Continuous and more effective duodenal ulcer healing under therapy with bismuth and two antibiotics than with dual therapy comprising omeprazole and amoxicillin.

Abstract

To determine the speed of the healing process of duodenal ulcers during eradication regimens with and without a high-dose anti-secretory drug. An outpatient department of a university hospital as a community-based and referral centre. A total of 101 patients with proven duodenal ulcer and a positive urease test were randomized into two groups: one group received the classic triple therapy (bismuth subnitrate 3 x 375 mg for 4 weeks + tetracycline 3 x 500 mg + metronidazole 3 x 250 mg daily, both for 2 weeks ), the other group received dual therapy comprising amoxicillin 2 x 1000 mg + omeprazole 2 x 20 mg daily, both for 2 weeks. All patients underwent a control endoscopy 2 and 6 weeks after the beginning of treatment. Eradication was assumed if a urease test and culture were negative in all specimens taken from antral and corpus mucosa. In total, 93 patients completed all 6 weeks of the study (45 patients in the triple therapy group and 48 patients in the dual therapy group). The disappearance of ulcer pain was faster in the group under the regimen including omeprazole (dual therapy) than in the group with triple therapy (2.4+/-2.7 days versus 4.5+/-3.5 days; P< 0.01). The two-week healing rate was significantly higher in the patients treated with dual therapy than in the group treated with triple therapy (77% versus 33.3%; P< 0.01); however, 12 out of 37 patients with a healed ulcer in the dual therapy group had an ulcer relapse at 6 weeks (six became symptomatic). Only in one of these 12 patients was Helicobacter pylori eradicated. Fifteen of the 45 patients with triple therapy had healed ulcers at 2 weeks, and of these 14 remained healed at 6 weeks (H. pylori was eradicated in eight patients). The six-week healing rate with dual therapy was the same as with classic triple therapy (64.6% versus 77.6%); the eradication rate was lower in the former group than in the latter (30.4% versus 51.1% respectively; P=0.056). A high dose of a proton pump inhibitor (PPI) combined with amoxicillin results in rapid ulcer healing and pain disappearance, but is associated with early ulcer relapse due to lack of eradication of H. pylori. Its addition to regimens with bismuth and antibiotics is not necessary to achieve ulcer healing.