The placebo-controlled, relapse prevention studies (PCRPS) have recently been recently been singled out as redundant, disproportionately harmful, unnecessary and therefore ethically impermissible (1). The logic of comparison behind PCRPS has… Click to show full abstract
The placebo-controlled, relapse prevention studies (PCRPS) have recently been recently been singled out as redundant, disproportionately harmful, unnecessary and therefore ethically impermissible (1). The logic of comparison behind PCRPS has also been questioned as they apply different methodological procedures, such as duration of treatment prior to randomization and/or different treatment discontinuation strategies (2). Furthermore, there seems to be a real threat that withdrawal syndromes and other overlapping phenomena (such as rebound effects) cannot be reliably distinguished from relapse (as primary endpoint), and as such have high confounding potential (2). This article is protected by copyright. All rights reserved.
               
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