Colloidal bismuth subcitrate, ranitidine, and ranitidine plus metronidazole in the treatment of duodenal ulcer and Helicobacter pylori infection: a controlled and prospective study.

A controlled, prospective clinical trial of colloidal bismuth subcitrate (CBS), ranitidine and ranitidine plus metronidazole for the treatment of duodenal ulcer (DU) is reported here, with evaluation of the possible pathogenic role of Helicobacter pylori (HP) on DU in a six-month follow-up. A total of 42 patients with active DU on endoscopy were randomly selected to receive oral CBS (300 mg 1 hour before each meal, and at bedtime, n = 16), ranitidine (150 mg bid; n = 12) or ranitidine (150mg b.i.d.) plus metronidazole (250 mg t.i.d; n = 14) treatment for one month. Ulcer healing was endoscopically evaluated. Healed patients received another two-week treatment; unhealed subjects received another one-month treatment with the same agents. Healed patients were followed endoscopically at 1, 3, and 6 months after the cessation of medication without maintenance therapy. Unhealed or relapsed subjects were excluded. To assess HP status, during each endoscopy two prepyloric mucosal biopsies were taken for urease testing and culture of HP. The prevalence of HP in patients with DU was 95.2%. Data showed that those treated with CBS had a lower DU healing rate than those treated with ranitidine or ranitidine plus metronidazole after the one-month treatment, but there was no statistical significance in the DU healing rates after the two-month treatment, and at follow-up six months after the cessation of medication. After one month of treatment those treated by CBS showed the highest rates of HP clearance on gastric antral mucosa among the three groups.(ABSTRACT TRUNCATED AT 250 WORDS)