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, 13C-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.
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 / R.M. Zagari, A. Romiti, E. Ierardi, A.G. Gravina, A. Panarese, G. Grande, E. Savarino, G. Maconi, E. Stasi, L.H. Eusebi, F. Farinati, R. Conigliaro, F. Bazzoli, M. Romano. - In: HELICOBACTER. - ISSN 1083-4389. - 23:4(2018 Aug), pp. e12502.1-e12502.7.
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
G. MaconiWriting – Review & Editing
;
2018
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, 13C-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.File | Dimensione | Formato | |
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