The "three-in-one" formulation of bismuth quadruple therapy for Helicobacter pylori eradication with or without probiotics supplementation: Efficacy and safety in daily clinical practice

Rocco Maurizio Zagari, Alessandra Romiti, Enzo Ierardi, Antonietta G Gravina, Alba Panarese, Giuseppe Grande, Edoardo Savarino, Giovanni Maconi, Elisa Stasi, Leonardo Henry Eusebi, Fabio Farinati, Rita Conigliaro, Franco Bazzoli, Marco Romano

Research output: Contribution to journalArticle

Abstract

BACKGROUND: Clinical trials have shown a good efficacy of the "three-in-one" formulation of bismuth quadruple therapy (BQT) for Helicobacter (H.) pylori eradication. We aimed to assess the efficacy and safety of the three-in-one BQT in clinical practice, and investigate the effect of probiotic supplementation, in Italy.

MATERIALS AND METHODS: A retrospective database, multicentre observational study was conducted in seven Italian Hospitals. Consecutive H. pylori-positive patients who received the three-in-one BQT for 10 days were included in the analysis. H. pylori eradication was assessed by histology, 13 C-urea breath test, or stool antigen test. Compliance and adverse events were evaluated by interview.

RESULTS: A total of 376 patients were included in the intention-to-treat (ITT) and 352 in the per protocol (PP) analyses. One hundred and ninety-three subjects received probiotics supplementation. Overall, eradication rates were 90.2% (95% Confidence Interval (CI):86.7-93.0) in ITT and 94.6% (95% CI: 91.7-96.7) in PP analyses. The compliance was good (≥90% of treatment taken) in 94.9% of patients. The proportion of patients with a good compliance was not different with and without probiotics supplementation (94.8% vs 95.1%). Eradication rates were equally high for first-line (91.4%), second-line (87.5%), and third-line treatments (91.7%) in the ITT analysis (P = .48). Adverse events were reported by 32.4% of patients, but only 6.1% of patients discontinued treatment.

CONCLUSIONS: The three-in-one BQT is highly effective and well tolerated for H. pylori eradication in daily clinical practice. Probiotics supplementation fails to improve compliance.

Original languageEnglish
Pages (from-to)e12502
Number of pages7
JournalHelicobacter
Volume23
Issue number4
DOIs
Publication statusPublished - Aug 2018

Keywords

  • Adult
  • Aged
  • Anti-Bacterial Agents/administration & dosage
  • Bismuth/administration & dosage
  • Drug Therapy, Combination/adverse effects
  • Female
  • Helicobacter Infections/drug therapy
  • Helicobacter pylori/drug effects
  • Humans
  • Italy
  • Male
  • Metronidazole/administration & dosage
  • Middle Aged
  • Probiotics/administration & dosage
  • Proton Pump Inhibitors/administration & dosage
  • Retrospective Studies
  • Tetracycline/administration & dosage

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    Zagari, R. M., Romiti, A., Ierardi, E., Gravina, A. G., Panarese, A., Grande, G., Savarino, E., Maconi, G., Stasi, E., Eusebi, L. H., Farinati, F., Conigliaro, R., Bazzoli, F., & Romano, M. (2018). The "three-in-one" formulation of bismuth quadruple therapy for Helicobacter pylori eradication with or without probiotics supplementation: Efficacy and safety in daily clinical practice. Helicobacter, 23(4), e12502. https://doi.org/10.1111/hel.12502