In 2019, based on incomplete evaluation, Prescrire concluded that, in addition to medical support, baclofen, at doses below 80 mg per day, is an option which can help some alcohol dependent patients to control their alcohol consumption a little more effectively. At these doses, evaluation is mainly based on the analysis of nine trials which included nearly 700 patients. The efficacy data are weak, but at doses below 80 mg per day, the adverse effects of baclofen (mainly neuropsychiatric and gastrointestinal disorders) are in general acceptable.

Our analysis of the harm-benefit balance at higher doses of baclofen was based mainly on two randomised, double-blind trials, Alpadir and Bacloville.

With higher doses, serious adverse effects of baclofen are too frequent, including more frequent hospitalisations and increased mortality. In addition to its predictable neuropsychiatric adverse effects (depression with suicide attempts or suicide, decompensation of mental health disorders, abuse, addiction and withdrawal syndromes), baclofen also carries a risk of cardiorespiratory disorders. The unpredictable nature of these adverse effects warrants close monitoring of patients. The drug may also have a teratogenic action, though this is difficult to distinguish from the effects of alcohol and other substances taken by pregnant patients.

Overall, for alcohol-dependent patients who are unable to control dangerous alcohol consumption, the published results of the Bacloville trial support the empirical impression that baclofen, at gradually escalated doses, may have some efficacy. Baclofen is a modestly useful option when taken at moderate doses of around 30 mg per day. The drug's harm-benefit balance is unfavourable at doses above 80 mg per day.

©Prescrire 1 May 2021

Source: "Queries and Comments. Baclofen for alcohol dependence: what is the evidence of efficacy?" Prescrire International 2021; 30 (226): 134-135. Subscribers only.

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