Conboy Lisa A, Wasserman Rachel H, Jacobson Eric E, Davis Roger B, Legedza Anna T R, Park Min, Rivers Andrea L, Morey Elizabeth B, Nam Bong Hyun, Lasagna Louis, Kirsch Irving, Lembo Anthony J, Kaptchuk Ted J, Kerr Catherine E
Osher Institute, Division for Research and Education in Complementary and Integrative Therapies, Harvard Medical School, 401 Park Drive, Suite 22A, Boston, MA 02115, USA.
Contemp Clin Trials. 2006 Apr;27(2):123-34. doi: 10.1016/j.cct.2005.11.012. Epub 2006 Jan 19.
Little is known about placebo effects with scientific precision. Poor methodology has confounded our understanding of the magnitude and even the existence of the placebo effect. Investigating placebo effects presents special research challenges including: the design of appropriate controls for studying placebo effects including separating such effects from natural history and regression to the mean, the need for large sample sizes to capture expected small effects, and the need to understand such potential effects from a patient's perspective. This article summarizes the methodology of an ongoing NIH-funded randomized controlled trial aimed at investigating whether the placebo effect in irritable bowel syndrome (IBS) exists and whether the magnitude of such an effect can be manipulated to vary in a manner analogous to "dose dependence." The trial also uses an innovative combination of quantitative and qualitative methods.
关于安慰剂效应的科学精准度，我们所知甚少。糟糕的研究方法混淆了我们对安慰剂效应大小乃至其存在与否的理解。研究安慰剂效应面临特殊的研究挑战，包括：设计用于研究安慰剂效应的适当对照，包括将此类效应与自然病程及均值回归区分开来；需要大样本量以捕捉预期的微小效应；以及需要从患者角度理解此类潜在效应。本文总结了一项正在进行的由美国国立卫生研究院资助的随机对照试验的方法，该试验旨在调查肠易激综合征（IBS）中是否存在安慰剂效应，以及这种效应的大小是否可以像“剂量依赖性”那样被操控而发生变化。该试验还采用了定量和定性方法的创新组合。
