Roger D. Weiss, Michael J. Ostacher, Michael W. Otto, Joseph R. Calabrese, Mark Fossey, Stephen R. Wisniewski, Charles L. Bowden, Andrew A. Nierenberg, Mark H. Pollack, Ihsan M. Salloum J Clin Psychiatry 2005;66(6):730-735
Baclofen, a French Exception, Seriously Harms Alcohol Use Disorder Patients Without Benefit
To the Editor: Dr Andrade’s analysis of the Bacloville trial in a recent Clinical and Practical Psychopharmacology column, in which he concluded that “individualized treatment with high-dose baclofen (30-300 mg/d) may be a useful second-line approach in heavy drinkers” and that “baclofen may be particularly useful in patients with liver disease,” deserves comment.1
First, Andrade failed to recall that the first pivotal trial of baclofen, ALPADIR (NCT01738282; 320 patients, as with Bacloville), was negative (see Braillon et al2).
Second, Dr Andrade should have warned readers that Bacloville’s results are most questionable, lacking robustness. Although he cited us,3 he overlooked the evidence we provided indicating that the Bacloville article4 was published without acknowledging major changes to the initial protocol, affecting the primary outcome. Coincidentally (although as skeptics, we do not believe in coincidence), the initial statistical team was changed when data were sold to the French pharmaceutical company applying for the marketing authorization in France. As Ronald H. Coase warned, “If you torture the data long enough, it will confess.”