Prospective comparative study between two first-line regimens for Helicobacter pylori eradication: Non-bismuth quadruple versus bismuth quadruple therapy.
Compliance
Cumplimiento terapéutico
Efectos secundarios
Eradication treatment
Helicobacter pylori
Side effects
Tratamiento de erradicación
Journal
Gastroenterologia y hepatologia
ISSN: 0210-5705
Titre abrégé: Gastroenterol Hepatol
Pays: Spain
ID NLM: 8406671
Informations de publication
Date de publication:
Historique:
received:
27
09
2019
revised:
26
11
2019
accepted:
05
12
2019
pubmed:
8
4
2020
medline:
4
6
2021
entrez:
8
4
2020
Statut:
ppublish
Résumé
The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas. To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy. Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires. 404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p=0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p=0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p=0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p=0.109), being longer (12 vs 7 days, p<0.0001) and more severe (p<0.0001) with OCAM. In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile.
Sections du résumé
BACKGROUND
BACKGROUND
The Maastricht V Consensus recommends quadruple therapies as first-line Helicobacter pylori treatment in high clarithromycin (CLA) resistance areas.
AIMS
OBJECTIVE
To compare efficacy, side effects and compliance between quadruple concomitant non-bismuth vs bismuth quadruple therapy.
METHOD
METHODS
Prospective study enrolling H. pylori-positive patients. Omeprazol and a three-in-one formulation of bismuth-metronidazol-tetracycline (OBMT-3/1) for 10 days, or combination of omeprazol-clarithromycin-amoxicillin-metronidazol (OCAM) for 14 days, were prescribed. Eradication outcome was assessed by urea breath test or histology. Side effects and compliance were recorded during the treatment period with specific questionnaires.
RESULTS
RESULTS
404 patients were recruited (median age 53 years; 62.87% women). In 382 (183 with OCAM, 199 with OBMT-3/1) the post-treatment test result was available. The eradication rates were 85.94% (CI95%: 80.20-90.52) with OCAM and 88.21% (CI95%: 83.09-92.22) with OBMT-3/1 (p=0.595) in intention-to-treat analysis, whilst in per protocol analysis they were 91.12% (CI95%: 85.78-94.95) and 96.17% (CI95%: 92.28-98.45) respectively (p=0.083). Compliance over 90% was 91.35% with OCAM and 92.04% with OBMT-3/1 (p=0.951). Some side effect was present in 94.02% with OCAM and in 88.89% with OBMT-3/1 (p=0.109), being longer (12 vs 7 days, p<0.0001) and more severe (p<0.0001) with OCAM.
CONCLUSIONS
CONCLUSIONS
In a high CLA-resistance area, there are no differences between OBMT-3/1 and OCAM in H. pylori eradication and compliance rates, but OBMT-3/1 achieves a higher safety profile.
Identifiants
pubmed: 32253018
pii: S0210-5705(20)30075-3
doi: 10.1016/j.gastrohep.2019.12.002
pii:
doi:
Substances chimiques
Drug Combinations
0
Bismuth
U015TT5I8H
Types de publication
Comparative Study
Journal Article
Langues
eng
spa
Sous-ensembles de citation
IM
Pagination
301-309Informations de copyright
Copyright © 2020 Elsevier España, S.L.U. All rights reserved.