Evidence map›Paper›PMID 26422466›Full record

Trial reportPloS one2015

Patient-Provider Interactions Affect Symptoms in Gastroesophageal Reflux Disease: A Pilot Randomized, Double-Blind, Placebo-Controlled Trial.

Michelle L Dossett, Lin Mu, Roger B Davis, Iris R Bell, Anthony J Lembo, Ted J Kaptchuk, Gloria Y Yeh

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

Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01915173 (Response to Supplement and Placebo in GERD), which is not on this map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
9.3field-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.

NCT01915173 nacompletednot on this map

Response to Supplement and Placebo in GERD

TypeinterventionalSponsorBeth Israel Deaconess Medical CenterRan2013 to 2014Enrolled24ConditionsGastroesophageal Reflux Disease (GERD), Heartburn, DyspepsiaArmsSupplement, Placebo, Expanded Interview, Standard Interview
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Review
  6. Article
  7. Article
  8. Article
  9. Article
  10. Placebo Effects in Traumatic Brain Injury.Journal of neurotrauma · 2018
    Review
  11. The Role of Social and Interpersonal Factors in Placebo Analgesia.International review of neurobiology · 2018
    Review
  12. Homeopathy Use by US Adults: Results of a National Survey.American journal of public health · 2016
    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

7 authors at 3 institutions in 1 country.

Michelle L DossettDepartment of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Lin MuDepartment of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America; Clinical Research Center, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Roger B DavisDepartment of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America; Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, Massachusetts, United States of America.
Iris R BellDepartment of Family and Community Medicine, The University of Arizona College of Medicine, Tucson, Arizona, United States of America.
Anthony J LemboDepartment of Medicine, Division of Gastroenterology, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Ted J KaptchukDepartment of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America; Program in Placebo Studies, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America.
Gloria Y YehDepartment of Medicine, Division of General Medicine and Primary Care, Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States of America.
Beth Israel Deaconess Medical Center · USHarvard University · USUniversity of Arizona · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
Research Training in Complementary and Integrative MedicineT32AT000051 · NCCIH · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI GLORIA Y YEH · 1999 to 2026
$10.2M
Mentoring and Research in Placebo Studies, Asian Medicine, and CAMK24AT004095 · NCCIH · HARVARD MEDICAL SCHOOL · PI KAPTCHUK, TED · 2007 to 2016
$1.4M
NCATS NIH HHS 1UL1 TR001102-01NCATS NIH HHS UL1 TR001102NCCIH NIH HHS K24 AT004095NCCIH NIH HHS T32 AT000051
6 · The paper itself

Abstract

backgroundIt is unclear whether the benefits that some patients derive from complementary and integrative medicine (CIM) are related to the therapies recommended or to the consultation process as some CIM provider visits are more involved than conventional medical visits. Many patients with gastrointestinal conditions seek out CIM therapies, and prior work has demonstrated that the quality of the patient-provider interaction can improve health outcomes in irritable bowel syndrome, however, the impact of this interaction on gastroesophageal reflux disease (GERD) is unknown. We aimed to assess the safety and feasibility of conducting a 2 x 2 factorial design study preliminarily exploring the impact of the patient-provider interaction, and the effect of an over-the-counter homeopathic product, Acidil, on symptoms and health-related quality of life in subjects with GERD.

methods24 subjects with GERD-related symptoms were randomized in a 2 x 2 factorial design to receive 1) either a standard visit based on an empathic conventional primary care evaluation or an expanded visit with questions modeled after a CIM consultation and 2) either Acidil or placebo for two weeks. Subjects completed a daily GERD symptom diary and additional measures of symptom severity and health-related quality of life.

resultsThere was no significant difference in GERD symptom severity between the Acidil and placebo groups from baseline to follow-up (p = 0.41), however, subjects who received the expanded visit were significantly more likely to report a 50% or greater improvement in symptom severity compared to subjects who received the standard visit (p = 0.01). Total consultation length, perceived empathy, and baseline beliefs in CIM were not associated with treatment outcomes.

conclusionAn expanded patient-provider visit resulted in greater GERD symptom improvement than a standard empathic medical visit. CIM consultations may have enhanced placebo effects, and further studies to assess the active components of this visit-based intervention are warranted.

trial registrationClinicalTrials.gov NCT01915173.

Indexed as

AdolescentAdultAgedAged, 80 and overAntacidsComplementary TherapiesFemaleFollow-Up StudiesGastroesophageal RefluxHistamine H2 AntagonistsHumansMaleMiddle AgedProton Pump InhibitorsSeverity of Illness IndexTreatment OutcomeAntacidsHistamine H2 AntagonistsProton Pump Inhibitors

Identifiers

PMID26422466
PMCPMC4589338
OpenAlexW1913401155

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.