PMID- 24210741
OWN - NLM
STAT- MEDLINE
DCOM- 20141017
LR  - 20220330
IS  - 1872-7123 (Electronic)
IS  - 0165-1781 (Linking)
VI  - 215
IP  - 1
DP  - 2014 Jan 30
TI  - Nocebo in clinical trials for depression: a meta-analysis.
PG  - 82-6
LID - S0165-1781(13)00670-7 [pii]
LID - 10.1016/j.psychres.2013.10.019 [doi]
AB  - Nocebo refers to adverse events (AEs) related to negative expectations that 
      medical treatment will likely harm instead of heal and can be assessed in 
      placebo-controlled randomized clinical trials (RCTs). We sought to examine the 
      AEs following placebo administration in RCTs for depression (D). After a 
      systematic Medline search for RCTs in depression published in the last decade 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. Data were extracted from 21 RCTs fulfilling search criteria. Of 
      3255 placebo-treated patients, 44.7% (95% CI: 22.3-68.3%) reported at least one 
      AE, and 4.5% (95% CI: 3.4-5.8%) discontinued placebo treatment due to 
      intolerance. AE rates in placebo and active drug treated patients were correlated 
      quantitatively (r=0.915, p<0.001) and qualitatively, but not dropout rates 
      (r=0.047). We conclude that almost one out of 20 placebo treated patients 
      discontinued treatment due to AEs, indicating a significant nocebo in trials for 
      depression treatment adversely affecting adherence and efficacy of current 
      treatments in clinical practice, with additional implications for trial 
      designing.
CI  - (c) 2013 Published by Elsevier Ireland Ltd.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AD  - Neurology Department, Athens Naval Hospital, 77A Vas. Sofias Avenue, 11521 
      Athens, Greece. Electronic address: dmitsikostas@ath.forthnet.gr.
FAU - Mantonakis, Leonidas
AU  - Mantonakis L
AD  - First Psychiatric Department, Aeginition Hospital, Athens University, Athens, 
      Greece.
FAU - Chalarakis, Nikolaos
AU  - Chalarakis N
AD  - First Psychiatric Department, Aeginition Hospital, Athens University, Athens, 
      Greece.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20131025
PL  - Ireland
TA  - Psychiatry Res
JT  - Psychiatry research
JID - 7911385
RN  - 0 (Antidepressive Agents)
SB  - IM
MH  - Antidepressive Agents/*adverse effects
MH  - Depression/*drug therapy
MH  - Depressive Disorder/*drug therapy
MH  - Humans
MH  - *Nocebo Effect
MH  - Randomized Controlled Trials as Topic
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Adverse events
OT  - Clinical trials
OT  - Depression
OT  - Meta-analysis
OT  - Nocebo
EDAT- 2013/11/12 06:00
MHDA- 2014/10/18 06:00
CRDT- 2013/11/12 06:00
PHST- 2013/03/05 00:00 [received]
PHST- 2013/09/14 00:00 [revised]
PHST- 2013/10/20 00:00 [accepted]
PHST- 2013/11/12 06:00 [entrez]
PHST- 2013/11/12 06:00 [pubmed]
PHST- 2014/10/18 06:00 [medline]
AID - S0165-1781(13)00670-7 [pii]
AID - 10.1016/j.psychres.2013.10.019 [doi]
PST - ppublish
SO  - Psychiatry Res. 2014 Jan 30;215(1):82-6. doi: 10.1016/j.psychres.2013.10.019. 
      Epub 2013 Oct 25.