Brinkhaus Benno, Pach Daniel, Lüdtke Rainer, Willich Stefan N
Institute of Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center, Luisenstr. 57, 10098 Berlin, Germany.
Contemp Clin Trials. 2008 Mar;29(2):149-56. doi: 10.1016/j.cct.2007.06.005. Epub 2007 Jun 30.
Randomised placebo-controlled trials (RCT) are an invaluable tool for testing the efficacy of new treatment strategies. The choice of placebo in an RCT can affect not only patients' physical and psychological response to a particular intervention, but also the trial setting, the success of patient blinding to the intervention, and therefore the outcome of the study and the efficacy of treatment in general. Therefore the placebo is intrinsically tied to the trial's methodology and results. However, although placebos are an important component in randomised trials, their quality is often left unquestioned. A placebo which was not properly validated may even have specific effects that lead to false negative results. To address this deficit, we propose a measure of placebo quality using the term placebo to assess the physical aspect of a dummy treatment used in the placebo group of a randomised controlled trial (RCT). The Placebo Quality Checklist (PQC) described here may help investigators select an appropriate placebo and help both investigators and critical readers interpret the findings of studies with more care.
随机安慰剂对照试验（RCT）是测试新治疗策略疗效的宝贵工具。RCT中安慰剂的选择不仅会影响患者对特定干预的生理和心理反应，还会影响试验环境、患者对干预的盲法成功与否，进而影响研究结果以及总体治疗效果。因此，安慰剂与试验方法和结果有着内在联系。然而，尽管安慰剂是随机试验的重要组成部分，但其质量常常未受到质疑。未经适当验证的安慰剂甚至可能产生特定效应，导致假阴性结果。为解决这一不足，我们提出一种使用“安慰剂”一词来衡量安慰剂质量的方法，以评估随机对照试验（RCT）安慰剂组中使用的虚拟治疗的物理方面。这里描述的安慰剂质量检查表（PQC）可能有助于研究人员选择合适的安慰剂，并帮助研究人员和批判性读者更谨慎地解读研究结果。
