Department of Psychology and Behavioural Sciences

Ina Skyt

Lessons learned from nocebo effects in clinical trials for pain conditions and neurodegenerative disorders

Research output: Contribution to journal/Conference contribution in journal/Contribution to newspaperReviewResearchpeer-review

  • Martina Amanzio, Institute of Turin NIT
  • ,
  • Sara Palermo, Università degli Studi di Torino
  • ,
  • Ina Skyt
  • Lene Vase

It has been demonstrated that patients in the placebo arm of a clinical trial may experience adverse events (AEs), which may lead to nonadherence and dropout. However, so far, it is unknown to which extent this phenomenon is observed consistently across different diseases such as pain and neurodegenerative disorders. The current review shows for the first time that different diseases share a common risk for patients in terms of a negative outcome: a large percentage of placebo-treated patients experience AEs in pain conditions (up to 59%) and neurodegenerative disorders (up to 66%). In addition, the rate of patients who discontinue because of AEs is up to 10% and 11% in pain conditions and neurodegenerative disorders, respectively. We highlight methodological shortcomings with the aim of suggesting how the detection and reporting of AEs can be improved in future trials. The insights from the current review should be taken into consideration when designing clinical trials to tailor individualized treatments.

Original languageEnglish
JournalJournal of Clinical Psychopharmacology
Volume36
Issue5
Pages (from-to)475-482
Number of pages8
ISSN0271-0749
DOIs
Publication statusPublished - 1 Oct 2016

    Research areas

  • adverse events in clinical trials, expectancy theory, Key Words randomized controlled trials, nocebo effect, placebo groups

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