Xuesaitong oral preparation as adjuvant therapy for treating acute cerebral infarction: A systematic review and meta-analysis of randomized controlled trials

Cerebral infarction is the second leading cause of death and the third most common cause of disability. The use of anti-platelet aggregation drugs is prone to bleeding, liver and kidney damage, gastrointestinal reactions, and is not suitable for patients to take for a long time. Xuesaitong oral preparations (XSTOP), a traditional Chinese medicine formula, has shown therapeutic effect on treating cerebral infarction based on the clinical practice and pharmacological mechanism.The study aims to evaluate the effectiveness and safety of XSTOP combined with conventional treatment (CT) in treatment of acute cerebral infarction (ACI), and to provide the reliable evidence for clinical application.We performed a literature search in Chinese National Knowledge Infrastructure (CNKI), Wanfang Database, VIP Database, PubMed, EMBASE, Cochrane Library and Web of Science from their inceptions to August 2021. Systematic searches for randomized controlled trials (RCTs) of XSTOP in treatment of ACI. Odds ratio (OR) or mean difference (MD) with their 95% confidence interval was calculated between with and without XSTOP therapy. Cochrane risk of bias tool was used to evaluate the methodological quality of the included trials.Eight RCTs involving 827 patients were included in this meta-analysis. By comparing XSTOP plus conventional treatment with conventional treatment alone, the meta-analysis gave the following results: (1) Total effective rate (OR = 4.53, 95% CI[2.85, 7.19], P < 0.0001); (2) National Institutes of Health Stroke Scale (NIHSS) score (MD = -3.22, 95% CI[-4.52, -1.92], P＜0.00001); (3) Plasma viscosity (PV) (MD = -0.74, 95%CI [-0.96, -0.51], P＜0.00001), hole blood high-cut viscosity (HBV) (MD = -0.63, 95%CI [-0.73, -0.53], P = 0.84), whole blood low-cut viscosity (LBV) (MD = -0.37, 95%CI [-0.56, -0.19], P = 0.96), fibrinogen (FIB) (MD = -23.78, 95%CI [-28.57, -18.99], P = 1.00), hematocrit (Hct) (MD = -2.76, 95%CI [-3.16, -2.36], P = 0.96); (4) China Stroke Scale (CSS) score (MD = -6.53, 95% CI[-9.07, -3.99], P＜0.00001); (5) No significant adverse reactions were reported; (6) The evidence was downgraded to "very low" quality, according to GRADE system.XSTOP plus CT is conditional recommended to improve the total effective rate, NIHSS score, PV, CSS score, and no serious adverse reactions were noted. The GRADE assessment indicates that the overall certainty quality of evidence is very low. Further large-scale, well-designed and high-quality RCTs are needed to confirm the positive results. As all studies included were conducted in China. It is unclear if the findings of this meta-analysis could be generalized to other populations.