title: Concomitant versus sequential therapy for the treatment of Helicobacter pylori infection: a Greek randomized prospective study.
abstract: OBJECTIVE
  The objective of this study is to compare, in Greece, a region with >20% local resistance to clarithromycin, the efficacy rates of the concomitant versus the sequential H. pylori eradication therapy.
  
  
  METHODS
  Our prospective randomized study included 364 patients with newly diagnosed H. pylori infection, randomized to receive a 10-day concomitant or 10-day sequential therapy. Treatment outcome was assessed by C(13)-urea breath test at least 4 weeks after therapy. Intention to treat (ITT) and per protocol (PP) analysis of the eradication rates were performed. Secondary end points included patient compliance and safety.
  
  
  RESULTS
  The concomitant therapy group achieved statistically significant higher eradication rates when compared with the sequential treatment group, both in the ITT and in the PP analysis (84.6% versus 70.9%, p = 0.002, and 90.6% versus 78.1%, p = 0.001, respectively), after adjusting for age, gender, smoking status, and the presence or not of ulcer and/or non-ulcer dyspepsia. Both groups displayed excellent compliance rates (99.5% for the concomitant therapy group and 96.2% for the sequential therapy group, p = 0.067). Regarding treatment safety, major adverse events that led to the discontinuation of both regimens were few, with no statistical difference between the two groups (7.0% for the concomitant therapy group and 2.9% for the sequential therapy group).
  
  
  CONCLUSIONS
  Concomitant therapy led to statistically significant higher eradication rates over sequential therapy. Both therapies showed excellent compliance and an acceptable safety profile. The 10-day quadruple concomitant scheme should be the adopted for first-line H. pylori eradication in Greece.
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Periklis
authors.initials: P
authors.lastname: Apostolopoulos
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Ioannis
authors.initials: I
authors.lastname: Koumoutsos
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Ekmektzoglou
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Dogantzis
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Erasmia
authors.initials: E
authors.lastname: Vlachou
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Chrisostomos
authors.initials: C
authors.lastname: Kalantzis
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Panagiotis
authors.initials: P
authors.lastname: Tsibouris
authors.affiliation: a Department of Gastroenterology , Army Share Fund Hospital (NIMTS) , Athens , Greece.
authors.forename: Georgios
authors.initials: G
authors.lastname: Alexandrakis
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000494:pharmacology; D000890:Anti-Infective Agents / Q000008:administration & dosage* / Q000494:pharmacology; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000494:pharmacology; D004334:Drug Administration Schedule; D024901:Drug Resistance, Multiple, Bacterial; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D006115:Greece; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D055118:Medication Adherence; D008795:Metronidazole / Q000008:administration & dosage / Q000494:pharmacology; D008875:Middle Aged; D000077402:Pantoprazole; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D000077402:Pantoprazole; D017291:Clarithromycin
keywords: Concomitant; Greece; Helicobacter pylori; sequential