High dose omeprazole treatment combined with amoxicillin eradicates Helicobacter pylori

Objective: To test the hypothesis that omeprazole facilitates the eradication of Helicobacter pylori. This paper seeks to continue this hypothesis and to search for treatment with a low incidence of side effects. Design and patients: Sixty patients with a duodenal ulcer and H. pylori colonization were randomly assigned to either omeprazole (OME) 40 mg twice daily for 10 days followed by 20 mg for a total duration of 6 weeks (n = 30), or omeprazole 40 mg twice daily with amoxicillin (AMO) 1000 mg (OME + AMO) for the first 10 days followed by 20 mg OME only for a similar 6-week period (n = 30). Results: Four patients on OME monotherapy and three patients on OME + AMO had to be withdrawn because of lack of compliance (0/1; OME/OME + AMO), missing follow-up control examinations (2/1; OME/OME + AMO), side effects (1/0; OME/OME + AMO), or negative H. pylori status at the time of recruitment (1/1; OME/OME + AMO). All duodenal ulcers healed in patients on OME + AMO and 25 out of 26 (96%) duodenal ulcers healed in patients on OME monotherapy. H. pylori was eradicated in 22 out of 27 patients (82%) receiving OME + AMO; no ulcer relapses occurred within 9 months in these 22 patients. In the five patients who remained H. pylori-positive after OME + AMO therapy relapse was not detected during a 9-month follow-up. In the OME group all patients remained H. pylori positive and duodenal ulcers relapsed in 12 out of 25 patients (48%) within a median follow-up of 9 months. Side effects were absent in the OME + AMO group; one patient with OME had severe headaches. Conclusions: The results further support preliminary data that H. pylori eradication may heal duodenal ulcer disease. The well tolerated OME + AMO regimen which carried a high H. pylori eradication rate makes it a potential therapeutic agent for the healing of duodenal ulcer disease.