title: 7-day rescue therapy with ranitidine bismuth citrate after Helicobacter pylori treatment failure.
abstract: BACKGROUND
  Quadruple rescue therapy requires a complex scheme with four drugs.
  
  
  OBJECTIVE
  To evaluate the efficacy of ranitidine bismuth citrate-tetracycline-metronidazole rescue regimen, and to compare two different metronidazole dose schemes.
  
  
  METHODS
  Prospective multicentre study including proton-pump inhibitor + clarithromycin + amoxicillin failures. Rescue regimen included two 7-day treatment: (i) ranitidine bismuth citrate (400 mg b.d.)-tetracycline (500 mg q.d.s.)-metronidazole (500 mg t.d.s.; RTM1); or (ii) the same regimen but with metronidazole 250 mg q.d.s. (RTM2). Eradication was confirmed with (13)C-urea breath test.
  
  
  RESULTS
  A total of 150 patients were included (58 RTM1, 92 RTM2). All patients but two (one in each group) returned after treatment. About 86% in group RTM1 and 95% in RTM2 correctly took all the medications (P = 0.076). Per-protocol eradication rates with RTM1 and RTM2 were 74 (95% CI: 60-84) and 69% (59-78). The intention-to-treat eradication rates were 64 (51-75) and 70% (59-78; P > 0.05). The type of regimen was not associated with eradication in the multivariate analysis. Adverse effects were more frequent with RTM1 (41%) than with RTM2 (30%; P > 0.05).
  
  
  CONCLUSIONS
  Seven-day triple rescue therapy with ranitidine bismuth citrate-tetracycline-metronidazole is effective for Helicobacter pylori eradication, and represents an encouraging alternative to quadruple therapy, with the advantage of simplicity. The administration of metronidazole every 6 h (together with tetracycline), and at a low dose (250 mg), achieves similar efficacy and is probably associated with a better compliance and a lower incidence of adverse effects.
authors.affiliation: Servicio de Aparato Digestivo, Hospital Universitario de la Princesa, Madrid, Spain. gisbert@meditex.es
authors.forename: J P
authors.initials: JP
authors.lastname: Gisbert
authors.forename: J
authors.initials: J
authors.lastname: Fuentes
authors.forename: D
authors.initials: D
authors.lastname: Carpio
authors.forename: L
authors.initials: L
authors.lastname: Tito
authors.forename: J
authors.initials: J
authors.lastname: Guardiola
authors.forename: A
authors.initials: A
authors.lastname: Tomas
authors.forename: D
authors.initials: D
authors.lastname: Olivares
authors.forename: X
authors.initials: X
authors.lastname: Calvet
mesh_terms: D000328:Adult; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001729:Bismuth / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004338:Drug Combinations; D004359:Drug Therapy, Combination / Q000627:therapeutic use; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006635:Histamine H2 Antagonists / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008795:Metronidazole / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D011446:Prospective Studies; D011899:Ranitidine / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D013752:Tetracycline / Q000627:therapeutic use; D017211:Treatment Failure
chemical_list: D000897:Anti-Ulcer Agents; D004338:Drug Combinations; D006635:Histamine H2 Antagonists; D008795:Metronidazole; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D013752:Tetracycline; D001729:Bismuth