MEDIUM-DOSE OR HIGH-DOSE OMEPRAZOLE PLUS AMOXICILLIN ERADICATES HELICOBACTER-PYLORI IN GASTRIC-ULCER DISEASE

Objective: To compare the efficacy of two omeprazole/amoxicillin regim ens concerning Helicobacter pylori eradication, ulcer healing, pain re lief, and safety in patients with gastric ulcer disease. Methods: In a prospective, single-blind, single-center study, 70 patients with acti ve, H. pylori-positive (histology and/or culture) gastric ulcers were randomly treated with either omeprazole 20 mg b.i.d. plus amoxicillin 1 g b.i.d. (group I; n = 35) or with omeprazole 40 mg b.i.d. plus amox icillin 1 g b.i.d. over 2 wk, followed by full dose ranitidine for ano ther 4 wk. Patients were investigated clinically and endoscopically pr ior to treatment and after 6 wk, including the assessment of H. pylori status by means of urease test, specific culture, and histology. Resu lts: Patients of group I and II had similar demographic and clinical c haracteristics. Three patients were lost to follow-up. The overall pro portion of H. pylori eradication was 88.1% (group I, 91.2%; group II, 84.8%, p = NS). The ulcer healing rate was 79.1% after 6 wk, 92.5% aft er 10 wk, and 100% after 6 months, without a statistically significant difference between the study groups. Complete pain relief occurred af ter a median of 2 days (group I) and 1.5 days (group II, p = NS), resp ectively. Six patients (9.0%) complained of side effects that led to d iscontinuation of amoxicillin treatment in three patients (4.5%). Conc lusions: Omeprazole plus amoxicillin is a highly effective and well-to lerated therapy regimen to eradicate H.pylori from the gastric mucosa of patients with gastric ulcer disease. In addition, the results clear ly suggest that medium- and high-dose omeprazole schedules are equally effective with regard to bacterial eradication, ulcer healing, pain r elief, and safety in gastric ulcers. Thus, medium- and not high-dose o meprazole plus amoxicillin should be the treatment regimen of first ch oice to eradicate H. pylori in gastric ulcer disease.