CLINICAL TRIAL
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL
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Ranitidine versus colloidal bismuth subcitrate in combination with amoxicillin and metronidazole for eradicating Helicobacter pylori in patients with duodenal ulcer.

One hundred twenty-two patients were randomly assigned to three groups of treatment (A, B, and C), with (1) ranitidine (300 mg q.d. for 6 weeks), (2) ranitidine (300 mg q.d. for 6 weeks) with amoxicillin (500 mg t.i.d.) and metronidazole (500 mg b.i.d.) for the first 12 days, or (3) colloidal bismuth subcitrate (120 mg q.i.d. for 6 weeks) with amoxicillin and metronidazole (at same dosages as in the latter group). Six weeks after the beginning of treatment, an endoscopy showed that ulcers had healed in 49 of 52 patients (94.2%) from whom Helicobacter pylori had been eradicated and in 59 of 70 patients (84.3%) from whom it had not (NS). The rates of H. pylori eradication in groups A, B, and C were zero, 47.5%, and 86.8%, respectively. At 6, 12, and 18 months, an endoscopy was repeated for monitoring ulcer recurrence and H. pylori status. Reinfection rates at 6 months were 42.1% and 15.1% in groups B and C, respectively (P < .05). At 18 months, ulcers recurred in 82.9% (63) of 76 patients with noneradicated H. pylori infection, vs. 5.7% (2) of 35 patients without H. pylori infection (P < .001). We conclude that colloidal bismuth subcitrate is more effective for eradication of H. pylori than ranitidine when given with amoxicillin plus metronidazole for the treatment of duodenal ulcer, as both early reinfection and ulcer recurrence are diminished.

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