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

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.

SUBMITTER: Bornstein NM

PROVIDER: S-EPMC5884916 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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

Bornstein Natan M NM Guekht Alla A Vester Johannes J Heiss Wolf-Dieter WD Gusev Eugene E Hömberg Volker V Rahlfs Volker W VW Bajenaru Ovidiu O Popescu Bogdan O BO Muresanu Dafin D

Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology 20171216 4

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 ...[more]

PMID: 29248999

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Project description:BackgroundAcupuncture therapy has been widely used to treat post-stroke cognitive impairment (PSCI). However, acupuncture therapy includes multiple forms. Which acupuncture therapy provides the best treatment outcome for patients with PSCI remains controversial.ObjectiveWe aimed to compare and evaluate the efficacy and safety of different acupuncture-related therapies for PSCI in an attempt to identify the best acupuncture therapies that can improve cognitive function and self-care in daily life for patients with PSCI, and bring new insights to clinical practice.MethodWe searched eight databases including PubMed, Embase, Web of Science, Cochrane Central Register of Controlled Trials, China Biomedical Literature Database (CBM), China Science and Technology Journal (VIP) database, China National Knowledge Infrastructure (CNKI) database, and Wan fang database to find randomized controlled trials (RCTs) of acupuncture-related therapies for PSCI from the inception of the database to January 2023. Two researchers independently assessed the risk of bias in the included studies and extracted the study data. Pairwise meta-analyzes for direct comparisons were performed using Rev. Man 5.4 software. Bayesian network meta-analysis (NMA) was performed using STATA 17.0 and R4.2.4 software. The quality of evidence from the included studies was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. Adverse effects (AEs) associated with acupuncture therapy were collected by reading the full text of the included studies to assess the safety of acupuncture therapy.ResultsA total of 62 RCTs (3 three-arm trials and 59 two-arm trials) involving 5,073 participants were included in this study. In the paired meta-analysis, most acupuncture-related therapies had a positive effect on cognitive function and self-care of daily living in patients with PSCI compared with cognitive training. Bayesian NMA results suggested that ophthalmic acupuncture plus cognitive training (79.7%) was the best acupuncture therapy for improving MMSE scores, with scalp acupuncture plus cognitive training ranking as the second (73.7%). The MoCA results suggested that warm acupuncture plus cognitive training (86.5%) was the best acupuncture therapy. In terms of improvement in daily living self-care, scalp acupuncture plus body acupuncture (87.5%) was the best acupuncture therapy for improving MBI scores. The most common minor AEs included subcutaneous hematoma, dizziness, sleepiness, and pallor.ConclusionAccording to our Bayesian NMA results, ophthalmic acupuncture plus cognitive training and warm acupuncture plus cognitive training were the most effective acupuncture treatments for improving cognitive function, while scalp acupuncture plus body acupuncture was the best acupuncture treatment for improving the performance of self-care in daily life in patients with PSCI. No serious adverse effects were found in the included studies, and acupuncture treatment appears to be safe and reliable. However, due to the low methodological quality of the included studies, our findings need to be treated with caution. High-quality studies are urgently needed to validate our findings.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/#recordDetails, identifier: CRD42022378353.

Project description:BackgroundEnhanced neural plasticity early after stroke suggests the potential to improve outcomes with intensive rehabilitation therapy. Most patients do not get such therapy, however, due to limited access, changing rehabilitation therapy settings, low therapy doses, and poor compliance.ObjectiveTo examine the feasibility, safety, and potential efficacy of an established telerehabilitation (TR) program after stroke initiated during admission to an inpatient rehabilitation facility (IRF) and completed in the patient's home.MethodsParticipants with hemiparetic stroke admitted to an IRF received daily TR targeting arm motor function in addition to usual care. Treatment consisted of 36, 70-minute sessions (half supervised by a licensed therapist via videoconference), over a 6-week period, that included functional games, exercise videos, education, and daily assessments.ResultsSixteen participants of 19 allocated completed the intervention (age 61.3 ± 9.4 years; 6 female; baseline Upper Extremity Fugl-Meyer [UEFM] score 35.9 ± 6.4 points, mean ± SD; NIHSS score 4 (3.75, 5.25), median, IQR; intervention commenced 28.3 ± 13.0 days post-stroke). Compliance was 100%, retention 84%, and patient satisfaction 93%; 2 patients developed COVID-19 and continued TR. Post-intervention UEFM improvement was 18.1 ± 10.9 points (P < .0001); Box and Blocks, 22.4 ± 9.8 blocks (P = .0001). Digital motor assessments, acquired daily in the home, were concordant with these gains. The dose of rehabilitation therapy received as usual care during this 6-week interval was 33.9 ± 20.3 hours; adding TR more than doubled this to 73.6 ± 21.8 hours (P < .0001). Patients enrolled in Philadelphia could be treated remotely by therapists in Los Angeles.ConclusionsThese results support feasibility, safety, and potential efficacy of providing intense TR therapy early after stroke.Clinical trial registrationclinicaltrials.gov; NCT04657770.

Project description:BackgroundCerebrolysin is a mixture of low-molecular-weight peptides and amino acids derived from pigs' brain tissue, which has potential neuroprotective and neurotrophic properties. It is widely used in the treatment of acute ischaemic stroke in Russia, Eastern Europe, China, and other Asian and post-Soviet countries.ObjectivesTo assess the benefits and risks of cerebrolysin for treating acute ischaemic stroke.Search methodsIn May 2016 we searched the Cochrane Stroke Group Trials Register, CENTRAL, MEDLINE, Embase, Web of Science Core Collection, with Science Citation Index, LILACS, OpenGrey, and a number of Russian Databases. We also searched reference lists, ongoing trials registers and conference proceedings, and contacted the manufacturer of cerebrolysin, EVER Neuro Pharma GmbH (formerly Ebewe Pharma).Selection criteriaRandomised controlled trials (RCTs) comparing cerebrolysin, started within 48 hours of stroke onset and continued for any time, with placebo or no treatment in people with acute ischaemic stroke.Data collection and analysisTwo review authors independently applied inclusion criteria, assessed trial quality and risk of bias, and extracted data.Main resultsWe identified six RCTs (1501 participants) that met the inclusion criteria.We evaluated risk of bias and judged it to be unclear for generation of allocation sequence in four studies and low in two studies; unclear for allocation concealment in five studies and low in one study; high for incomplete outcome data (attrition bias) in five studies and unclear in one study; unclear for blinding; high for selective reporting in four studies and unclear in two; and high for other sources of bias in three studies and unclear in the rest. The manufacturer of cerebrolysin, pharmaceutical company EVER Neuro Pharma, supported three multi-centre studies, either totally, or providing cerebrolysin and placebo, randomisation codes, research grants, or statisticians.None of the included trials reported on poor functional outcome defined as death or dependence at the end of the follow-up period or early death (within two weeks of stroke onset).All-cause death: we extracted data from five trials (1417 participants). There was no difference in the number of deaths: 46/714 in cerebrolysin group versus 47/703 in placebo group; risk ratio (RR) 0.91 95% confidence interval (CI) 0.61 to 1.35 (5 trials, 1417 participants, moderate-quality evidence).Serious adverse events (SAEs): there was no significant difference in the total number of SAEs with cerebrolysin (RR 1.16, 95% CI 0.81 to 1.67). This comprised no difference in fatal SAEs (RR 0.90, 95% CI 0.59 to 1.38) and an increase in the number of people with non-fatal SAEs (20/667 with cerebrolysin and 8/668 with placebo: RR 2.47, 95% CI 1.09 to 5.58, P = 0.03) (3 trials, 1335 participants, moderate-quality evidence).Total number of people with adverse events: three trials reported on this. There was no difference in the total number of people with adverse events: 308/667 in cerebrolysin group versus 307/668 in placebo group; RR 0.97 95% CI 0.86 to 1.09, random-effects model (3 trials, 1335 participants, moderate-quality evidence).Authors' conclusionsThe findings of this Cochrane Review do not demonstrate clinical benefits of cerebrolysin for treating acute ischaemic stroke. We found moderate-quality evidence of an increase in non-fatal SAEs with cerebrolysin use but not in total SAEs.

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

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

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