News Release

Baclofen promotes alcohol abstinence in alcoholics with liver cirrhosis

Peer-Reviewed Publication

The Lancet_DELETED

The drug baclofen is effective at promoting alcohol abstinence in alcohol-dependent patients with liver cirrhosis, and could have an important role in treatment of these individuals. These are the conclusions of authors of an Article published in this week's edition of The Lancet.

Alcohol remains the most frequent cause of liver cirrhosis in developed countries. Persistent alcohol intake in people with alcoholic cirrhosis is associated with high mortality. The most effective management strategy for these individuals is to achieve total alcohol abstinence, since medical and surgical treatments for alcoholic liver diseases have limited success when drinking continues.

Dr Giovanni Addolorato, Institute of Internal Medicine, Catholic University of Rome, Italy, and colleagues did a trial of 148 alcohol-dependent patients with liver cirrhosis that had been referred to their institute. 84 of these were randomised to receive either oral baclofen (42) or placebo (42). Total alcohol abstinence and duration of this abstinence were assessed during outpatient visits, with relapse defined as alcohol intake of more than four standard drinks per day or overall consumption of 14 or more standard drinks per week over a period of at least four weeks. One standard drink was defined as equal to 12g absolute alcohol.

The researchers found that 71% of the baclofen patients (30/42) achieved and maintained alcohol abstinence, compared to 29% (12/42) of those receiving placebo. Patients taking baclofen also abstained from alcohol for more than twice as long as patients given placebo (62.8 days versus 30.8 days).

The authors say: "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."

They conclude: "Our results suggest that baclofen, because of its anticraving action and safety, could have an important role for treatment of alcohol-dependent patients with advanced liver disease."

In an accompanying Comment, Dr James Garbutt, Department of Psychiatry, University of North Carolina, USA, and Dr Barbara Flannery, Transdisciplinary Behavioural Science Programme, RTI International, Baltimore, MD, USA, say that many drug trials for alcoholism exclude those with medical, psychiatric, and comorbid substance misuse problems, and thus their validity in real-world settings is reduced.

However they conclude: "Despite the scientific success of discovering effective drugs for alcoholism, use of these medications by clinicians has lagged. The findings of modern clinical trials, such as the one reported by Addolorato and colleagues, should be transferred to primary care settings if these treatments are to substantially affect public health."

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Dr Giovanni Addolorato, Institute of Internal Medicine, Catholic University of Rome, Italy T) +39 (0) 6 30154334 / +39-333-3783613 E) g.addolorato@rm.unicatt.it

Dr James Garbutt, Department of Psychiatry, University of North Carolina, USA T) +1 919-966-4652 E) jc_garbutt@med.unc.edu

View the paper associated with this release at the link below:

http://multimedia.thelancet.com/pdf/press/Baclofen.pdf


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