title: Concomitant, sequential, and hybrid therapy for H. pylori eradication: a pilot study.
abstract: OBJECTIVE
  Since the efficacy of the standard triple therapies for Helicobacter pylori eradication has decreased, novel antibiotic regimens have been introduced, including concomitant, sequential, and hybrid therapies. We aimed to compare the cure rates achieved by these new therapy regimens.
  
  
  METHODS
  This was a multicenter, open-label, pilot study enrolling consecutive non-ulcer dyspepsia patients with H. pylori infection never previously treated for the infection. Patients were randomized to receive one of the following treatments: (a) concomitant therapy: omeprazole 20mg, amoxicillin 1g, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (b) sequential therapy: omeprazole 20mg and amoxicillin 1g for 5 days followed by omeprazole 20mg, clarithromycin 500 mg, and tinidazole 500 mg for 5 days; (c) hybrid therapy: omeprazole 20mg, and amoxicillin 1g for 7 days followed by omeprazole 20mg, amoxicillin 1g, clarithromycin 500 mg, and tinidazole 500 mg, for 7 days. All drugs were administered twice daily. Bacterial eradication was checked 6 weeks after treatment by using a (13)C-urea breath test. A 10-day, second-line therapy with omeprazole 20mg, levofloxacin 250 mg, and amoxicillin 1g, all given twice daily, was offered to the eradication failure patients.
  
  
  RESULTS
  Overall, 270 patients were enrolled, but 13 patients early interrupted treatment due to side effects. At intention-to-treat (ITT) and per-protocol analysis (PP), the eradication rates were 85.5% and 91.6% with the concomitant regimen, 91.1% and 92.1% with the sequential therapy, and 80% and 85.7% with the hybrid regimen. Differences were not statistically significant. H. pylori infection was cured in 10 (55.6%) patients with the second-line regimen.
  
  
  CONCLUSIONS
  In our study, both concomitant and sequential therapy, but not hybrid therapy, reached high eradication rates. The success rate of second-line levofloxacin-based triple therapy is decreasing.
authors.affiliation: Gastroenterology and Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.
authors.forename: Angelo
authors.initials: A
authors.lastname: Zullo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Scaccianoce
authors.forename: Vincenzo
authors.initials: V
authors.lastname: De Francesco
authors.forename: Valentina
authors.initials: V
authors.lastname: Ruggiero
authors.forename: Pasquale
authors.initials: P
authors.lastname: D'Ambrosio
authors.forename: Luigi
authors.initials: L
authors.lastname: Castorani
authors.forename: Leonilde
authors.initials: L
authors.lastname: Bonfrate
authors.forename: Lucy
authors.initials: L
authors.lastname: Vannella
authors.forename: Cesare
authors.initials: C
authors.lastname: Hassan
authors.forename: Piero
authors.initials: P
authors.lastname: Portincasa
mesh_terms: D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D064704:Levofloxacin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D054328:Proton Pump Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D014011:Tinidazole / Q000008:administration & dosage / Q000009:adverse effects; D014508:Urea
chemical_list: D000900:Anti-Bacterial Agents; D054328:Proton Pump Inhibitors; D014011:Tinidazole; D064704:Levofloxacin; D000658:Amoxicillin; D014508:Urea; D017291:Clarithromycin; D009853:Omeprazole