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To the Editor: Since alcoholic patients represent an extremely heterogeneous population, the design of the COMBINE Study¹ was selective, with a goal of striving for high internal validity at the expense of generalizability. The selection process a priori favored patients for whom completing the trial was expected. Of the 4965 potential patients screened, only 1383 were enrolled. Abstinence, an inclusion requirement, was achieved by about 92% without prior inpatient detoxification. Patients were abstinent before onset of study treatment, and a large proportion remained abstinent throughout. Since both placebo response (78% days abstinent) and data completeness (94% with complete drinking data) are extraordinarily high for alcohol-dependent patients, the COMBINE Study may have targeted a subpopulation of such patients with a low need for a specific relapse prevention treatment. Consequently, even though the percent days abstinent for both naltrexone and acamprosate was in the range reported by previous studies that combined and . . . [Full Text of this Article]

Falk Kiefer, MD
falk.kiefer@zi-mannheim.de

Karl Mann, MD
Department of Addictive Behavior and Addiction Medicine
Central Institute of Mental Health
University of Heidelberg
Mannheim, Germany