Evidence map›Paper›PMID 38129806›Full record

ArticleBMC gastroenterology2023

Efficacy comparison of 7- and 14-day P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: rationale and design of an open-label, multicenter, randomized controlled trial.

Chang Kyo Oh, Hyun Lim, Seung In Seo, Sang Pyo Lee, Chang Seok Bang, Woon Geon Shin, Jin Bae Kim, Hyun Joo Jang, Gwang Ho Baik

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMC gastroenterology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 16% 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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 5 citations in OpenAlex.

  1. Pooled it
  2. Amoxicillin high-dose dual therapy forWorld journal of gastroenterology · 2025
    Trial
  3. Article
  4. Article
  5. Gastric Stem Cell Biology and Helicobacter pylori Infection.Current topics in microbiology and immunology · 2023
    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

9 authors at 4 institutions in 1 country.

Chang Kyo OhDepartment of Internal Medicine, Gangnam Sacred Heart Hospital, Hallym University College of Medicine, 1 Singil-ro, Yeoungdeungpo-gu, Seoul, 07441, Korea.
Hyun LimDepartment of Internal Medicine, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22 Gwanpyeong-ro 170-gil, Dongan-gu, Anyang, 14068, Korea. hlim77@hallym.or.kr.
Seung In SeoDepartment of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, 150 Seongan-ro, Gangdong-gu, Seoul, 05355, Korea.
Sang Pyo LeeDepartment of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong, 18450, Korea.
Chang Seok BangDepartment of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, 77 Sakju-ro, Chuncheon, 24253, Korea.
Woon Geon ShinDepartment of Internal Medicine, Kangdong Sacred Heart Hospital, Hallym University College of Medicine, 150 Seongan-ro, Gangdong-gu, Seoul, 05355, Korea.
Jin Bae KimDepartment of Internal Medicine, Gangnam Sacred Heart Hospital, Hallym University College of Medicine, 1 Singil-ro, Yeoungdeungpo-gu, Seoul, 07441, Korea.
Hyun Joo JangDepartment of Internal Medicine, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong, 18450, Korea.
Gwang Ho BaikDepartment of Internal Medicine, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, 77 Sakju-ro, Chuncheon, 24253, Korea.
Hallym University · KRHallym University Chuncheon Sacred Heart Hospital · KRKangdong Sacred Heart Hospital · KRHallym Polytechnic University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOwing to its strong acid inhibition, potassium-competitive acid blocker (P-CAB) based regimens for Helicobacter pylori (H. pylori) eradication are expected to offer clinical advantages over proton pump inhibitor (PPI) based regimens. This study aims to compare the efficacy and adverse effects of a 7-day and a 14-day P-CAB-based bismuth-containing quadruple regimen (PC-BMT) with those of a 14-day PPI-based bismuth-containing quadruple regimen (P-BMT) in patients with high clarithromycin resistance.

methodsThis randomized multicenter controlled clinical trial will be performed at five teaching hospitals in Korea. Patients with H. pylori infection who are naive to treatment will be randomized into one of three regimens: 7-day or 14-day PC-BMT (tegoprazan 50 mg BID, bismuth subcitrate 300 mg QID, metronidazole 500 mg TID, and tetracycline 500 mg QID) or 14-day P-BMT. The eradication rate, treatment-related adverse events, and drug compliance will be evaluated and compared among the three groups. Antibiotic resistance testing by culture will be conducted during the trial, and these data will be used to interpret the results. A total of 366 patients will be randomized to receive 7-day PC-BMT (n = 122), 14-day PC-BMT (n = 122), or 14-day P-BMT (n = 122). The H. pylori eradication rates in the PC-BMT and P-BMT groups will be compared using intention-to-treat and per-protocol analyses. DISCUSSION: This study will demonstrate that the 7-day or 14-day PC-BMT is well tolerated and achieve similar eradication rates to those of 14-day P-BMT. Additionally, the 7-day PC-BMT will show fewer treatment-related adverse effects and higher drug compliance, owing to its reduced treatment duration.

trial registrationKorean Clinical Research Information Service registry, KCT0007444. Registered on 28 June 2022, https://cris.nih.go.kr/cris/index/index.do .

Indexed as

Helicobacter InfectionsHelicobacter pyloriAmoxicillinAnti-Bacterial AgentsBismuthDrug Therapy, CombinationHumansMetronidazoleMulticenter Studies as TopicProton Pump InhibitorsRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeAmoxicillinAnti-Bacterial AgentsBismuthMetronidazoleProton Pump InhibitorsBismuth-containing quadruple therapyHelicobacter pyloriPotassium-competitive acid blockersProton pump inhibitors

Identifiers

PMID38129806
PMCPMC10734161
OpenAlexW4390053112

What Socratic holds

Textmetadata
LicenceCC BY
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 Socratic graph.