title: Ranitidine bismuth citrate plus clarithromycin 7-day regimen is effective in eradicating Helicobacter pylori in patients with duodenal ulcer.
abstract: BACKGROUND
  No clinical study has been performed to-date to evaluate the efficacy of the dual therapy of ranitidine bismuth citrate (RBC) plus clarithromycin (C) 500 mg b.d. given for 7 days for the eradication of H. pylori.
  
  
  OBJECTIVE
  To assess the eradication rates achieved by treatment with RBC 400 mg b.d. for 28 days combined with clarithromycin 500 mg b.d. for 7 days in H. pylori-positive duodenal ulcer patients.
  
  
  METHODS
  One hundred and twelve H. pylori-positive patients with endoscopically proven active duodenal ulcer were included in a multicentre, open, randomized trial. H. pylori infection was initially detected by CLO-test and histology on antral and corpus biopsies, and by 13C-urea breath test (UBT). Patients were included if at least two of the tests were positive for H. pylori infection. Patients were randomized to receive RBC 400 mg b.d. for 4 weeks combined with clarithromycin 500 mg b.d. for the first 7 days (Group A) or 14 days (Group B). A second endoscopy was performed at least 28 days after the end of therapy for the assessment of ulcer healing and H. pylori infection. Eradication was assumed if all the tests (CLO-test, histology and UBT) were negative for H. pylori.
  
  
  RESULTS
  Fifty patients in Group A and 55 in Group B were assessed for H. pylori eradication and ulcer healing. The eradication rates according to intention-to-treat analysis were 75% in Group A and 80% in Group B. Considering only those patients with evaluable data at least 28 days after the end of therapy, H. pylori eradication was achieved in 84% and 82% in Group A and B, respectively. No statistically significant difference in eradication was found between the two groups by Mantel-Haenszel test. Only one patient, in Group A, was withdrawn because of adverse events (epigastric pain and pruritus).
authors.affiliation: Gastroenterology Unit, Policlinico S. Orsola, Bologna, Italy.
authors.forename: P
authors.initials: P
authors.lastname: Pozzato
authors.forename: M
authors.initials: M
authors.lastname: Zagari
authors.forename: A
authors.initials: A
authors.lastname: Cardelli
authors.forename: F A
authors.initials: FA
authors.lastname: Catalano
authors.forename: A
authors.initials: A
authors.lastname: Giglio
authors.forename: F
authors.initials: F
authors.lastname: Lami
authors.forename: A
authors.initials: A
authors.lastname: Pilotto
authors.forename: G
authors.initials: G
authors.lastname: Scarpulla
authors.forename: A
authors.initials: A
authors.lastname: Spadaccini
authors.forename: D
authors.initials: D
authors.lastname: Susi
authors.forename: R
authors.initials: R
authors.lastname: Tosatto
authors.forename: A
authors.initials: A
authors.lastname: Olivieri
authors.forename: F
authors.initials: F
authors.lastname: Bazzoli
authors.forename: E
authors.initials: E
authors.lastname: Roda
mesh_terms: D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001729:Bismuth / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; C073340:ranitidine bismuth citrate; D011899:Ranitidine; D017291:Clarithromycin; D001729:Bismuth