Evidence map›Paper›PMID 28796053›Full record

Trial reportMedicine2017

Berberine containing quadruple therapy for initial Helicobacter pylori eradication: An open-label randomized phase IV trial.

Di Zhang, Li Ke, Zhen Ni, Yu Chen, Lin-Hui Zhang, Shao-Hua Zhu, Chan-Juan Li, Lei Shang, Jie Liang, Yong-Quan Shi

Open access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in Medicine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 1 pooled it
3.0field-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.

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

25 citing papers in PubMed, 1 synthesis or guideline pooled it, 34 citations in OpenAlex.

  1. Allicin as add-on therapy forWorld journal of gastroenterology · 2019
    Pooled it
  2. Trial
  3. Trial
  4. Review
  5. Review
  6. Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Review
  12. Review
  13. The Aging Stomach: Clinical Implications ofInternational journal of molecular sciences · 2024
    Review
  14. Article
  15. Review of Phytochemical Potency as a Natural Anti-Molecules (Basel, Switzerland) · 2023
    Review
  16. Focusing onFrontiers in cellular and infection microbiology · 2023
    Review
  17. Article
  18. Article
  19. Review
  20. 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 at 2 institutions in 1 country.

Di ZhangState Key Laboratory of Cancer Biology & Institute of Digestive Diseases, Xijing Hospital, Department of Health Statistics, Fourth Military Medical University, Xi'an, Shaanxi Province, China.
Li Ke
Zhen Ni
Yu Chen
Lin-Hui Zhang
Shao-Hua Zhu
Chan-Juan Li
Lei Shang
Jie Liang
Yong-Quan Shi
Xijing Hospital · CNAir Force Medical University · CN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to increasing antimicrobial resistance, a bismuth-based quadruple regimen has been recommended as an alternative first-line therapy for Helicobacter pylori (H pylori) eradication. However, different results are varied greatly and the availability of bismuth was limited in some countries. We assessed the efficacy and safety of 14-day berberine-containing quadruple therapy as an alternative regimen for H pylori eradication.

methodsIn a randomized, open-label, non-inferiority, phase IV trial between November 25, 2014, and October 15, 2015, 612 treatment-naive patients were randomly assigned to 14-day berberine-containing (n = 308) or 14-day bismuth-containing (n = 304) quadruple therapy. The primary outcomes were eradication rates determined by the C urea breath test (C-UBT) 28 days after the end of treatment. The secondary outcomes were adverse events and compliance.

resultsThe baseline demographic data including age, gender, body mass index (BMI), general condition and severity score were not statistically different in both groups. The eradication rates in bismuth and berberine groups were 86.4% (266/308) and 90.1% (274/304) in intention-to-treat (ITT) analysis (P = .149), and 89.6% (266/297) and 91.3% (273/299) in per-protocol (PP) analysis (P = .470), respectively. No statistically significant difference was found in the overall incidence of adverse events between both groups (35.7% vs 28.6%, P = .060).

conclusionsBoth regimens achieved the recommended efficacy for H pylori eradication. The berberine-containing quadruple regimen was not inferior to bismuth-containing quadruple regimen and can be recommended as an alternative regimen for H pylori eradication in the local region.

Indexed as

AdultAge FactorsAmoxicillinAntacidsAnti-Bacterial AgentsBerberineBismuthBody Mass IndexBreath TestsClarithromycinDrug Therapy, CombinationEsomeprazoleFemaleHelicobacter InfectionsHelicobacter pyloriHumansAmoxicillinAntacidsAnti-Bacterial AgentsBerberineBismuthClarithromycinEsomeprazoleProton Pump Inhibitors

Identifiers

PMID28796053
PMCPMC5556219
OpenAlexW2743324359

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

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.