Evidence map›Paper›PMID 35120572›Full record

Trial reportBMC psychology2022

Patients' experiences treated with open-label placebo versus double-blind placebo: a mixed methods qualitative study.

Julia W Haas, Giulio Ongaro, Eric Jacobson, Lisa A Conboy, Judy Nee, Johanna Iturrino, Vikram Rangan, Anthony Lembo, Ted J Kaptchuk, Sarah Ballou

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC psychology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 3% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 2 syntheses or guidelines pooled it, 47 citations in OpenAlex.

  1. Pooled it
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  16. Article
  17. Neural underpinnings of open-label placebo effects in emotional distress.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2023
    Article
  18. Placebo: a brief updated review.Naunyn-Schmiedeberg's archives of pharmacology · 2022
    Review
  19. Article
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 3 institutions in 2 countries.

Julia W Haas *Division of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Giulio Ongaro *Program in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.
Eric JacobsonDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Lisa A ConboyDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Judy NeeDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Johanna IturrinoDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Vikram RanganDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Anthony LemboDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA.
Ted J KaptchukProgram in Placebo Studies, Beth Israel Deaconess Medical Center/Harvard Medical School, Boston, MA, USA.
Sarah BallouDivision of Gastroenterology, Beth Israel Deaconess Medical Center/Harvard Medical School, 330 Brookline Ave, Boston, MA, 02215, USA. sballou@bidmc.harvard.edu.
Beth Israel Deaconess Medical Center · USHarvard University · USHarvard Global Health Institute · US

Funding

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
Economic and Social Research Council ES/V009664/1NCCIH NIH HHS R01 AT008573NIH HHS R01AT008573
6 · The paper itself

Abstract

backgroundThere is increasing evidence suggesting that open-label placebo (OLP) is an effective treatment for several medical conditions defined by self-report. However, little is known about patients' experiences with OLP, and no studies have directly compared patients' experiences in double-blind placebo (DBP) conditions.

methodsThis study was nested in a large randomized-controlled trial comparing the effects of OLP and DBP treatments in individuals with irritable bowel syndrome (IBS). We randomly selected 33 participants for interviews concerning their experiences in the parent trial. The data were qualitatively analyzed using an iterative immersion/crystallization approach. We then compared the qualitative interview data to the quantitative IBS severity data assessed during the parent trial, using a mixed methods approach.

resultsTwo prominent interview themes were identified: (1) the participants' feelings about their treatment allocation and (2) their reflections about the treatment. Both OLP and DBP participants mentioned hope and curiosity as major feelings driving them to engage with their treatment. However, while DBP participants tended to be more enthusiastic about their allocation, OLP participants were more ambivalent. Furthermore, OLP participants reflected more on their treatment, often involving noticeable cognitive and emotional processes of self-reflection. They offered a variety of explanations for their symptom improvement and were significantly less likely to attribute it to the treatment itself than DBP participants (Χ

conclusionOLP and DBP participants share feelings of hope, uncertainty and curiosity but differ in the extent of conscious reflection. The counter-intuitive OLP prompts more self-examination, ambivalent feelings and active engagement compared to DBP. At the same time, OLP participants are more reluctant to attribute symptom improvement to their treatment. Our findings substantially add to the emerging picture of factors that distinguish OLP and DBP and their potential mechanisms.

Indexed as

Irritable Bowel SyndromeDouble-Blind MethodHumansRetrospective StudiesTreatment OutcomeIrritable bowel syndromeOpen-label placeboPlacebo effectQualitative research

Identifiers

PMID35120572
PMCPMC8815135
OpenAlexW4210262146

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.