Comment: The quality of evidence is downgraded by study limitations (more withdrawals in nalmefenegroup than placebogroup and incomplete outcome data).
A systematic review and meta-analysis included 5 double-blind randomized clinical trials (n=2567) evaluating nalmefene to treat adult alcohol dependence. None of these studies was performed in adults with alcohol dependence who consume more than 60 g of alcohol per day (for men) or more than 40 g per day (for women). Subjects were instructed to take nalmefene or placebo when they believed drinking to be imminent. No RCT compared nalmefene with another medication. Mortality at 6 months (RR 0.39, 95% CI 0.08 to 2.01; 4 trials, n=1892) and 1 year (RR 0.98, 95% CI 0.04 to 23.95) and quality of life at 6 mo (SF-36 physical component summary score: mean difference (MD) 0.85, 95% CI -0.32 to 2.01; SF-36 mental component summary score: MD 1.01, 95% CI -1.33 to 3.34; 3 trials, n=1200) were not different across groups. Differences were encountered for alcohol consumption outcomes such as monthly number of heavy drinking days at 6 mo (MD -1.65, 95% CI -2.41 to -0.89; 5 trials) and at 1 y (MD -1.60, 95% CI -2.85 to -0.35; 1 trial) and total alcohol consumption at 6 mo (SMD -0.20, 95% CI -0.30 to -0.10; 5 trials). There were more withdrawals for nalmefene than for placebo, including more withdrawals for safety reasons at both 6 mo (RR 3.65, 95% CI 2.02 to 6.63; 4 trials) and 1 y (RR 7.01, 95% CI 1.72 to 28.63; 1 trial).
Date of latest search: 10 February 2016