Evidence map›Paper›PMID 27460100›Full record

Trial reportBMC gastroenterology2016

Comparison of sequential therapy and amoxicillin/tetracycline containing bismuth quadruple therapy for the first-line eradication of Helicobacter pylori: a prospective, multi-center, randomized clinical trial.

Ju Yup Lee, Nayoung Kim, Kyung Sik Park, Hyun Jin Kim, Seon Mee Park, Gwang Ho Baik, Ki-Nam Shim, Jung Hwan Oh, Suck Chei Choi, Sung Eun Kim and 6 more

Registry-linked trialAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC gastroenterology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02159976 (A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea), which is not on this map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing 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.

NCT02159976 nacompletednot on this map

A Prospective, Multi-center, Randomized, Open-label, Parallel Design Clinical Trial to Compare 10-day Sequential Therapy and 14-day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in Korea

TypeinterventionalSponsorSeoul National University Bundang HospitalRan2014 to 2016Enrolled390ConditionsHelicobacter Pylori InfectionArmsPantoprazole, Amoxicillin, Clarithromycin, Metronidazole, Tetracycline
3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Female Gender is a Poor Predictive Factor of Functional Dyspepsia Resolution afterThe Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2018
    Trial
  4. Review
  5. Review
  6. Tailored eradicationWorld journal of gastroenterology · 2019
    Article
  7. 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

16 authors.

Ju Yup LeeDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Nayoung KimDepartment of Internal Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea. nayoungkim49@empas.com.
Kyung Sik ParkDepartment of Internal Medicine, Keimyung University School of Medicine, Daegu, South Korea.
Hyun Jin KimDepartment of Internal Medicine and Institute of Health Science, Gyeongsang National University School of Medicine, Jinju, Gyeongsangnam-do, South Korea.
Seon Mee ParkDepartment of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, South Korea.
Gwang Ho BaikDepartment of Internal Medicine, Hallym University College of Medicine, Chuncheon Sacred Heart Hospital, Chuncheon, South Korea.
Ki-Nam ShimDepartment of Internal Medicine, Ewha Womans University School of Medicine, Seoul, South Korea.
Jung Hwan OhDepartments of Internal Medicine, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea.
Suck Chei ChoiDepartment of Internal Medicine, Wonkwang University School of Medicine, Iksan, South Korea.
Sung Eun KimDepartment of Internal Medicine, Kosin University College of Medicine, Busan, South Korea.
Won Hee KimDigestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.
Seon-Young ParkDepartment of Internal Medicine, Chonnam National University Medical School, Gwangju, South Korea.
Gwang Ha KimDepartment of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
Bong Eun LeeDepartment of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea.
Yunju JoDepartment of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, South Korea.
Su Jin HongDepartment of Internal Medicine and Research Institute, Soonchunhyang University College of Medicine, Bucheon, South Korea.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe <80 % Helicobacter pylori eradication rate with sequential therapy is unsatisfactory. Modified bismuth quadruple therapy, replacing metronidazole with amoxicillin, could be promising because H. pylori resistance to tetracycline or to amoxicillin is relatively low. A 14-day modified bismuth quadruple protocol as first-line H. pylori treatment was compared with 10-day sequential therapy.

methodsIn total, 390 H. pylori-infected subjects participated in the randomized clinical trial: 10-day sequential therapy (40 mg pantoprazole plus 1 g amoxicillin twice a day for 5 days, then 40 mg pantoprazole and 500 mg clarithromycin twice a day and 500 mg metronidazole three times a day for 5 days) or 14-day modified bismuth quadruple therapy (40 mg pantoprazole, 600 mg bismuth subcitrate, 1 g tetracycline, and 1 g amoxicillin, twice a day). (13)C-urea breath test, rapid urease testing, or histology was performed to check for eradication.

resultsIntention-to-treat (ITT) eradication rates of 10-day sequential and 14-day quadruple therapy were 74.6 % and 68.7 %, respectively, and the per-protocol (PP) rates were 84.2 and 76.5 %, respectively. The eradication rate was higher in the sequential therapy group, but neither the ITT nor the PP analyses had a significant difference (P = 0.240 and P = 0.099, respectively). However, the adverse events were significantly lower in the modified bismuth quadruple therapy group than the sequential therapy group (36.9 vs. 47.7 %, P = 0.040).

conclusionsTen-day sequential therapy appears to be more effective despite frequent adverse events. However, both 10-day SQT and 14-day PBAT did not reach the excellent eradication rates that exceed 90 %. Additional trials are needed to identify a more satisfactory first-line eradication therapy.

trial registrationClinicalTrials.gov ( NCT02159976 ); Registration date: 2014-06-03, CRIS ( KCT0001176 ); Registration date: 2014-07-23.

Indexed as

Helicobacter pyloriAmoxicillinAntacidsAnti-Bacterial AgentsBismuthDrug Administration ScheduleDrug Resistance, BacterialDrug Therapy, CombinationFemaleGastritisHelicobacter InfectionsHumansMaleMedication AdherenceMiddle AgedProspective StudiesAmoxicillinAntacidsAnti-Bacterial AgentsBismuthTetracyclineAmoxicillinBismuthEradicationHelicobacter pyloriQuadrupleTetracycline

Identifiers

PMID27460100
PMCPMC4962407

What Socratic 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 Socratic graph.