Acamprosate for alcohol dependence

Evidence Summaries

Level of Evidence = C
Acamprosate may be more effective than placebo in the management of alcohol dependence.

Comment: The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding in most studies) and by inconsistency (unexplained variability in results).

A Cochrane review 1 included 24 RCTs with a total of 6915 participants. Compared to placebo, acamprosate was shown to significantly reduce the risk of any drinking (RR 0.86; 95% CI 0.81 to 0.91; 24 trials, n=6172); NNT 9.09 (95% CI 6.66 to 14.28) and to significantly increase the cumulative abstinence duration (mean difference MD 10.94; 95% CI 5.08 to 16.81; 19 trials, n=5224), while secondary outcomes (gamma-glutamyltransferase, heavy drinking) did not reach statistical significance. Diarrhea was the only side effect that was more frequently reported under acamprosate than placebo RD 0.11 (95% 0.09 to 0.13); NNTB 9.09 (95% CI 7.69 to 11.11). Effects of industry-sponsored trials RR 0.88 (95% 0.80 to 0.97) did not significantly differ from those of non-profit funded trials RR 0.88 (95% CI 0.81 to 0.96). In addition, the linear regression test did not indicate a significant risk of publication bias (p = 0.861).

A systematic review and meta-analysis 2 assessed the efficacy of acamprosate or naltrexone in reducing lapse/relapse compared to placebo in the treatment of alcohol dependence and treatment discontinuation. 22 RCTs studied acamprosate (n=5236) and 27 RCTs naltrexone (n=4199). The risk of returning to any drinking at 6 months was significantly lower for acamprosate (RR 0.83, 95% CI 0.78 to 0.89). There was little difference in the risk of participants discontinuing treatment for any reason (RR  0.91, 95% CI 0.83 to 1.00) or due to adverse events (RR 1.30, 95% CI 0.96 to 1.75) for the acamprosate compared to placebo groups. For natrexone, the risk of individuals returning to any drinking at approximately 3 months was reduced significantly (RR 0.92, 95% CI  0.86 to 1.00), as was the risk of individuals relapsing to heavy drinking at 3 months (RR  0.85, 95% CI  0.78 to 0.93). There was no significant difference between naltrexone and placebo for the risk of individuals discontinuing treatment for any reason (RR  0.94, 95% CI  0.84 to 1.05), but. risk discontinuing treatment due to adverse events was higher (RR  1.72, 95% CI  1.10 to 2.70).


1. Rösner S, Hackl-Herrwerth A, Leucht S et al. Acamprosate for alcohol dependence. Cochrane Database Syst Rev 2010;(9):CD004332 [Review content assessed as up-to-date: 29 July 2009].  [PMID:20824837]

2. Donoghue K, Elzerbi C, Saunders R et al. The efficacy of acamprosate and naltrexone in the treatment of alcohol dependence, Europe versus the rest of the world: a meta-analysis. Addiction 2015;110(6):920-30.  [PMID:25664494]

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