title: A prospective, randomized study of quadruple therapy and high-dose dual therapy for treatment of Helicobacter pylori resistant to both metronidazole and clarithromycin.
abstract: OBJECTIVE
  Failure of primary anti-H. pylori therapy results in a high rate of antimicrobial resistance. Here, we investigated the efficacy of high-dose dual therapy and quadruple therapy as salvage treatments for eradication of H. pylori resistant to both metronidazole and clarithromycin.
  
  
  METHODS
  Patients with at least one treatment failure and infected with H. pylori resistant to both metronidazole and clarithromycin, were randomized to receive either omeprazole 4 x 40 mg and amoxicillin 4 x 750 mg; or omeprazole 2 x 20 mg, bismuthcitrate 4 x 107 mg, metronidazole 4 x 500 mg and tetracycline 4 x 500 mg. Both regimens were given for 14 days. In cases of persistent infection, a cross-over therapy was performed.
  
  
  RESULTS
  Eighty-four patients were randomized. Cure of H. pylori infection was achieved in 31 patients after dual therapy and in 35 patients after quadruple therapy (per protocol: 83.8% (95% CI, 67.9-93.8) and 92.1% (95% CI, 78.6-98.3), respectively (p=0.71); intention to treat: 75.6% (95% CI: 59.7-87.6) and 81.4% (95% CI: 66.6-91.6), respectively (p=0.60)). Cross-over therapy was performed in six of nine patients, four of whom were cured of the infection.
  
  
  CONCLUSIONS
  Both high-dose dual therapy and quadruple therapy are effective in curing H. pylori infection resistant to both metronidazole and clarithromycin in patients who experienced previous treatment failures.
authors.affiliation: Medical Department I, Technical University Hospital, Dresden, Germany.
authors.forename: Stephan
authors.initials: S
authors.lastname: Miehlke
authors.forename: Christian
authors.initials: C
authors.lastname: Kirsch
authors.forename: Wulf
authors.initials: W
authors.lastname: Schneider-Brachert
authors.forename: Christian
authors.initials: C
authors.lastname: Haferland
authors.forename: Michael
authors.initials: M
authors.lastname: Neumeyer
authors.forename: Elke
authors.initials: E
authors.lastname: Bästlein
authors.forename: Jens
authors.initials: J
authors.lastname: Papke
authors.forename: Enno
authors.initials: E
authors.lastname: Jacobs
authors.forename: Michael
authors.initials: M
authors.lastname: Vieth
authors.forename: Manfred
authors.initials: M
authors.lastname: Stolte
authors.forename: Norbert
authors.initials: N
authors.lastname: Lehn
authors.forename: Ekkehard
authors.initials: E
authors.lastname: Bayerdörffer
mesh_terms: D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000627:therapeutic use; D017291:Clarithromycin / Q000494:pharmacology; D024901:Drug Resistance, Multiple, Bacterial; D004359:Drug Therapy, Combination; D005260:Female; D005753:Gastric Mucosa / Q000382:microbiology / Q000473:pathology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori / Q000187:drug effects* / Q000235:genetics; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage / Q000627:therapeutic use; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000627:therapeutic use; D010406:Penicillins / Q000627:therapeutic use; D013752:Tetracycline / Q000008:administration & dosage / Q000627:therapeutic use; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D010406:Penicillins; D008795:Metronidazole; D000658:Amoxicillin; D014508:Urea; D013752:Tetracycline; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole; D001729:Bismuth