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Crb4.0
Cerebrolysin Research
Mostly mechanism / observationalLimited safety
10 peer-reviewed studies
What the evidence says
Mostly mechanism / observational
Most Cerebrolysin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from medium-quality meta-analyses and randomised trials published 2011–2023 with a typical study size of 597 participants.
Based on 10 studies · 7 meta-analyses · 3 RCTs · 11,816 total participants
Confidence
High
By outcome
Stroke & recovery
Mostly mechanism / observational4 studies
Cognitive function
Mostly mechanism / observational4 studies
Traumatic brain injury
Mostly mechanism / observational3 studies
Safety profile
Mostly mechanism / observational3 studies
Neuroprotection & brain aging
Too few graded studies1 study
Active research area
4 studies in the last 5 years · Latest meta-analysis: 2023
201120172023
1Meta-Analysisn=1,601 · large study2020
Moderate-quality evidence indicates that Cerebrolysin probably has little or no beneficial effect on preventing all-cause death in acute ischaemic stroke ... Moderate-quality evidence also indicates a potential increase in non-fatal serious adverse events with Cerebrolysin use.
Cochrane systematic review/meta-analysis of 7 RCTs (1601 participants) in acute ischaemic stroke
No difference in all-cause death (RR 0.90, 95% CI 0.61-1.32; moderate-quality evidence)
Increase in the number of people with non-fatal serious adverse events (RR 2.15, 95% CI 1.01-4.55), more pronounced at the 30 mL / 10-day schedule (RR 2.86, 95% CI 1.23-6.66)
We performed a systematic search and meta-analysis ... to determine the safety profile of Cerebrolysin in acute ischemic stroke, filling existing safety information gaps and inconsistent results.
Systematic review/meta-analysis pooling 2202 patients from 12 RCTs
Focused on the safety profile (risk ratios for adverse outcomes) in acute ischaemic stroke
Reported non-statistically-significant differences for the analysed safety outcomes
4RCT2016
Cerebrolysin had a beneficial effect on function and global outcome in early rehabilitation patients after stroke ... Because this study was exploratory and had a relatively small sample size, the results should be confirmed in a large-scale, randomized clinical trial.
Muresanu DF, Heiss WD, Hoemberg V, Bajenaru O, et al. · Stroke (2016)
Phase II randomised, double-blind, placebo-controlled multicentre trial; 30 mL/day for 21 days plus rehabilitation, started 24-72 h after stroke
Primary endpoint (Action Research Arm Test at day 90) favoured Cerebrolysin (MW 0.71, 95% CI 0.63-0.79; P<0.0001)
Authors themselves flag it as exploratory with a small sample needing confirmation
Cerebrolysin had a beneficial effect on motor function ... the corresponding number-needed-to-treat (NNT) for clinically relevant changes in early NIHSS was 7.1 (95% CI: 4 to 22).
Guekht A, Vester J, Heiss WD, Gusev E, et al. · Neurol Sci (2017)
Individual-patient-data meta-analysis pooling the two CARS trials (N = 442)
Action Research Arm Test at day 90 favoured Cerebrolysin (MW 0.62, P<0.0001)
Early NIHSS benefit (MW 0.59, P<0.002); NNT 7.1 for early improvement
6Meta-Analysis2015
This meta-analysis provides evidence that Cerebrolysin has an overall beneficial effect and a favorable benefit-risk ratio in patients with mild-to-moderate AD.
Treatment with Cerebrolysin was associated with a statistically significant change in GCS and GOS. Mortality of any cause and the length of stay was not affected by the treatment.
Jarosz K, Kojder K, Andrzejewska A, Solek-Pastuszka J, et al. · Brain Sci (2023)
Systematic review/meta-analysis of 10 clinical studies (retrospective + prospective), 8749 patients with traumatic brain injury
Statistically significant improvement in Glasgow Coma Scale and Glasgow Outcome Scale
NO effect on all-cause mortality and no effect on length of stay
Although no statistically significant differences were observed in the primary outcome measures, the descriptive trends in the study support existing literature.
Verisezan Rosu O, Jemna N, Hapca E, Benedek I, et al. · Front Neurosci (2023)
Three-arm RCT in 93 TBI patients: Cerebrolysin+rTMS, Cerebrolysin+sham, or placebo+sham
Primary outcome (composite cognitive scores at 3 and 6 months) showed NO statistically significant differences between arms
Only non-significant descriptive trends favoured the active arms