Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study
Prevalence and factors associated with use of placebo control groups in randomized controlled trials in psoriasis: A cross-sectional study
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DOI：
10.1016/j.jaad.2006.07.005
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发表时间：
2006-11-01
影响因子：
13.8
通讯作者：
Margolis, David J.
中科院分区：
文献类型：
--
作者：
Katz, Kenneth A.;Karlawish, Jason H.;Margolis, David J.
背景：在临床试验中使用安慰剂对照组的伦理学和科学性一直存在广泛的争论。然而，很少有研究考察与选择控制组相关的因素。我们的目的是评估在银屑病随机对照试验中使用安慰剂对照的流行率，并确定在这些试验中使用安慰剂对照的相关因素。方法：这是一项关于2001年1月1日至2005年12月20日发表的银屑病随机对照试验的横断面研究，并在Cochrane中央对照试验登记中检索。我们提取了关于使用的对照组的类型、设计问题(纳入的患者数量、主要终点)、疾病特征(牛皮癣类型和严重程度)和科学外问题(试验地点、资金来源和发表年份)的数据。我们使用双变量和多变量Logistic回归来确定与使用安慰剂对照组相关的因素。结果：在194篇引用文献中，187篇可供审查。来自38种期刊的134篇文章中的135项试验符合纳入标准。83项试验(61.5%)招募了8171名受试者(41.7%)，只使用了主动对照，52项试验(38.5%)招募了11406名受试者(58.3%)使用了安慰剂对照。经试验地点和资金来源调整后，更有可能使用安慰剂对照的试验包括在美国进行的试验(优势比[OR]，5.79；95%可信区间[CI]，2.45-13.68；P
Background: The ethics and science of using placebo control groups in clinical trials have been widely debated. Few studies, however, have examined factors associated with choice of control group.Objective. Our aim was to assess the prevalence of use of placebo controls in randomized controlled trials in psoriasis and to identify factors associated with use of placebo controls in these trials.Methods: This is a cross-sectional Study of randomized controlled trials in psoriasis published from January 1, 2001 to December 20, 2005 and indexed in the Cochrane Central Register of Controlled Trials. We extracted data on types of control groups used, design issues (number of patients enrolled, primary end point), disease characteristics (psoriasis type and severity), and extrascientific issues (trial location, funding source, and year Of publication). We used bivariable and multivariable logistic regression to determine factors associated with use of a placebo control group.Results: Of 194 citations, 187 were available for review. One hundred thirty-five trials from 134 articles in 38 journals met inclusion criteria. Eighty-three trials (61.5%) enrolling 8171 subjects (41.7%) used active controls only, and 52 trials (38.5%) enrolling 11,406 Subjects (58.3%) used placebo controls. Adjusted for trial location and funding source, trials significantly more likely to have used placebo controls included those conducted in the United States (odds ratio [OR], 5.79; 95% confidence interval [CI], 2.45-13.68; P