Safety and Efficacy of Cerebrolysin for Neurorecovery After Acute Ischemic Stroke: A Systematic Review and Meta-Analysis of 14 Randomized Controlled Trials

Abstract

Cerebrolysin, a neurotrophic compound, has been investigated as a neurorestorative therapy in acute ischemic stroke, although findings are inconsistent due to limitations in study inclusion and outcome reporting. This systematic review and meta-analysis evaluated the efficacy and safety of Cerebrolysin in improving neurological and functional outcomes following acute ischemic stroke. Fourteen randomized controlled trials (N = 2,884 patients) comparing Cerebrolysin to placebo were included. The primary outcome was change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to follow-up, while secondary outcomes included functional independence (modified Rankin Scale (mRS) 0-2), serious adverse events (SAEs), mortality, and hemorrhagic transformation. Risk of bias was assessed using the revised Cochrane Risk of Bias (RoB 2.0) tool, and certainty of evidence was evaluated using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) framework. Pooled analysis showed that Cerebrolysin significantly improved neurological recovery (mean difference in NIHSS change: +1.39; 95% confidence interval (CI): 0.53-2.25; p = 0.020). Functional independence showed a non-significant trend in favor of Cerebrolysin (risk ratio (RR) = 1.31; 95% CI: 0.90-1.91; p > 0.05). No significant differences were observed in SAEs (RR = 1.08; 95% CI: 0.84-1.40), mortality (RR = 0.86; 95% CI: 0.68-1.09), or hemorrhagic transformation (RR = 0.55; 95% CI: 0.32-0.92). These findings suggest that Cerebrolysin significantly enhances early neurological recovery after ischemic stroke, with a comparable safety profile. Further high-quality trials are warranted to confirm its impact on long-term functional outcomes.