Journal
STATISTICAL METHODS IN MEDICAL RESEARCH
Volume 28, Issue 4, Pages 1141-1156Publisher
SAGE PUBLICATIONS LTD
DOI: 10.1177/0962280217748339
Keywords
Placebo response; placebo effects; treatment effects; controlling placebo effects; randomized controlled trials; research designs; causal inference
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The placebo serves as an indispensable control in many randomized trials. When analyzing the benefit of a new treatment, researchers are often confronted with large placebo effects that diminish the treatment effect. Various alternative methods have been proposed for analyzing placebo and treatment effects in studies where large placebo effects are expected or have already occurred. This paper presents an overview of methodological work that has been proposed for assessing and/or controlling for placebo effects in randomized trials. Throughout this paper, two main approaches are discussed. The first approach considers designs that represent alternatives to the classical placebo-controlled randomized trial design. Separately, the second approach considers adopting new methods for the statistical analysis of placebo and treatment effects to be implemented after the data have been collected using a classical randomized trial design.
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