Placebos without deception: a randomized controlled trial in irritable bowel syndrome

Placebos without deception: a randomized controlled trial in irritable bowel syndrome

Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patie...

Full description

Saved in:
Bibliographic Details
Published in:PloS one Vol. 5; no. 12; p. e15591
Main Authors: Kaptchuk, Ted J, Friedlander, Elizabeth, Kelley, John M, Sanchez, M Norma, Kokkotou, Efi, Singer, Joyce P, Kowalczykowski, Magda, Miller, Franklin G, Kirsch, Irving, Lembo, Anthony J
Format: Journal Article
Language:English
Published: United States Public Library of Science 22-12-2010
Public Library of Science (PLoS)
Subjects:
Adult
Archives & records
Attention Deficit Hyperactivity Disorder
Care and treatment
Child care
Clinical medicine
Clinical trials
Constipation
Control methods
Deception
Ethics
Female
History of medicine
Humans
Informed consent
Intestine
Irritable bowel syndrome
Irritable Bowel Syndrome - drug therapy
Male
Medical personnel
Medical schools
Medicine
Middle Aged
Patient Satisfaction
Patients
Physicians
Pills
Placebo effect
Placebos
Qualitative research
Quality of life
Randomization
Sugar
Time Factors
Treatment Outcome
Womens health
United States > US
Massachusetts
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:Placebo treatment can significantly influence subjective symptoms. However, it is widely believed that response to placebo requires concealment or deception. We tested whether open-label placebo (non-deceptive and non-concealed administration) is superior to a no-treatment control with matched patient-provider interactions in the treatment of irritable bowel syndrome (IBS). Two-group, randomized, controlled three week trial (August 2009-April 2010) conducted at a single academic center, involving 80 primarily female (70%) patients, mean age 47 ± 18 with IBS diagnosed by Rome III criteria and with a score ≥ 150 on the IBS Symptom Severity Scale (IBS-SSS). Patients were randomized to either open-label placebo pills presented as "placebo pills made of an inert substance, like sugar pills, that have been shown in clinical studies to produce significant improvement in IBS symptoms through mind-body self-healing processes" or no-treatment controls with the same quality of interaction with providers. The primary outcome was IBS Global Improvement Scale (IBS-GIS). Secondary measures were IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR) and IBS Quality of Life (IBS-QoL). Open-label placebo produced significantly higher mean (±SD) global improvement scores (IBS-GIS) at both 11-day midpoint (5.2 ± 1.0 vs. 4.0 ± 1.1, p<.001) and at 21-day endpoint (5.0 ± 1.5 vs. 3.9 ± 1.3, p = .002). Significant results were also observed at both time points for reduced symptom severity (IBS-SSS, p = .008 and p = .03) and adequate relief (IBS-AR, p = .02 and p = .03); and a trend favoring open-label placebo was observed for quality of life (IBS-QoL) at the 21-day endpoint (p = .08). Placebos administered without deception may be an effective treatment for IBS. Further research is warranted in IBS, and perhaps other conditions, to elucidate whether physicians can benefit patients using placebos consistent with informed consent. ClinicalTrials.gov NCT01010191.
Bibliography:Conceived and designed the experiments: TJK JMK EK FGM IK AJL. Performed the experiments: AJL EF JMK MNS JPS MK. Analyzed the data: JMK AJL IK TJK MK JPS. Wrote the paper: TJK AJL JMK FGM IK EK.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0015591