Medium- and high-dose omeprazole plus amoxicillin for eradication of Helicobacter pylori in duodenal ulcer disease.

The purpose of the present study was to investigate the Helicobacter pylori eradication potency of combined amoxicillin-omeprazole treatment in patients with duodenal ulcer disease and to compare the efficacy of two omeprazole and amoxicillin doses concerning H. pylori eradication, ulcer healing, pain relief, and safety. Ninety patients with active H. pylori-positive (culture and/or histology) duodenal ulcer disease were randomly treated with either omeprazole 20 mg twice a day plus amoxicillin 1 g twice a day (group I, N = 30), omeprazole 40 mg twice a day plus amoxicillin 1 g twice a day (group II, N = 30), or omeprazole 40 mg twice a day plus amoxicillin 1 g three times a day (group III, N = 30) over two weeks, followed by ranitidine at bedtime for another four weeks. The overall proportion of H. pylori eradication was 83% and of ulcer healing 92% without statistically significant differences between the study groups. Complete pain relief occurred after a median of one day in all groups. Six patients complained of side effects during the therapy phase, which led to therapy discontinuation in one female patient. In conclusion, omeprazole plus amoxicillin is a highly effective and well-tolerated therapy regimen to eradicate H. pylori in duodenal ulcer disease. In addition, the results suggest that there is no clear dose-response relation between the dosages of omeprazole and amoxicillin used in this study on the one hand and the H. pylori eradication rates on the other.

RCT Entities:   Population Interventions Outcomes