Green Stuart A
Department of Orthopaedic Surgery, University of California, Irvine, Irvine, CA 92868, USA.
Clin Orthop Relat Res. 2002 Dec(405):311-9. doi: 10.1097/00003086-200212000-00039.
The single-blind or double-blind, placebo-controlled randomized clinical trial is considered the gold standard for evaluating the potential efficacy of pharmaceuticals, medical devices, and treatment protocols. The characteristic features of placebo-controlled clinical evaluations include two essential elements: a sham intervention and subject ignorance about the bogus nature of that intervention. Although it commonly is assumed that such clinical trials were developed in the 1930s, the first published report that used intentional subject ignorance and sham intervention was the result of a 1784 French royal commission investigation into mesmerism, headed by Benjamin Franklin. The strategy the Franklin commission used to debunk Franz Mesmer's assertions about health and illness served as a model for subsequent inquiries that use placebo controls and blinded assessment to arrive at their conclusions.
单盲或双盲、安慰剂对照随机临床试验被视为评估药物、医疗器械和治疗方案潜在疗效的金标准。安慰剂对照临床评估的特征包括两个基本要素:假干预以及受试者对该干预虚假性质的不知情。尽管人们通常认为此类临床试验是在20世纪30年代发展起来的,但首份使用受试者故意不知情和假干预的发表报告是1784年由本杰明·富兰克林领导的法国皇家委员会对催眠术进行调查的结果。富兰克林委员会用来揭穿弗朗茨·梅斯梅尔关于健康与疾病论断的策略,为后续使用安慰剂对照和盲法评估得出结论的调查提供了范例。