The Efficacy and Safety of Cerebrolysin on Functional Outcomes in Acute Ischemic Stroke: An Updated Systematic Review and Meta-analysis of Randomized Controlled Trials
Rahman Syed1, Ameer Afzal Khan2, Anfal Khan2, Mohsin Ali2, Tirath Patel3
1Swat Medical College, Swat, 2Saidu Medical College, Swat, 3Trinity Medical Sciences University School of Medicine, Ratho mill, Kingstown, Saint Vincent and the Grenadines
Objective:

This systematic review and meta-analysis aim to investigate the improvements in functional outcomes with cerebrolysin in patients suffering from acute ischemic stroke.

Background:

Cerebrolysin is a neurotropic agent that is used in stroke recovery, with studies examining its impact on neurological function, activities of daily living, and the assessment of cognitive performance in post-stroke patients.

Design/Methods:
This meta-analysis included 11 randomized controlled trials (RCTs) with sample sizes ranging from 46 to 1070 participants, comparing Cerebrolysin (doses over 5-28 days, starting 24-72 hours post-stroke) to placebo or control. Outcomes were pooled using mean difference (MD) and Risk ratios (RR), with heterogeneity assessed via I². Subgroup analyses were performed for 30-day and 90-day post-stroke intervals. Safety was evaluated using adverse events (AEs), serious adverse events (SAEs), and mortality.
Results:

Four studies reported NIHSS as a continuous outcome. At 30 days, the pooled mean difference (MD) was –1.27 [–1.89, 0.65] (I² = 35%), and at 90 days –2.06 [–2.86, –1.46] (I² = 0%), with an overall MD of –1.51 [–2.06, –0.96] (I² = 40%), favoring Cerebrolysin. Arm function improved significantly (MD = 9.92 [0.95–18.89]), though heterogeneity was high. Modified Rankin Scale (mRS) showed a favorable trend (RR = 1.52 [0.75–3.08]). Barthel Index continuous analysis indicated improved mobility (MD = 8.67 [2.23–15.11]). Cognitive assessments (MMSE) showed modest gains with Cerebrolysin, while Fugl-Meyer scores revealed small-to-moderate effects, particularly for upper limb recovery during later follow-up, suggesting progressive benefit over time.

Conclusions:

Cerebrolysin demonstrates potential benefits in reducing NIHSS scores, improving ARAT and BI as continuous outcomes, and enhancing upper limb FMA in later phases, with favorable trends in mRS and MMSE, though heterogeneity and non-significant effects in some dichotomous outcomes limit conclusions. Safety profiles were comparable to placebo, supporting its use as an adjunct in stroke rehabilitation.

10.1212/WNL.0000000000216736
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