Evidence map›Paper›PMID 22796132›Full record

Trial reportGastroenterology2012

A combination of esomeprazole and aspirin reduces tissue concentrations of prostaglandin E(2) in patients with Barrett's esophagus.

Gary W Falk, Navtej S Buttar, Nathan R Foster, Katie L Allen Ziegler, Catherine J Demars, Yvonne Romero, Norman E Marcon, Thomas Schnell, Douglas A Corley, Prateek Sharma and 12 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00474903 (Randomized, Double-Blinded Phase II Trial of Esomeprazole Versus Esomeprazole + Two Doses of Aspirin in Barrett's Esophagus Patients), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
7.9field-weighted citation impact, top 2% 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.

NCT00474903 phase2completednot on this map

Randomized, Double-Blinded Phase II Trial of Esomeprazole Versus Esomeprazole + Two Doses of Aspirin in Barrett's Esophagus Patients

TypeinterventionalSponsorNational Cancer Institute (NCI)Ran2007 to 2011Enrolled122ConditionsBarrett Esophagus, Esophageal CancerArmsacetylsalicylic acid, esomeprazole magnesium, placebo
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 63 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Trial
  6. Metformin does not reduce markers of cell proliferation in esophageal tissues of patients with Barrett's esophagus.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2015
    Trial
  7. Article
  8. Drug repurposing for cancer therapy.Signal transduction and targeted therapy · 2024
    Review
  9. Review
  10. Review
  11. Article
  12. Chemoprevention in Barrett's esophagus and esophageal adenocarcinoma.Therapeutic advances in gastroenterology · 2021
    Review
  13. Review
  14. Chemoprevention of esophageal adenocarcinoma.Gastroenterology report · 2020
    Review
  15. Review
  16. Barrett's oesophagus: Current controversies.World journal of gastroenterology · 2017
    Review
  17. Review
  18. Article
  19. Review
  20. Barrett's oesophagus: frequency and prediction of dysplasia and cancer.Best practice & research. Clinical gastroenterology · 2015
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors at 13 institutions in 3 countries.

Gary W FalkHospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, USA. gary.falk@uphs.upenn.edu
Navtej S Buttar
Nathan R Foster
Katie L Allen Ziegler
Catherine J Demars
Yvonne Romero
Norman E Marcon
Thomas Schnell
Douglas A Corley
Prateek Sharma
Marcia R Cruz-Correa
Chin Hur
David E Fleischer
Amitabh Chak
Kenneth R Devault
David S Weinberg
Gary Della'Zanna
Ellen Richmond
Thomas C Smyrk
Sumithra J Mandrekar
Paul J Limburg
Cancer Prevention Network
Mayo Clinic · USNational Institutes of Health · USEdward Hines, Jr. VA Hospital · USFox Chase Cancer Center · USHospital of the University of Pennsylvania · USJacksonville College · USKaiser Permanente San Francisco Medical Center · USKansas City VA Medical Center · USMassachusetts General Hospital · USMayo Clinic in Arizona · USSt. Michael's Hospital · CAUniversity Hospitals Case Medical Center · USUniversity of Puerto Rico System · PR

Funding

ZESTRIL VS. VERAPAMIL IN THE TREATMENT OF HYPERTENSIONM01RR000585 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 1985 to 2006
$30.4M
Targeting 15-PGDH in Colon Cancer Prognosis, Prediction, Treatment and PreventionP50CA150964 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI MARKOWITZ, SANFORD D. · 2011 to 2022
$24.6M
PHASE 1 AND PHASE 2 CLINICAL TRIALS OF CANCER CHEMOPREVENTIVE AGENTS -261035000N01CN035000 · CN · UNIVERSITY OF SOUTHERN CALIFORNIA · PI LIMBURG, PAUL J · 1985 to 2006
–
NCI NIH HHS N01 CN035000NCRR NIH HHS M01 RR000585
6 · The paper itself

Abstract

unlabelledBACKGROUND&

aimsProton pump inhibitors and nonsteroidal anti-inflammatory drugs might prevent esophageal adenocarcinoma in patients with Barrett's esophagus (BE), but there are limited data from clinical trials to support this concept. We conducted a randomized, double-blind, placebo-controlled, phase 2 trial to assess the effects of the combination of aspirin (3 different doses) and esomeprazole on tissue concentrations of prostaglandin (PG) E(2) in patients with BE with no dysplasia or low-grade dysplasia.

methodsParticipants were recruited through the multicenter Cancer Prevention Network and randomly assigned to groups that were given 40 mg esomeprazole twice daily in combination with an aspirin placebo once daily (arm A; n = 30), with 81 mg aspirin once daily (arm B; n = 47), or with 325 mg aspirin once daily (arm C; n = 45) for 28 days. We collected esophageal biopsy specimens before and after the intervention period to determine the absolute change in mean concentration of PGE(2) (the primary end point).

resultsBased on data from 114 patients, baseline characteristics were similar among groups. The absolute mean tissue concentration of PGE(2) was reduced by 67.6 ± 229.68 pg/mL in arm A, 123.9 ± 284.0 pg/mL in arm B (P = .10 vs arm A), and 174.9 ± 263.62 pg/mL in arm C (P = .02 vs arm A).

conclusionsIn combination with esomeprazole, short-term administration of higher doses of aspirin, but not lower doses or no aspirin, significantly reduced tissue concentrations of PGE(2) in patients with BE with either no dysplasia or low-grade dysplasia. These data support further evaluation of higher doses of aspirin and esomeprazole to prevent esophageal adenocarcinoma in these patients. Clinical trial registration number NCT00474903.

Indexed as

AdultAgedAged, 80 and overAspirinBarrett EsophagusBiomarkersBiopsyCyclooxygenase InhibitorsDinoprostoneDouble-Blind MethodDown-RegulationDrug Therapy, CombinationEsomeprazoleEsophagoscopyEsophagusFemaleAspirinBiomarkersCyclooxygenase InhibitorsDinoprostoneEsomeprazoleProton Pump Inhibitors

Identifiers

PMID22796132
PMCPMC3458136
OpenAlexW2004826442

What OpenQuestion holds

Textmetadata
LicenceTDM
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.