Singer Ernst A
Department of Pharmacology, University of Vienna Medical School, Vienna, Austria.
Sci Eng Ethics. 2004 Jan;10(1):51-6. doi: 10.1007/s11948-004-0062-0.
The use of placebo in clinical trials has been repeatedly challenged as being unacceptable from an ethical point of view. The present paper responds to this criticism by taking up the issue in the light of the pertinent provisions of the Helsinki Declaration. Examples from different therapeutic areas are given that highlight the importance of placebo in situations in which its use is acceptable according to the Declaration. Particular emphasis is given to the question of active control trials, which, under conditions of low assay sensitivity, may become an ethically less acceptable approach than the use of a placebo control.
从伦理角度来看,在临床试验中使用安慰剂一直受到反复质疑,被认为是不可接受的。本文根据《赫尔辛基宣言》的相关规定来探讨这一问题,以回应这种批评。文中给出了不同治疗领域的例子,这些例子凸显了在《宣言》认为使用安慰剂可接受的情况下,安慰剂的重要性。文中特别强调了阳性对照试验的问题,即在检测灵敏度较低的情况下,与使用安慰剂对照相比,阳性对照试验在伦理上可能成为一种较不可接受的方法。