Lessons Learned From Nocebo Effects in Clinical Trials for Pain Conditions and Neurodegenerative Disorders
| Autor: | Martina Amanzio, Lene Vase, Sara Palermo, Ina Skyt |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
medicine.medical_specialty
MEDLINE Alternative medicine Pain Placebo 03 medical and health sciences 0302 clinical medicine adverse events in clinical trials medicine Humans Pharmacology (medical) 030212 general & internal medicine expectancy theory Nocebo Effect placebo groups Intensive care medicine Adverse effect Psychiatry Expectancy theory Clinical Trials as Topic business.industry Medicine (all) nocebo effect Neurodegenerative Diseases Clinical trial Psychiatry and Mental health Outcome and Process Assessment Health Care Key Words randomized controlled trials business adverse events in clinical trials expectancy theory Key Words randomized controlled trials nocebo effect placebo groups Medicine (all) Psychiatry and Mental Health Pharmacology (medical) 030217 neurology & neurosurgery |
| Zdroj: | Amanzio, M, Palermo, S, Skyt, I & Vase, L 2016, ' Lessons learned from nocebo effects in clinical trials for pain conditions and neurodegenerative disorders ', Journal of Clinical Psychopharmacology, vol. 36, no. 5, pp. 475-482 . https://doi.org/10.1097/JCP.0000000000000556 |
| ISSN: | 1533-712X 0271-0749 |
| DOI: | 10.1097/jcp.0000000000000556 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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