Naltrexone (50 mg) plus psychotherapy in alcohol-dependent patients: a meta-analysis of randomized controlled trials.

Background: Alcoholism is a chronic and potentially fatal disease. One of the therapeutic options is pharmacotherapy with the opioid antagonist naltrexone in combination with psychotherapy.

Objectives: The objective of this review was to compare the clinical effectiveness of naltrexone (50 mg/day) versus that of a placebo in alcohol-dependent patients receiving psychotherapy.

Methods: The clinical effectiveness of the treatment was assessed in accordance with the principles of systematic review, as outlined in the Cochrane Collaboration guidelines (Cochrane Reviewer's Handbook) and the guidelines of the Polish Agency for Health Technology Assessment (AHTAPol).

Results: Statistical significances in favor of the treatment modality were found in both the percentage of patients maintaining total abstinence and the percentage of relapsed patients.

Conclusion: The analysis herein demonstrates that for short (12-16 weeks) period of treatment, a combination of naltrexone administration and psychotherapy results in high clinical efficacy with a safety profile comparable to that of the placebo in the treatment of alcohol-dependent patients. The side effects of naltrexone treatment are usually mild and transient.