title: Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Digestive Services, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IP), , Madrid, Spain.
authors.forename: Adrian G
authors.initials: AG
authors.lastname: McNicholl
authors.forename: Alicia C
authors.initials: AC
authors.lastname: Marin
authors.forename: Javier
authors.initials: J
authors.lastname: Molina-Infante
authors.forename: Manuel
authors.initials: M
authors.lastname: Castro
authors.forename: Jesús
authors.initials: J
authors.lastname: Barrio
authors.forename: Julio
authors.initials: J
authors.lastname: Ducons
authors.forename: Xavier
authors.initials: X
authors.lastname: Calvet
authors.forename: Cristobal
authors.initials: C
authors.lastname: de la Coba
authors.forename: Miguel
authors.initials: M
authors.lastname: Montoro
authors.forename: Felipe
authors.initials: F
authors.lastname: Bory
authors.forename: Angeles
authors.initials: A
authors.lastname: Perez-Aisa
authors.forename: Montserrat
authors.initials: M
authors.lastname: Forné
authors.forename: Javier P
authors.initials: JP
authors.lastname: Gisbert
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001944:Breath Tests; D017291:Clarithromycin / Q000627:therapeutic use; D060740:Disease Eradication; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D016015:Logistic Models; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use; D010437:Peptic Ulcer / Q000188:drug therapy*; D011446:Prospective Studies; D016896:Treatment Outcome; D014508:Urea / Q000378:metabolism; D055815:Young Adult
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D008795:Metronidazole; D000658:Amoxicillin; D014508:Urea; D017291:Clarithromycin; D009853:Omeprazole
keywords: ANTIBIOTIC THERAPY; CLINICAL TRIALS; HELICOBACTER PYLORI