Evidence map›Paper›PMID 38887840›Full record

Trial reportUnited European gastroenterology journal2024

Culture-based susceptibility-guided tailored versus empirical concomitant therapy as first-line Helicobacter pylori treatment: A randomized clinical trial.

Jeong Hoon Lee, Byung-Hoon Min, Eun Jeong Gong, Jun Young Kim, Hee Kyong Na, Ji Yong Ahn, Do Hoon Kim, Kee Don Choi, Yang Won Min, Hyuk Lee and 3 more

Abstract readRandomized Controlled TrialMulticenter StudyComparative Study
In one paragraph

Trial report in United European gastroenterology journal, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 2 pooled it
–field-weighted citation impact
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

9 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Concomitant Versus Tailored Therapy Based on Antibiotic Resistance Profiles forJGH open : an open access journal of gastroenterology and hepatology · 2025
    Review
  7. Article
  8. Overcoming antibiotic-resistantWorld journal of gastroenterology · 2025
    Review
  9. 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

13 authors.

Jeong Hoon LeeDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Byung-Hoon MinDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.ORCID 0000-0001-8048-361X
Eun Jeong GongDepartment of Internal Medicine, Hallym University College of Medicine, Chuncheon, Korea.ORCID 0000-0003-3996-3472
Jun Young KimDepartment of Medicine, Samsung Changwon Hospital, Sungkyunkwan University School of Medicine, Changwon, Korea.
Hee Kyong NaDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Ji Yong AhnDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Do Hoon KimDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0002-4250-4683
Kee Don ChoiDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
Yang Won MinDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hyuk LeeDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jun Haeng LeeDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Hwoon-Yong JungDepartment of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.ORCID 0000-0003-1281-5859
Jae J KimDepartment of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.

Funding

Korean College of Helicobacter and Upper Gastrointestinal Research KCHUGR-201902505
6 · The paper itself

Abstract

backgroundWith the increasing resistance to antimicrobial agents, susceptibility-guided tailored therapy has been emerging as an ideal strategy for Helicobacter pylori treatment. However, susceptibility-guided tailored therapy requires additional cost, time consumption, and invasive procedure (endoscopy) and its superiority over empirical quadruple therapy as the first-line H. pylori treatment remains unclear.

aimsTo compare the efficacy of culture-based susceptibility-guided tailored versus empirical concomitant therapy as the first-line Helicobacter pylori treatment.

methodsThis open-label, randomized trial was performed in four Korean institutions. A total of 312 Patients with H. pylori-positive culture test and naïve to treatment were randomly assigned in a 3:1 ratio to either culture-based susceptibility-guided tailored therapy (clarithromycin-based or metronidazole-based triple therapy for susceptible strains or bismuth quadruple therapy for dual-resistant strains, n = 234) or empirical concomitant therapy (n = 78) for 10 days. Eradication success was evaluated by

resultsPrevalence of dual resistance to both clarithromycin and metronidazole was 8%. H. pylori eradication rates for tailored and concomitant groups were 84.2% and 83.3% by intention-to-treat analysis (p = 0.859), respectively, and 92.9% and 91.5% by per-protocol analysis, respectively (p = 0.702), which were comparable between the two groups. However, eradication rates for dual-resistant strains were significantly higher in the tailored group than in the concomitant group. All adverse events were grade 1 or 2 based on the Common Terminology Criteria for Adverse Events and the incidence was significantly lower in the tailored group. The proportion of patients discontinuing treatment for adverse events was comparable between the two groups (2.1% vs. 2.6%).

conclusionsThe culture-based susceptibility-guided tailored therapy failed to show superiority over the empirical concomitant therapy in terms of eradication rate. Based on these findings, the treatment choice in clinical practice would depend on the background rate of antimicrobial resistance, availability of resources and costs associated with culture and susceptibility testing.

Indexed as

Anti-Bacterial AgentsClarithromycinDrug Therapy, CombinationHelicobacter InfectionsHelicobacter pyloriMetronidazoleMicrobial Sensitivity TestsAdultAgedAmoxicillinBismuthBreath TestsDrug Resistance, BacterialFemaleHumansMaleAmoxicillinAnti-Bacterial AgentsBismuthClarithromycinMetronidazoleProton Pump Inhibitorsantibiotic resistancebiopsycostEGDSendoscopyesophagogastroduodenoscopyhistologyH. pylorimicrobiologyquadruple therapy

Identifiers

PMID38887840
PMCPMC11497715

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.