Efficacy and safety of

Background: Shuxuening injection (SXNI), a standardized injectable formulation of Methods: Randomized controlled trials published before 1 September 2025, were searched in eight databases. Patients had vascular cognitive impairment (VCI), with the control group receiving conventional treatment and the treatment group receiving additional SXNI therapy. The primary outcome was the Mini-Mental State Examination (MMSE), while secondary outcomes included the Hasegawa Dementia Scale (HDS), Barthel Index (BI), overall response rate, National Institutes of Health Stroke Scale (NIHSS), and adverse event incidence. Risk of bias was assessed using the revised Cochrane Risk of Bias tool. Risk ratios (RR) were used for binary variables; mean differences (MD) with 95% confidence intervals (CI) were used for continuous variables. Results: Twenty-two trials (n = 2,375) were included. All trials were conducted in China between 2005 and 2025. Compared with the control group, SXNI was associated with higher MMSE (MD 3.61, 95% CI 3.06-4.17), HDS (MD 1.30, 95% CI 0.21-2.39), and BI (MD 9.06, 95% CI 4.66-13.45), a higher overall response rate (RR 1.27, 95% CI 1.21-1.33), and lower NIHSS (MD -6.17, 95% CI -7.90 to -4.45). Seven studies reported adverse events; and there was no significant difference in the incidence of adverse events (RR 0.72, 95% CI 0.36-1.44). Conclusion: The addition of SXNI to conventional treatment may provide additional benefits in cognition, neurological function, and activities of daily living with no significant increase in reported adverse events compared with conventional treatment. However, the certainty of evidence is limited by methodological weaknesses and uncertainty regarding the comparability of preparations from different manufacturers. Therefore, high-quality studies are needed to confirm these findings. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=557472, identifier CRD42024557472.