/Baclofen, effective but not miraculous
Baclofen, Effective But Not Miraculous

Baclofen, effective but not miraculous

Several expected results on baclofen were presented on September 3 at a congress in Berlin. The treatment does not seem to do better than a placebo in terms of help with abstinence (before or after withdrawal). At high doses, it would nevertheless help reduce the consumption of heavy drinkers by a few drinks. The clinical benefit of this treatment would therefore remain limited, even though numerous data relating to its side effects have not yet been made public.

Data from four studies on the effectiveness of baclofen – including two French – were discussed this weekend at the World Congress of Alcoholology in Berlin. One of this research, the German BACLAD study, had already been published in 2015. Very encouraging results were then observed in terms ofabstinence. However, in addition to being comparable to those obtained with existing drugs, the small number of study participants – 56 – made it essential to conduct more rigorous investigations.

The second study presented, conducted by Dutch researchers, involved varying doses of baclofen (less than 150 mg / day). At these doses, no significant difference was observed in terms of maintenance of abstinence after weaning, compared to a group treated with placebo.

Two French studies were presented during the congress. The first, conducted by Professor Michel Reynaud, compared the administration (to patients without serious pathologies associated with their alcoholism) of high doses baclofen (180 mg / day) to that of a placebo. Here again, the results obtained disappointed expectations. Indeed, no difference between the two groups tested was observed, neither in terms ofabstinence, nor in terms of reduction in consumption alcohol.

The only differencestatistically significant registered concerns the compulsive craving for alcohol in heavy drinkers (on average, a daily drink less than in the control group), which makes Professor Reynaud say that the drug “Is of clinical interest”. Asked by Allodocteurs.fr, the researcher estimates that the number of participants (320, of whom 130 discontinued their participation in the study) was “too weak” to achieve solid results. He also believes that “The expectation generated by the media for baclofen” may have discouraged some participants who expected an effect “miracle”.

Adverse effects (drowsiness, fatigue, insomnia, etc.) appeared to be “more frequent with baclofen”, although “[qu’]no serious problems were recorded ”.

Bacloville trial: statistically significant results

During the Berlin Congress, preliminary results of the highly anticipated “Bacloville” trial were also unveiled. This study involved 320 patients (102 of whom left the study), without selection or prior weaning, followed in town by general practitioners. The doses used here were higher than the trial conducted by Prof. Reynaud (up to 300 mg / day). The data presented show that baclofen is at least 15% better than placebo in terms of reducing consumption to thresholds defined as “low” by researchers (less than 20 g of alcohol per day for women, and less than 40 g / d for men). These results are statistically significant, but are comparable to the results obtained with existing treatments.

Above all, the data in terms of safety and adverse effects have not yet been published for Bacloville, where the drug doses used were particularly high. The results of a study specifically devoted to the undesirable effects of baclofen on all users, ordered by the ANSM from the French health insurance, are expected at the end of 2016.