Guest guest Posted February 15, 2004 Report Share Posted February 15, 2004 http://journals.apa.org/prevention/volume5/pre0050023a.html Prevention & Treatment, Volume 5, Article 23, posted July 15, 2002 Copyright 2002 by the American Psychological Association ---- ---------- The Emperor's New Drugs: An Analysis of Antidepressant Medication Data Submitted to the U.S. Food and Drug Administration Irving Kirsch University of Connecticut Thomas J. Moore The George Washington University School of Public Health and Health Services Alan Scoboria and Sarah S. Nicholls University of Connecticut ---- ---------- ABSTRACT This article reports an analysis of the efficacy data submitted to the U.S. Food and Drug Administration for approval of the 6 most widely prescribed antidepressants approved between 1987 and 1999. Approximately 80% of the response to medication was duplicated in placebo control groups, and the mean difference between drug and placebo was approximately 2 points on the 17-item (50-point) and 21- item (62-point) Hamilton Depression Scale. Improvement at the highest doses of medication was not different from improvement at the lowest doses. The proportion of the drug response duplicated by placebo was significantly greater with observed cases (OC) data than with last observation carried forward (LOCF) data. If drug and placebo effects are additive, the pharmacological effects of antidepressants are clinically negligible. If they are not additive, alternative experimental designs are needed for the evaluation of antidepressants. Keywords: drug efficacy, placebo, meta-analysis, depression Quote Link to comment Share on other sites More sharing options...
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