title: Five-day regimens containing ranitidine bismuth citrate plus high-dose clarithromycin and either amoxycillin or tinidazole for Helicobacter pylori infection.
abstract: BACKGROUND
  Ranitidine bismuth citrate (RBC)-based triple therapies for a period of 7 days have proved to be an effective treatment for Helicobacter pylori.
  
  
  OBJECTIVE
  To investigate the eradication efficacy, safety profile and patient compliance of two RBC-based triple therapies given for 5 days.
  
  
  METHODS
  Eighty H. pylori-positive patients with dyspeptic symptoms, referred to us for gastroscopy, were consecutively enrolled in this prospective, randomized, open-label study. These patients were randomly assigned to receive a 5-day course of RBC 400 mg b.d. plus clarithromycin 500 mg b.d. and either tinidazole 500 mg b.d. (RBCCT group) or amoxycillin 1 g b.d. (RBCCA group). The H. pylori status was assessed by means of histology and rapid urease test at entry, and by 13C-urea breath test 8 weeks after the completion of treatment.
  
  
  RESULTS
  All enrolled patients completed the study. Thirty-seven of 40 patients treated with RBCCT (both PP and ITT analysis: 93%; 95% CI: 80-98%) and 35 of 40 in the RBCCA group (both PP and ITT analysis: 88%; 95% CI: 73-96%) returned H. pylori-negative. Slight or mild side-effects occurred in 4/40 patients (10%) in the RBCCT group and in 5/40 (12%) in the RBCCA group.
  
  
  CONCLUSIONS
  This is the first study demonstrating the efficacy of RBC-based triple therapies given for only 5 days. RBC regimens containing high-dose clarithromycin and either amoxycillin or tinidazole prove to be well tolerated, safe and preserve good eradication rates even when administered for a shorter than conventional duration.
authors.affiliation: Department of Internal Medicine and Gastroenterology, Catholic University of Rome, Italy. dora.erasmo@tiscalinet.it
authors.forename: G
authors.initials: G
authors.lastname: Cammarota
authors.forename: O
authors.initials: O
authors.lastname: Cannizzaro
authors.forename: V
authors.initials: V
authors.lastname: Ojetti
authors.forename: R
authors.initials: R
authors.lastname: Cianci
authors.forename: A
authors.initials: A
authors.lastname: Pastorelli
authors.forename: A
authors.initials: A
authors.lastname: Armuzzi
authors.forename: N
authors.initials: N
authors.lastname: Gentiloni
authors.forename: A
authors.initials: A
authors.lastname: Gasbarrini
authors.forename: G
authors.initials: G
authors.lastname: Pirozzi
authors.forename: G
authors.initials: G
authors.lastname: Gasbarrini
mesh_terms: D000658:Amoxicillin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; 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*; D001944:Breath Tests; D017291:Clarithromycin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004415:Dyspepsia / Q000188:drug therapy / Q000209:etiology; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D016480:Helicobacter pylori; D006801:Humans; D010406:Penicillins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011899:Ranitidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D014011:Tinidazole / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014508:Urea / Q000032:analysis
chemical_list: D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D010406:Penicillins; D014011:Tinidazole; C073340:ranitidine bismuth citrate; D000658:Amoxicillin; D011899:Ranitidine; D014508:Urea; D017291:Clarithromycin; D001729:Bismuth