Efficacy and Safety of the Use of Baclofen in the Treatment of Alcohol Dependent (a Double-Blind, Randomized, Placebo-Controlled Pilot Study)

Objective. To study the efficacy and use of baclofen (Baclosan) for stabilizing remission in patients with alcoholism. Materials and methods. A total of 32 patients with alcoholism were randomized to two groups. Patients of group 1 (16 patients) received baclofen (50 mg/day) for three months; patients of group 2 received a placebo of identical appearance. All patients were required to attend the clinic every week for monitoring of remission (alcohol consumption) and assessment of the levels of alcohol attraction (craving), affective disorders (depression and anxiety), and γ-glutamyltransferase (GGT) activity, and for monitoring of compliance with medication (urine riboflavin). Alcohol consumption was monitored by retrospective analysis and assay of GGT. Anxiety was evaluated using the Hamilton and Spielberger scales. Depression was assessed on the Montgomery-Asberg Depression Scale. Alcohol cravings were assessed using obsessive-compulsive, Pennsylvania, and visual analog scales. Overall assessment of treatment efficacy was obtained using the Clinical Global Impression scale. The study followed a double-blind design. Results and conclusions. No significant difference in measures of the efficacy of stabilizing remission was seen between the baclofen and placebo groups in patients with alcoholism (probably due to insufficiently large cohort sizes). Measures of holding patients in remission and of alcohol consumption in the baclofen group were somewhat better than in the placebo group; between-group differences in these measures approached statistical significance, pointing to a greater efficacy for baclofen than placebo in alcoholism. Baclofen did not show any significant difference from placebo in terms of the number of side effects (adverse events) and effects on liver enzyme activity, which is evidence for its good tolerance and safety in this contingent of patients. The authors take the view that evidence-based conclusions regarding The efficacy of baclofen in the treatment of alcoholism require further studies in patients using larger cohorts.

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