title: Lessons Learned From Nocebo Effects in Clinical Trials for Pain Conditions and Neurodegenerative Disorders.
abstract: 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.
authors: From the *Department of Psychology and Neuroscience Institute of Turin NIT and †Department of Neuroscience, Neurology II, University of Turin, Turin, Italy; and ‡Department of Psychology and Behavioural Sciences, Aarhus University; and §Danish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark.
authors: Martina
authors: M
authors: Amanzio
authors: Sara
authors: S
authors: Palermo
authors: Ina
authors: I
authors: Skyt
authors: Lene
authors: L
authors: Vase
mesh_terms: D002986:Clinical Trials as Topic; D006801:Humans; D019636:Neurodegenerative Diseases / Q000188:drug therapy*; D064786:Nocebo Effect; D010043:Outcome and Process Assessment, Health Care / Q000592:standards*; D010146:Pain / Q000188:drug therapy*