Horng Sam H, Miller Franklin G
Department of Brain and Cognitive Sciences, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA.
Neurotherapeutics. 2007 Jul;4(3):531-6. doi: 10.1016/j.nurt.2007.03.001.
Neurological disease has been a central focus in the ongoing ethical debate over the use of invasive placebo controls, especially sham surgery. The risk to research subjects and necessary use of deception involved in these procedures must be balanced against the methodological need to control for bias and the placebo effect. We review a framework formulated for the ethical assessment of sham surgery in the context of research evaluating novel procedures for neurological conditions. Special issues raised include the growing evidence of expectation and conditioning effects in a number of neurological diseases, the escalating scale of risk from different types of invasive placebo interventions, and the increasing use of cross-over designs, which allow a switch from placebo to active intervention without additional procedures.
在关于使用侵入性安慰剂对照（尤其是假手术）的持续伦理辩论中，神经疾病一直是核心关注点。这些程序给研究对象带来的风险以及所涉及的欺骗手段的必要使用，必须与控制偏差和安慰剂效应的方法学需求相权衡。我们回顾了一个为在评估神经疾病新程序的研究背景下对假手术进行伦理评估而制定的框架。引发的特殊问题包括在多种神经疾病中期望和条件作用效应的证据越来越多、不同类型侵入性安慰剂干预的风险规模不断升级，以及交叉设计的使用日益增加，交叉设计允许在不进行额外程序的情况下从安慰剂转换为积极干预。
