title: Impact of quadruple regimen of clarithromycin added to metronidazole-containing triple therapy against Helicobacter pylori infection following clarithromycin-containing triple-therapy failure.
abstract: BACKGROUND
  The establishment of an optimal second-line regimen for Helicobacter pylori infection is required. Although quadruple therapy should overcome resistance to either clarithromycin or metronidazole, the effects of a quadruple regimen in second-line therapy are unknown. This study aims to evaluate the efficacy of triple therapy composed of proton pump inhibitor/amoxicillin plus metronidazole with the combined additive effects of clarithromycin as a second-line quadruple therapy against H. pylori infection.
  
  
  METHODS
  Participants were 104 patients in whom first-line therapy containing proton pump inhibitor-amoxicillin-clarithromycin failed. Before starting second-line therapy, patients underwent endoscopy to obtain H. pylori strain for antibiotic susceptibility tests. Patients were randomized to receive rabeprazole (10 mg), amoxicillin (750 mg), and metronidazole (250 mg), either with clarithromycin (200 mg; RAMC group) or without (RAM group); all treatments were administered twice daily for 7 days. H. pylori eradication was confirmed by (13)C-urea breath tests performed 2 to 3 months post-therapy.
  
  
  RESULTS
  As shown by intention-to-treat/per-protocol analyses, the cure rates for H. pylori infection were 88.5%/93.9% and 82.7%/84.3% for the RAMC and RAM groups. Although the study probably had an insufficient power to show a significant difference between the cure rates of the two regimens, the eradication rates showed a clear trend in favor of the RAMC group. There were no severe side-effects in any group.
  
  
  CONCLUSIONS
  In Japan, the RAMC regimen is thought to be a promising alternative strategy for second-line eradication of H. pylori infection.
authors.affiliation: Department of Internal Medicine, Division of Gastroenterology, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo. nobue@nms.ac.jp
authors.forename: Nobue
authors.initials: N
authors.lastname: Ueki
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Miyake
authors.forename: Masafumi
authors.initials: M
authors.lastname: Kusunoki
authors.forename: Tomotaka
authors.initials: T
authors.lastname: Shindo
authors.forename: Tetsuro
authors.initials: T
authors.lastname: Kawagoe
authors.forename: Seiji
authors.initials: S
authors.lastname: Futagami
authors.forename: Taku
authors.initials: T
authors.lastname: Tsukui
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Inagaki
authors.forename: Choitsu
authors.initials: C
authors.lastname: Sakamoto
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000627:therapeutic use; D017291:Clarithromycin / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori / Q000187:drug effects*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000627:therapeutic use*; D008875:Middle Aged; D011446:Prospective Studies; D054328:Proton Pump Inhibitors / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D054328:Proton Pump Inhibitors; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin