PMID- 27580494
OWN - NLM
STAT- MEDLINE
DCOM- 20170428
LR  - 20191210
IS  - 1533-712X (Electronic)
IS  - 0271-0749 (Linking)
VI  - 36
IP  - 5
DP  - 2016 Oct
TI  - Lessons Learned From Nocebo Effects in Clinical Trials for Pain Conditions and 
      Neurodegenerative Disorders.
PG  - 475-82
LID - 10.1097/JCP.0000000000000556 [doi]
AB  - 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.
FAU - Amanzio, Martina
AU  - Amanzio M
AD  - From the *Department of Psychology and Neuroscience Institute of Turin NIT and 
      daggerDepartment of Neuroscience, Neurology II, University of Turin, Turin, Italy; and 
      double daggerDepartment of Psychology and Behavioural Sciences, Aarhus University; and 
       section signDanish Pain Research Center, Aarhus University Hospital, Aarhus, Denmark.
FAU - Palermo, Sara
AU  - Palermo S
FAU - Skyt, Ina
AU  - Skyt I
FAU - Vase, Lene
AU  - Vase L
LA  - eng
PT  - Journal Article
PT  - Review
PL  - United States
TA  - J Clin Psychopharmacol
JT  - Journal of clinical psychopharmacology
JID - 8109496
SB  - IM
MH  - *Clinical Trials as Topic
MH  - Humans
MH  - Neurodegenerative Diseases/*drug therapy
MH  - *Nocebo Effect
MH  - Outcome and Process Assessment, Health Care/*standards
MH  - Pain/*drug therapy
EDAT- 2016/09/01 06:00
MHDA- 2017/04/30 06:00
CRDT- 2016/09/01 06:00
PHST- 2016/09/01 06:00 [entrez]
PHST- 2016/09/01 06:00 [pubmed]
PHST- 2017/04/30 06:00 [medline]
AID - 00004714-201610000-00013 [pii]
AID - 10.1097/JCP.0000000000000556 [doi]
PST - ppublish
SO  - J Clin Psychopharmacol. 2016 Oct;36(5):475-82. doi: 10.1097/JCP.0000000000000556.