Placebo-controlled studies in depression:: necessary, ethical and feasible
Placebo-controlled studies in depression:: necessary, ethical and feasible
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DOI：
10.1007/s00406-003-0400-2
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发表时间：
2003-02-01
影响因子：
4.7
通讯作者：
Möller, HJ
中科院分区：
文献类型：
--
作者：
Baldwin, D;Broich, K;Möller, HJ
安慰剂对照试验广泛用于新药物治疗的开发。在患者可以接受现有有效且可接受的治疗的临床情况下，它们有时会被认为是不道德的。有人认为，潜在抗抑郁药的研究应该仅采用比较器控制设计，从而必须发现新化合物至少与现有治疗方法一样有效。相比之下，其他人则认为，单独使用对照试验本身就是不道德的，因为更多的患者将接受可能无益的治疗。本文回顾了在抑郁症患者中进行安慰剂对照治疗研究的基本原理，探讨了潜在的伦理问题，并描述了在研究潜在有价值的新型抗抑郁药物的疗效和耐受性时应适用的规定。新抗抑郁药的安慰剂对照研究在科学和伦理上都是合理的；对安慰剂对照研究的限制将阻碍更有效、耐受性更好的抗抑郁药物的问世。
Placebo-controlled trials are used widely in the development of new pharmacological treatments. They have sometimes been challenged as being unethical, in clinical situations where patients can receive an existing effective and acceptable treatment. It has been argued that studies of potential antidepressants should employ only a comparator-controlled design, whereby new compounds have to be found at least a's efficacious as existing treatments. By contrast, others have argued that sole use of comparator-controlled trials is itself unethical, as more patients will be exposed to potentially unhelpful treatments. This article reviews the rationale for conducting placebo-controlled treatment studies in depressed patients, examines the underlying ethical issues, and describes the provisions that should be applied when investigating the efficacy and tolerability of potentially valuable new antidepressant treatments. Placebo-controlled studies of new antidepressants are justified, both scientifically and ethically; restrictions on placebo-controlled investigations will hinder the arrival of more efficacious and better tolerated antidepressants.