Xuesaitong injection for acute cerebral infarction: Efficacy and safety meta-analysis of randomized controlled trials

BACKGROUND: A comprehensive meta-analysis was carried out to assess the efficacy and safety of Xuesaitong injection as an adjuvant to conventional therapy in treating acute cerebral infarction (ACI). METHODS: We systematically searched major biomedical databases, including English and Chinese literature, for relevant randomized controlled trials (RCTs) published before March 2025. Two researchers independently conducted study selection and data extraction. The meta-analysis was carried out with the help of RevMan 5.3, with sensitivity analyses conducted in STATA. The GRADE framework was used to comprehensively assess the quality of evidence, ensuring a comprehensive assessment of methodological rigor and clinical applicability across included studies. RESULTS: The results showed that Xuesaitong injection improved the efficacy of treatment for ACI, yielding a relative response rate higher than conventional therapy alone (RR = 1.20, 95 %CI [1.17, 1.24], p < 0.00001). In the group receiving adjunctive therapy, significant improvements were observed in the neurofunctional deficit score (SMD = -0.93, 95% CI [-1.14, -0.72], p < 0.00001). Furthermore, hemorheological parameters, particularly plasma viscosity, showed marked enhancements (SMD = -0.89, 95 %CI [-1.34, -0.45], p < 0.00001). Although the rates of adverse events remained comparable across the different groups. The GRADE assessment indicated a "low" to "moderate" quality of evidence for these outcomes. CONCLUSION: This study established stricter screening criteria and updated the included literature. The evidence indicated that the combination of Xuesaitong and traditional therapy might offer a therapeutic benefit compared to monotherapy for ACI. However, the findings may not be universally applicable since most of the research is derived from China. Definite conclusions require further multicenter clinical trials employing stricter methodological standards.