Evidence map›Paper›PMID 41211681›Full record

Trial reportHelicobacter

Different Doses of Ilaprazole for Dual Therapy Versus Bismuth-Quadruple Therapy for Helicobacter pylori Infection: A Three-Arm, Randomized Clinical Trial.

Qiang Han, Ming Zu, Shiyu Du, Yinyan Guo, Yuanmin Zhu, Yali Wang, Xiuqing Liu, Hongwei Guo, Yanli Cheng, Shigang Ding

Abstract readRandomized Controlled TrialMulticenter StudyEquivalence Trial
In one paragraph

Trial report in Helicobacter. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–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

2 citing papers in PubMed.

  1. Trial
  2. 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

10 authors.

Qiang HanDepartment of Gastroenterology, The First Hospital of Tsinghua University, Beijing, China.ORCID https://orcid.org/0009-0004-8056-1031
Ming ZuDepartment of Gastroenterology, Peking University Third Hospital, Beijing, China.
Shiyu DuDepartment of Gastroenterology, China-Japan Friendship Hospital, Beijing, China.
Yinyan GuoDepartment of Gastroenterology, Beijing Haidian Hospital, Beijing, China.
Yuanmin ZhuDepartment of Gastroenterology, Aerospace Center Hospital, Beijing, China.
Yali WangDepartment of Gastroenterology, The First Hospital of Tsinghua University, Beijing, China.
Xiuqing LiuDepartment of Gastroenterology, The First Hospital of Tsinghua University, Beijing, China.
Hongwei GuoDepartment of Gastroenterology, The First Hospital of Tsinghua University, Beijing, China.
Yanli ChengDepartment of Gastroenterology, The First Hospital of Tsinghua University, Beijing, China.
Shigang DingDepartment of Gastroenterology, Peking University Third Hospital, Beijing, China.ORCID https://orcid.org/0000-0002-0831-0965

Funding

China Health & Medical Development Foundation
6 · The paper itself

Abstract

backgroundCurrent Helicobacter pylori (H. pylori) eradication regimens-standard triple, bismuth-containing quadruple, and non-bismuth quadruple therapies-still face issues such as adverse effects and poor compliance. High-dose dual therapy, with its simplicity, lower pill burden, and comparable efficacy, has recently gained attention. However, existing studies are largely single-center with small sample sizes and lack sufficient evidence-based support. This study aims to further evaluate the efficacy and safety of ilaprazole-based dual and quadruple therapies for H. pylori eradication.

methodsThis was a prospective, multicenter, randomized controlled, non-inferiority clinical trial conducted at five hospitals from January to November 2023. A total of 480 patients were randomly assigned to one of three treatment groups for 14 days: Group A (ilaprazole 5 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 220 mg, all administered twice daily), Group B (ilaprazole 5 mg twice daily and amoxicillin 1 g three times daily), and Group C (ilaprazole 10 mg twice daily and amoxicillin 1 g three times daily). The eradication rates, adverse events, and patient compliance were recorded.

resultsThe eradication rates of H. pylori in Groups A, B, and C were 76.9%, 88.1%, and 88.7% (p = 0.004) by intention-to-treat analysis, respectively, and 78.3%, 90.4%, and 91.0% (p = 0.001) using modified intention-to-treat analysis, and 81.8%, 92.1%, 92.2% (p = 0.005) by per-protocol analysis. The adverse event rates were 28.0%, 10.2%, 10.8% in Groups A, B, and C, respectively (p < 0.001), while patient compliance rates were 91.1%, 98.1%, 98.7%, respectively (p = 0.001). Sex, smoking history, alcohol intake, and sharing tableware or cups did not affect the efficacy of the three treatment regimens.

conclusionsThe standard- or high-dose dual therapy with ilaprazole demonstrated superior efficacy, safety, and patient compliance compared to quadruple therapy. No significant differences were observed between these dual therapies, which are expected to become promising alternatives for the primary treatment of H. pylori infection.

trial registrationChinese Clinical Trial Registry: ChiCTR2400086862.

Indexed as

2-PyridinylmethylsulfinylbenzimidazolesAnti-Bacterial AgentsBismuthHelicobacter InfectionsHelicobacter pyloriAdultAgedAmoxicillinClarithromycinDrug Therapy, CombinationFemaleHumansMaleMiddle AgedProspective StudiesProton Pump Inhibitors2-PyridinylmethylsulfinylbenzimidazolesAmoxicillinAnti-Bacterial AgentsBismuthClarithromycinilaprazoleProton Pump Inhibitorsbismuth‐quadruple therapyclinical trialdual therapyH. pyloriilaprazole

Identifiers

PMID41211681
PMCPMC12598915

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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.