Columbia University Medical Center, New York - Presbyterian Hospital, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, United States of America.
Department of Psychiatry, Columbia University, New York State Psychiatric Institute, 1051 Riverside Drive, New York, NY 10032, United States of America.
Schizophr Res. 2021 Mar;229:122-131. doi: 10.1016/j.schres.2020.11.022. Epub 2020 Nov 22.
Recent ethical critiques have proposed that placebo-controlled, relapse prevention trials in schizophrenia are no longer justifiable and are therefore unethical. This review provides an historical perspective on the justifications for these trials and how arguments evolved over several decades. We identified 87 placebo-controlled, relapse prevention trials published over the last seventy years and examined the purpose for each trial. We found that first-generation trials had compelling justifications, yet these arguments changed considerably over time. Second-generation trials offered comparatively weaker-and sometimes no-justifications for their conduct. Without clear and compelling justifications for a given trial, it is not ethical to continue using this study design.
最近的伦理批评提出，精神分裂症的安慰剂对照、防止复发试验不再合理，因此不道德。本综述提供了这些试验的合理性的历史视角，以及这些论点如何在几十年中演变。我们确定了过去七十年中发表的 87 项安慰剂对照、防止复发试验，并检查了每个试验的目的。我们发现第一代试验有令人信服的理由，但这些论点随着时间的推移发生了很大变化。第二代试验提供了相对较弱的理由，有时甚至没有理由进行试验。如果没有明确和有说服力的理由，继续使用这种研究设计是不道德的。
