Evidence map›Paper›PMID 28957341›Full record

Trial reportPloS one2017

Efficacy and safety of sequential versus quadruple therapy as second-line treatment for helicobacter pylori infection-A randomized controlled trial.

Daniela Munteanu, Ohad Etzion, Gil Ben-Yakov, Daniel Halperin, Leslie Eidelman, Doron Schwartz, Victor Novack, Naim Abufreha, Pavel Krugliak, Alexander Rozenthal and 4 more

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01481844 (Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection), which is not on this 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.

NCT01481844 phase3completednot on this map

Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection

TypeinterventionalSponsorSoroka University Medical CenterRan2011 to 2014Enrolled101ConditionsOptimization of Second Line Treatment Protocol for H Pylori EradicationArmsLansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole, Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline
3 · Its place in the literature

Who cites it

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

  1. Guideline
  2. Guideline
  3. Comparison of 7- and 14-Day Eradication Therapy forJournal of Korean medical science · 2020
    Trial
  4. Trial
  5. Article
  6. Update on the second-line treatment ofTherapeutic advances in gastroenterology · 2023
    Review
  7. Article
  8. Tailored eradicationWorld journal of gastroenterology · 2019
    Article
  9. Practice guidelines for the management ofSaudi journal of gastroenterology : official journal of the Saudi Gastroenterology Association
    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

14 authors.

Daniela MunteanuInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Ohad EtzionInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Gil Ben-YakovInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Daniel HalperinClinical Research Center (CRC), Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of The Negev, Beer-Sheva, Israel.
Leslie EidelmanInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Doron SchwartzInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Victor NovackClinical Research Center (CRC), Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of The Negev, Beer-Sheva, Israel.
Naim AbufrehaInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Pavel KrugliakInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Alexander RozenthalInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Nava GasparInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Alexander MoshkaloInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Vitaly DizingofInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Alexander FichInstitute of Gastroenterology and Liver Diseases, Soroka University Medical Center, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsQuadruple therapy is recommended as second-line treatment for Helicobacter pylori eradication failure. However, high cost, multiple side effects, and low adherence rates are major drawbacks to its routine use. Our aim was to compare the efficacy and safety of sequential versus quadruple regimens as second line treatment for persistent Helicobacter pylori infection.

methodsProspective, randomized, open label trial was conducted at a large academic, tertiary care center in Israel. Patients who previously failed a standard triple treatment eradication course were randomly assigned (1:1) to receive a 10-day sequential therapy course, or a 14-day quadruple regimen. Compliance and adverse events were evaluated by telephone questionnaires. The primary endpoint for analysis was the rate of Helicobacter pylori eradication as defined by either a negative 13C-urea breath-test, or stool antigen test, 4-16 weeks after treatment assessed under the non-inferiority hypothesis. The trial was terminated prematurely due to low recruitment rates. See S1 Checklist for CONSORT checklist.

resultsOne hundred and one patients were randomized. Per modified intention-to-treat analysis, eradication rate was 49% in the sequential versus 42.5% in the quadruple regimen group (p-value for non-inferiority 0.02). Forty-two (84.0%) versus 33 (64.7%) patients completed treatment in the sequential and quadruple groups respectively (p 0.027). Gastrointestinal side effects were more common in the quadruple regimen group.

conclusionSequential treatment when used as a second line regimen, was non-inferior to the standard of care quadruple regimen in achieving Helicobacter pylori eradication, and was associated with better compliance and fewer adverse effects. Both treatment protocols failed to show an adequate eradication rate in the population of Southern Israel.

trial registrationClinicalTrials.gov NCT01481844.

Indexed as

AdultAnti-Bacterial AgentsCohort StudiesDrug Therapy, CombinationFemaleHelicobacter InfectionsHelicobacter pyloriHumansMaleTreatment OutcomeAnti-Bacterial Agents

Identifiers

PMID28957341
PMCPMC5619725

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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.