BACKGROUND: Helicobacter pylori is the main acquired factor in the pathogenesis of duodenal ulcer disease. METHODS: This multicentre study conducted in 32 general practice centres in the UK and Ireland was a double-blind, placebo-controlled, randomized, parallel-group comparison of triple therapy (n = 98: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, and metronidazole 400 mg t.d.s. for the first week) and dual therapy (n = 85: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, with placebo during the first week) for the eradication of H. pylori in patients with symptomatic duodenal ulcer disease. Patients who were successfully treated entered a follow-up phase for 12 months to assess symptomatic relapse and use of health-care resources. RESULTS:Eradication of H. pylori based on a second 13C-urea breath test was successful in 95% (95% confidence interval (CI) = 90-100%) of patients receiving omeprazole triple therapy and 53% (95% CI = 41-65%) of those receiving omeprazole dual therapy (P < 0.0001 between groups, all data available analysis). The all-patients-treated analysis gave eradication rates of 80 and 44% for omeprazole triple therapy and omeprazole dual therapy, respectively. Symptomatic relapse occurred in 16% (18/116) of the H. pylori-negative patients who entered the 12-month follow-up period, and there were significant reductions in the number of consultations, investigations and prescriptions relating to upper gastrointestinal symptoms compared with the 12 months prior to the eradication therapies (all P < 0.0001). The two treatment strategies were comparable in terms of the number of adverse events reported. CONCLUSIONS:Omeprazole triple therapy provides a highly effective treatment for the eradication of H. pylori infection in patients in general practice, with an adverse event profile similar to that seen with omeprazole dual therapy. The successful eradication of H. pylori with these omeprazole regimens results in a significant decrease in the use of health-care resources in the 12 months following treatment.
RCT Entities:
BACKGROUND:Helicobacter pylori is the main acquired factor in the pathogenesis of duodenal ulcer disease. METHODS: This multicentre study conducted in 32 general practice centres in the UK and Ireland was a double-blind, placebo-controlled, randomized, parallel-group comparison of triple therapy (n = 98: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, and metronidazole 400 mg t.d.s. for the first week) and dual therapy (n = 85: omeprazole 40 mg once daily and amoxycillin 1 g b.d. for 2 weeks, with placebo during the first week) for the eradication of H. pylori in patients with symptomatic duodenal ulcer disease. Patients who were successfully treated entered a follow-up phase for 12 months to assess symptomatic relapse and use of health-care resources. RESULTS: Eradication of H. pylori based on a second 13C-urea breath test was successful in 95% (95% confidence interval (CI) = 90-100%) of patients receiving omeprazole triple therapy and 53% (95% CI = 41-65%) of those receiving omeprazole dual therapy (P < 0.0001 between groups, all data available analysis). The all-patients-treated analysis gave eradication rates of 80 and 44% for omeprazole triple therapy and omeprazole dual therapy, respectively. Symptomatic relapse occurred in 16% (18/116) of the H. pylori-negative patients who entered the 12-month follow-up period, and there were significant reductions in the number of consultations, investigations and prescriptions relating to upper gastrointestinal symptoms compared with the 12 months prior to the eradication therapies (all P < 0.0001). The two treatment strategies were comparable in terms of the number of adverse events reported. CONCLUSIONS:Omeprazole triple therapy provides a highly effective treatment for the eradication of H. pyloriinfection in patients in general practice, with an adverse event profile similar to that seen with omeprazole dual therapy. The successful eradication of H. pylori with these omeprazole regimens results in a significant decrease in the use of health-care resources in the 12 months following treatment.