Evidence map›Paper›PMID 25886722›Full record

ArticleBMC gastroenterology2015

Beyond Maastricht IV: are standard empiric triple therapies for Helicobacter pylori still useful in a South-European country?

Nuno Almeida, Maria Manuel Donato, José Manuel Romãozinho, Cristina Luxo, Olga Cardoso, Maria Augusta Cipriano, Carol Marinho, Alexandra Fernandes, Carlos Calhau, Carlos Sofia

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in BMC gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05449028 (Helicobacter Pylori Eradication Therapy in Portugal), which is not on this map. Cited by 5 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 2 pooled it
3.2field-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.

NCT05449028 naunknown statusnot on this mapstarted 2022, after this paper: background citation

Helicobacter Pylori Eradication Therapy in Portugal: Prospective, Randomized, Blind and Multicentre Trial on the Efficacy of Quadruple Therapies and Their Clinical Impact, and Immunological and Gut Microbiota Changes

TypeinterventionalSponsorUnidade Local de Saúde de Coimbra, EPERan2022 to 2024Enrolled230ConditionsHelicobacter Pylori, Gut Microbiota, ImmunologyArmsH. pylori eradication scheme A, H. pylori eradication scheme B, H. pylori eradication scheme C, H. pylori eradication scheme D, H. pylori eradication scheme E
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 2 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Article
  4. Article
  5. 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

10 authors at 3 institutions in 1 country.

Nuno AlmeidaGastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. nunoperesalmeida@gmail.com.
Maria Manuel DonatoGastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. mariamanueldonato@gmail.com.
José Manuel RomãozinhoGastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. jmromaozinho@gmail.com.
Cristina LuxoLaboratory of Microbiology, Faculty of Pharmacy, Coimbra University, Azinhaga de Santa Comba, 3000-548, Coimbra, Portugal. crisluxo@ci.uc.pt.
Olga CardosoLaboratory of Microbiology, Faculty of Pharmacy, Coimbra University, Azinhaga de Santa Comba, 3000-548, Coimbra, Portugal. ocardoso@ci.uc.pt.
Maria Augusta CiprianoPathology Department, Coimbra University Hospital Centre, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. augustacipriano@gmail.com.
Carol MarinhoPathology Department, Coimbra University Hospital Centre, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carol.marinho@huc.min-saude.pt.
Alexandra FernandesGastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. xanafmuc@hotmail.com.
Carlos CalhauGastroenterology Centre, Faculty of Medicine, Coimbra University, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carloscalhau1@gmail.com.
Carlos SofiaGastroenterology Department, Centro Hospitalar e Universitário de Coimbra, Praceta Mota Pinto e Avenida Bissaya Barreto, 3000-075, Coimbra, Portugal. carlos.sofia@huc.min-saude.pt.
Hospitais da Universidade de Coimbra · PTInstituto Superior Bissaya Barreto · PTUniversity of Coimbra · PT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEmpiric triple treatments for Helicobacter pylori (H. pylori) are increasingly unsuccessful. We evaluated factors associated with failure of these treatments in the central region of Portugal.

methodsThis single-center, prospective study included 154 patients with positive (13)C-urea breath test (UBT). Patients with no previous H. pylori treatments (Group A, n = 103) received pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and clarithromycin (CLARI) 500 mg 12/12 h, for 14 days. Patients with previous failed treatments (Group B, n = 51) and no history of levofloxacin (LVX) consumption were prescribed pantoprazole 40 mg 2×/day, amoxicillin 1000 mg 12/12 h and LVX 250 mg 12/12 h, for 10 days. H. pylori eradication was assessed by UBT 6-10 weeks after treatment. Compliance and adverse events were assessed by verbal and written questionnaires. Risk factors for eradication failure were determined by multivariate analysis.

resultsIntention-to-treat and per-protocol eradication rates were Group A: 68.9% (95% CI: 59.4-77.1%) and 68.8% (95% CI: 58.9-77.2%); Group B: 52.9% (95% CI: 39.5-66%) and 55.1% (95% CI: 41.3-68.2%), with 43.7% of Group A and 31.4% of Group B reporting adverse events. Main risk factors for failure were H. pylori resistance to CLARI and LVX in Groups A and B, respectively. Another independent risk factor in Group A was history of frequent infections (OR = 4.24; 95% CI 1.04-17.24). For patients with no H. pylori resistance to CLARI, a history of frequent infections (OR = 4.76; 95% CI 1.24-18.27) and active tobacco consumption (OR = 5.25; 95% CI 1.22-22.69) were also associated with eradication failure.

conclusionsEmpiric first and second-line triple treatments have unacceptable eradication rates in the central region of Portugal and cannot be used, according to Maastricht recommendations. Even for cases with no H. pylori resistance to the used antibiotics, results were unacceptable and, at least for CLARI, are influenced by history of frequent infections and tobacco consumption.

Indexed as

Helicobacter pylori2-PyridinylmethylsulfinylbenzimidazolesAdultAgedAmoxicillinAnti-Bacterial AgentsBreath TestsClarithromycinDrug Resistance, BacterialDrug Therapy, CombinationFemaleHelicobacter InfectionsHumansLevofloxacinMaleMedication Adherence2-PyridinylmethylsulfinylbenzimidazolesAmoxicillinAnti-Bacterial AgentsClarithromycinLevofloxacinNitroimidazolesPantoprazoleProton Pump Inhibitors

Identifiers

PMID25886722
PMCPMC4339300
OpenAlexW1978729610

What OpenQuestion holds

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LicenceCC BY
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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.