Evidence map›Paper›PMID 25792708›Full record

Trial reportGut2016

A randomised, double-blind trial comparing budesonide formulations and dosages for short-term treatment of eosinophilic oesophagitis.

Stephan Miehlke, Petr Hruz, Michael Vieth, Christian Bussmann, Ulrike von Arnim, Monther Bajbouj, Christoph Schlag, Ahmed Madisch, Christiane Fibbe, Henning Wittenburg and 11 more

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

Trial report in Gut, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02280616 (Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis), which is not on this map. Cited by 94 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
94citing papers in PubMed, 8 pooled it
21.8field-weighted citation impact, top 1% 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.

NCT02280616 phase2completednot on this map

Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis

TypeinterventionalSponsorDr. Falk Pharma GmbHRan2011 to 2014Enrolled76ConditionsEosinophilic EsophagitisArmslow dose budesonide tablet, high dose budesonide tablet, high dose budesonide suspension, Placebo
3 · Its place in the literature

Who cites it

94 citing papers in PubMed, 8 syntheses or guidelines pooled it, 209 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Guideline
  6. Pooled it
  7. Pooled it
  8. Pooled it
  9. Trial
  10. Trial
  11. Heartburn and dyspepsia symptom severity improves after treatment and correlates with histology in adults with eosinophilic esophagitis.Diseases of the esophagus : official journal of the International Society for Diseases of the Esophagus · 2019
    Trial
  12. Trial
  13. Eosinophilic gastrointestinal diseases.Nature reviews. Disease primers · 2026
    Review
  14. Review
  15. Review
  16. Review
  17. Article
  18. Article
  19. Daily or Twice Daily Treatment With Topical Steroids Results in Similar Responses in Eosinophilic Esophagitis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Article
  20. Review

34 more citing papers are in PubMed but not listed here.

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

21 authors at 16 institutions in 3 countries.

Stephan MiehlkeCentre for Digestive Diseases Eppendorf, Hamburg, Germany.
Petr HruzDepartment of Gastroenterology & Hepatology, University Hospital, Basel, Switzerland.
Michael ViethInstitute for Pathology, Klinikum Bayreuth, Bayreuth, Germany.
Christian BussmannInstitute for Pathology, Kantonsspital, Luzern, Switzerland.
Ulrike von ArnimDepartment of Gastroenterology & Hepatology, University Hospital, Magdeburg, Germany.
Monther BajboujDepartment of Gastroenterology, Technical University Hospital, Munich, Germany.
Christoph SchlagDepartment of Gastroenterology, Technical University Hospital, Munich, Germany.
Ahmed MadischMedical Department I, Klinikum Siloah, Hannover, Germany.
Christiane FibbeMedical Department, Israelitisches Krankenhaus, Hamburg, Germany.
Henning WittenburgDepartment of Internal Medicine, Division of Gastroenterology and Rheumatology, University of Leipzig, Leipzig, Germany.
Hans Dieter AllescherMedical Department, Klinikum Garmisch-Partenkirchen, Garmisch-Partenkirchen, Germany.
Max ReinshagenMedical Department, Klinikum Braunschweig, Braunschweig, Germany.
Stefan SchubertGastroenterologist in Private Practice, Berlin, Germany.
Jan TackDepartment of Gastroenterology, University Hospital, Leuven, Belgium.
Michaela MüllerDepartment of Gastroenterology, Deutsche Klinik für Diagnostik, Wiesbaden, Germany.
Patrick KrummenerlDepartment of Internal Medicine, Krankenhaus Martha-Maria Halle-Dölau, Halle (Saale), Germany.
Joris ArtsDepartment of Gastroenterology, AZ Sint-Lucas Brugge, Brugge, Belgium.
Ralph MuellerDr. Falk Pharma GmbH, Freiburg, Germany.
Karin DilgerDr. Falk Pharma GmbH, Freiburg, Germany.
Roland GreinwaldDr. Falk Pharma GmbH, Freiburg, Germany.
Alex StraumannSwiss EoE Research Network, Olten, Switzerland.
Dr Falk Pharma (Germany) · DETechnical University of Munich · DEAZ Sint-Lucas · BEBayreuth Medical Center · DEDeutsche Klinik für Diagnostik · DEEppendorf (Germany) · DEGarmisch-Partenkirchen Medical Center · DEIsraelitisches Krankenhaus · DEKlinikum Braunschweig · DEKlinikum Region Hannover · DEKU Leuven · BELuzerner Kantonsspital · CHMartha-Maria Hospital · DEPathodiagnostik Berlin · DEUniversity Hospital Magdeburg · DEUniversity Hospital of Basel · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo investigate the efficacy and safety of two different budesonide formulations (effervescent tablet for orodispersible use (BET) and viscous suspension (BVS)) with different daily dosages for short-term treatment of eosinophilic oesophagitis (EoE).

designAdults with active EoE (n=76) randomly received 14 days' treatment with either BET 2×1 mg/day (BET1, n=19) or BET 2×2 mg/day (BET2, n=19), or BVS 2×5 mL (0.4 mg/mL)/day (BVS, n=19) or placebo (n=19) in a double-blind, double-dummy fashion, with a 2-week follow-up. Primary end point was histological remission (mean of <16 eosinophils/mm(2 )hpf). Secondary end points included endoscopy score, dysphagia score, drug safety and patient's preference for drug formulation.

resultsHistological remission occurred in 100%, 94.7% and 94.7% of budesonide (BET1, BET2, BVS, respectively) and in 0% of placebo recipients (p<0.0001). The improvement in total endoscopic intensity score was significantly higher in the three budesonide groups compared with placebo. Dysphagia improved in all groups at the end of treatment; however, improvement of dysphagia persisted only in those treated with BET1 (p=0.0196 vs placebo). There were no serious adverse events. Local fungal infection (stained fungi) occurred in two patients of each budesonide group (10.5%). The effervescent tablet was preferred by 80% of patients.

conclusionsBET or BVS was highly effective and safe for short-term treatment of EoE. The 1 mg (twice daily) dosage was equally effective as the 2 mg twice daily dosage. The majority of patients preferred the effervescent tablet formulation. CLINICALTRIALSGOV NUMBER: NCT02280616; EudraCT number, 2009-016692-29.

Indexed as

Administration, OralAdolescentAdultAgedAnti-Inflammatory AgentsBudesonideDouble-Blind MethodDrug Administration ScheduleEosinophilic EsophagitisFemaleFollow-Up StudiesHumansMaleMiddle AgedRemission InductionSuspensionsAnti-Inflammatory AgentsBudesonideSuspensionsTabletsDYSPHAGIAOESOPHAGITIS

Identifiers

PMID25792708
PMCPMC4789829
OpenAlexW2138276111

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.