Evidence map›Paper›PMID 27080034›Full record

Trial reportBMC gastroenterology2016

Randomized, multicenter study: on-demand versus continuous maintenance treatment with esomeprazole in patients with non-erosive gastroesophageal reflux disease.

Ekkehard Bayerdörffer, Marc-Andre Bigard, Werner Weiss, Fermín Mearin, Luis Rodrigo, Juan Enrique Dominguez Muñoz, Hennie Grundling, Tore Persson, Lars-Erik Svedberg, Nanna Keeling and 1 more

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

Trial report in BMC gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02670642 (On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
2.3field-weighted citation impact, top 12% 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.

NCT02670642 phase3completednot on this map

On Demand vs Continuous Treatment of Endoscopy Negative Subjects With Gastroesophageal Reflux Disease (GERD) With Esomeprazole 20-mg Once Daily Over a 6 Months Long Term Treatment Phase. An Open, Randomised, Multicenter Study. NEED.

TypeinterventionalSponsorAstraZenecaRan2001 to 2002Enrolled877ConditionsGastroesophageal RefluxArmsEsomeprazole
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 36 citations in OpenAlex.

  1. Guideline
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Article
  8. [Drug Therapy for Gastroesophageal Reflux Disease].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025
    Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Article
  17. Review
  18. Review
  19. Problems Associated with Deprescribing of Proton Pump Inhibitors.International journal of molecular sciences · 2019
    Review
  20. Efficacy of on-demand therapy using 20-mg vonoprazan for non-erosive reflux disease.Esophagus : official journal of the Japan Esophageal Society · 2019
    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

11 authors at 6 institutions in 4 countries.

Ekkehard BayerdörfferDepartment of Internal Medicine, Lohr Health Centre, Lohr, Germany. bayerdoerffer@gmx.de.
Marc-Andre BigardGastroenterology Unit, University Hospital, Vandoeuvre les Nancy, France.
Werner Weiss4th Medical Department, Hospital Rudolfstiftung, Vienna, Austria.
Fermín MearinGastroenterology Service, Centro Médico Teknon, Barcelona, Spain.
Luis RodrigoGastroenterology Service, Hospital Central de Asturias, Oviedo, Spain.
Juan Enrique Dominguez MuñozDepartment of Gastroenterology, University Hospital, Santiago de Compostela, Spain.
Hennie GrundlingDepartment of Internal Medicine, Universitas Hospital, Bloemfontein, South Africa.
Tore PerssonAstraZeneca R&D, Gothenburg, Sweden.
Lars-Erik SvedbergAstraZeneca R&D, Gothenburg, Sweden.
Nanna KeelingAstraZeneca R&D, Gothenburg, Sweden.
Stefan EklundAstraZeneca R&D, Gothenburg, Sweden.
AstraZeneca (Sweden) · SEDélégation Centre-Est · FRHospital Quirón Teknon · ESHospital Universitario Central de Asturias · ESRudolfinerhaus Hospital · ATUniversidade de Santiago de Compostela · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundMost patients with gastroesophageal reflux disease experience symptomatic relapse after stopping acid-suppressive medication. The aim of this study was to compare willingness to continue treatment with esomeprazole on-demand versus continuous maintenance therapy for symptom control in patients with non-erosive reflux disease (NERD) after 6 months.

methodsThis multicenter, open-label, randomized, parallel-group study enrolled adults with NERD who were heartburn-free after 4 weeks' treatment with esomeprazole 20 mg daily. Patients received esomeprazole 20 mg daily continuously or on-demand for 6 months. The primary variable was discontinuation due to unsatisfactory treatment. On-demand treatment was considered non-inferior if the upper limit of the one-sided 95 % confidence interval (CI) for the difference between treatments was <10 %.

resultsOf 877 patients enrolled, 598 were randomized to maintenance treatment (continuous: n = 297; on-demand: n = 301). Discontinuation due to unsatisfactory treatment was 6.3 % for on-demand and 9.8 % for continuous treatment (difference -3.5 % [90 % CI: -7.1 %, 0.2 %]). In total, 82.1 and 86.2 % of patients taking on-demand and continuous therapy, respectively, were satisfied with the treatment of heartburn and regurgitation symptoms, a secondary variable (P = NS). Mean study drug consumption was 0.41 and 0.91 tablets/day, respectively. Overall, 5 % of the on-demand group developed reflux esophagitis versus none in the continuous group (P < 0.0001). The Gastrointestinal Symptom Rating Scale Reflux dimension was also improved for continuous versus on-demand treatment. Esomeprazole was well tolerated.

conclusionsIn terms of willingness to continue treatment, on-demand treatment with esomeprazole 20 mg was non-inferior to continuous maintenance treatment and reduced medication usage in patients with NERD who had achieved symptom control with initial esomeprazole treatment.

trial registrationClinicalTrials.gov identifier (NCT number): NCT02670642 ; Date of registration: December 2015.

Indexed as

Patient SatisfactionAdultDrug Administration ScheduleEsomeprazoleEsophagitis, PepticFemaleGastroesophageal RefluxHeartburnHumansMaintenance ChemotherapyMaleMiddle AgedProton Pump InhibitorsTreatment OutcomeEsomeprazoleProton Pump InhibitorsDiscontinuationEsomeprazoleGastroesophageal reflux diseaseHeartburnNon-erosive reflux diseaseOn-demand

Identifiers

PMID27080034
PMCPMC4831110
OpenAlexW2337560442

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.