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大型抑郁症研究中的安慰剂反应:可变,实质性和不断增长
B Timothy Walsh1, Stuart N Seidman, Robyn Sysko
1Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 1051 Riverside Dr, Unit 98, New York, NY 10032, USA.
JAMA
|April 10, 2002
概括
大型抑郁症 (MDD) 试验中的安慰剂反应率随着时间的推移显著增加,反映了药物反应趋势. 这突显了安慰剂组在抗抑郁药研究中的科学重要性.
科学领域:
- 精神病学是一种精神病学.
- 临床试验 临床试验
- 药理学 药理学 是一个学科.
背景情况:
- 关于在临床试验中对主要抑郁症 (MDD) 药物进行安慰剂对照组的必要性存在争论.
- 由于有效抗抑郁药的可用性,引起了伦理方面的担忧,质疑新试验中需要安慰剂组的必要性.
研究的目的:
- 分析抗抑郁药试验中的安慰剂对照组随时间变化的特征.
主要方法:
- 我们对MEDLINE和PsychLit进行了系统的搜索,搜索了1981年至2000年期间发表的对照试验,这些试验涉及患有MDD的成人门诊患者.
- 分析了符合纳入标准的75项试验,提取了数据,并由多位作者解决了差异.
主要成果:
- 平均安慰剂反应率为29.7%,而平均活性药物反应率为50.1%.
- 假药和药物反应率都与出版年有显著的正相关性.
- 出版年和响应率之间的相关性在安慰剂中比在药物治疗中更强.
结论:
- 在MDD试验中对安慰剂的反应是可变的,通常是相当大的,并且近年来显著增加,类似于药物反应.
- 这些发现强调了将安慰剂组纳入抗抑郁药试验的科学重要性.
- 需要持续努力,以尽量减少风险,以道德方式进行安慰剂组的试验.
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