Eradication of Helicobacter pylori in peptic ulcer disease with amoxycillin, 2.0 g, and omeprazole, 80 or 120 mg: a prospective randomized trial.

BACKGROUND

The appropriate dose of proton pump inhibitors needed for eradicating Helicobacter pylori by dual therapy is still controversial.

DESIGN

The study was conducted as a single-blind, single-centre trial.

METHODS

Fifty-four patients with active duodenal ulcers were treated with amoxycillin tablets, 750 mg three times daily, and omeprazole, either 40 mg twice daily (group 1) or 40 mg three times daily (group 2), for 14 days in a prospective randomized trial. H. pylori eradication was assessed 10 weeks after starting treatment. Biopsies were taken for rapid urease tests and histological analysis and 13C-urea breath tests were ordered.

RESULTS

In both groups ulcer healing was complete in 96.3% of patients after 10 weeks. Ten weeks after starting treatment, Helicobacter pylori was eradicated in 76.9% of the patients in group 1 and 74.1% of those in group 2, as shown by rapid urease tests and histological analysis. In the subgroup of fully compliant patients (n = 49) the eradication rates were 80% and 79.2%, respectively. Hyperacidity significantly reduced the eradication rates. Patients showing successful H. pylori eradication were significantly older (59 +/- 14.0 years vs. 49 +/- 15.6 years; P = 0.025). Eradication rates were lower in smokers than in non-smokers (36.4% vs. 83.9%; P = 0.006).

CONCLUSION

It is concluded that higher omeprazole doses should be reserved for younger patients and smokers; in others they are not needed.