Evidence map›Paper›PMID 32348007›Full record

Trial reportJournal of digestive diseases2020

A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment.

Jian Zhang, Chuan Han, Wen Quan Lu, Na Wang, Si Ran Wu, Yong Xi Wang, Jin Ping Ma, Jie Hong Wang, Cheng Hao, Dong Hong Yuan and 2 more

4 registry-linked trialsOpen access · hybridAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of digestive diseases, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
2.9field-weighted citation impact, top 9% 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.

NCT03609892 phase4completednot on this map

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Berberine Plus Amoxicillin Quadruple Therapy Versus Tetracycline Plus Furazolidone Quadruple Therapy

TypeinterventionalSponsorXijing Hospital of Digestive DiseasesRan2018 to 2019Enrolled658ConditionsGastric Ulcer, Chronic Gastritis, Gastric Cancer, Helicobacter Pylori InfectionArmsBerberine, Amoxicillin, Esomeprazole, Bismuth, Tetracycline
NCT05431075 phase4completednot on this mapstarted 2022, after this paper: background citation

Bismuth-containing Quadruple Therapy for Helicobacter Pylori First-line Treatment: A Multicenter Randomized Clinical Trial of Different Tetracycline Doses and Frequencies.

TypeinterventionalSponsorShandong UniversityRan2022 to 2024Enrolled406ConditionsHelicobacter Pylori InfectionArmsAmoxicillin, Tetracycline tid, Tetracycline qid, Bismuth Potassium Citrate, Colloidal Bismuth Pectin
NCT05432115 phase4unknown statusnot on this mapstarted 2022, after this paper: background citation

Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.

TypeinterventionalSponsorShandong UniversityRan2022 to 2023Enrolled407ConditionsHelicobacter Pylori InfectionArmsTetracyclin
NCT05802888 phase4unknown statusnot on this mapstarted 2023, after this paper: background citation

Bismuth Quadruple Therapy in Helicobacter Pylori Rescue Therapy: A Multicenter Randomized Non-Inferiority Trial of Different Tetracycline Doses and Frequencies.

TypeinterventionalSponsorShandong UniversityRan2023 to 2024Enrolled260ConditionsHelicobacter Pylori InfectionArmsTetracycline 500mg tid, Tetracycline 500mg qid
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 26 citations in OpenAlex.

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  18. Current guidelines forWorld journal of clinical cases · 2022
    Review
  19. A Survey ofAntimicrobial agents and chemotherapy · 2022
    Article
  20. Treatment of refractoryFrontiers in microbiology · 2022
    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

12 authors at 6 institutions in 1 country.

Jian ZhangState Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.
Chuan HanState Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.ORCID https://orcid.org/0000-0002-0330-1082
Wen Quan LuDepartment of Gastroenterology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.
Na WangState Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.
Si Ran WuState Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.
Yong Xi WangDepartment of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.
Jin Ping MaDepartment of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.
Jie Hong WangDepartment of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.
Cheng HaoDepartment of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.
Dong Hong YuanDepartment of Gastroenterology, Yan'an University Affiliated Hospital, Yan'an, Shaanxi Province, China.
Na LiuDepartment of Gastroenterology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.
Yong Quan ShiState Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.ORCID https://orcid.org/0000-0001-9515-7577
National Clinical Research Center for Digestive Diseases · CNAffiliated Hospital of Shaanxi University of Chinese Medicine · CNXian Yang Central Hospital · CNFirst Affiliated Hospital of Zhengzhou University · CNSecond Affiliated Hospital of Xi'an Jiaotong University · CNYanan University Affiliated Hospital · CN

Funding

Booster Plan of XiJing Hospital XJZT18ML11Science and Technology Innovation as a Whole Plan Projects of Shaanxi Province 2018TD-003
6 · The paper itself

Abstract

objectiveHelicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication.

methodsWe conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892).

resultsAltogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established margin of noninferiority, at -10% (the lower bounds of the 95% CI were -7.66% and -9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies.

conclusionThe efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.

Indexed as

AdultAmoxicillinAnti-Bacterial AgentsBerberineDrug Therapy, CombinationFemaleFurazolidoneHelicobacter InfectionsHelicobacter pyloriHumansMaleMiddle AgedTetracyclineTreatment OutcomeAmoxicillinAnti-Bacterial AgentsBerberineFurazolidoneTetracyclineamoxicillinberberineHelicobacter pylorirescue therapy

Identifiers

PMID32348007
PMCPMC7383804
OpenAlexW3017986851

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.