Piercy M A, Sramek J J, Kurtz N M, Cutler N R
California Clinical Trials, Beverly Hills 90211, USA.
Ann Pharmacother. 1996 Sep;30(9):1013-9. doi: 10.1177/106002809603000917.
To review literature on placebo response in anxiety, to discuss sources and levels of placebo response in various anxiety disorders, and to suggest methods to prevent high placebo response rates in clinical research trials.
Data from scientific literature were identified using a MEDLINE search, and were extracted and summarized for this review.
Representative findings were selected from clinical and epidemiologic studies, review articles, letters to the editor, book chapters, and proceedings.
Data from English-language reports of studies on humans were included. Only the most representative conclusions drawn from review articles were used.
Anxiety disorders in general are thought to be extremely susceptible to a variety of influences, including patient characteristics and environmental variables. Reported placebo response levels in clinical studies of anxiolytics for generalized anxiety disorder and panic disorder vary widely, with a tendency to be rather high, although studies in social phobia and obsessive compulsive disorder appear to have consistently low placebo response rates. Comparisons of anxiety studies with studies of other indications, such as depression, show similar overall placebo response rates. To determine efficacy, drug response rates and placebo response rates must be clearly differentiated.
Examination of the literature suggests that placebo response rates in studies of anxiolytics are influences by a number of factors, including both endogenous and exogenous variables. High placebo response rates may mask true drug response rates and may result from poor study design or lack of procedural standardization. The use of certain design methods may help to prevent high placebo response rates in anxiolytic clinical trials.
回顾关于焦虑症中安慰剂反应的文献,讨论各种焦虑症中安慰剂反应的来源和水平,并提出在临床研究试验中预防高安慰剂反应率的方法。
使用医学主题词表(MEDLINE)检索确定科学文献中的数据,并提取和总结以供本综述使用。
从临床和流行病学研究、综述文章、致编辑的信、书籍章节和会议记录中选择代表性研究结果。
纳入来自关于人类研究的英文报告中的数据。仅使用从综述文章中得出的最具代表性的结论。
一般认为焦虑症极易受到多种影响,包括患者特征和环境变量。在广泛性焦虑症和恐慌症的抗焦虑药临床研究中报告的安慰剂反应水平差异很大,尽管社交恐惧症和强迫症的研究似乎安慰剂反应率一直较低,但仍有偏高的趋势。将焦虑症研究与其他适应症(如抑郁症)的研究进行比较,总体安慰剂反应率相似。为了确定疗效,必须明确区分药物反应率和安慰剂反应率。
对文献的研究表明,抗焦虑药研究中的安慰剂反应率受多种因素影响,包括内源性和外源性变量。高安慰剂反应率可能掩盖真实的药物反应率,可能是由于研究设计不佳或缺乏程序标准化导致的。使用某些设计方法可能有助于在抗焦虑药临床试验中预防高安慰剂反应率。