The quality of evidence is downgraded by study limitations (unclear allocation concealment and blinding of outcome assessment in half of the studies).
A Cochrane review «Baclofen for alcohol use disorder»1 «Agabio R, Saulle R, Rösner S et al. Baclofen for alcohol use disorder. Cochrane Database Syst Rev 2023;1(1):CD012557. »1 included 17 studies with a total of 1818 subjects with alcohol dependence and currently drinking. In 16 studies, participants received psychosocial treatments and 10 studies detoxified participants before treatment. The mean duration of the interventions was mostly 12 to 15 weeks. Baclofen increased the percentage of days abstinent and appeared to decrease the risk to relapse (table «Baclofen compared to placebo for alcohol use disorder »1). There was no difference between baclofen and placebo for the primary outcomes: heavy drinking days; number of drinks per drinking days; number of participants with at least one adverse event; and dropouts due to adverse events (table «Baclofen compared to placebo for alcohol use disorder »1).
| Outcome | Relative effect (95% CI) | Risk with placebo | Risk difference with intervention - baclofen (95% CI) | № of participants (studies) - Certainty of the evidence |
|---|---|---|---|---|
| Relapse: return to any drinking at the end of treatment | RR 0.87 (0.77 to 0.99) | 816 per 1000 | 710 per 1000 (628 to 808 | 1057 (12) Moderate |
| Frequency of use: % days of abstinence at the end of treatment | - | 53,58 | Mean difference (MD) 9.07 higher (3.3 higher to 14.85 higher) | 1273 (16) High |
| Frequency of use: % of heavy drinking days at the end of treatment | - | SMD 0.18 lower (0.48 lower to 0.11 higher) | 840 (13) Moderate | |
| Amount of use: drink per drinking days at the end of treatment | - | 4.28 | MD 0.45 lower (1.2 lower to 0.3 higher) | 392 (9) Moderate |
| Adverse events: number of participants with at least one side effect | RR 1.05 (0.99 to 1.11) | 636 per 1000 | 668 per 1000 (629 to 706) | 738 (10) High |