PMID- 24916828
OWN - NLM
STAT- MEDLINE
DCOM- 20160229
LR  - 20211021
IS  - 1432-1459 (Electronic)
IS  - 0340-5354 (Linking)
VI  - 262
IP  - 3
DP  - 2015 Mar
TI  - Adverse events of placebo-treated, drug-resistant, focal epileptic patients in 
      randomized controlled trials: a systematic review.
PG  - 501-15
LID - 10.1007/s00415-014-7391-y [doi]
AB  - Health-related quality of life of patients with epilepsy is heavily influenced by 
      antiepileptic drug (AED) tolerability. However, an accepted method for precise 
      assessment of AED-induced adverse events (AEs) has not yet been established. 
      Assessment of tolerability and of the frequency of predefined AEs among 
      drug-resistant epilepsy patients through an analysis of placebo-treated patients 
      from randomized controlled studies (RCTs) performed in patients with partial 
      onset epilepsies (POS) and evaluation of factors which may influence the 
      occurrence of AEs in these patients are the objectives of this study. We searched 
      all double-blind, placebo-controlled trials investigating any AED on adult 
      patients with POS and extracted both for patients treated with placebo and for 
      those treated with the active drug, number of patients, number of responders, 
      number of patients withdrawing because of AEs, number of patients with AEs, and 
      number of patients with 11 predefined AEs. We also explored the effect of 
      multiple factors on AEs reporting. Seventy-nine RCTs were included in our study 
      with 12,594 patients, 6,793 of whom randomized to placebo. In placebo-treated 
      patients, overall responder rate was 15.2 %, proportion of placebo-treated 
      patients withdrawing because of AEs was 3.9 %, and proportion of patients with AE 
      was 60.3 %. The four most frequently reported AEs were headache (12.4 %) 
      somnolence (8.6 %), dizziness (8.2 %), and fatigue (7.9 %). Several factors were 
      found to influence these outcomes. Several factors influence AEs' appearance in 
      RCTs. Among the most important, we found the expectations of patients and doctors 
      and their attitudes on the positive or negative effect of a drug.
FAU - Zaccara, Gaetano
AU  - Zaccara G
AD  - Unit of Neurology, Department of Medicine, Florence Health Authority, San 
      Giovanni di Dio Hospital, Via Di Torregalli n 3, 50143, Florence, Italy, 
      gaetano.zaccara@asf.toscana.it.
FAU - Giovannelli, Fabio
AU  - Giovannelli F
FAU - Cincotta, Massimo
AU  - Cincotta M
FAU - Loiacono, Giulia
AU  - Loiacono G
FAU - Verrotti, Alberto
AU  - Verrotti A
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
PT  - Systematic Review
DEP - 20140611
PL  - Germany
TA  - J Neurol
JT  - Journal of neurology
JID - 0423161
RN  - 0 (Anticonvulsants)
SB  - IM
MH  - Anticonvulsants/*adverse effects
MH  - Databases, Bibliographic/statistics & numerical data
MH  - Drug Resistant Epilepsy/psychology/*therapy
MH  - Female
MH  - Humans
MH  - *Placebo Effect
MH  - *Randomized Controlled Trials as Topic
EDAT- 2014/06/12 06:00
MHDA- 2016/03/02 06:00
CRDT- 2014/06/12 06:00
PHST- 2014/02/28 00:00 [received]
PHST- 2014/05/27 00:00 [accepted]
PHST- 2014/05/27 00:00 [revised]
PHST- 2014/06/12 06:00 [entrez]
PHST- 2014/06/12 06:00 [pubmed]
PHST- 2016/03/02 06:00 [medline]
AID - 10.1007/s00415-014-7391-y [doi]
PST - ppublish
SO  - J Neurol. 2015 Mar;262(3):501-15. doi: 10.1007/s00415-014-7391-y. Epub 2014 Jun 
      11.