Evidence map›Paper›PMID 28545508›Full record

Trial reportTrials2017

Open-label versus double-blind placebo treatment in irritable bowel syndrome: study protocol for a randomized controlled trial.

Sarah Ballou, Ted J Kaptchuk, William Hirsch, Judy Nee, Johanna Iturrino, Kathryn T Hall, John M Kelley, Vivian Cheng, Irving Kirsch, Eric Jacobson and 3 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02802241 (Effects of Open-label vs Double-blind Treatment in IBS.), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 8% 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.

NCT02802241 nacompletednot on this map

Effects of Open-label vs Double-blind Treatment in IBS.

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2016 to 2019Enrolled340ConditionsIrritable Bowel Syndrome, Placebo Effect, Placebos, Peppermint OilArmsplacebo, peppermint oil
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 57 citations in OpenAlex.

  1. Pooled it
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  6. Are They Side Effects? Extraintestinal Symptoms Reported During Clinical Trials of Irritable Bowel Syndrome May Be More Severe at Baseline.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Trial
  7. Effect of a Short-Term Intervention withInternational journal of environmental research and public health · 2022
    Trial
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  12. Article
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  17. Synergistic Effect ofNutrients · 2023
    Article
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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

13 authors at 3 institutions in 1 country.

Sarah BallouDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA. sballou@bidmc.harvard.edu.ORCID 0000-0002-6746-1958
Ted J KaptchukProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
William HirschDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Judy NeeDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Johanna IturrinoDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Kathryn T HallProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
John M KelleyProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
Vivian ChengDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Irving KirschProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
Eric JacobsonDepartment of Global Health and Social Medicine Harvard Medical School, 641 Huntington Avenue, Boston, MA, 02115, USA.
Lisa ConboyProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
Anthony LemboDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, 330 Brookline Avenue, Boston, MA, 02215, USA.
Roger B DavisProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Avenue, Boston, MA, 02215, USA.
Beth Israel Deaconess Medical Center · USBrigham and Women's Hospital · USHarvard University · US

Funding

RESEARCH TRAINING IN GASTROENTEROLOGYT32DK007760 · NIDDK · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KELLY, CIARAN P · 1999 to 2019
$4.6M
Efficacy of Open-Label Placebo, Double-Blind Placebo, and Peppermint Oil in IBSR01AT008573 · NCCIH · BETH ISRAEL DEACONESS MEDICAL CENTER · PI KAPTCHUK, TED, LEMBO, ANTHONY J · 2015 to 2019
$4.3M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
Epidemiological, pharmacogenomic and clinical impact of catechol-O-methyltransferase on cardiovascular diseaseK01HL130625 · NHLBI · BRIGHAM AND WOMEN'S HOSPITAL · PI HALL, KATHRYN TAYO · 2016 to 2021
$921k
NCCIH NIH HHS K24 AT004095NCCIH NIH HHS R01 AT008573NHLBI NIH HHS K01 HL130625NIDDK NIH HHS T32 DK007760
6 · The paper itself

Abstract

backgroundPlacebo medications, by definition, are composed of inactive ingredients that have no physiological effect on symptoms. Nonetheless, administration of placebo in randomized controlled trials (RCTs) and in clinical settings has been demonstrated to have significant impact on many physical and psychological complaints. Until recently, conventional wisdom has suggested that patients must believe that placebo pills actually contain (or, at least, might possibly contain) active medication in order to elicit a response to placebo. However, several recent RCTs, including patients with irritable bowel syndrome (IBS), chronic low back pain, and episodic migraine, have demonstrated that individuals receiving open-label placebo (OLP) can still experience symptomatic improvement and benefit from honestly described placebo treatment. METHODS AND

designThis paper describes an innovative multidisciplinary trial design (n = 280) that attempts to replicate and expand upon an earlier IBS OLP study. The current study will compare OLP to double-blind placebo (DBP) administration which is made possible by including a nested, double-blind RCT comparing DBP and peppermint oil. The study also examines possible genetic and psychological predictors of OLP and seeks to better understand participants' experiences with OLP and DBP through a series of extensive interviews with a randomly selected subgroup. DISCUSSION: OLP treatment is a novel strategy for ethically harnessing placebo effects. It has potential to re-frame theories of placebo and to influence how physicians can optimize watch-and-wait strategies for common, subjective symptoms. The current study aims to dramatically expand what we know about OLP by comparing, for the first time, OLP and DBP administration. Adopting a unique, multidisciplinary approach, the study also explores genetic, psychological and experiential dimensions of OLP. The paper ends with an extensive discussion of the "culture" of the trial as well as potential mechanisms of OLP and ethical implications.

trial registrationClinicalTrials.gov, identifier: NCT02802241 . Registered on 14 June 2016.

Indexed as

Placebo EffectClinical ProtocolsDouble-Blind MethodGastrointestinal AgentsHumansInterviews as TopicIrritable Bowel SyndromeMentha piperitaPlant OilsResearch DesignTime FactorsTreatment OutcomeGastrointestinal Agentspeppermint oilPlant OilsIrritable bowel syndromeMulti-disciplinary modelsOpen-label placeboPeppermint oilPlacebo effectsResearch methods

Identifiers

PMID28545508
PMCPMC5445390
OpenAlexW2620212921

What OpenQuestion holds

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Registered trials

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.