Evidence map›Paper›PMID 25304129›Full record

Trial reportBMC gastroenterology2014

Symptom profile in partial responders to a proton pump inhibitor compared with treatment-naïve patients with gastroesophageal reflux disease: a post hoc analysis of two study populations.

Nimish Vakil, Anna Niklasson, Hans Denison, Anna Rydén

2 registry-linked trialsOpen access · goldAbstract readClinical Trial
In one paragraph

Trial report in BMC gastroenterology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
0.4field-weighted citation impact, top 34% 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.

NCT00291746 phase4completednot on this map

A Single-Blind Single Arm Study to Validate the Reflux Disease Questionnaire (RDQ) for the Diagnosis of Reflux Disease in Primary Care in Patients Treated With Esomeprazole 40 mg o.d.

TypeinterventionalSponsorAstraZenecaRan2005 to 2006Enrolled350ConditionsGastroesophageal RefluxArmsEsomeprazole, Bravo technique
NCT00703534 phase2completednot on this map

Validation of Patient-reported Outcomes Measures for the Assessment of GERD Symptoms and Their Subsequent Impact on Patients With Partial Response to Proton Pump Inhibitor (PPI) Treatment in a Two Part Multi-center Phase IIa Study Including a Four Week Randomised, Double-blind, Placebo-controlled, Parallel-group Treatment Period

TypeinterventionalSponsorAstraZenecaRan2008 to 2009Enrolled478ConditionsGERD, Acid Reflux Disease, Heartburn, RegurgitationArmsAZD3355, Placebo, Gelusil®
3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Proton Pump Inhibitor-Refractory Gastroesophageal Reflux Disease.The Medical clinics of North America · 2019
    Review
  3. Review
  4. Review
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

4 authors at 1 institution in 1 country.

Nimish VakilUniversity of Wisconsin School of Medicine and Public Health, Aurora Summit Hospital, 36500 Aurora Drive, Summit WI 53066, USA. nvakil@wisc.edu.
Anna Niklasson
Hans Denison
Anna Rydén
AstraZeneca (Sweden) · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundPartial response to proton pump inhibitor (PPI) therapy poses a healthcare challenge. This study aimed to compare symptom profiles in partial PPI responders and treatment-naïve patients with gastroesophageal reflux disease (GERD).

methodsA post hoc analysis of data from two studies was performed. Partial PPI responders with GERD (n = 580; NCT00703534) had frequent (≥ 3 days/week) heartburn and/or regurgitation despite PPI therapy; patients with no improvement were excluded. Treatment-naïve patients with GERD (diagnosed by endoscopy and pH-metry; n = 203; NCT00291746) had frequent (≥ 3 days/week) upper gastrointestinal symptoms. The Gastrointestinal Symptom Rating Scale (GSRS) was completed by all patients at study entry and by treatment-naïve patients after PPI therapy.

resultsThe highest (mean [95% confidence interval]) discomfort scores were reported in the Reflux (heartburn, regurgitation), Indigestion, and Abdominal pain domains of the GSRS, both in partial PPI responders (4.3 [4.2-4.4], 3.7 [3.6-3.8], and 3.4 [3.3-3.5], respectively) and in treatment-naïve patients (3.5 [3.3-3.7], 3.6 [3.4-3.7], and 3.1 [3.0-3.3], respectively). Partial PPI responders reported more discomfort than treatment-naïve patients in the Reflux, Abdominal pain, and Constipation domains (4.3 [4.2-4.4] vs. 3.5 [3.3-3.7], 3.4 [3.3-3.5] vs. 3.1 [3.0-3.3], and 2.5 [2.4-2.6] vs. 2.1 [1.9-2.2], respectively). All GSRS domain scores improved in treatment-naïve patients following PPI therapy.

conclusionsSymptom patterns in partial PPI responders were similar to those in treatment-naïve patients with GERD, but partial PPI responders experienced more severe reflux, abdominal pain, and constipation than did treatment-naïve patients.

Indexed as

Abdominal PainAdultAgedConstipationDiarrheaDyspepsiaFemaleGastroesophageal RefluxHeartburnHumansMaleMiddle AgedProton Pump InhibitorsTreatment OutcomeProton Pump Inhibitors

Identifiers

PMID25304129
PMCPMC4287106
OpenAlexW2034534797

What OpenQuestion holds

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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.