Evidence map›Paper›PMID 21203519›Full record

Trial reportPloS one2010

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

Ted J Kaptchuk, Elizabeth Friedlander, John M Kelley, M Norma Sanchez, Efi Kokkotou, Joyce P Singer, Magda Kowalczykowski, Franklin G Miller, Irving Kirsch, Anthony J Lembo

7 registry-linked trialsOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 7 registered trials, which are not on this map. Cited by 308 papers, 14 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
308citing papers in PubMed, 14 pooled it
24.9field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01010191 nacompletednot on this map

Pilot Randomized Controlled Trial

TypeinterventionalSponsorHarvard University Faculty of MedicineRan2008 to 2010Enrolled70ConditionsIrritable Bowel SyndromeArmsSugar pill
NCT02522988 nacompletednot on this mapstarted 2015, after this paper: background citation

The Use of an Open Label Placebo to Treat Cancer Related Fatigue in Cancer Survivors

TypeinterventionalSponsorUniversity of Alabama at BirminghamRan2015 to 2021Enrolled74ConditionsFatigueArmsOpen-label placebo intervention
NCT03294148 nacompletednot on this mapstarted 2017, after this paper: background citation

Mind-body Treatments for Chronic Back Pain

TypeinterventionalSponsorUniversity of Colorado, BoulderRan2017 to 2019Enrolled151ConditionsChronic Pain, Back Pain Lower Back Chronic, Back Pain, LowArmsOpen-Label Placebo Treatment for Chronic Back Pain, Psychotherapy Treatment for Chronic Back Pain
NCT03547661 nacompletednot on this mapstarted 2018, after this paper: background citation

Open-Label Placebo Treatment of Women With Premenstrual Syndrome: A Randomized Controlled Trial

TypeinterventionalSponsorJens GaabRan2018 to 2021Enrolled150ConditionsPremenstrual SyndromeArmsP-Dragees rosa Lichtenstein
NCT03934138 naunknown statusnot on this mapstarted 2019, after this paper: background citation

Does the Subject's Understanding of Underlying Placebo Mechanisms Compensate for the Loss of Efficacy Associated With the Disclosure of the Use of a Placebo

TypeinterventionalSponsorLaboratoire TIMC-IMAGRan2019 to 2020Enrolled126ConditionsAcute PainArmsEducational movie on placebo mechanisms, Informative movie on hand washing
NCT05351333 naactive not recruitingnot on this mapstarted 2022, after this paper: background citation

Conditioning & Open-Label Placebo (COLP) for Opioid Management in Intensive Inpatient Rehabilitation

TypeinterventionalSponsorSpaulding Rehabilitation HospitalRan2022 to 2026Enrolled66ConditionsSpinal Cord Injuries, Polytrauma, BurnsArmsplacebo
NCT06350786 narecruitingnot on this mapstarted 2024, after this paper: background citation

Conditioned Open-label Placebos to Facilitate Opioid Reduction in Patients With Subacute or Chronic Pain Pain: a Randomized Controlled Trial

TypeinterventionalSponsorCosima LocherRan2024 to 2026Enrolled86ConditionsChronic Pain, Subacute PainArmsP-Dragees blue Lichtenstein, Placebo dragees, Control group (EM)
3 · Its place in the literature

Who cites it

308 citing papers in PubMed, 14 syntheses or guidelines pooled it, 904 citations in OpenAlex.

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248 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 5 institutions in 2 countries.

Ted J KaptchukBeth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, United States of America.
Elizabeth Friedlander
John M Kelley
M Norma Sanchez
Efi Kokkotou
Joyce P Singer
Magda Kowalczykowski
Franklin G Miller
Irving Kirsch
Anthony J Lembo
Harvard University · USBeth Israel Deaconess Medical Center · USMassachusetts General Hospital · USNational Institutes of Health · USUniversity of Hull · GB

Funding

Omics and Variable Responses to Placebo and Acupuncture in Irritable Bowel SyndroR01AT004662 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KAPTCHUK, TED, KOKKOTOU, EFI G. · 2009 to 2013
$2.3M
SHAM DEVICE, PILL PLACEBO OR TREATMENT FOR ARM PAINR01AT000402 · NCCIH · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI KAPTCHUK, TED J · 2000 to 2003
$1.6M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
NCCIH NIH HHS K24 AT004095NCCIH NIH HHS R01 AT00402-01NCCIH NIH HHS R01 AT004662NCCIH NIH HHS R01AT004662
6 · The paper itself

Abstract

backgroundPlacebo 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).

methodsTwo-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).

findingsOpen-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).

conclusionPlacebos 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.

trial registrationClinicalTrials.gov NCT01010191.

Indexed as

PlacebosAdultDeceptionFemaleHumansIrritable Bowel SyndromeMaleMiddle AgedPatient SatisfactionTime FactorsTreatment OutcomePlacebos

Identifiers

PMID21203519
PMCPMC3008733
OpenAlexW2105330971

What OpenQuestion holds

Textmetadata
LicenceCC0
Read underepoch 390

Registered trials

and 1 more above

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.