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

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 108; no. 5; p. 1412
• Main Authors: Bayerdörffer, E, Miehlke, S, Mannes, G A, Sommer, A, Höchter, W, Weingart, J, Heldwein, W, Klann, H, Simon, T, Schmitt, W
• Format: Journal Article
• Language: English
• Published: United States 01.05.1995
• Subjects: Adolescent; Adult; Aged; Amoxicillin - administration & dosage; Double-Blind Method; Drug Therapy, Combination; Duodenal Ulcer - drug therapy; Duodenal Ulcer - etiology; Female; Germany; Helicobacter Infections - complications; Helicobacter Infections - drug therapy; Helicobacter pylori; Humans; Male; Middle Aged; Omeprazole - administration & dosage; Recurrence; Germany
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1016/0016-5085(95)90689-4

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." 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). 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. 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.