PMID- 21973313
OWN - NLM
STAT- MEDLINE
DCOM- 20120814
LR  - 20220330
IS  - 1468-1331 (Electronic)
IS  - 1351-5101 (Linking)
VI  - 19
IP  - 5
DP  - 2012 May
TI  - Nocebo in fibromyalgia: meta-analysis of placebo-controlled clinical trials and 
      implications for practice.
PG  - 672-80
LID - 10.1111/j.1468-1331.2011.03528.x [doi]
AB  - BACKGROUND: Nocebo refers to adverse effects (AEs) generated by negative 
      expectations that medical treatment will likely harm instead of heal and can be 
      assessed in placebo-controlled randomized clinical trials (RCTs). We examined AEs 
      following placebo administration in RCTs for fibromyalgia (FM), a condition 
      characterized by patients' poor medication adherence, which may affect outcome 
      and/or increase healthcare costs. METHODS:   Following a systematic Medline 
      search for RCTs for FM pharmacologic treatment published between 2001 and 2010, 
      we assessed percentages of placebo-treated patients reporting at least one AE or 
      discontinuing because of placebo intolerance and searched for factors influencing 
      nocebo's extent. Percentages were compared with those revealed by similar 
      meta-analyses of RCTs for multiple sclerosis and primary headaches. RESULTS:   
      Data were extracted from 16 RCTs fulfilling search criteria. Of 2026 
      placebo-treated patients, 67.2% (95%CI: 51.0-81.5%) reported at least one AE, and 
      9.5% (95%CI: 8.3-10.9%) discontinued placebo treatment because of intolerance. 
      AEs in placebo arms corresponded quantitatively and qualitatively to those in 
      active drug arms (rho > 0.88, P < 0.0001). Younger age and larger placebo arm size 
      were associated with increased dropout rates. Patients with depression were more 
      likely to withdraw from trials. Nocebo dropouts in FM trials were fourfold and 
      twofold higher than in RCTs for multiple sclerosis treatment and migraine 
      preventive treatment, respectively. CONCLUSIONS:   Nocebo is remarkably prevalent 
      in FM patients participating in RCTs. Because nocebo contributes to drug 
      intolerance and treatment failure in clinical practice, identification of 
      predisposing factors and efforts to prevent nocebo by educating these patients 
      appropriately may be important for FM outcome.
CI  - (c) 2011 The Author(s). European Journal of Neurology (c) 2011 EFNS.
FAU - Mitsikostas, D D
AU  - Mitsikostas DD
AD  - Department of Neurology, Naval Hospital, Athens, Greece. 
      dmitsikostas@ath.forthnet.gr
FAU - Chalarakis, N G
AU  - Chalarakis NG
FAU - Mantonakis, L I
AU  - Mantonakis LI
FAU - Delicha, E-M
AU  - Delicha EM
FAU - Sfikakis, P P
AU  - Sfikakis PP
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Review
DEP - 20111004
PL  - England
TA  - Eur J Neurol
JT  - European journal of neurology
JID - 9506311
RN  - 0 (Placebos)
SB  - IM
MH  - Fibromyalgia/*drug therapy
MH  - Humans
MH  - MEDLINE/statistics & numerical data
MH  - Placebos/*adverse effects
MH  - Randomized Controlled Trials as Topic/*methods/*psychology
EDAT- 2011/10/07 06:00
MHDA- 2012/08/15 06:00
CRDT- 2011/10/07 06:00
PHST- 2011/10/07 06:00 [entrez]
PHST- 2011/10/07 06:00 [pubmed]
PHST- 2012/08/15 06:00 [medline]
AID - 10.1111/j.1468-1331.2011.03528.x [doi]
PST - ppublish
SO  - Eur J Neurol. 2012 May;19(5):672-80. doi: 10.1111/j.1468-1331.2011.03528.x. Epub 
      2011 Oct 4.