The growing off-label use of baclofen as a treatment for alcohol use disorders (AUDs) may be “premature,” according to a meta-analysis published in Addiction.

Baclofen, a GABA-B agonist, has been used to treat spasticity associated with multiple sclerosis (MS) and spinal cord injury or disease. Compared to currently approved treatments for AUDs, baclofen is excreted primarily through the kidneys which may be advantageous for patients with alcohol-related liver disease who cannot tolerate the approved therapies. 

Previous clinical trials have compared baclofen and placebo on various drink-related outcomes (eg, abstinence rate, number of heavy drinking days or abstinent days) but measuring other outcomes may help explain its mechanism of action in AUDs, including known risk factors for harmful drinking. To determine the efficacy of baclofen in reducing drinking behavior, craving, depression, and anxiety, University of Liverpool researchers conducted a meta-analysis on randomized-controlled trials. 

A total of 12 trials comparing baclofen with placebo were included (N=590). The studies included data on at least 1 of the primary (drinking related: heavy drinking days, abstinent days, abstinence rates) or secondary (craving, anxiety, depression) outcome measures.

Data showed a significant effect on abstinence rates with the use of baclofen (odds ratio [OR] 2.67, 95% CI: 1.03, 6.93) but no other significant effects on treatment efficacy (heavy drinking days SMD -0.26, 95% CI: -0.68, 0.15) or mechanism of action (craving SMD: -0.13, 95% CI: -0.36, 0.09) were seen. No superior effect was seen for baclofen use on increasing number of abstinent days or reducing heavy drinking, craving, anxiety or depression. 

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Study author Dr. Andy Jones, added, “This new meta-analysis shows that baclofen is no more effective than placebo on a range of key outcome measures, suggesting that the current increasing use of baclofen as a treatment for alcohol use disorders is premature.”

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