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Objective
To evaluate the efficacy and tolerability of baclofen vs. placebo for long‐term treatment of alcohol use disorder.
Method
Systematic review and meta‐analysis following methods of the Cochrane Collaboration Handbook (PROSPERO registration: CRD42017073663). Primary outcome was the random‐effects summary estimate of all standardized mean differences (SMDs), as calculated from the primary outcomes of each study.
Results
Fourteen double‐blind RCTs (1522 patients) were included. Heterogeneity was substantial for most analyses (I2 about 75%). Baclofen showed a small, but not statistically significant superiority over placebo: SMD = 0.22 ([95% CI: −0.03; 0.47], P = 0.09). This result was supported by a leave‐one‐out‐analysis, and Orwin's fail‐safe N, by predefined secondary analyses (on abstinence rates and amount of drinking), and by a post hoc‐analysis of high‐dose studies (>80 mg/day). An analysis of low risk of bias studies (SMD = 0.10 [−0.20; 0.41], P = 0.51, I2 = 43.3%) found no effect. Exclusion of four studies focusing on patients with comorbidity yielded a small positive effect. Drop‐out rates were similar.
Conclusion
Our results question baclofen's utility in the long‐term treatment of alcohol use disorder at both normal and high doses. While the confidence intervals indicate that marginally harmful or moderately beneficial effects of baclofen remain a possibility, the most likely effect size is slightly above placebo effects.