There is “no evidence” that high-dose baclofen is more effective than other methods of dropping alcohol, concludes a study published Wednesday (November 30th), which questions the prescribing of alcohol In France.
According to this new study, conducted by a team of researchers at the University of Amsterdam, patients treated with low-dose, high-dose baclofen or placebo experienced comparable relapse rates.
151 alcoholic patients receiving psychosocial support participated in the study: 31 received low-dose baclofen (30 mg daily), 58 had the same drug at high doses (up to 150 mg per day ), And 62, placebo. After 16 weeks, the rate of relapse was “about 25%” in each group, according to the article, published in the journal European Neuropsychopharmacology.
At the same time, side effects such as fatigue, drowsiness and dry mouth were frequently observed.
“In August 2015, a small German randomized study showed that high-dose baclofen showed good results, but the control group had received no treatment. Our patients, including the placebo group, Psychosocial monitoring, “said Reinout Wiers, a psychologist specializing in addictions, who oversaw the study.
Already 200,000 patients in France
All in all, these studies show that baclofen seems to be as effective as a psychosocial treatment, but does not provide any additional efficacy, “adds addiction psychologist Professor Wiers, believing it to be” premature “To prescribe it on a large scale to alcoholic patients,” as is currently the case in France “.
The popularity of this drug, initially indicated against involuntary muscular contractures, has exploded in France since the publication in 2008 of the book of the cardiologist Olivier Ameisen, who told how he had suppressed his desire to drink by taking this musorelaxant in high dose. Between 2007 and 2013, about 200,000 French patients were prescribed baclofen to treat their alcoholism, recalls the article.
To regulate the prescriptions, the medicines agency ANSM has established in 2014 a temporary recommendation of use with a maximum dose of 80 mg per day. At the end of August, 7024 patients were reported to the ANSM, but according to the Health Insurance, about 100,000 patients would be treated with baclofen, marketed by Novartis under the trade name Lioresal and Sanofi under the trade name Zentiva.
A French study on the same subject, presented in September, showed that baclofen had not been more effective than placebo in terms of abstinence, but had resulted in a greater reduction in the amount of baclofen, Alcohol consumption.
As the Guardian points out, several experiments have shown contradictory results in recent years. But this new study was carried out on a larger sample, with many control methods, to avoid a maximum bias.
The results of a new study on the undesirable effects of baclofen, commissioned by the ANSM to Health Insurance, are expected at the end of 2016.