The Lessebo Effect in Disease Modification Trials in Parkinson's Disease.
Mov Disord
; 38(7): 1346-1350, 2023 07.
Article
em En
| MEDLINE
| ID: mdl-37093589
ABSTRACT
BACKGROUND:
The impact of expectation of benefit on outcomes is well established in Parkinson's disease (PD). A reduction of a treatment effect due to a perceived placebo allocation (lessebo effect) in randomized controlled trials (RCTs) was documented for symptomatic treatments.OBJECTIVES:
To evaluate the lessebo effect in disease modification RCTs (DMT) in PD.METHODS:
Subject-level meta-analyses of active treatment arms of DMT (n = 1149 subjects) FS-1, FS-TOO (probability of placebo allocation/P(placebo) = 0.33) and DATATOP, PRECEPT, QE2 (P(placebo) = 0.25). We tested the association between P(placebo) and time to dopaminergic treatment initiation using a marginal Cox proportional hazards model.RESULTS:
The adjusted hazard ratio (P(placebo) = 0.25 vs. 0.33) for initiation of dopaminergic treatment was 1.15 (95% CI 0.92-1.43).CONCLUSIONS:
We did not observe the lessebo effect in DMT. The necessary use of a placebo (and no active comparator) is a limitation. The prospective measurement of expectation of benefit could help to evaluate the many impacts of placebo use. © 2023 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Doença de Parkinson
Tipo de estudo:
Clinical_trials
/
Evaluation_studies
/
Observational_studies
/
Risk_factors_studies
Limite:
Humans
Idioma:
En
Ano de publicação:
2023
Tipo de documento:
Article