101. Randomized comparison of 1-hour topical method vs. amoxycillin plus omeprazole for eradication of Helicobacter pylori in duodenal ulcer patients
- Author
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K, Przytulski, J, Regula, A, Dziurkowska-Marek, M, Kohut, E, Hennig, T, Marek, J, Ostrowski, A, Nowak, and E, Butruk
- Subjects
Adult ,Male ,Helicobacter pylori ,Amoxicillin ,Penicillins ,Middle Aged ,Anti-Ulcer Agents ,Ranitidine ,Clinical Protocols ,Duodenal Ulcer ,Metronidazole ,Pronase ,Humans ,Drug Therapy, Combination ,Female ,Bismuth ,Intubation, Gastrointestinal ,Omeprazole - Abstract
A novel 1-h topical method eradicated Helicobacter pylori in 96% of dyspeptic patients. The eradication rate of amoxycillin/omeprazole therapy varies from 0 to 93%.To compare both methods in patients with endoscopically proven duodenal ulcer.Eighty patients (59 males, 21 females; median age 43 years) were randomized into two therapeutic groups. The first group (group A) was treated with a 6-week course of ranitidine 300 mg/day, then omeprazole 20 mg b.d. with pronase 36000 units/day for 2 days, followed by 1-h topical therapy with a solution of bismuth, metronidazole, amoxycillin and pronase. The second group (group B) consisted of patients treated with omeprazole 20 mg b.d. and amoxycillin 2 g/day for 2 weeks, followed by a 4-week course of ranitidine 300 mg/day. Eradication of H. pylori was assessed by urease test, histology, a polymerase chain reaction and a 13C-urea breath test, all of which were performed 4 weeks after discontinuation of the antibacterial treatment.Eradication rates in groups A and B were 2.5% and 35% in an intention-to-treat analysis, respectively. Side-effects were encountered in 40.5% and 12.5% of subjects in groups A and B, respectively. Treatment tolerance was rated as poor by 54% of patients in group A and 2.5% of patients in group B.Both treatment regimens, the 1-h topical method and amoxycillin with omeprazole, have low eradication rates in patients with duodenal ulcer. In addition, the topical treatment is characterized by a high rate of side-effects and poor tolerance. Based on the results of our study, neither method can be recommended for eradication of H. pylori in patients with duodenal ulcer.
- Published
- 1998