PMID- 31103487
OWN - NLM
STAT- MEDLINE
DCOM- 20200626
LR  - 20200626
IS  - 1873-5126 (Electronic)
IS  - 1353-8020 (Linking)
VI  - 65
DP  - 2019 Aug
TI  - Nocebo response in Parkinson's disease: A systematic review and meta-analysis.
PG  - 13-19
LID - S1353-8020(19)30210-X [pii]
LID - 10.1016/j.parkreldis.2019.04.015 [doi]
AB  - OBJECTIVE: To estimate the magnitude of the nocebo response in Parkinson's 
      disease and explore possible associations with study characteristics. METHODS: 
      Databases were searched up to February 2017. Placebo-controlled, parallel-group 
      randomized controlled trials investigating pharmacological interventions in 
      people with Parkinson's disease were included. Data were derived from the last 
      measured within-group response in the placebo and intervention arms of randomized 
      controlled trials, after independent extraction. A random-effects model was used 
      to pool study data. The main outcome was the nocebo response, measured as the 
      proportion of placebo-treated participants experiencing any adverse events (AEs). 
      We also measured the proportion of patients with serious AEs (SAEs), and the 
      rates of study dropouts (including due to AEs) and death. PROSPERO registration 
      number is CRD42017070471. RESULTS: We included 236 randomized controlled trials, 
      with a combined population of 17,381 participants allocated to placebo. The 
      nocebo response was 56.0% (95% CI, 51.7%-60.4%; 148 trials; I(2) = 98%). SAEs 
      were reported in 4.0% (95% CI, 3.4%-4.6%, 157 trials; I(2) = 73%) of 
      placebo-treated patients, dropouts in 14.0% (95% CI, 12.5%-15.5%, 225 trials; 
      I(2) = 91%), dropouts due to AEs in 5.7% (95% CI, 5.1%-6.4%, 219 trials; 
      I(2) = 73%). Deaths occurred in 0.6% (95% CI, 0.5%-0.7%, 227 trials; I(2) = 0%). 
      Similar proportions were identified in patients in intervention arms. 
      CONCLUSIONS: The magnitude of the nocebo response in parallel-designed randomized 
      controlled trials in Parkinson's disease is substantial and should be considered 
      in the interpretation of safety results and in the design and interpretation of 
      future clinical trials.
CI  - Copyright (c) 2019 Elsevier Ltd. All rights reserved.
FAU - Leal Rato, Miguel
AU  - Leal Rato M
AD  - Neurology, Department of Neurosciencies and Mental Health, Hospital de Santa 
      Maria, Centro Hospitalar Universitario Lisboa Norte, Lisbon, Portugal. Electronic 
      address: mlealrato@gmail.com.
FAU - Duarte, Goncalo S
AU  - Duarte GS
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, 
      Lisbon, Portugal. Electronic address: gduarte@campus.ul.pt.
FAU - Ferreira, Afonso N
AU  - Ferreira AN
AD  - Cardiology Department, Hospital Santa Maria, CHULN, Lisbon Academic Medical 
      Centre, Portugal; Centro Cardiovascular da Universidade de Lisboa, Faculdade de 
      Medicina, Lisbon, Portugal. Electronic address: afonsonunesferreira@gmail.com.
FAU - Alves, Mariana
AU  - Alves M
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, 
      Lisbon, Portugal; Servico de Medicina III, Hospital Pulido Valente, CHULN, 
      Lisbon, Portugal. Electronic address: marianaalves88@gmail.com.
FAU - Mainoli, Beatrice
AU  - Mainoli B
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, 
      Lisbon, Portugal. Electronic address: beatrice.mainoli@gmail.com.
FAU - Teodoro, Tiago
AU  - Teodoro T
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; St George's University of London, St 
      George's University Hospitals NHS Foundation Trust, London, United Kingdom. 
      Electronic address: tiagoteodoro@gmail.com.
FAU - Mestre, Tiago A
AU  - Mestre TA
AD  - Parkinson's Disease and Movement Disorders Center, Division of Neurology, 
      Department of Medicine, The Ottawa Hospital Research Institute, University of 
      Ottawa Brain and Mind Institute, Ottawa, Ontario, Canada. Electronic address: 
      tmestre@gmail.com.
FAU - Costa, Joao
AU  - Costa J
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, 
      Lisbon, Portugal. Electronic address: jncosta@medicina.ulisboa.pt.
FAU - Ferreira, Joaquim J
AU  - Ferreira JJ
AD  - Laboratory of Clinical Pharmacology and Therapeutics, Faculdade de Medicina, 
      Universidade de Lisboa, Lisbon, Portugal; Instituto de Medicina Molecular, 
      Lisbon, Portugal; CNS - Campus Neurologico Senior, Torres Vedras, Portugal. 
      Electronic address: jferreira@medicina.ulisboa.pt.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20190420
PL  - England
TA  - Parkinsonism Relat Disord
JT  - Parkinsonism & related disorders
JID - 9513583
SB  - IM
MH  - Humans
MH  - *Nocebo Effect
MH  - Parkinson Disease/diagnosis/*epidemiology/*therapy
MH  - Randomized Controlled Trials as Topic/*methods
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical trials
OT  - Meta-analysis
OT  - Nocebo
OT  - Parkinson's disease
OT  - Placebo
OT  - Systematic review
EDAT- 2019/05/20 06:00
MHDA- 2020/06/27 06:00
CRDT- 2019/05/20 06:00
PHST- 2018/11/22 00:00 [received]
PHST- 2019/02/23 00:00 [revised]
PHST- 2019/04/19 00:00 [accepted]
PHST- 2019/05/20 06:00 [pubmed]
PHST- 2020/06/27 06:00 [medline]
PHST- 2019/05/20 06:00 [entrez]
AID - S1353-8020(19)30210-X [pii]
AID - 10.1016/j.parkreldis.2019.04.015 [doi]
PST - ppublish
SO  - Parkinsonism Relat Disord. 2019 Aug;65:13-19. doi: 
      10.1016/j.parkreldis.2019.04.015. Epub 2019 Apr 20.