Evidence map›Paper›PMID 32020360›Full record

Trial reportDigestive diseases and sciences2020

14-Day High-Dose Amoxicillin- and Metronidazole-Containing Triple Therapy With or Without Bismuth as First-Line Helicobacter pylori Treatment.

Laisheng Luo, Yingjie Ji, Lou Yu, Yu Huang, Xiao Liang, David Y Graham, Hong Lu

Registry-linked trialAbstract readRandomized Controlled TrialEquivalence Trial
PubMed Publisher
In one paragraph

Trial report in Digestive diseases and sciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03557437 (Efficacy of High Dose of Amoxicillin And Metronidazole Plus Bismuth For Helicobacter Pylori Treatment In Naive Patients), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
3.7field-weighted citation impact, top 6% 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.

NCT03557437 phase4completednot on this map

Efficacy of High Dose of Amoxicillin And Metronidazole Plus Bismuth For Helicobacter Pylori Treatment In Naive Patients : A Randomized Clinical Trial

TypeinterventionalSponsorShanghai Jiao Tong University School of MedicineRan2018 to 2019Enrolled216ConditionsHelicobacter Pylori InfectionArmsEsomeprazole, Amoxicillin, Metronidazole, Bismuth Potassium Citrate
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 22 citations in OpenAlex.

  1. Trial
  2. Eradication ofFuture science OA · 2024
    Article
  3. Article
  4. Primary Antibiotic Resistance ofPathogens (Basel, Switzerland) · 2022
    Review
  5. Primer for Development of Guidelines for Helicobacter pylori Therapy Using Antimicrobial Stewardship.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2022
    Review
  6. 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

7 authors at 2 institutions in 2 countries.

Laisheng LuoDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
Yingjie JiDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
Lou YuDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
Yu HuangDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
Xiao LiangDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China.
David Y GrahamDepartment of Medicine, Michael E. DeBakey Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX, USA.
Hong LuDivision of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, 145 Middle Shandong Road, Shanghai, 200001, China. hlu@sjtu.edu.cn.ORCID 0000-0002-3127-6048
Shanghai Jiao Tong University · CNMichael E. DeBakey VA Medical Center · US

Funding

the Shanghai Science and Technology Committee 19411970300
6 · The paper itself

Abstract

backgroundAmoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy had been shown to reliably achieve high eradication rates. The role of individual components remains undefined.

aimTo identify the additional benefit/role of bismuth in amoxicillin, metronidazole, proton pump inhibitor, bismuth quadruple therapy for Helicobacter pylori (H. pylori) treatment.

methodsThis was a non-inferiority factorial design trial. Treatment-naive H. pylori-infected subjects were randomly (1:1) assigned to receive 14-day amoxicillin- and metronidazole-containing triple therapy consisting of esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg both thrice daily with or without 220 mg bismuth twice a day. Six weeks after treatment, H. pylori eradication was assessed by

resultsFrom July 2018 to June 2019, a total of two hundred and sixteen subjects were randomized. Both therapies achieved high eradication rates. Per-protocol with bismuth = 97.9% (94/96, 95% CI 95.1-100%) and without bismuth = 94.7% (90/95, 95% CI 90.3-99.1%) (P = 0.43). Intent-to-treat analysis = 90.7% (98/108, 95% CI 85.2-96.2%) versus 88.9% (96/108, 95% CI 82.8-95.0%) with and without bismuth (P = 0.65). The two regimens were not inferior by intent-to-treat or per-protocol analyses. Metronidazole resistance did not affect the efficacy of either therapy.

conclusionNeither the presence nor absence of bismuth or metronidazole resistance reduced the effectiveness of triple therapy containing esomeprazole 20 mg twice a day, amoxicillin 1 g, and metronidazole 400 mg thrice daily in this population. The clinical trial was registered with ClinicalTrials.gov, NCT03557437.

Indexed as

Drug Therapy, CombinationHelicobacter InfectionsHelicobacter pyloriAmoxicillinAnti-Bacterial AgentsBismuthBreath TestsDrug MonitoringDrug ResistanceFemaleGastrointestinal AgentsHumansMaleMetronidazoleMicrobial Sensitivity TestsMiddle AgedAmoxicillinAnti-Bacterial AgentsBismuthGastrointestinal AgentsMetronidazoleProton Pump InhibitorsAmoxicillinBismuthHelicobacter pyloriMetronidazoleTriple therapy

Identifiers

PMID32020360
OpenAlexW3005125828

What OpenQuestion holds

Textmetadata
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.