Dunlop B W, Banja J
Department of Psychiatry and Behavioral Sciences, Emory University School of Medicine, 1256 Briarcliff Road NE, Building A, 3rd Floor, Atlanta, GA 30322, USA.
J Med Ethics. 2009 Jun;35(6):384-9. doi: 10.1136/jme.2008.028357.
The use of placebo as a control condition in clinical trials of major depressive disorder and anxiety disorders continues to be an area of ethical concern. Typically, opponents of placebo controls argue that they violate the beneficent-based, "best proven diagnostic and therapeutic method" that the original Helsinki Declaration of 1964 famously asserted participants are owed. A more consequentialist, oppositional argument is that participants receiving placebo might suffer enormously by being deprived of their usual medication(s). Nevertheless, recent findings of potential for suicidality in young people treated with antidepressants, along with meta-analyses suggesting that antidepressants add no significant clinical benefit over placebos, warrant a re-evaluation of the arguments against placebo. Furthermore, the nature of placebo treatment in short-term clinical trials is often not well understood, and lack of understanding can foster opposition to it. This paper will show how scientific justifications for placebo use are morally relevant. The fundamental ethical importance of placebo controls is discussed in relation to several aspects of clinical trials, including detection of adverse events, accurate assessment of clinical benefit, advancing understanding of the heterogeneity of depression and anxiety disorders and respecting informed consent requirements. Prohibiting the use of placebo controls is morally concerning in that such prohibitions allow for the possibility of serious adverse public health consequences. Moral worries that research participants receiving placebo are being unduly jeopardised will be shown to be exaggerated, especially in relation to the net benefits for end-users to be gained from the quality of data resulting from using placebo controls.
在重度抑郁症和焦虑症的临床试验中使用安慰剂作为对照条件，仍然是一个伦理关注的领域。通常，安慰剂对照的反对者认为，它们违反了基于 beneficent 的“已证实的最佳诊断和治疗方法”，1964 年最初的《赫尔辛基宣言》著名地宣称参与者应得到这种方法。一个更具结果主义的反对观点是，接受安慰剂的参与者可能会因被剥夺常用药物而遭受巨大痛苦。然而，最近关于使用抗抑郁药治疗的年轻人有自杀倾向的发现，以及荟萃分析表明抗抑郁药相对于安慰剂没有显著的临床益处，这就需要重新评估反对安慰剂的论点。此外，短期临床试验中安慰剂治疗的性质往往没有得到很好的理解，而缺乏理解可能会助长对它的反对情绪。本文将展示安慰剂使用的科学依据如何在道德上具有相关性。安慰剂对照的基本伦理重要性在与临床试验的几个方面相关的讨论中得到体现，包括不良事件的检测、临床益处的准确评估、增进对抑郁症和焦虑症异质性的理解以及尊重知情同意要求等。禁止使用安慰剂对照在道德上令人担忧，因为这种禁令可能会导致严重不良的公共卫生后果发生。那种认为接受安慰剂的研究参与者受到过度危害的道德担忧将被证明是夸大了的观点，特别是考虑到使用安慰剂对照所产生的数据质量给最终用户带来的净收益时。
