Evidence map›Paper›PMID 24698653›Full record

Trial reportHelicobacter2014

High-dose extended-release lansoprazole (dexlansoprazole) and amoxicillin dual therapy for Helicobacter pylori infections.

Taraq A Attumi, David Y Graham

Open access · greenAbstract readClinical Trial
In one paragraph

Trial report in Helicobacter, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 30 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 2 pooled it
5.0field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 2 syntheses or guidelines pooled it, 50 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Newer, Older, and Alternative Agents for the Eradication ofAntibiotics (Basel, Switzerland) · 2023
    Review
  8. Review
  9. Therapeutic eradication choices inTherapeutic advances in gastroenterology · 2023
    Review
  10. Article
  11. Vonoprazan and high-dose amoxicillin dual therapy forJGH open : an open access journal of gastroenterology and hepatology · 2023
    Article
  12. Update on the first-line treatment ofTherapeutic advances in gastroenterology · 2022
    Review
  13. Article
  14. Article
  15. Diagnosis ofDiagnostics (Basel, Switzerland) · 2021
    Review
  16. High dose PPI-amoxicillin dual therapy for the treatment ofTherapeutic advances in gastroenterology · 2020
    Review
  17. Optimizing proton pump inhibitors inWorld journal of gastroenterology · 2019
    Review
  18. Efficacy of dexlansoprazole-based triple therapy forTherapeutic advances in gastroenterology · 2019
    Article
  19. Houston Consensus Conference on Testing for Helicobacter pylori Infection in the United States.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2018
    Article
  20. 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

2 authors at 1 institution in 1 country.

Taraq A AttumiMichael E. DeBakey Veterans Affairs Medical Center, RM 3A-320 (111D), 2002 Holcombe Boulevard and Baylor College of Medicine, Houston, TX, 77030, USA.
David Y Graham
Baylor College of Medicine · US

Funding

Tissue Analysis & Molecular Imaging CoreP30DK056338 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI Geoffrey A Preidis · 2001 to 2026
$28.3M
REGULATION OF CXC CHEMOKINE EXPRESSION BY H. PYLORIR01DK062813 · NIDDK · BAYLOR COLLEGE OF MEDICINE · PI YAMAOKA, YOSHIO · 2004 to 2013
$3.0M
Obesity, H pylori and Risk of Barrett's EsophagusR01CA116845 · NCI · BAYLOR COLLEGE OF MEDICINE · PI EL-SERAG, HASHEM B · 2007 to 2011
$2.8M
NCI NIH HHS R01 CA116845NIDDK NIH HHS DK56338NIDDK NIH HHS P30 DK056338NIDDK NIH HHS R01 DK062813
6 · The paper itself

Abstract

backgroundHelicobacter pylori infections have become increasingly difficult to treat.

aimTo examine whether amoxicillin and high-dose dexlansoprazole would reliably achieve an H. pylori eradication rate of ≥90%.

methodsAn open-label prospective pilot study of H. pylori eradication in treatment-naïve subjects with active H. pylori infection (positive by two tests). THERAPY: amoxicillin 1 g and dexlansoprazole 120 mg each twice a day at approximately 12-hour intervals for 14 days. Success was accessed by urea breath test. An effective therapy was defined as a per-protocol treatment success of 90% or greater; treatment success of 80% or less was prespecified as an unacceptable result.

resultsAfter 13 subjects were entered (12 men, one woman; average age of 54 years), the prespecified stopping rule of six treatment failures was achieved (i.e., the 95% confidence interval excluded achieving the required 90% success rate even if the proposed study of 50 completed patients were entered) and enrollment was stopped. Per-protocol and intention-to-treat treatment success were both 53.8%; (7/13); 95% CI = 25-80%. Compliance was 100%. Three patients (23%) reported side effects, all of which were mild and none interrupted therapy.

conclusionTheoretically, dual PPI plus amoxicillin should reliably eradicate H. pylori provided nearly neutral intragastric pH can be maintained. Clearly, dexlansoprazole, despite being administered at high dose and twice a day (i.e., total daily dose 240 mg), failed to achieve an intragastric milieu consistent with dual PPI plus amoxicillin therapy being an effective anti-H. pylori regimen.

Indexed as

AmoxicillinAnti-Bacterial AgentsBreath TestsDexlansoprazoleDrug Therapy, CombinationFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedPilot ProjectsProspective StudiesProton Pump InhibitorsTreatment OutcomeUreaAmoxicillinAnti-Bacterial AgentsDexlansoprazoleProton Pump InhibitorsUreaamoxicillinclinical trialdexlansoprazoleeradication therapyHelicobacter pyloriproton-pump inhibitors

Identifiers

PMID24698653
PMCPMC4111781
OpenAlexW1992827772

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.