Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice. Issue 2 (11th May 2013)

• Record Type: Journal Article
• Authors: McNicholl, Adrian G; Marin, Alicia C; Molina-Infante, Javier; Castro, Manuel; Barrio, Jesús; Ducons, Julio; Calvet, Xavier; de la Coba, Cristobal; Montoro, Miguel; Bory, Felipe; Perez-Aisa, Angeles; Forné, Montserrat; Gisbert, Javier P
• Other Names: Ramas Mercedes author non-byline.; Millán Raquel author non-byline.; Aranguren Patxi author non-byline.; García-Iglesias Pilar author non-byline.; Belloc Blanca author non-byline.; Bessa Xavier author non-byline.; Sainz Empar author non-byline.; Gisbert Jose-Luis author non-byline.; Lamas Eloisa author non-byline.; Figuerola Ariadna author non-byline.; Álvarez Cristina author non-byline.; Marcos Eusebio S author non-byline.; Moreno Maria-Isabel author non-byline.; Abad-Santos Francisco author non-byline.
• Is Part Of: Gut. Volume 63:Issue 2(2014)
• Page Start: 244
• Page End: 249
• Publication Date: 2013-05-11
• Subjects: CLINICAL TRIALS -- HELICOBACTER PYLORI -- ANTIBIOTIC THERAPY; Gastroenterology -- Periodicals; 616.33
• DOI: 10.1136/gutjnl-2013-304820
• Languages: English
• ISSNs: 0017-5749

Abstract

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 .