Notable efficacy of Shugan Jieyu capsule in treating adult with post-stroke depression: A PRISMA-compliant meta-analysis of randomized controlled trials

Abstract

Ethnopharmacological relevance: Post stroke depression (PSD), which happens in 40%-60% stroke patients, is one of the most common complications after cerebrovascular accident. Shugan Jieyu Capsule (SGJYC), a traditional Chinese medicine, has been widely prescribed for PSD in China.

Aim of the study: This study designed and conducted a PRISMA compliant meta-analysis to evaluate the efficacy of SGJYC in treating adults with PSD of randomized controlled trials (RCTs) under the condition that none PRISMA-compliant systematic evaluation or meta-analysis was conducted to fully evaluate the efficacy of SGJYC.

Methods: The study protocol has been registered in PROSPERO with registration number CRD42021250162. PubMed, ScienceDirect, CNKI, and Wanfang Databases were systematically searched to include eligible RCTs which used SGJYC and other antidepressants or placebo for the treatment of PSD adults with the Hamilton Depression Scale (HAMD). The Cochrane Risk of Bias 2 (RoB2) tool was used to evaluate the quality of included RCTs. Outcome measures including HAMD continuous data, efficacy data, and remission data were extracted for meta-analysis on a random-effects model. Adequate essential analyses including subgroup analysis, sensitivity analysis, and meta-regression analysis were performed according to the characteristics of RCTs to test the reliability and robustness of the overall effect sizes. Publication bias was detected with funnel plot, Egger's test, and Begg's test. The evidence strength of this meta-analysis was assessed with the GRADE method.

Results: A total of 63 eligible RCTs and 6036 participants were included. The RoB2 found that the overall risk of included RCTs was high. The MD of continuous data was 3.59 (95% CI: [2.63, 4.55]) with statistical significance (P < 0.00001) and significant heterogeneity (Chi² = 2083.77, I² = 97%, p < 0.00001). The OR of efficacy data was 2.12 (95% CI: [1.82, 2.47]) with statistical significance (P < 0.00001) and insignificant heterogeneity (Chi² = 60.52, I² = 22%, P = 0.09). The OR of remission data was 1.66 (95% CI: [1.45, 1.91]) with statistical significance (P < 0.00001) and insignificant heterogeneity (Chi² = 26.45, I² = 0%, P = 0.96). Adequate essential analyses found consistent results of overall effect sizes and most publication bias analyses found insignificant results. The overall evidence strength was assessed as moderate.

Conclusion: The moderate evidence strength from this PRISMA-compliant meta-analysis found that SGJYC has notable efficacy in treating adults with PSD, although the quality of included RCT was low. The high-quality RCTs with large-sample, multi-centers, and long follow-up periods are still warranted to improve the evidence quality of SGJYC for PSD in further study.

Keywords: Meta-analysis; Post-stroke depression; Randomized controlled trials; Shugan Jieyu capsule.