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The study included 84 alcohol-dependent patients with liver cirrhosis who received either oral baclofen (42 patients) or a placebo (42 patients). Total alcohol abstinence and duration of this abstinence were assessed during outpatient visits. Relapse was defined as alcohol intake of more than four standard drinks per day (a standard drink defined as equal to 12 grams of absolute alcohol) or overall consumption of 14 or more standard drinks per week over a period of at least four weeks.
Among those taking baclofen, 71 percent (30 of 42 patients) achieved and maintained alcohol abstinence, compared to 29 percent (12 of 42) of those who took the placebo. The study also found that patients taking baclofen abstained from alcohol for more than twice as long as those taking the placebo -- 62.8 days vs. 30.8 days.
"Our results show that oral administration of baclofen is significantly more effective than placebo at achieving and maintaining alcohol abstinence and at increasing cumulative abstinence duration in alcohol-dependent patients with liver cirrhosis. This reduction in self-reported alcohol use was associated with significant reductions in clinical markers of liver injury, findings that confirm self-reported data and suggest that the reduction in alcohol consumption was sufficient to lessen liver injury," Dr. Giovanni Addolorato, of the Institute of Internal Medicine at the Catholic University of Rome, said in a prepared statement.
"Our results suggest that bacolfen, because of its anti-craving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease," the researchers concluded.
Alcohol is the most common cause of liver cirrhosis in developed nations, according to background information in the study.
-- Robert Preidt
SOURCE: The Lancet, news release, Dec. 7, 2007
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