Equally high efficacy of 4, 7 and 10-day triple therapies to eradicate Helicobacter pylori infection in patients with ulcer disease

Background: In patients with ulcer disease the optimal dose and duration of Helicobacter pylori treatment containing omeprazole (O), metronidazole (M) and clarithromycin (C) has yet to be established. The efficacy might be in fluenced by metronidazole- and clarithromycin-resistance. Aim: To study the effect of duration of OMC treatment on its efficacy and i nfluence of metronidazole-resistance and clarithromycin-resistance on the o ptimal duration. Materials and methods: Ulcer patients (n = 76) were randomized to three dou ble-blind treatments of 10 days: OMC 4 consisted of 4 days b.d. 20 mg omepr azole, 400 mg metronidazole and 250 mg clarithromycin switched over to 6 da ys b.d. 20 mg omeprazole and placebo antibiotics (n = 27); OMC 7 consisted of 7 days b.d, omeprazole 20 mg, metronidazole 400 mg and clarithromycin 25 0 mg and 3 days b.d. omeprazole 20 mg and placebo antibiotics (n=25); OMC 1 0 consisted of 10 days b.d. omeprazole 20 mg, metronidazole 400 mg and clar ithromycin 250 mg (n = 24), H, pylori was assessed by biopsies for culture and histology pre- and 4-6 weeks after OMC therapy. Metronidazole-resistanc e and clarithromycin-resistance were assessed by the E-test. Results: Intention-to-treat-eradication rates were: OMC 4, 96%; OMC 7, 92%; and OMC 10, 96% (N.S.). All of the three per protocol eradication rates we re 100% (95% CT: 85.2-100). Of 75 isolates, 16 were metronidazole-resistant and one was clarithromycin-resistant. Conclusion: In H. pylori-positive ulcer patients, OMC 4 is highly efficacio us and as effective as OMC 7 and OMC 10. No influence of metronidazole-resi stance or clarithromycin-resistance was observed.