To the Editor: Dr Johnson and colleagues1 reported the results of a randomized controlled trial of topiramate for treating alcohol dependence. We believe that the study raises ethical concerns and leaves unanswered several questions about data interpretation and practical applicability.
First, current guidelines2 regard psychosocial treatments as essential components of treatment for alcohol dependence and, while noting the benefits of adjunctive pharmacotherapy in selected patients, do not suggest that medications should replace psychosocial interventions. Yet in the study by Johnson et al, participants received counseling focused on medication adherence without concurrent addiction-focused therapy, and fewer than 8% of participants attended Alcoholics Anonymous meetings. Therefore, this raises the ethical question of whether study participants had appropriate access to currently recommended therapy. Because of the exclusion criteria, participants were likely less ill than average and might have done well with psychosocial therapies alone (without the risks associated with topiramate).
Stringer S, Rueve M, Mossman D. Topiramate as Treatment for Alcohol Dependence. JAMA. 2008;299(4):405-407. doi:10.1001/jama.299.4.405-c