Evidence map›Paper›PMID 25460556›Full record

Trial reportClinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association2015

High-dose dual therapy is superior to standard first-line or rescue therapy for Helicobacter pylori infection.

Jyh-Chin Yang, Chun-Jung Lin, Hong-Long Wang, Jin-De Chen, John Y Kao, Chia-Tung Shun, Chien-Wei Lu, Bor-Ru Lin, Ming-Jium Shieh, Ming-Chu Chang and 9 more

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

Trial report in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01163435 (Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication - A Prospective, Comparative Study), which is not on this map. Cited by 93 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
93citing papers in PubMed, 5 pooled it
12.0field-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.

NCT01163435 phase4completednot on this map

Efficacy of High Dose Dual Therapy, Sequential Therapy and Triple Therapy in H. Pylori Eradication - A Prospective, Comparative Study

TypeinterventionalSponsorNational Taiwan University HospitalRan2010 to 2013Enrolled618ConditionsHelicobacter InfectionArmshigh dose dual therapy, sequential therapy, clarithromycin-based triple therapy, levofloxacin-based triple therapy
3 · Its place in the literature

Who cites it

93 citing papers in PubMed, 5 syntheses or guidelines pooled it, 196 citations in OpenAlex.

  1. Guideline
  2. Guideline
  3. Efficacy of second-line regimens forBMJ open gastroenterology · 2020
    Pooled it
  4. Pooled it
  5. ACG Clinical Guideline: Treatment of Helicobacter pylori Infection.The American journal of gastroenterology · 2017
    Guideline
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Frontiers in cellular and infection microbiology · 2022
    Trial
  11. Trial
  12. Trial
  13. Trial
  14. Optimized high-dose amoxicillin-proton-pump inhibitor dual therapies fail to achieve high cure rates in China.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    Trial
  15. Article
  16. Antibiotics (Basel, Switzerland) · 2026
    Review
  17. Review
  18. Review
  19. Article
  20. Potassium-competitive acid blockers forFrontiers in cellular and infection microbiology · 2026
    Review

33 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

19 authors at 5 institutions in 2 countries.

Jyh-Chin YangDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: jcyang47@ntu.edu.tw.
Chun-Jung LinSchool of Pharmacy, National Taiwan University, Taipei, Taiwan.
Hong-Long WangDepartment of Statistics, National Taipei University, New Taipei City, Taiwan.
Jin-De ChenDepartment of Internal Medicine, National Taiwan University Hospital Bei-Hu Branch, Taipei, Taiwan.
John Y KaoDivision of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan. Electronic address: jykao@med.umich.edu.
Chia-Tung ShunDepartment of Forensic Medicine and Pathology, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Chien-Wei LuSchool of Pharmacy, National Taiwan University, Taipei, Taiwan.
Bor-Ru LinDepartment of Integrated Diagnostics and Therapeutics, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Ming-Jium ShiehDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Ming-Chu ChangDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Yu-Ting ChangDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Shu-Chen WeiDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Lin-Chih LinDepartment of Internal Medicine, Non-Profit Proprietary Miners Hospital, Keelung, Taiwan.
Wen-Chun YehDepartment of Internal Medicine, New Taipei City Hospital San Chung Branch, New Taipei City, Taiwan.
Jen-Shin KuoDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Chien-Chih TungDepartment of Integrated Diagnostics and Therapeutics, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Yew-Loong LeongDepartment of Internal Medicine, West Garden Hospital, Taipei, Taiwan.
Teh-Hong WangDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
Jau-Min WongDepartment of Internal Medicine, Hospital and College of Medicine, National Taiwan University, Taipei, Taiwan.
National Taiwan University Hospital · TWNational Taiwan University · TWNational Taipei University · TWTaipei City Hospital · TWUniversity of Michigan–Ann Arbor · US

Funding

University of Michigan Center for Gastrointestinal ResearchP30DK034933 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI OMARY, BISHR · 1986 to 2021
$22.5M
Role of Dendritic Cells in H pylori-induced Treg-mediated Host Immune ToleranceR01DK087708 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI KAO, JOHN Y · 2011 to 2015
$2.0M
NIDDK NIH HHS P30 DK034933NIDDK NIH HHS R01 DK087708
6 · The paper itself

Abstract

BACKGROUND &

aimsThe efficacy of treatment of Helicobacter pylori infection has decreased steadily because of increasing resistance to clarithromycin, metronidazole, and levofloxacin. Resistance to amoxicillin is generally low, and high intragastric pH increases the efficacy of amoxicillin, so we investigated whether a combination of a high-dose proton pump inhibitor and amoxicillin (dual therapy) was more effective than standard first-line or rescue therapies in eradicating H pylori.

methodsWe performed a large-scale multihospital trial to compare the efficacy of a high-dose dual therapy (HDDT) with that of standard therapies in treatment-naive (n = 450) or treatment-experienced (n = 168) patients with H pylori infection. Treatment-naive patients were randomly assigned to groups given HDDT (rabeprazole 20 mg and amoxicillin 750 mg, 4 times/day for 14 days, group A1), sequential therapy for 10 days (group B1), or clarithromycin-containing triple therapy for 7 days (group C1). Treatment-experienced patients were randomly assigned to groups given HDDT for 14 days (group A2), sequential therapy for 10 days (B2), or levofloxacin-containing triple therapy for 7 days (C2). H pylori infection was detected by using the (13)C-urea breath test. We evaluated factors associated with treatment outcomes.

resultsIn the intention-to-treat analysis, H pylori was eradicated in 95.3% of patients in group A1 (95% confidence interval [CI], 91.9%-98.8%), 85.3% in B1 (95% CI, 79.6%-91.1%), and 80.7% in group C1 (95% CI, 74.3%-87.1%). Infection was eradicated in 89.3% of patients in group A2 (95% CI, 80.9%-97.6%), 51.8% in group B2 (95% CI, 38.3%-65.3%), and 78.6% (95% CI, 67.5%-89.7%) in group C2. The efficacy of HDDT was significantly higher than that of currently recommended regimens, irrespective of CYP2C19 genotype. Bacterial resistance to drugs was associated with treatment failure. There were no significant differences between groups in adverse events or patient adherence.

conclusionsHDDT is superior to standard regimens as empirical first-line or rescue therapy for H pylori infection, with similar safety profiles and tolerability. ClinicalTrials.gov number: NCT01163435.

Indexed as

AdultAgedAnti-Bacterial AgentsDrug Therapy, CombinationFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedProspective StudiesProton Pump InhibitorsTreatment OutcomeAnti-Bacterial AgentsProton Pump InhibitorsBacterial InfectionMicrobePPIProton Pump InhibitorStomach

Identifiers

PMID25460556
PMCPMC4404168
OpenAlexW2098162091

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.