PMID- 23145482
OWN - NLM
STAT- MEDLINE
DCOM- 20130815
LR  - 20220330
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 20
IP  - 3
DP  - 2013 Mar
TI  - Nocebo as a potential confounding factor in clinical trials for Parkinson's 
      disease treatment: a meta-analysis.
PG  - 527-533
LID - 10.1111/ene.12014 [doi]
AB  - BACKGROUND AND PURPOSE: Nocebo refers to adverse events (AEs) generated by 
      patient's negative expectations that medical treatment will likely harm instead 
      of heal and can be assessed in placebo-controlled randomized controlled trials 
      (RCTs). We examined AEs following placebo administration in RCTs for Parkinson's 
      disease (PD). METHODS: After a systematic Medline search for RCTs for PD 
      pharmacologic treatments published between 2000 and 2010, we assessed percentages 
      of placebo-treated patients reporting at least one AE or discontinuing due to 
      placebo intolerance and searched for factors influencing nocebo's extent. 
      RESULTS: Data were extracted from 41 RCTs fulfilling search criteria. Of 3544 
      placebo-treated patients, 64.7% (95% CI: 53.6-74.4) reported at least one AE and 
      8.8% (95% CI: 6.8-11.5) discontinued placebo treatment due to intolerance. The 
      number of AEs per 100 person-months was 25.9 (95% CI: 16.8-39.8). Nocebo dropout 
      rate was positively related to study population size and year of publication. 
      Increased number of AEs per 100 person-months was negatively correlated with the 
      duration of treatment. AE rates, dropout rates, and AEs per 100 person-months in 
      placebo- and active drug-treated patients were strongly correlated (r = 0.941, 
      0.695, and 0.824, respectively). CONCLUSIONS: Our analysis indicates a 
      significant dropout rate related to nocebo in trials for PD treatment. Adherence 
      and efficacy may be adversely affected with additional implications for clinical 
      practice.
CI  - (c) 2012 The Author(s) European Journal of Neurology (c) 2012 EFNS.
FAU - Stathis, P
AU  - Stathis P
AD  - Neurology Department, Sismanoglion Hospital, Athens, Greece.
FAU - Smpiliris, M
AU  - Smpiliris M
AD  - Neurology Department, Sismanoglion Hospital, Athens, Greece.
FAU - Konitsiotis, S
AU  - Konitsiotis S
AD  - Neurology Department, University of Ioannina, Ioannina, Greece.
FAU - Mitsikostas, D D
AU  - Mitsikostas DD
AD  - Neurology Department, Athens Naval Hospital, Athens, Greece.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20121112
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
SB  - IM
MH  - Humans
MH  - Parkinson Disease/*drug therapy
MH  - *Placebo Effect
MH  - Randomized Controlled Trials as Topic/*psychology
EDAT- 2012/11/14 06:00
MHDA- 2013/08/16 06:00
CRDT- 2012/11/14 06:00
PHST- 2012/05/28 00:00 [received]
PHST- 2012/09/17 00:00 [accepted]
PHST- 2012/11/14 06:00 [entrez]
PHST- 2012/11/14 06:00 [pubmed]
PHST- 2013/08/16 06:00 [medline]
AID - 10.1111/ene.12014 [doi]
PST - ppublish
SO  - Eur J Neurol. 2013 Mar;20(3):527-533. doi: 10.1111/ene.12014. Epub 2012 Nov 12.