with poststroke depression
modified Sini San (MSS)
fluoxetine hydrochloride
response rate, Hamilton depression rating scale (HAMD) scores, modified Edinburgh-Scandinavia stroke scale (SSS) scores
Abstract
The aim of this meta-analysis was to evaluate the efficacy and safety of modified Sini San (MSS) for poststroke depression (PSD). 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. 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. 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.