What can be done to control the placebo response in clinical trials? A narrative review.

Expectation measurements Placebo effect Placebo response Randomized controlled trials Training

Journal

Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342

Informations de publication

Date de publication:
08 2021
Historique:
received: 10 03 2021
revised: 30 06 2021
accepted: 01 07 2021
pubmed: 9 7 2021
medline: 25 9 2021
entrez: 8 7 2021
Statut: ppublish

Résumé

The desire to reduce high placebo response rates in clinical trials is a popular concept. However, few studies have rigorously examined the effectiveness of methods to control for placebo responses that are relevant to randomized controlled trials. The primary objective of this review was to evaluate the effect of experimental placebo manipulations in randomized controlled trials (RCTs). We critically reviewed studies designed to manipulate placebo responses including positive expectations regarding the effectiveness of the placebo treatment, manipulating the time spent with subjects, and training study staff and subjects to accurately report symptom severity. These efforts have generally resulted in reduced placebo response and improved discrimination between drug and placebo. Interventions that neutralize staff and subject expectations and improve the ability of subjects to accurately report symptom severity have shown the most promise. Reduction of the placebo response has the potential to accelerate the development of new therapeutics.

Identifiants

pubmed: 34237458
pii: S1551-7144(21)00239-1
doi: 10.1016/j.cct.2021.106503
pmc: PMC8719632
mid: NIHMS1737650
pii:
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

106503

Subventions

Organisme : NCCIH NIH HHS
ID : R01 AT010333
Pays : United States
Organisme : NCCIH NIH HHS
ID : R01 AT011347
Pays : United States
Organisme : NIDCR NIH HHS
ID : R01 DE025946
Pays : United States

Informations de copyright

Copyright © 2021 Elsevier Inc. All rights reserved.

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Auteurs

Kathryn Evans (K)

WCG Analgesic Solutions, Wayland, MA, United States of America. Electronic address: kevans@analgesicsolutions.com.

Luana Colloca (L)

University of Maryland, School of Nursing & School of Medicine, Baltimore, MD, United States of America.

Marta Pecina (M)

University of Pittsburg School of Medicine, Pittsburg, PA, United States of America.

Nathaniel Katz (N)

WCG Analgesic Solutions, Wayland, MA, United States of America; Tufts University School of Medicine, Boston, MA, United States of America.

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