title: Efficacy of 2-week, second-line Helicobacter pylori eradication therapy using rabeprazole, amoxicillin, and metronidazole for the Japanese population.
abstract: BACKGROUND
  Following the failure of first-line Helicobacter pylori eradication therapy using a proton pump inhibitor, amoxicillin, and clarithromycin, second-line therapy is conducted for 1 week using metronidazole instead of clarithromycin in Japan. Recent studies indicate that metronidazole-containing therapy has a higher eradication rate with prolonged treatment duration, even with metronidazole resistance. The aim of this study was to reveal the efficacy of 2-week metronidazole-containing second-line therapy.
  
  
  METHODS
  Eighty-two consecutive outpatients who had failed in the first-line eradication therapy were enrolled and second-line therapy was initiated with 10 mg rabeprazole, 750 mg amoxicillin, and 250 mg metronidazole twice daily. After they had been screened by hematological examination 1 week after initiation, the treatment was continued for 2 weeks after initiation in patients without hematological abnormality. Cure was essentially confirmed by the urea breath test.
  
  
  RESULTS
  After one patient was lost, hematological examination showed elevated serum aminotransferase in 14 of 81 patients. Although it was mild without clinical issues, they were ethically excluded from this study. In the remaining 67 patients and the lost patient, the eradication rate with 2-week therapy was 65/68 (96%, 95% confidence interval: 88-98%) by intention to treat analysis and 65/65 (100%, 94-100%) by per protocol analysis. The main adverse event was soft stools (39%), and no serious adverse event was observed.
  
  
  CONCLUSIONS
  This 2-week metronidazole-containing second-line therapy provides high efficacy in Japan where metronidazole resistance is rare.
authors.affiliation: Department of Intestinal Inflammation Research, Hyogo College of Medicine, Nishinomiya, Hyogo 663-8501, Japan. k-hori@hyo-med.ac.jp
authors.forename: Kazutoshi
authors.initials: K
authors.lastname: Hori
authors.forename: Hiroto
authors.initials: H
authors.lastname: Miwa
authors.forename: Takayuki
authors.initials: T
authors.lastname: Matsumoto
mesh_terms: D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000658:Amoxicillin / Q000008:administration & dosage* / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D044466:Asian People; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects; D006801:Humans; D007564:Japan; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D011446:Prospective Studies; D064750:Rabeprazole; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000900:Anti-Bacterial Agents; D008795:Metronidazole; D064750:Rabeprazole; D000658:Amoxicillin