Double-blind trial of omeprazole and amoxicillin to cure Helicobacter pylori infection in patients with duodenal ulcers

Background/Aims Anti- Helicobacter pylori treatment with combinations of omeprazole and amoxicillin is a promising treatment option. The aim of this study was to investigate whether a daily omeprazole dose of 120 mg combined with amoxicillin would cure H. pylori infection at a rate comparable with t...

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Veröffentlicht in:Gastroenterology (New York, N.Y. 1943) N.Y. 1943), 1995-05, Vol.108 (5), p.1412-1417
Hauptverfasser: Bayerdörffer, Ekkehard, Miehlke, Stephan, Mannes, Gerd A., Sommer, Albrecht, Höchter, Wilhelm, Weingart, Josef, Heldwein, Walter, Klann, Hermann, Simon, Thomas, Schmitt, Wolfgang, Bästlein, Elke, Eimiller, Albert, Hatz, Rudolf, Lehn, Norbert, Dirschedl, Peter, Stolte, Manfred
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Sprache:eng
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Zusammenfassung:Background/Aims Anti- Helicobacter pylori treatment with combinations of omeprazole and amoxicillin is a promising treatment option. The aim of this study was to investigate whether a daily omeprazole dose of 120 mg combined with amoxicillin would cure H. pylori infection at a rate comparable with that achieved with “triple therapy.” Methods In a double-blind, randomized, controlled, and multicenter trial in Germany, 270 patients with an H. pylori-associated duodenal ulcer were treated with 40 mg omeprazole three times a day and 750 mg amoxicillin three times a day for the first 14 days (n = 139) followed by 20 mg omeprazole once daily until day 42 or with omeprazole plus 750 mg amoxicillin placebo three times a day for the same time period (n = 131). Results Cure rates of H. pylori infection were 91% in the omeprazole plus amoxicillin group, 0% in the omeprazole plus placebo group, and 89% and 0%, respectively, performing an intention-to-treat analysis. Cure of H. pylori infection in patients pretreated with omeprazole was only 58% compared with 95% in patients who were not. The cumulative 12-month relapse rates were 11.3% and 44% in the treatment groups and 1.6% in H. pylori -negative and 49% in H. pylori-positive patients. Conclusions The combination of 120 mg omeprazole daily and 2.25 g amoxicillin daily with its H. pylori cure rate of around 90% is one of the best tolerated and most effective treatment regimens.
ISSN:0016-5085
1528-0012
DOI:10.1016/0016-5085(95)90689-4