Magnitude of the placebo effect in randomized trials of antiepileptic agents

Jorge G. Burneo, Victor M. Montori, Edward Faught

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

Placebo-controlled randomized trials ideally produce unbiased estimates of the treatment effect after accounting for nonpharmacological effects (regression to the mean, Hawthorne, and placebo effects). Recognizing that the magnitude of these effects may help understand why investigators need to control for them, we sought to measure this magnitude. We reviewed published meta-analyses of randomized, placebo-controlled add-on trials of antiepileptic medications versus placebo, included in the Cochrane Library. In randomized trials of antiepileptic agents for epilepsy, 9.3-16.6% of patients in the placebo arm had a >50% reduction in seizure frequency. This effect represents 20-50% of the effect observed with active agents. Because patients with epilepsy in the placebo arm of randomized trials experience a large clinical benefit due to non pharmacological effects, randomized controlled trials are necessary to gauge the true magnitude of the treatment effect of new antiepileptic agents.

Original languageEnglish (US)
Pages (from-to)532-534
Number of pages3
JournalEpilepsy and Behavior
Volume3
Issue number6
DOIs
StatePublished - Dec 2002

Keywords

  • Antiepileptic agents
  • Epilepsy
  • Placebo
  • Randomized trials

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology
  • Behavioral Neuroscience

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