Are we drawing the right conclusions from randomised placebo-controlled trials? A post-hoc analysis of data from a randomised controlled trial

Diana M Van Die, Kerry M Bone, Henry G Burger, Helena Jane Teede

Research output: Contribution to journalArticleResearchpeer-review

20 Citations (Scopus)

Abstract

Assumptions underlying placebo controlled trials include that the placebo effect impacts on all study arms equally, and that treatment effects are additional to the placebo effect. However, these assumptions have recently been challenged, and different mechanisms may potentially be operating in the placebo and treatment arms. The objective of the current study was to explore the nature of placebo versus pharmacological effects by comparing predictors of the placebo response with predictors of the treatment response in a randomised, placebo-controlled trial of a phytotherapeutic combination for the treatment of menopausal symptoms. A substantial placebo response was observed but no significant difference in efficacy between the two arms.
Original languageEnglish
Pages (from-to)1 - 7
Number of pages7
JournalBMC Medicine
Volume9
Issue number41
DOIs
Publication statusPublished - 2009

Cite this