Systematic review: Baclofen dosing protocols for alcohol use disorders used in observational studies

The popularity of baclofen as an anti-craving agent in the treatment of alcohol use disorders (AUDs) has increased, especially in patients with established liver disease. However, evidence-based guidelines to inform practice are lacking. The aim of this systematic review is explore the prescribing practices of baclofen in AUD treatment. Electronic databases were searched for relevant articles from 2002. Assessment of eligibility criteria for inclusion was performed independently by two investigators. The main outcomes of interest were maximum dose, starting dose, titration regimen, effectiveness, and tolerability. Twenty-five studies reporting outcomes in 613 patients treated with baclofen for an AUD were identified. Starting doses ranged between 5 and 50 mg/d. Titration was study-dependent, and doses were increased until either therapeutic target (abstinence or study-defined low risk drinking) was achieved or adverse events resulted in a dose reduction or discontinuation. The maximum dose for individual patients ranged between 20 and 630 mg/d. Seven studies reported at least one patient using >300 mg/d. In studies with 10 or more patients, we found a negative correlation between dose and proportion of patients achieving the therapeutic goal. However, this was skewed by one study. A range of serious adverse events were reported. Most were reported at doses over 100 mg/d, but others presented at lower doses. Baclofen is a promising therapeutic in this area. Evidence is required, however, to support practitioners in prescribing doses that optimise outcomes and reduce adverse events.