PMID- 31156432
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20201001
IS  - 1663-9812 (Print)
IS  - 1663-9812 (Electronic)
IS  - 1663-9812 (Linking)
VI  - 10
DP  - 2019
TI  - Are Patients With Schizophrenia Spectrum Disorders More Prone to Manifest 
      Nocebo-Like-Effects? A Meta-Analysis of Adverse Events in Placebo Groups of 
      Double-Blind Antipsychotic Trials.
PG  - 502
LID - 10.3389/fphar.2019.00502 [doi]
LID - 502
AB  - Background: Antipsychotic clinical trials use to present adverse events (AEs) for 
      the drug under evaluation to treat schizophrenia. Interestingly, patients who 
      receive the placebo during antipsychotic trials often report several AEs, but 
      little is known about the essence of these negative effects in patients with 
      schizophrenia spectrum disorders (SCD). In the present meta-analysis, we 
      evaluated the relationship between the level of psychiatric symptomatology 
      expressed as Positive and Negative Syndrome Scale (PANSS) scores and the rates of 
      AEs reported in the placebo arms of double-blind clinical trials, for commonly 
      prescribed atypical antipsychotic medications. Methods: We selected 58 clinical 
      trials describing AEs in SCD placebo groups, which compared atypical 
      antipsychotic medications with placebo. A total of 6,301 placebo-treated patients 
      were considered. AE profiles of the class were clusterized using MedDRA 
      classification and analysed using a meta-regression approach. Results: In the 
      placebo arms the proportions of patients with any AE was 66.3% (95% CI: 
      62.7-69.8%). The proportion of withdrawal of patients treated with placebo 
      because of AEs was 7.2% (95% CI: 5.9-8.4%). Interestingly, the AEs in the placebo 
      arms corresponded to those of the antipsychotic-atypical-medication-class against 
      which the placebo was compared. Namely, using meta-regression analysis we found 
      an association between the level of psychiatric symptomatology measured with 
      PANSS scores and higher AEs reported as nervous system (p = 0.020) and 
      gastrintestinal disorders (p = 0.004). Moreover, the level of a higher 
      psychiatric symptomatology expressed with PANSS scores was also related with 
      higher AEs associated with psychiatric symptoms (p = 0.017). Conclusion: These 
      findings emphasise that the AEs in placebo arms of clinical trials of 
      antipsychotic medications were substantial. Importantly, a higher level of 
      psychiatric symptomatology makes SCD patients more prone to express AEs, thus 
      contributing to possible drop-outs and to a lower adherence to treatments. These 
      results are consistent with the expectation theory of placebo and nocebo effects.
FAU - Palermo, Sara
AU  - Palermo S
AD  - Department of Psychology, University of Turin, Turin, Italy.
AD  - European Innovation Partnership on Active and Healthy Ageing, Brussels, Belgium.
FAU - Giovannelli, Fabio
AU  - Giovannelli F
AD  - Section of Psychology, Department of Neuroscience, Psychology, Drug Research, 
      Child Health, University of Florence, Florence, Italy.
FAU - Bartoli, Massimo
AU  - Bartoli M
AD  - Department of Psychology, University of Turin, Turin, Italy.
FAU - Amanzio, Martina
AU  - Amanzio M
AD  - Department of Psychology, University of Turin, Turin, Italy.
AD  - European Innovation Partnership on Active and Healthy Ageing, Brussels, Belgium.
LA  - eng
PT  - Systematic Review
DEP - 20190517
PL  - Switzerland
TA  - Front Pharmacol
JT  - Frontiers in pharmacology
JID - 101548923
PMC - PMC6533921
OTO - NOTNLM
OT  - adverse events
OT  - atypical antipsychotic drugs
OT  - expectation theory
OT  - nocebo effects
OT  - placebo
OT  - randomized clinical trials
OT  - schizophrenia
EDAT- 2019/06/04 06:00
MHDA- 2019/06/04 06:01
PMCR- 2019/05/17
CRDT- 2019/06/04 06:00
PHST- 2019/01/15 00:00 [received]
PHST- 2019/04/23 00:00 [accepted]
PHST- 2019/06/04 06:00 [entrez]
PHST- 2019/06/04 06:00 [pubmed]
PHST- 2019/06/04 06:01 [medline]
PHST- 2019/05/17 00:00 [pmc-release]
AID - 10.3389/fphar.2019.00502 [doi]
PST - epublish
SO  - Front Pharmacol. 2019 May 17;10:502. doi: 10.3389/fphar.2019.00502. eCollection 
      2019.