Abstract

Baclofen is increasingly used for alcohol dependence treatment but its use remains controversial. Therefore, this study aimed to assess the efficacy and safety of baclofen use on alcohol dependence. This is systematic review and meta-analysis of randomized controlled trials. PubMed, Science Direct, Scopus and Thai databases were systematically searched. Randomized controlled trials investigating efficacy and safety of baclofen on alcohol dependence were included. Study selection, data extraction and quality assessment were performed independently by two reviewers. The clinical therapeutic efficacy and adverse events of baclofen were assessed and were pooled using a random-effects model. Heterogeneity was assessed by I² and chi-squared test. Sixteen studies with 1539 alcohol dependence patients were included. Baclofen increased risk of abstinence (risk ratio=1.32; 95 % confidence interval: 1.12, 1.55; p=0.0006) and abstinence duration (standard mean difference=1.07 d (95 % confidence interval: 0.13, 2.01; p=0.04) significantly. Moreover, baclofen significantly decreased heavy drinking days (standard mean difference=-1.14 d; 95 % confidence interval:-1.95, -0.34; p=0.007). However, there were no significant effects on times to relapse, craving and number of alcohol drinks. No serious adverse event associated with baclofen was reported during treatments. The meta-regression found baclofen dose was significantly associated with craving. This meta-analysis indicated that baclofen treatment in alcohol dependence patients is associated with better outcomes in risk of abstinence, abstinence duration and heavy drinking days. However, larger welldesigned studies are required to confirm these conclusions.