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Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice.

Abstract：

OBJECTIVES:No trial has compared non-bismuth quadruple 'sequential' and 'concomitant' regimens in settings with increasing clarithromycin rates. The study aims to compare the effectiveness and safety of these therapies for Helicobacter pylori treatment. DESIGN:Prospective randomised clinical trial in 11 Spanish hospitals. Patients naïve to eradication therapy with non-investigated/functional dyspepsia or peptic ulcer disease were included. Randomised (1:1) to sequential (omeprazole (20 mg/12 h) and amoxicillin (1 g/12 h) for 5 days, followed by 5 days of omeprazole (20 mg/12 h), clarithromycin (500 mg/12 h) and metronidazole (500 mg/12 h)), or concomitant treatment (same drugs taken concomitantly for 10 days). Eradication was confirmed with (13)C-urea breath test or histology 4 weeks after treatment. Adverse events (AEs) and compliance were evaluated with questionnaires and residual medication count. RESULTS:338 consecutive patients were randomised. Mean age was 47 years, 60% were women, 22% smokers and 20% had peptic ulcer. Concomitant and sequential eradication rates were, respectively, 87% vs 81% by intention-to-treat (p=0.15) and 91% vs 86% (p=0.131) per protocol. Respective compliances were 83% vs 82%. Treatment-emergent AEs were reported in 59% of patients (no differences found between treatments). AEs were mostly mild (60%), and average length was 6.1 days, causing discontinuation only in 12 patients. Multivariate analysis: 'concomitant' treatment showed an OR of 1.5 towards better eradication rate in a borderline significance CI (95% CI 0.9 to 2.8). CONCLUSIONS:Concomitant therapy led to a non-statistically significant advantage (5%) over sequential therapy, coming closer to 90% cure rates. Both therapies showed an acceptable safety profile. ClincialTrials.gov: NCT01273441.

journal_name

Gut

journal_title

Gut

authors

McNicholl AG,Marin AC,Molina-Infante J,Castro M,Barrio J,Ducons J,Calvet X,de la Coba C,Montoro M,Bory F,Perez-Aisa A,Forné M,Gisbert JP,Participant Centres.

doi

10.1136/gutjnl-2013-304820

subject

Has Abstract

pub_date

2014-02-01 00:00:00

pages

244-9

issue

eissn

0017-5749

issn

1468-3288

pii

gutjnl-2013-304820

journal_volume

pub_type

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Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice.