Seven-day triple therapy with ranitidine bismuth citrate or omeprazole and two antibiotics for eradication of Helicobacter pylori in duodenal ulcer: a multicentre, randomized, single-blind study

Aliment Pharmacol Ther. 2000 Mar;14(3):325-30. doi: 10.1046/j.1365-2036.2000.00708.x.

Abstract

Aim: To investigate the efficacy of a 1-week triple therapy with amoxycillin, clarithromycin, and omeprazole or ranitidine bismuth citrate (RBC) in curing Helicobacter pylori infection and healing duodenal ulcers.

Methods: One hundred and ninety-two consecutive out-patients with duodenal ulcer, in whom H. pylori infection was confirmed by histology and a urease biopsy test, were randomly assigned to a 1-week treatment with either 400 mg b.d. ranitidine bismuth citrate (RAC group) or 20 mg omeprazole b.d. (OAC group) in combination with 1 g amoxycillin b.d. and 500 mg clarithromycin b.d.

Results: Eradication of H. pylori was successful in 77% (per protocol) and 61% (intention-to-treat) of the patients in the RAC group and in 79% (per protocol) and 70% (intention-to-treat) of those in the OAC group. The difference was not significant. Per protocol analysis showed ulcers were healed in 97% of patients in the RAC group and 96% in the OAC group. Adverse effects were seen in four patients in each group: they caused discontinuation of the therapy in one patient of the OAC group.

Conclusions: Eradication rates obtained in this study were lower than those expected on the basis of previously reported studies. The two 1-week treatment regimens were equally effective in healing H. pylori associated duodenal ulcer disease.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Amoxicillin / therapeutic use
  • Anti-Bacterial Agents / therapeutic use*
  • Anti-Ulcer Agents / therapeutic use*
  • Bismuth / therapeutic use*
  • Clarithromycin / therapeutic use
  • Duodenal Ulcer / drug therapy*
  • Duodenal Ulcer / microbiology
  • Female
  • Helicobacter Infections / drug therapy*
  • Helicobacter Infections / microbiology
  • Helicobacter pylori*
  • Humans
  • Male
  • Middle Aged
  • Omeprazole / therapeutic use
  • Patient Compliance
  • Penicillins / therapeutic use
  • Prospective Studies
  • Ranitidine / analogs & derivatives*
  • Ranitidine / therapeutic use*
  • Single-Blind Method

Substances

  • Anti-Bacterial Agents
  • Anti-Ulcer Agents
  • Penicillins
  • ranitidine bismuth citrate
  • Amoxicillin
  • Ranitidine
  • Clarithromycin
  • Omeprazole
  • Bismuth