OBJECTIVE: to study the ulcer recurrence rate of Helicobacter pylori-positive duodenal ulcers at 1 yr after eradication of the bacteria by triple therapy. METHOD:Patients with H. pylori-positive duodenal ulcers were randomized to receive either triple therapy for 1 wk plus omeprazole for 4 wk (Triple+OMP) (n = 78), or omeprazole alone (OMP) for 4 wk (N = 77). Patients were followed up every 3 months for symptom enquiry. At 1 yr, all asymptomatic patients were invited to attend for gastroscopy. RESULTS: At 8 wk, 16 patients in the OMP group and four in the Triple+OMP group had an ulcer. During the 1-yr period, 12 patients in the OMP group and no patient in the Triple+OMP group developed symptomatic ulcers. At follow-up endoscopy at 1 yr, another 10 ulcers were detected in the OMP group and two in the Triple+OMP group. Fifteen patients in the OMP group and 13 in the Triple+OMP group were lost to follow-up. In total, ulcers were detected in 39 of 61 (64%) assessable patients in the OMP group, and in six of 65 (9%) assessable patients in the Triple+OMP group after 1 yr (chi 2 test: p < 0.001). Of the patients whose H. pylori were successfully eradicated by Triple+OMP at 8 wk, 90% remained H. pylori negative at 1 yr. CONCLUSION: Triple therapy for 1 wk eradicates H. pylori infection and significantly reduces duodenal ulcer relapses.
RCT Entities:
OBJECTIVE: to study the ulcer recurrence rate of Helicobacter pylori-positive duodenal ulcers at 1 yr after eradication of the bacteria by triple therapy. METHOD:Patients with H. pylori-positive duodenal ulcers were randomized to receive either triple therapy for 1 wk plus omeprazole for 4 wk (Triple+OMP) (n = 78), or omeprazole alone (OMP) for 4 wk (N = 77). Patients were followed up every 3 months for symptom enquiry. At 1 yr, all asymptomatic patients were invited to attend for gastroscopy. RESULTS: At 8 wk, 16 patients in the OMP group and four in the Triple+OMP group had an ulcer. During the 1-yr period, 12 patients in the OMP group and no patient in the Triple+OMP group developed symptomatic ulcers. At follow-up endoscopy at 1 yr, another 10 ulcers were detected in the OMP group and two in the Triple+OMP group. Fifteen patients in the OMP group and 13 in the Triple+OMP group were lost to follow-up. In total, ulcers were detected in 39 of 61 (64%) assessable patients in the OMP group, and in six of 65 (9%) assessable patients in the Triple+OMP group after 1 yr (chi 2 test: p < 0.001). Of the patients whose H. pylori were successfully eradicated by Triple+OMP at 8 wk, 90% remained H. pylori negative at 1 yr. CONCLUSION: Triple therapy for 1 wk eradicates H. pyloriinfection and significantly reduces duodenal ulcer relapses.