Evidence map›Paper›PMID 16162678›Full record

Trial reportGut2006

Accuracy of breath tests using low doses of 13C-urea to diagnose Helicobacter pylori infection: a randomised controlled trial.

L Gatta, C Ricci, A Tampieri, J Osborn, F Perna, V Bernabucci, D Vaira

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Gut, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed, 2 pooled it
2.5field-weighted citation impact, top 11% 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

24 citing papers in PubMed, 2 syntheses or guidelines pooled it, 56 citations in OpenAlex.

  1. Urea breath test forWorld journal of gastroenterology · 2024
    Pooled it
  2. Non-invasive diagnostic tests for Helicobacter pylori infection.The Cochrane database of systematic reviews · 2018
    Pooled it
  3. Clinical efficiency of Helicobacter pylori eradication in the treatment of patients with acute central serous chorioretinopathy.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2016
    Trial
  4. Trial
  5. Trial
  6. Article
  7. Article
  8. Article
  9. Article
  10. Evaluation of urea breath test as a diagnostic tool forWorld journal of gastroenterology · 2024
    Article
  11. Article
  12. Review
  13. Breath Biomarkers in Diagnostic Applications.Molecules (Basel, Switzerland) · 2021
    Review
  14. Review
  15. Real-world data ofJGH open : an open access journal of gastroenterology and hepatology · 2020
    Article
  16. Article
  17. Update on diagnostic value of breath test in gastrointestinal and liver diseases.World journal of gastrointestinal pathophysiology · 2016
    Review
  18. Review
  19. Review
  20. 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 3 institutions in 1 country.

L GattaDepartment of Internal Medicine and Gastroenterology, S Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy.
C Ricci
A Tampieri
J Osborn
F Perna
V Bernabucci
D Vaira
Policlinico S.Orsola-Malpighi · ITAzienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia · ITSapienza University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 13C-urea breath test (UBT) for detecting Helicobacter pylori infection is a non-invasive method based on the organism's urease activity. Since its first description, the method has been extensively modified. However, only the dose of 13C-urea and the measurement equipment are directly related to the cost of the test.

aims(1) To assess the diagnostic accuracy before eradication therapy of three UBTs using 25, 15, and 10 mg of 13C-urea, respectively; and (2) to determine diagnostic performance in the post-eradication setting showing the highest values for sensitivity and specificity with the lowest dose of 13C-urea.

methodsThree hundred consecutive patients were randomised to be tested with one of the three UBTs. All patients underwent upper endoscopy with biopsies. A total of 222 more patients were enrolled to evaluate the second aim. Infected patients were offered treatment and asked to return 4-6 weeks after the end of therapy to perform endoscopic follow up and to carry out 13C-UBT.

resultsIn the pretreatment setting, 13C-UBT 25 mg had a sensitivity of 100% (95% confidence interval (CI) 91.8-100) and a specificity of 100% (95% CI 93.7-100); 13C-UBT 15 mg had a sensitivity of 96.1% (95% CI 86.8-98.9) and a specificity of 100% (95% CI 92.6-100); and 13C-UBT 10 mg had a sensitivity of 89.1% (95% CI 77-95.3) and a specificity of 100% (95% CI 93.3-100). As the test with the best performance and the lowest dose of 13C-urea was 13C-UBT 15 mg, it was evaluated after treatment, reporting a sensitivity of 100% (95% CI 79.6-100) and a specificity of 98.9% (95% CI 94.3-99.8). DISCUSSION: UBTs using 25 and 15 mg of 13C-urea were both accurate in the diagnosis of H pylori infection in untreated patients. 13C-UBT 15 mg was also accurate for follow up of patients after treatment.

Indexed as

Helicobacter pyloriAdultAge FactorsBreath TestsCarbon IsotopesDrug Administration ScheduleEndoscopyFemaleHelicobacter InfectionsHumansMaleMiddle AgedProspective StudiesRespiratory Tract InfectionsROC CurveSensitivity and SpecificityCarbon IsotopesUrea

Identifiers

PMID16162678
PMCPMC1856187
OpenAlexW2078058325

What OpenQuestion holds

Textmetadata
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.