Aim: Gamma-hydroxybutyric acid (GHB) is used to treat alcohol withdrawal syndrome (AWS) at short term, and to reduce alcohol relapses among alcohol dependent subjects at mid-term. The objective of this paper is to synthesize results of a Cochrane review on efficacy of GHB for treating alcohol dependence at mid-term.
Methods: The search strategy was conducted on MEDLINE, EMBASE, PsycINFO, CINAHL and on the Cochrane Library. Pharmaceutical companies were contacted and references of papers were checked in order to identify unpublished studies. Randomized controlled trials (RCT), clinical controlled trials (CCT), and controlled prospective studies (CPS) were considered. Three authors blindly evaluated the quality of the studies and extracted the data.
Results: Seven RCT studies evaluating efficacy of GHB for treating alcohol dependence at mid-term were included in the review; all were conducted in Italy. GHB appears to be more effective than placebo on alcohol abstinence (RR 2.63; 1.22-5.71), controlled drinking (RR 2.43; 1.07-5.54), relapses to heavy drinking (RR 0.37; 0.21-0.63), and number of daily drinks (MD -4.60; -6.18,-3.02). GHB appears to be more effective than naltrexone on alcohol abstinence (RR 1.78; 1.21-2.62) but not on other outcomes. The effect on Alcohol Craving Scale favours GHB vs placebo (MD -4.50; -5.81,-3.19), vs naltrexone (MD -1.90; -2.45,-1.35) and vs disulfiram (MD -1.40; -1.86,-0.94). Side effects are similar to naltrexone and disulfiram.
Discussion: The low number of available studies, the low sample size and the low quality of the included studies limit the validity of the results and suggest the need of conducting new high-quality randomized trials with appropriate sample size.