title: Randomized clinical trial comparing two one-week triple-therapy regimens for the eradication of Helicobacter pylori infection and duodenal ulcer healing.
abstract: OBJECTIVE
  One-week triple therapy has been shown to be effective in Helicobacter pylori eradication and duodenal ulcer healing. However, the optimal therapeutic combination has not yet been identified. Bismuth-containing regimens have the advantage of requiring only one antibiotic. It has been suggested that high doses of omeprazole improve the bactericidal efficacy of antimicrobial regimens against H. pylori. We evaluated the efficacy of two 1-wk triple-therapy regimens for H. pylori eradication and duodenal ulcer healing.
  
  
  METHODS
  On an intention-to-treat basis, 182 patients with H. pylori-associated duodenal ulcer were randomized. Group OCB patients (n = 91) were given omeprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and colloidal bismuth subcitrate 120 mg q.i.d. for 7 days. Group OCA patients (n = 91) were treated with omeprazole and clarithromycin at the same doses plus amoxicillin 1 g b.i.d., also for 7 days. Endoscopies were performed at entry and at 4 wk after the end of treatment. The presence of H. pylori was assessed by urease test, histology, Gram stain, and culture. No patient received follow-up treatment.
  
  
  RESULTS
  H. pylori eradication rates achieved in the OCB and OCA groups were similar whether by intention-to-treat (82.4% vs 88.9% ;p = 0.21) or per protocol analysis (83.3% vs 89.9%; p = 0.19). Duodenal ulcer healing rates also were the same for OCB and OCA in intention-to treat (91.2% vs 91.1%) and per protocol analysis (92.2% vs 92.1%), respectively (p = 0.98).
  
  
  CONCLUSIONS
  High rates of H. pylori eradication and duodenal ulcer healing were obtained with both short-treatment regimens, which were safe and well-tolerated. Colloidal bismuth subcitrate seems to be a good alternative to amoxicillin in the triple-therapy combination with omeprazole and clarithromycin. The omeprazole dose does not seem to play a major role in H. pylori eradication in these therapeutic combinations.
authors.affiliation: Department of Gastroenterology, Hospital Mútua de Terrassa, University of Barcelona, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Forné
authors.forename: J M
authors.initials: JM
authors.lastname: Viver
authors.forename: M
authors.initials: M
authors.lastname: Esteve
authors.forename: F
authors.initials: F
authors.lastname: Fernández-Bañares
authors.forename: J
authors.initials: J
authors.lastname: Lite
authors.forename: J C
authors.initials: JC
authors.lastname: Espinós
authors.forename: S
authors.initials: S
authors.lastname: Quintana
authors.forename: A
authors.initials: A
authors.lastname: Salas
authors.forename: J
authors.initials: J
authors.lastname: Garau
mesh_terms: D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage; D000863:Antacids / Q000008:administration & dosage; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage; D017291:Clarithromycin / Q000008:administration & dosage; D003627:Data Interpretation, Statistical; D004359:Drug Therapy, Combination; D004381:Duodenal Ulcer / Q000188:drug therapy*; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000008:administration & dosage; D009942:Organometallic Compounds / Q000008:administration & dosage; D010406:Penicillins / Q000008:administration & dosage; D013997:Time Factors
chemical_list: D000863:Antacids; D000900:Anti-Bacterial Agents; D000897:Anti-Ulcer Agents; D009942:Organometallic Compounds; D010406:Penicillins; D000658:Amoxicillin; D017291:Clarithromycin; C002791:bismuth tripotassium dicitrate; D009853:Omeprazole