OBJECTIVES: We studied prospectively in a single-blind controlled manner the efficacy of 4-wk triple-antibiotic therapy, with amoxicillin (500 mg p.o., t.i.d.), metronidazole (250 mg p.o., t.i.d.), and bismuth subsalicylate tablets (524 mg p.o., q.i.d.), plus omeprazole (20 mg p.o., q.d.) and compared it with omeprazole (id) in the treatment of duodenal ulcer (DU) patients colonized with Helicobacter pylori. METHODS:One hundred DU patients were entered prospectively over a 12-month period. Fifty-seven of them received triple therapy plus omeprazole and 43 received omeprazole alone. Clinical, endoscopic, and bacteriological evaluations were performed on admission and at 28 days, 4, 8, and 12 months after treatment. RESULTS: After 4-wk treatment (day 28), the ulcer healing rate was high, but there was no significant difference between rates in the triple therapy and omeprazole groups (99% vs. 91%). In contrast, the long-term DU recurrence rate after 12-month follow-up was significantly lower (p > 0.01) for triple therapy (3/57, 5%), compared with omeprazole (34/43, 79%). The difference (higher relapse rate for omeprazole-treated patients) was significant (p < 0.001) by the second evaluation, 4 months after treatment. The eradication rate of H. pylori was also significantly higher among DU patients treated with triple therapy (p < 0.001) during all prospective evaluations, grand mean, 82% (range 82-87%), compared with the omeprazole-treated group, in which there were no cases in which H. pylori was eradicated. Follow-up revealed that 2/47 H. pylori-eradicated patients became reinfected after 1 yr, giving a reinfection rate of 4.2 patient/yr. CONCLUSIONS: Four-week triple-antibiotic therapy plus omeprazole constitutes an adequate alternative for treatment of Chilean DU patients.
RCT Entities:
OBJECTIVES: We studied prospectively in a single-blind controlled manner the efficacy of 4-wk triple-antibiotic therapy, with amoxicillin (500 mg p.o., t.i.d.), metronidazole (250 mg p.o., t.i.d.), and bismuth subsalicylate tablets (524 mg p.o., q.i.d.), plus omeprazole (20 mg p.o., q.d.) and compared it with omeprazole (id) in the treatment of duodenal ulcer (DU) patients colonized with Helicobacter pylori. METHODS: One hundred DU patients were entered prospectively over a 12-month period. Fifty-seven of them received triple therapy plus omeprazole and 43 received omeprazole alone. Clinical, endoscopic, and bacteriological evaluations were performed on admission and at 28 days, 4, 8, and 12 months after treatment. RESULTS: After 4-wk treatment (day 28), the ulcer healing rate was high, but there was no significant difference between rates in the triple therapy and omeprazole groups (99% vs. 91%). In contrast, the long-term DU recurrence rate after 12-month follow-up was significantly lower (p > 0.01) for triple therapy (3/57, 5%), compared with omeprazole (34/43, 79%). The difference (higher relapse rate for omeprazole-treated patients) was significant (p < 0.001) by the second evaluation, 4 months after treatment. The eradication rate of H. pylori was also significantly higher among DU patients treated with triple therapy (p < 0.001) during all prospective evaluations, grand mean, 82% (range 82-87%), compared with the omeprazole-treated group, in which there were no cases in which H. pylori was eradicated. Follow-up revealed that 2/47 H. pylori-eradicated patients became reinfected after 1 yr, giving a reinfection rate of 4.2 patient/yr. CONCLUSIONS: Four-week triple-antibiotic therapy plus omeprazole constitutes an adequate alternative for treatment of Chilean DU patients.