Open-label placebo vs double-blind placebo for irritable bowel syndrome: a randomized clinical trial.
Journal
Pain
ISSN: 1872-6623
Titre abrégé: Pain
Pays: United States
ID NLM: 7508686
Informations de publication
Date de publication:
01 09 2021
01 09 2021
Historique:
received:
25
11
2020
accepted:
02
02
2021
pubmed:
20
2
2021
medline:
14
9
2021
entrez:
19
2
2021
Statut:
ppublish
Résumé
It is commonly believed that blinding to treatment assignment is necessary for placebos to have an effect. However, placebos administered without concealment (ie, open-label placebos [OLPs]) have recently been shown to be effective in some conditions. This study had 2 objectives: first, to determine whether OLP treatment is superior to no-pill control (NPC) in irritable bowel syndrome (IBS) and, second, to compare the efficacy of OLP against double-blind placebo (DBP). In a 6-week, 3-arm, randomized clinical trial, participants were randomized in equal proportions to 3 arms: OLP, DBP, or NPC. Two hundred sixty-two adults (72.9% women), with a mean age of 42.0 (SD = 18.1) years, participated in the primary study. The mean improvement on the IBS Severity Scoring System from baseline to the 6-week end point was significantly greater in OLP compared with that in NPC (90.6 vs 52.3, P = 0.038). Open-label placebo and DBP did not differ significantly on IBS Severity Scoring System improvement (100.3 vs 90.6, P = 0.485). Standardized effect sizes were moderate for OLP vs NPC (d = 0.43) and small for OLP vs DBP (d = 0.10). Participants treated with OLP reported clinically meaningful improvements in IBS symptoms that were significantly greater than those on NPC. Open-label placebo and DBP had similar effects that did not differ significantly, suggesting that blinding may not be necessary for placebos to be effective and that OLP could play a role in the management of patients with refractory IBS.
Identifiants
pubmed: 33605656
doi: 10.1097/j.pain.0000000000002234
pii: 00006396-202109000-00013
pmc: PMC8357842
mid: NIHMS1672741
doi:
Banques de données
ClinicalTrials.gov
['NCT02802241']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
2428-2435Subventions
Organisme : NCCIH NIH HHS
ID : R01 AT008573
Pays : United States
Organisme : NCCIH NIH HHS
ID : T32 AT000051
Pays : United States
Informations de copyright
Copyright © 2021 International Association for the Study of Pain.
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