T Bschor1,2, J Henssler3, M Müller4, C Baethge5. 1. Department of Psychiatry, Schlosspark-Hospital, Berlin, Germany. 2. Department of Psychiatry and Psychotherapy, University Hospital, Technische Universität Dresden, Dresden, Germany. 3. Department of Psychiatry and Psychotherapy, Charité University Medicine, St Hedwig-Krankenhaus, Berlin, Germany. 4. Department of Emergency Medicine, Inselspital, Bern University Hospital and University of Bern, Bern, Switzerland. 5. Department of Psychiatry and Psychotherapy, University of Cologne Medical School, Cologne, Germany.
Abstract
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.
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.
Authors: Warren B Logge; Richard W Morris; Andrew J Baillie; Paul S Haber; Kirsten C Morley Journal: Psychopharmacology (Berl) Date: 2019-02-20 Impact factor: 4.530
Authors: Mehdi Farokhnia; Sara L Deschaine; Armin Sadighi; Lisa A Farinelli; Mary R Lee; Fatemeh Akhlaghi; Lorenzo Leggio Journal: Mol Psychiatry Date: 2018-10-31 Impact factor: 15.992
Authors: Renaud de Beaurepaire; Julia M A Sinclair; Mathis Heydtmann; Giovanni Addolorato; Henri-Jean Aubin; Esther M Beraha; Fabio Caputo; Jonathan D Chick; Patrick de La Selle; Nicolas Franchitto; James C Garbutt; Paul S Haber; Philippe Jaury; Anne R Lingford-Hughes; Kirsten C Morley; Christian A Müller; Lynn Owens; Adam Pastor; Louise M Paterson; Fanny Pélissier; Benjamin Rolland; Amanda Stafford; Andrew Thompson; Wim van den Brink; Lorenzo Leggio; Roberta Agabio Journal: Front Psychiatry Date: 2019-01-04 Impact factor: 4.157