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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
Author(s) -
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
Publication year - 2018
Publication title -
helicobacter
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.206
H-Index - 79
eISSN - 1523-5378
pISSN - 1083-4389
DOI - 10.1111/hel.12502
Subject(s) - medicine , helicobacter pylori , adverse effect , urea breath test , confidence interval , gastroenterology , observational study , breath test , intention to treat analysis , clinical trial , surgery , helicobacter pylori infection
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.