This review attempted to evaluate the efficacy and safety of baclofen as a therapy for alcohol withdrawal syndrome (AWS) in people with alcoholism.
AWS is a distressing and life-threatening condition that usually affects people who are alcohol dependent when they discontinue or decrease their alcohol consumption. The most common effects include shaking, restlessness, difficulty sleeping, nightmares, sweats, high heart rate, fever, feeling sick, vomiting, fits, hallucinations, increased agitation, tremulousness, and delirium. In severe cases, people may lose consciousness, their heart may stop, and they may die. The medicine baclofen has demonstrated potential to reduce symptoms of severe AWS in people with alcoholism. Treatment with baclofen is easy to manage, without producing any obvious side effects. This is an updated version of the original Cochrane Review published in 2015, Issue 4.
Search date: the evidence is current to March 2017.
We searched scientific databases for clinical trials comparing baclofen with placebo (a pretend treatment) or another potentially useful medicine in people with AWS. We included three randomised controlled trials (clinical studies where people are randomly put into one of two or more treatment groups) with 141 participants. The study from the USA compared baclofen to placebo given over at least 72 hours. The participants were mainly men with the average age 47 years. One study took place in Italy and compared baclofen to diazepam (a calming medicine) for 10 consecutive days. The participants were mainly men with an average age of 42 years. The Indian study compared baclofen to chlordiazepoxide given for nine days. The participants were all men with an average age of 38 years. None of studies were financed by a pharmaceutical company.
We are uncertain whether baclofen improves withdrawal symptoms and signs and reduces side effects when compared with placebo or other medicines as the quality of the evidence was very low.
Quality of the evidence
The quality of the evidence from the studies was very low and results should be interpreted with caution. In the future, well-designed, double-blind (where neither the participant nor the researcher knows which treatment has been given until after the results have been collected) RCTs with large numbers of participants are required to test how effective and well tolerated baclofen is in people with AWS.
No conclusions can be drawn about the efficacy and safety of baclofen for the management of alcohol withdrawal because we found insufficient and very low quality evidence.
Baclofen shows potential for rapidly reducing symptoms of severe alcohol withdrawal syndrome (AWS) in people with alcoholism. Treatment with baclofen is easy to manage and rarely produces euphoria or other pleasant effects, or craving for the drug. This is an updated version of the original Cochrane Review published in 2015, Issue 4.
To assess the efficacy and safety of baclofen for people with AWS.
We updated our searches of the following databases to March 2017: the Cochrane Drugs and Alcohol Group Specialised Register, CENTRAL, PubMed, Embase, and CINAHL. We also searched registers of ongoing trials. We handsearched the references quoted in the identified trials, and sought information from researchers, pharmaceutical companies, and relevant trial authors about unpublished or uncompleted trials. We placed no restrictions on language.
We included all randomised controlled clinical trials (RCTs) evaluating baclofen versus placebo or any other treatment for people with AWS. We excluded uncontrolled, non-randomised, or quasi-randomised trials. We included both parallel group and cross-over studies.
We used standard methodological procedures expected by Cochrane.
We included three RCTs with 141 randomised participants. We did not perform meta-analyses due to the different control interventions. For the comparison of baclofen and placebo (1 study, 31 participants), there was no significant difference in Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) scores (very low quality evidence). For the comparison of baclofen and diazepam (1 study, 37 participants), there was no significant difference in CIWA-Ar scores (very low quality evidence), adverse events (risk difference (RD) 0.00, 95% confidence interval (CI) -0.10 to 0.10; very low quality evidence), dropouts (RD 0.00, 95% CI -0.10 to 0.10; very low quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.10 to 0.10; very low quality evidence). For the comparison of baclofen and chlordiazepoxide (1 study, 60 participants), there was no significant difference in CIWA-Ar scores (mean difference (MD) 1.00, 95% CI 0.70 to 1.30; very low quality evidence), global improvement (MD 0.10, 95% CI -0.03 to 0.23; very low quality evidence), adverse events (RD 2.50, 95% CI 0.88 to 7.10; very low quality of evidence), dropouts (RD 0.00, 95% CI -0.06 to 0.06; very low quality evidence), and dropouts due to adverse events (RD 0.00, 95% CI -0.06 to 0.06; very low quality evidence).