The level of evidence of studies concluding on the efficacy and safety of baclofen is insufficient, according to the Cochrane review.
The Cochrane review on baclofen has been updated. The new observations, published at the end of last week, conclude to the absence of data allowing to highlight the effectiveness and the safety of this treatment in alcohol dependence.
To reach this conclusion, the authors reviewed several clinical trials in which baclofen was compared with a placebo or other prescribed treatment for alcohol dependence.
The analysis thus concerns 141 participants and three randomized trials. The first, carried out in the United States, compared baclofen to a placebo over an administration period of at least 72 hours. The second, in Italy, set about studying for ten days the effectiveness of baclofen compared to diazepam, a benzodiazepine better known by its brand name, Valium. The latest, conducted in India, compared baclofen to chlordiazepoxide, another benzodiazepine, given for nine days. None of this work was funded by the pharmaceutical industry.
“Very low” quality evidence
The authors believe that at this stage, it is not possible to say that baclofen would reduce withdrawal symptoms and limit side effects, compared to a placebo or other treatment. The quality of scientific evidence is thus qualified as “very low”.
The researchers call for taking the results of these three trials with great caution, because they do not allow to conclude on the effectiveness and the safety of baclofen. Scientists believe that double-blind work, according to stricter protocols and including larger cohorts, must be carried out in order to assess the real effectiveness of this treatment and its tolerance by patients.
French restrictions
This work will not fail to fuel the controversy over baclofen. In France, the drug is the subject of a temporary recommendation for use in the treatment of alcohol dependence. It still does not have a marketing authorization.
While many health professionals and patients insist on efficacy observed in the field, the French Medicines Safety Agency (ANSM) has decided to restrict the prescribed dose to 80 mg. This decision follows the discovery of side effects linked to baclofen taken in high doses. However, it is precisely in high amounts that the treatment seems to be effective, according to the experience reported by doctors.
.