Prospective double-blind trial of duodenal ulcer relapse after eradication of Campylobacter pylori

Lancet. 1988 Dec 24-31;2(8626-8627):1437-42. doi: 10.1016/s0140-6736(88)90929-4.

Abstract

100 consecutive patients with both duodenal ulcer and Campylobacter pylori infection were followed up to see whether eradication of C pylori affected ulcer healing or relapse. Patients were randomly assigned to 8 weeks of treatment with cimetidine or colloidal bismuth subcitrate (CBS), with tinidazole or placebo being given concurrently from days 1 to 10, inclusive. Endoscopy, biopsy, and culture were done at entry, in weeks 10, 22, 34, and 62, and whenever symptoms recurred. There was no maintenance therapy. C pylori persisted in all of the cimetidine-treated patients and in 95% of those treated with cimetidine/tinidazole, but was eradicated in 27% of the CBS/placebo group and 70% of the CBS/tinidazole group. When C pylori persisted, 61% of duodenal ulcers healed and 84% relapsed. When C pylori was cleared 92% of ulcers healed (p less than 0.001) and only 21% relapsed during the 12 month follow-up period (p less than 0.0001).

Publication types

  • Clinical Trial
  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Ulcer Agents / therapeutic use*
  • Campylobacter / isolation & purification
  • Campylobacter Infections / complications
  • Campylobacter Infections / drug therapy*
  • Cimetidine / therapeutic use
  • Double-Blind Method
  • Drug Therapy, Combination
  • Duodenal Ulcer / complications
  • Duodenal Ulcer / drug therapy*
  • Female
  • Gastric Mucosa / microbiology
  • Gastritis / drug therapy*
  • Gastritis / etiology
  • Humans
  • Male
  • Middle Aged
  • Organometallic Compounds / therapeutic use
  • Prospective Studies
  • Recurrence
  • Tinidazole / therapeutic use

Substances

  • Anti-Ulcer Agents
  • Organometallic Compounds
  • Tinidazole
  • Cimetidine
  • bismuth tripotassium dicitrate