OBJECTIVE: To establish the efficacy of omeprazole combined with two antibiotics for Helicobacter pylori eradication and duodenal ulcer relapse. PATIENTS: Thirty-seven patients with endoscopically proven duodenal ulcer and H. pylori infection. METHODS: Treatment consisted of 20 mg omeprazole daily for 4 weeks with the addition, during the second and third weeks, of amoxycillin (1 g three times daily) and metronidazole (1 g daily) (group A) or placebo (group B). Endoscopy and biopsy to assess ulcer recurrence and H. pylori status were performed at entry to the study, after 4 weeks of therapy, and 1 and 6 months after treatment. RESULTS:Duodenal ulcers healed in all patients. H. pylori infection was eradicated in 15 (79%) out of 19 patients in group A and one (6%) out of 16 patients in group B (P < 0.01). One patient in each of the groups was lost to follow-up after 6 weeks. During the 6 month follow-up period, duodenal ulcers recurred in three of the 16 patients with H. pylori eradication, compared with 16 of the 19 patients with persistent H. pylori infection (19 versus 84%; P < 0.01). CONCLUSION: The combination of omeprazole with amoxycillin and metronidazole is effective in H. pylori eradication. This triple therapy, which eradicates H. pylori, also significantly reduced duodenal ulcer relapse.
RCT Entities:
OBJECTIVE: To establish the efficacy of omeprazole combined with two antibiotics for Helicobacter pylori eradication and duodenal ulcer relapse. PATIENTS: Thirty-seven patients with endoscopically proven duodenal ulcer and H. pyloriinfection. METHODS: Treatment consisted of 20 mg omeprazole daily for 4 weeks with the addition, during the second and third weeks, of amoxycillin (1 g three times daily) and metronidazole (1 g daily) (group A) or placebo (group B). Endoscopy and biopsy to assess ulcer recurrence and H. pylori status were performed at entry to the study, after 4 weeks of therapy, and 1 and 6 months after treatment. RESULTS: Duodenal ulcers healed in all patients. H. pyloriinfection was eradicated in 15 (79%) out of 19 patients in group A and one (6%) out of 16 patients in group B (P < 0.01). One patient in each of the groups was lost to follow-up after 6 weeks. During the 6 month follow-up period, duodenal ulcers recurred in three of the 16 patients with H. pylori eradication, compared with 16 of the 19 patients with persistent H. pyloriinfection (19 versus 84%; P < 0.01). CONCLUSION: The combination of omeprazole with amoxycillin and metronidazole is effective in H. pylori eradication. This triple therapy, which eradicates H. pylori, also significantly reduced duodenal ulcer relapse.