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临床实践与研究中的安慰剂

Placebos in clinical practice and research.

作者信息

De Deyn P P, D'Hooge R

机构信息

Department of Neurology, Middelheim General Hospital, Antwerp, Belgium.

出版信息

J Med Ethics. 1996 Jun;22(3):140-6. doi: 10.1136/jme.22.3.140.

Abstract

The main current application of placebo is in clinical research. The term placebo effect refers to diverse non-specific, desired or non-desired effects of substances or procedures and interactions between patient and therapist. Unpredictability of the placebo effect necessitates placebo-controlled designs for most trials. Therapeutic and diagnostic use of placebo is ethically acceptable only in few well-defined cases. While "therapeutic" application of placebo almost invariably implies deception, this is not the case for its use in research. Conflicts may exist between the therapist's Hippocratic and scientific obligations. The authors provide examples in neuropsychiatry, illustrating that objective scientific data and well-considered guidelines may solve the ethical dilemma. Placebo control might even be considered an ethical obligation but some provisos should be kept in mind: (a) no adequate therapy for the disease should exist and/or (presumed) active therapy should have serious side-effects; (b) placebo treatment should not last too long; (c) placebo treatment should not inflict unacceptable risks, and (d) the experimental subject should be adequately informed and informed consent given.

摘要

安慰剂目前的主要应用领域是临床研究。安慰剂效应这一术语指的是物质或程序以及患者与治疗师之间相互作用所产生的各种非特异性、预期或非预期的效应。安慰剂效应的不可预测性使得大多数试验都需要采用安慰剂对照设计。仅在少数明确界定的情况下,安慰剂的治疗和诊断用途在伦理上才是可接受的。虽然安慰剂的“治疗”应用几乎总是意味着欺骗,但在研究中使用安慰剂并非如此。治疗师的希波克拉底誓言义务与科学义务之间可能存在冲突。作者提供了神经精神病学方面的例子,说明客观的科学数据和经过深思熟虑的指导方针可以解决伦理困境。安慰剂对照甚至可能被视为一种伦理义务,但应牢记一些前提条件:(a)该疾病不存在足够的治疗方法,和/或(假定的)积极治疗应具有严重的副作用;(b)安慰剂治疗不应持续太长时间;(c)安慰剂治疗不应带来不可接受的风险,以及(d)应充分告知实验对象并获得知情同意。

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