PMID- 26810717
OWN - NLM
STAT- MEDLINE
DCOM- 20170407
LR  - 20181113
IS  - 1432-1459 (Electronic)
IS  - 0340-5354 (Linking)
VI  - 263
IP  - 7
DP  - 2016 Jul
TI  - Analysis of nocebo effects of antiepileptic drugs across different conditions.
PG  - 1274-9
LID - 10.1007/s00415-015-8018-7 [doi]
AB  - The aim of this study was to assess the nocebo effect in all randomised 
      controlled trials (RCTs) exploring the effect of antiepileptic drugs (AEDs) in 
      the clinical conditions in which these compounds have been studied with the 
      exception of epilepsy. We searched for all double-blind, placebo-controlled 
      trials performed in adult patients, testing AEDs in any clinical condition except 
      epilepsy. The following data were extracted from the placebo arms: the number of 
      randomized patients, the number of patients withdrawing because of adverse 
      effects (AEs), and the number of patients with 11 predefined AEs (dizziness, 
      ataxia/coordination abnormal, diplopia, somnolence, fatigue, headache, memory 
      impairment, tremor, abnormal thinking, anxiety and depression). Outcome measures 
      were the percentages of patients whithdrawing due to AEs and reporting the 
      selected AEs. RCTs included in the analysis were grouped in six main categories 
      of clinical conditions (pain, movement disorders, psychiatric disorders, 
      substance abuse, obesity and binge eating disorders, and miscellanea). 
      Proportions of patients with 95 % confidence intervals (CIs) have been calculated 
      for all reported outcome measures. Thirteen AEDs were studied and the total 
      number of selected RCTs was 157. Significant percentages of placebo-treated 
      patients withdrawing due to AEs and with specific AEs were observed in several 
      cases. Significant differences emerged across different conditions. Comparisons 
      with results of a previous meta-analysis on all RCTs in patients with 
      drug-resistant epilepsies showed that ataxia, diplopia and fatigue were 
      significantly more frequent, and patients withdrawing were significantly less 
      frequent, in placebo-treated epileptic patients. Significant differences have 
      been identified in the AEDs-induced nocebo effect across different conditions. 
      Placebo-treated epilepsy patients have significantly more frequent neurological 
      AEs.
FAU - Zaccara, Gaetano
AU  - Zaccara G
AD  - Unit of Neurology, San Giovanni di Dio Hospital, Department of Medicine, Florence 
      Health Authority, Via Di Torregalli n 3, 50143, Florence, Italy. 
      gaetano.zaccara@uslcentro.toscana.it.
FAU - Giovannelli, Fabio
AU  - Giovannelli F
AD  - Unit of Neurology, San Giovanni di Dio Hospital, Department of Medicine, Florence 
      Health Authority, Via Di Torregalli n 3, 50143, Florence, Italy.
AD  - Department of Neuroscience, Psychology, Pharmacology and Child Health 
      (NEUROFARBA), University of Florence, Florence, Italy.
FAU - Giorgi, Filippo Sean
AU  - Giorgi FS
AD  - Section of Neurology, Department of Clinical and Experimental Medicine, 
      University of Pisa and Pisa University Hospital, Pisa, Italy.
FAU - Franco, Valentina
AU  - Franco V
AD  - C. Mondino National Neurological Institute, Pavia, Italy.
FAU - Gasparini, Sara
AU  - Gasparini S
AD  - Department of Medical and Surgical Sciences, Magna Graecia University of 
      Catanzaro, Catanzaro, Italy.
LA  - eng
PT  - Journal Article
PT  - Review
DEP - 20160125
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Anticonvulsants/therapeutic use
MH  - Databases, Bibliographic/statistics & numerical data
MH  - Double-Blind Method
MH  - Epilepsy/*drug therapy/psychology
MH  - Humans
MH  - *Nocebo Effect
MH  - Randomized Controlled Trials as Topic
OTO - NOTNLM
OT  - Adverse effects
OT  - Antiepileptic drugs
OT  - Meta-analysis
OT  - Nocebo effects
OT  - Placebo effects
EDAT- 2016/01/27 06:00
MHDA- 2017/04/08 06:00
CRDT- 2016/01/27 06:00
PHST- 2015/11/21 00:00 [received]
PHST- 2015/12/30 00:00 [accepted]
PHST- 2015/12/29 00:00 [revised]
PHST- 2016/01/27 06:00 [entrez]
PHST- 2016/01/27 06:00 [pubmed]
PHST- 2017/04/08 06:00 [medline]
AID - 10.1007/s00415-015-8018-7 [pii]
AID - 10.1007/s00415-015-8018-7 [doi]
PST - ppublish
SO  - J Neurol. 2016 Jul;263(7):1274-9. doi: 10.1007/s00415-015-8018-7. Epub 2016 Jan 
      25.