PMID- 25703333
OWN - NLM
STAT- MEDLINE
DCOM- 20150903
LR  - 20181202
IS  - 1525-5069 (Electronic)
IS  - 1525-5050 (Linking)
VI  - 43
DP  - 2015 Feb
TI  - Placebo and nocebo responses in drug trials of epilepsy.
PG  - 128-34
LID - S1525-5050(14)00658-1 [pii]
LID - 10.1016/j.yebeh.2014.12.004 [doi]
AB  - Placebo response can be defined as any therapeutic change on placebo, while the 
      nocebo response is any ill effect during placebo exposure. Several meta-analytic 
      approaches have investigated the extent of placebo response in randomized, 
      placebo-controlled, clinical trials of focal epilepsies. Placebo response rates 
      (proportion of patients with >/=50% improvement of seizures versus baseline) 
      ranging from 9.9% up to 15.2% have been reported. Interestingly, a sham response 
      of 15.8% has been noted in trials of transcranial magnetic stimulation. Recently, 
      nocebo response rates of 60.3% and 3.9% were noted, which were defined as the 
      proportion of patients with adverse events (AEs) and those withdrawing because of 
      intolerable AEs, respectively. Factors which were found to influence placebo 
      response were as follows: the year of publication (with more recent studies 
      showing higher rates of placebo response), some clinical characteristics of 
      recruited patients (lower placebo response rates with a history of 7 or more 
      prior lifetime AEDs, a high baseline seizure frequency, prior epilepsy surgery, 
      and higher age at diagnosis), trial design and statistical analysis, and whether 
      studies have been conducted in children or adults. Furthermore, placebo and 
      nocebo rates were correlated with respective seizure outcome and adverse events 
      of the experimental AED. Several mechanisms of placebo and nocebo responses are 
      discussed. Specifically, the role of positive or negative expectations of 
      patients and of investigators may influence the placebo and the nocebo response. 
      Finally, recommendations are given on how to address placebo and nocebo responses 
      in clinical practice.
CI  - Copyright (c) 2015 Elsevier Inc. All rights reserved.
FAU - Zaccara, Gaetano
AU  - Zaccara G
AD  - Unit of Neurology, Department of Medicine, Florence Health Authority, Firenze, 
      Italy. Electronic address: gaetano.zaccara@asf.toscana.it.
FAU - Giovannelli, Fabio
AU  - Giovannelli F
AD  - Unit of Neurology, Department of Medicine, Florence Health Authority, Firenze, 
      Italy; Department of Neuroscience, Psychology, Pharmacology and Child Health 
      (NEUROFARBA), University of Florence, Firenze, Italy.
FAU - Schmidt, Dieter
AU  - Schmidt D
AD  - Epilepsy Research Group, Berlin, Germany.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20150219
PL  - United States
TA  - Epilepsy Behav
JT  - Epilepsy & behavior : E&B
JID - 100892858
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Anticonvulsants/adverse effects/*therapeutic use
MH  - Clinical Trials as Topic
MH  - Epilepsy/*drug therapy
MH  - Humans
MH  - *Nocebo Effect
MH  - *Placebo Effect
MH  - Research Design
OTO - NOTNLM
OT  - Adverse effects
OT  - Antiepileptic drugs
OT  - Meta-regression
OT  - Nocebo effects
OT  - Placebo effects
OT  - Side effects
EDAT- 2015/02/24 06:00
MHDA- 2015/09/04 06:00
CRDT- 2015/02/24 06:00
PHST- 2014/10/10 00:00 [received]
PHST- 2014/12/02 00:00 [revised]
PHST- 2014/12/04 00:00 [accepted]
PHST- 2015/02/24 06:00 [entrez]
PHST- 2015/02/24 06:00 [pubmed]
PHST- 2015/09/04 06:00 [medline]
AID - S1525-5050(14)00658-1 [pii]
AID - 10.1016/j.yebeh.2014.12.004 [doi]
PST - ppublish
SO  - Epilepsy Behav. 2015 Feb;43:128-34. doi: 10.1016/j.yebeh.2014.12.004. Epub 2015 
      Feb 19.