Background: The treatment of baclofen can rapidly reduce symptoms of severe alcohol withdrawal syndrome (AWS) in alcoholic patients, with a significant reduction in the cost. Baclofen is easily manageable, what's more, no patient treated with baclofen reported euphoria or other pleasant effects caused by the drug and no subject reported any degree of craving for the drug.
Objectives: To assess the efficacy and safety of baclofen for patients with alcohol withdrawal syndrome.
Search strategy: We searched the Cochrane Central Register of Controlled Trials (September 2010), MEDLINE (1966 to September 2010), EMBASE (1980 to September 2010), and CINAHL (1982 to September 2010). We also searched the following registers of ongoing trials, e.g. Clinicaltrials.gov, Controlled trials.com, EUDRACT, etc. At the same time, we handsearched the references quoted in the identified trials, contact researchers, pharmaceutical companies and relevant trial authors seeking information about unpublished or incomplete trials. All searches included non-English language literature.
Selection criteria: All randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for patients with AWS. Uncontrolled, non-randomised or quasi-randomised trials were excluded. Both parallel group and cross-over design were included.
Data collection and analysis: Two reviewers independently assessed references retrieved for possible inclusion. All disagreements were resolved by an independent party. Study authors were contacted for additional information. Adverse effects information was collected from the trials.
Main results: We identified a total of 82 references from all electronic databases searched excluding duplicate. After screening of titles and abstracts, full papers of 7 studies were obtained and assessed for eligibility. Finally, only one study met the inclusion criteria, with 37 participants.
Authors' conclusions: The evidence of recommending baclofen for AWS is insufficient. More well designed RCTs are demanded to further prove its efficacy and safety.