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

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Bismuth
Probiotics
Helicobacter pylori
Safety
Compliance
Therapeutics
Confidence Intervals
Intention to Treat Analysis
Breath Tests
Italy
Multicenter Studies
Observational Studies
Urea
Histology
Clinical Trials
Databases
Interviews
Antigens

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

Cite this

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

In: Helicobacter, Vol. 23, No. 4, 08.2018, p. e12502.

Research output: Contribution to journalArticle

Zagari, RM, Romiti, A, Ierardi, E, Gravina, AG, Panarese, A, Grande, G, Savarino, E, Maconi, G, Stasi, E, Eusebi, LH, 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, vol. 23, no. 4, pp. e12502. https://doi.org/10.1111/hel.12502
Zagari, Rocco Maurizio ; Romiti, Alessandra ; Ierardi, Enzo ; Gravina, Antonietta G ; Panarese, Alba ; Grande, Giuseppe ; Savarino, Edoardo ; Maconi, Giovanni ; Stasi, Elisa ; Eusebi, Leonardo Henry ; Farinati, Fabio ; Conigliaro, Rita ; Bazzoli, Franco ; Romano, Marco. / 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. In: Helicobacter. 2018 ; Vol. 23, No. 4. pp. e12502.
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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.",
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T1 - The "three-in-one" formulation of bismuth quadruple therapy for Helicobacter pylori eradication with or without probiotics supplementation

T2 - Efficacy and safety in daily clinical practice

AU - Zagari, Rocco Maurizio

AU - Romiti, Alessandra

AU - Ierardi, Enzo

AU - Gravina, Antonietta G

AU - Panarese, Alba

AU - Grande, Giuseppe

AU - Savarino, Edoardo

AU - Maconi, Giovanni

AU - Stasi, Elisa

AU - Eusebi, Leonardo Henry

AU - Farinati, Fabio

AU - Conigliaro, Rita

AU - Bazzoli, Franco

AU - Romano, Marco

N1 - © 2018 John Wiley & Sons Ltd.

PY - 2018/8

Y1 - 2018/8

N2 - 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.

AB - 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.

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KW - Aged

KW - Anti-Bacterial Agents/administration & dosage

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KW - Drug Therapy, Combination/adverse effects

KW - Female

KW - Helicobacter Infections/drug therapy

KW - Helicobacter pylori/drug effects

KW - Humans

KW - Italy

KW - Male

KW - Metronidazole/administration & dosage

KW - Middle Aged

KW - Probiotics/administration & dosage

KW - Proton Pump Inhibitors/administration & dosage

KW - Retrospective Studies

KW - Tetracycline/administration & dosage

U2 - 10.1111/hel.12502

DO - 10.1111/hel.12502

M3 - Article

VL - 23

SP - e12502

JO - Helicobacter

JF - Helicobacter

SN - 1083-4389

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ER -