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Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice
  1. Adrian G McNicholl1,2,
  2. Alicia C Marin1,2,
  3. Javier Molina-Infante3,
  4. Manuel Castro2,4,
  5. Jesús Barrio5,
  6. Julio Ducons2,6,
  7. Xavier Calvet2,7,
  8. Cristobal de la Coba8,
  9. Miguel Montoro9,
  10. Felipe Bory10,
  11. Angeles Perez-Aisa11,
  12. Montserrat Forné2,12,
  13. Javier P Gisbert1,2,
  14. On behalf of the participant centres
  1. 1Digestive Services, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), Madrid, Spain
  2. 2Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Instituto de Salud Carlos III, Madrid, Spain 
  3. 3Digestive Services, Hospital San Pedro de Alcántara, Cáceres, Cáceres, Spain
  4. 4Digestive Services, Hospital Ntra. Sra. Virgen de Valme, Sevilla, Spain
  5. 5Digestive Services, Hospital Universitario Río Hortega, Valladolid, Valladolid, Spain
  6. 6Digestive Services, Hospital Clínico Universitario ‘Lozano Blesa’, Zaragoza, Spain
  7. 7Digestive Services, Hospital de Sabadell, Sabadell, Spain
  8. 8Digestive Services, Hospital de Cabueñes, Gijón, Spain
  9. 9Digestive Services, Hospital de San Jorge, Huesca, Spain
  10. 10Digestive Services, Hospital del Mar, Barcelona, Spain
  11. 11Digestive Unit, Agencia Sanitaria Costa del Sol, Marbella, Málaga, Spain
  12. 12Digestive Services, Hospital Mutua de Terrassa, Terrassa, Spain
  1. Correspondence to Dr Javier P Gisbert, Servicio de Aparato Digestivo, Hospital Universitario de la Princesa, c/Diego de León 62, Madrid 28006, Spain; javier.p.gisbert{at}gmail.com

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 13C-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.

  • CLINICAL TRIALS
  • HELICOBACTER PYLORI
  • ANTIBIOTIC THERAPY

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