Impact of colloidal bismuth subnitrate in the eradication rates of Helicobacter pylori infection-associated duodenal ulcer using a short treatment regimen with omeprazole and clarithromycin: a randomized study.

UNLABELLED: Recent trials have shown that duodenal ulcers treated by H2-blockers heal faster if Helicobacter pylori is eradicated concurrently.
OBJECTIVES: To evaluate the efficacy of a short treatment regimen in H. pylori eradication and ulcer healing and to assess the impact of colloidal bismuth subnitrate (CBS) in H. pylori eradication rate.
METHODS: Sixty-one patients with H. pylori-associated duodenal ulcer were randomized in two short treatment groups. Group A patients (31) were given omeprazole 20 mg b.i.d. x 8 days. Clarithromycin (500 mg, b.i.d.) and CBS (120 mg, q.i.d.) were added 24 h after starting omeprazole and were given for 7 days. Group B patients (30) were treated as group A patients but without CBS. Endoscopies were performed at entry and 4 wk after the end of treatment. Presence of H. pylori was assessed at each endoscopy by urease test, and biopsy specimens were examined for histological evidence of gastritis and by Gram stain and culture for H. pylori infection. No patient received follow-up treatment.
RESULTS: H. pylori eradication rates were achieved in 25/31 (80.6%) group A patients and in 15/30 (50%) in group B patients (p = 0.012). Duodenal ulcer healing was documented in 30/31 (96.8%) patients in group A and in 25/30 (83%) patients in group B.
CONCLUSIONS: The addition of CBS to the double therapy with omeprazole and clarithromycin substantially improves the eradication rate of H. pylori. Short therapy with omeprazole 20 mg/b.i.d., clarithromycin 500 mg/b.i.d., and CBS 120 mg/q.i.d. is a safe, well tolerated combination that achieves a 80.6% eradication rate of H. pylori and duodenal ulcer healing rates as good as those achieved by omeprazole 20 mg/d when given for 4 wk.

RCT Entities:   Population Interventions Outcomes