Effectiveness and Safety of Su He Xiang Pill in the Treatment of Acute Stroke: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Background and ObjectiveSu He Xiang Pill (SHXP) is a traditional Chinese medicine widely used for treating acute stroke. This study systematically evaluates the efficacy and safety of SHXP to provide evidence for integrated Traditional Chinese and Western Medicine treatment approaches for acute stroke.MethodsRandomized controlled trials (RCTs) on SHXP for acute stroke were retrieved from CNKI, Wanfang, VIP, PubMed, the Cochrane Library, and other databases up to December 2024. Two reviewers independently screened literature, selected eligible studies, extracted data, and performed meta-analysis using RevMan 5.4. The primary outcome was the National Institutes of Health Stroke Scale (NIHSS); secondary outcomes included China Stroke Scale (CSS), Barthel Index (BI), Modified Rankin Scale (mRS), and adverse drug reactions (ADR).ResultsA total of 26 RCTs involving 2537 patients were included. Compared with conventional treatment alone: ① SHXP significantly reduced NIHSS scores (19 studies, MD = -2.37, 95% CI: -3.05 to -1.70, p < 0.00001) ; ② SHXP significantly improved BI scores (5 studies, MD = 9.79, 95% CI: 8.71 to 10.86, p < 0.00001); ③ No significant increase in ADR was observed (17 studies, OR = 0.56, 95% CI: 0.39 to 0.82, p = 0.002).ConclusionsSHXP exhibits significant efficacy and safety in treating acute stroke (onset within 2 weeks), supporting its use in integrated Traditional Chinese and Western Medicine to improve clinical outcomes.