Evidence map›Paper›PMID 29248999›Full record

SynthesisNeurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology2018

Safety and efficacy of Cerebrolysin in early post-stroke recovery: a meta-analysis of nine randomized clinical trials.

Natan M Bornstein, Alla Guekht, Johannes Vester, Wolf-Dieter Heiss, Eugene Gusev, Volker Hömberg, Volker W Rahlfs, Ovidiu Bajenaru, Bogdan O Popescu, Dafin Muresanu

Registry-linked trialOpen access · hybridAbstract readMeta-Analysis
In one paragraph

Synthesis in Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00868283 (A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke), which is not on this map. Cited by 58 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
58citing papers in PubMed, 5 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00868283 phase4completednot on this map

A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Cerebrolysin in Patients With Acute Ischemic Stroke

TypeinterventionalSponsorEver Neuro Pharma GmbHRan2006 to 2011Enrolled1,071ConditionsIschemic StrokeArmsCerebrolysin, 0.9% Saline Solution
3 · Its place in the literature

Who cites it

58 citing papers in PubMed, 5 syntheses or guidelines pooled it, 112 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2023
    Pooled it
  5. Cerebrolysin for acute ischaemic stroke.The Cochrane database of systematic reviews · 2020
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Trial
  11. Trial
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Review
  18. C-REGS2-A multinational, high-quality comparative effectiveness study of Cerebrolysin in moderate acute ischemic stroke.International journal of stroke : official journal of the International Stroke Society · 2025
    Article
  19. Article
  20. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 9 institutions in 4 countries.

Natan M BornsteinShaare Zedek Medical Center, Jerusalem, and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Alla GuekhtRussian National Research Medical University and Moscow Research and Clinical Center for Neuropsychiatry, Ul. Donskaya 43, Moscow, 115419, Russia.
Johannes VesterDepartment of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Konrad-Zuse-Bogen 17, 82152, Krailling, Germany.
Wolf-Dieter HeissMax Planck Institute for Metabolism Research, Gleueler Street 50, 50931, Cologne, Germany.
Eugene GusevRussian National Research Medical University, Moscow, Russia.
Volker HömbergDepartment of Neurology, SRH Gesundheitszentrum Bad Wimpfen GmbH, Bad Wimpfen, Germany.
Volker W RahlfsDepartment of Biometry and Clinical Research, IDV Data Analysis and Study Planning, Konrad-Zuse-Bogen 17, 82152, Krailling, Germany.
Ovidiu BajenaruDepartment of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bulevardul Eroii Sanitari 8, 050474, Bucharest, Romania.
Bogdan O PopescuDepartment of Neurology, "Carol Davila" University of Medicine and Pharmacy, Bulevardul Eroii Sanitari 8, 050474, Bucharest, Romania.
Dafin MuresanuDepartment of Clinical Neurosciences, "Iuliu Hatieganu" University of Medicine and Pharmacy, Victor Babes Street No. 8, 400012, Cluj-Napoca, Romania. dafinm@ssnn.ro.
Carol Davila University of Medicine and Pharmacy · ROIuliu Hațieganu University of Medicine and Pharmacy · ROMax Planck Institute for Metabolism Research · DEMoscow Research and Clinical Center for Neuropsychiatry · RUPHV Dialysezentrum · DEPirogov Russian National Research Medical University · RUPTV Group (Germany) · DEShaare Zedek Medical Center · ILZimmer Biomet (Germany) · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

This meta-analysis combines the results of nine ischemic stroke trials, assessing efficacy of Cerebrolysin on global neurological improvement during early post-stroke period. Cerebrolysin is a parenterally administered neuropeptide preparation approved for treatment of stroke. All included studies had a prospective, randomized, double-blind, placebo-controlled design. The patients were treated with 30-50 ml Cerebrolysin once daily for 10-21 days, with treatment initiation within 72 h after onset of ischemic stroke. For five studies, original analysis data were available for meta-analysis (individual patient data analysis); for four studies, aggregate data were used. The combination by meta-analytic procedures was pre-planned and the methods of synthesis were pre-defined under blinded conditions. Search deadline for the present meta-analysis was December 31, 2016. The nonparametric Mann-Whitney (MW) effect size for National Institutes of Health Stroke Scale (NIHSS) on day 30 (or 21), combining the results of nine randomized, controlled trials by means of the robust Wei-Lachin pooling procedure (maximin-efficient robust test), indicated superiority of Cerebrolysin as compared with placebo (MW 0.60, P < 0.0001, N = 1879). The combined number needed to treat for clinically relevant changes in early NIHSS was 7.7 (95% CI 5.2 to 15.0). The additional full-scale ordinal analysis of modified Rankin Scale at day 90 in moderate to severe patients resulted in MW 0.61 with statistical significance in favor of Cerebrolysin (95% CI 0.52 to 0.69, P = 0.0118, N = 314). Safety aspects were comparable to placebo. Our meta-analysis confirms previous evidence that Cerebrolysin has a beneficial effect on early global neurological deficits in patients with acute ischemic stroke.

Indexed as

Amino AcidsBrain IschemiaHumansNeuroprotective AgentsRandomized Controlled Trials as TopicStrokeTreatment OutcomeAmino AcidscerebrolysinNeuroprotective AgentsCerebrolysinEarly benefitMeta-analysisNIHSSRecoveryStroke

Identifiers

PMID29248999
PMCPMC5884916
OpenAlexW2774733134

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.