Meta-analysis of cerebrolysin for Alzheimer's disease
Author(s): LI Yan, HE Dian, LI Zuo, CHU Lan, LIU Fang, FANG Xuming, TIAN Tian
Pages: 179-184
Year: 2017 Issue: 3
Journal: Journal of Clinical Neurology
Keyword: Alzheimer's disease; cerebrolysin; randomized controlled trial; meta-analysis;
Abstract: Objective To assess the absolute efficacy and safety of cerebrolysin for patients with Alzheimer''s disease(AD).Methods CENTRAL, MEDLINE、EMBASE, PsycINFO, CBMDisc(up to September 30,2015) were searched for the randomized, placebo-controlled, parallel-group clinical trials evaluating cerebrolysin as monotherapy for patients with AD dementia or mild cognitive impairment due to AD.The methodological quality of the original studies were evaluated by using the Cochrane collaboration''s tool.The influences of study limitations, inconsistency of results, imprecision of effect estimates, indirectness of evidence and publication bias on the quality of the body of evidence were assessed by using GRADEpro software (version 3.2).Results Six studies were included, involving 950 patients with AD dementia.Subgroup analyses indicated cerebrolysin at a dose of 30 ml improved cognitive function in patients with mild-to-moderate AD dementia at one month or six months of follow-up [standard mean difference (SMD)=-0.360,95%CI:-0.600——0.130,P=0.003;SMD =-0.350,95%CI:-0.590——0.100,P=0.005)].There was improvement in behavioural and psychiatric symptoms at six months of follow-up(SMD=-0.290,95%CI:-0.540——0.050,P=0.020).Cerebrolysin did not improve activities of daily living at one month or six months of follow-up (SMD=-0.160,95%CI:-0.350-0.040,P=0.120;SMD=-0.210,95%CI:-0.450-0.030,P=0.080).The incidence of adverse events (AEs) at one month or six month of follow-up was not different between the cerebrolysin group and the placebo group.No serious AEs occurred in both groups.All studies had methodological limitations, mainly on an unclear risk of detection bias.The pharmaceutical company funded or participated in the clinical trials, therefore,the potential risk of bias was high.Furthermore, the total sample size for most outcomes was insufficient, and the 95%CI of most results was wide.All these factors contributed to a decreased quality level of the evidence.Conclusions There is low/very low-quality evidence to show that cerebrolysin has slight effects in improving cognitive function and behavioural and psychiatric symptoms in patients with mild-to-moderate AD dementia.It has no effects in improving activities of daily living.
Pages: 179-184
Year: 2017 Issue: 3
Journal: Journal of Clinical Neurology
Keyword: Alzheimer's disease; cerebrolysin; randomized controlled trial; meta-analysis;
Abstract: Objective To assess the absolute efficacy and safety of cerebrolysin for patients with Alzheimer''s disease(AD).Methods CENTRAL, MEDLINE、EMBASE, PsycINFO, CBMDisc(up to September 30,2015) were searched for the randomized, placebo-controlled, parallel-group clinical trials evaluating cerebrolysin as monotherapy for patients with AD dementia or mild cognitive impairment due to AD.The methodological quality of the original studies were evaluated by using the Cochrane collaboration''s tool.The influences of study limitations, inconsistency of results, imprecision of effect estimates, indirectness of evidence and publication bias on the quality of the body of evidence were assessed by using GRADEpro software (version 3.2).Results Six studies were included, involving 950 patients with AD dementia.Subgroup analyses indicated cerebrolysin at a dose of 30 ml improved cognitive function in patients with mild-to-moderate AD dementia at one month or six months of follow-up [standard mean difference (SMD)=-0.360,95%CI:-0.600——0.130,P=0.003;SMD =-0.350,95%CI:-0.590——0.100,P=0.005)].There was improvement in behavioural and psychiatric symptoms at six months of follow-up(SMD=-0.290,95%CI:-0.540——0.050,P=0.020).Cerebrolysin did not improve activities of daily living at one month or six months of follow-up (SMD=-0.160,95%CI:-0.350-0.040,P=0.120;SMD=-0.210,95%CI:-0.450-0.030,P=0.080).The incidence of adverse events (AEs) at one month or six month of follow-up was not different between the cerebrolysin group and the placebo group.No serious AEs occurred in both groups.All studies had methodological limitations, mainly on an unclear risk of detection bias.The pharmaceutical company funded or participated in the clinical trials, therefore,the potential risk of bias was high.Furthermore, the total sample size for most outcomes was insufficient, and the 95%CI of most results was wide.All these factors contributed to a decreased quality level of the evidence.Conclusions There is low/very low-quality evidence to show that cerebrolysin has slight effects in improving cognitive function and behavioural and psychiatric symptoms in patients with mild-to-moderate AD dementia.It has no effects in improving activities of daily living.
Related Articles