A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders.
A renewed, ethical defense of placebo-controlled trials of new treatments for major depression and anxiety disorders.
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DOI：
10.1136/jme.2008.028357
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发表时间：
2009-06
影响因子：
4.1
通讯作者：
Banja J
中科院分区：
文献类型：
--
作者：
Dunlop BW;Banja J
在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问题。通常情况下，安慰剂对照的反对者认为，他们违反了基于利益的，“最好的证明诊断和治疗方法”，1964年的原始赫尔辛基宣言著名地宣称参与者是欠。一个更倾向于结果主义的反对观点是，接受安慰剂的参与者可能会因为被剥夺了他们通常的药物而遭受巨大的痛苦。然而，最近发现的潜在自杀倾向的年轻人与抗抑郁药治疗，沿着荟萃分析表明，抗抑郁药没有增加显着的临床效益比安慰剂，值得重新评估的论点，对安慰剂。此外，在短期临床试验中安慰剂治疗的性质往往没有很好地理解，缺乏理解可能会助长反对它。本文将展示如何安慰剂使用的科学理由是道德相关的。安慰剂对照的基本伦理重要性进行了讨论，涉及临床试验的几个方面，包括检测不良事件，准确评估临床获益，提高对抑郁症和焦虑症异质性的理解，尊重知情同意要求。禁止使用安慰剂对照在道德上是令人担忧的，因为这种禁令可能会造成严重的不良公共卫生后果。道德上的担忧，即接受安慰剂的研究参与者受到不适当的危害，将被证明是夸大的，特别是在涉及到最终用户从使用安慰剂对照产生的数据质量中获得的净收益。
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.
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DOI：
10.1007/s00406-003-0400-2
发表时间：
2003-02-01
影响因子：
4.7
作者：
Baldwin, D;Broich, K;Möller, HJ
通讯作者：
Möller, HJ
影响因子：
13.4
作者：
Brendel, David H.;Miller, Franklin G.
通讯作者：
Miller, Franklin G.
影响因子：
2.1
作者：
Freedman, B;Glass, KC;Weijer, C
通讯作者：
Weijer, C
影响因子：
15.8
作者：
Kirsch, Irving;Deacon, Brett J.;Huedo-Medina, Tania B.;Scoboria, Alan;Moore, Thomas J.;Johnson, Blair T.
通讯作者：
Johnson, Blair T.
影响因子：
--
作者：
Kessler, RC;Berglund, P;Walters, EE
通讯作者：
Walters, EE