BACKGROUND: This meta-analysis was conducted to evaluate the clinical effectiveness and safety of Salvianolic acids for injection (SAFI) plus conventional treatment (CT) for patients with acute cerebral infarction (ACI) and to assess the evidence to guide clinical practice.

MATERIAL AND METHODS: PubMed, EMBASE, Cochrane Library, Web of Science, and 4 Chinese electronic databases were searched to identify relevant randomized controlled trials (RCTs). The methodological quality of eligible studies was evaluated using the Cochrane risk of bias tool. The reporting quality of eligible studies was evaluated by Consolidated Standards of Reporting Trials (CONSORT) for traditional Chinese medicine. Meta-analysis and evidence quality were performed using RevMan 5.3 and Grading of Recommendations Assessment, Development, and Evaluation (GRADE).

RESULTS: A total of 14 RCTs involving 1309 patients were included. Meta-analysis showed that SAFI plus CT was better than CT alone in improving the total effective rate (RR=1.35, 95% CI 1.25 to 1.44, P<0.00001), reducing the National Institutes of Health Stroke Scale (NIHSS) score (130 mg: WMD=–3.31, 95% CI –3.80 to –2.47, P<0.00001; 100 mg: WMD=–1.91, 95% CI –2.28 to –1.54, P<0.00001), improving the activity of daily living and cognitive function of ACI, and improving the hemorheology (HBV: high shear rate blood viscosity, LBV: low shear rate blood viscosity, PV: plasma viscosity) and C-reactive protein (CRP).

CONCLUSIONS: SAFI plus CT in the treatment of ACI can improve the total effective rate, neurological deficit, and ability to perform activities of daily living, and there is no serious adverse reaction. Based on the GRADE system, the evidence quality is low. More large-scale, well-designed, and high-quality RCTs are required to confirm the positive results.

Keywords: Randomized controlled trial, Stroke, Activities of Daily Living, Alkenes, Brain Ischemia, cerebral infarction, Drugs, Chinese Herbal, Injections, polyphenols