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Duodenal ulcer healing rates in a one-year follow-up study with ranitidine bismuth citrate and antibiotics.

AbstractBACKGROUND/AIMS:
The aim of this study was to determine the one-year outcome of an eradication therapy with ranitidine bismuth citrate and antibiotics in Helicobacter pylori-positive duodenal ulcer patients in respect to ulcer and Helicobacter pylori relapse rates.
METHODOLOGY:
This multicenter, randomized, double-blind study involved 648 duodenal ulcer patients and had been carried out to compare the following regimens: ranitidine bismuth citrate b.i.d. co-prescribed with either clarithromycin 250 mg q.i.d. or clarithromycin 500 mg b.i.d. or clarithromycin 500 mg b.i.d. plus metronidazole 400 mg b.i.d. for 2 weeks, followed by a further 14 days of treatment with ranitidine bismuth citrate 400 mg b.i.d. to facilitate ulcer healing. H. pylori eradication was assessed by 13C-urea breath test and histology at least 4 weeks, 26 weeks and 52 weeks after the end of treatment. Ulcer relapse and H. pylori status were assessed 4 weeks, 26 weeks and 52 weeks post-treatment or if ulcer symptoms recurred. For the remainder of the follow-up period only serious adverse events were collected.
RESULTS:
At 12 months data of 438 (69%) patients were evaluable. The observed H. pylori eradication rates were 88-91%. H. pylori relapse rates were 2.1% after 26 weeks and 3.9% after 52 weeks. At the week 26 visit 26 patients (5.6%) and at the week 52 visit 25 patients (5.7%) had documented gastroesophageal reflux disease.
CONCLUSIONS:
Our data confirm the reduction of duodenal ulcer relapses after the cure of Helicobacter pylori infection.
AuthorsH Wurzer, K D Bardhan, M Marcelino, J Jahnsen, M Allmaier
JournalHepato-gastroenterology (Hepatogastroenterology) 2001 Nov-Dec Vol. 48 Issue 42 Pg. 1641-7 ISSN: 0172-6390 [Print] Greece
PMID11813591 (Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
Chemical References
  • Anti-Bacterial Agents
  • Metronidazole
  • ranitidine bismuth citrate
  • Ranitidine
  • Clarithromycin
  • Bismuth
Topics
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Bacterial Agents (administration & dosage, therapeutic use)
  • Bismuth (therapeutic use)
  • Clarithromycin (administration & dosage, therapeutic use)
  • Double-Blind Method
  • Drug Therapy, Combination
  • Duodenal Ulcer (drug therapy, microbiology)
  • Helicobacter Infections (drug therapy)
  • Helicobacter pylori
  • Humans
  • Metronidazole (administration & dosage, therapeutic use)
  • Middle Aged
  • Ranitidine (analogs & derivatives, therapeutic use)
  • Secondary Prevention
  • Treatment Outcome

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