The DU-MACH study: eradication of Helicobacter pylori and ulcer healing inpatients with acute duodenal ulcer using omeprazole based triple therapy

Aim: To investigate the efficacy of two omeprazole triple therapies for the eradication of Helicobacter pylori, ulcer healing and ulcer relapse during a 6-month treatment-free period in patients with active duodenal ulcer. Methods: This was a double-blind randomized study in 15 centres across Cana da, Patients (n = 149) were randomized to omeprazole 20 mg once daily (0) o r one of two 1-week b,d, eradication regimens: omeprazole 20 mg, metronidaz ole 400 mg and clarithromycin 250 mg (OMC) or omeprazole 20 mg, amoxycillin 1000 mg and clarithromycin 500 mg (OAC), All patients were treated for thr ee additional weeks with omeprazole 20 mg once daily. Ulcer healing was ass essed by endoscopy after 4 weeks of study therapy. H. pylori eradication wa s determined by a C-13-urea breath test and histology, performed at pre-ent ry, at 4 weeks after the end of all therapy and at 6 months. Results: The intention-to-treat (intention-to-treat) analysis contained 146 patients and the per protocol (per protocol) analysis, 114 patients. The e radication rates were (intention-to-treat/per protocol): OMC-85% and 92%, O AC-78% and 87% and 0-0% (0), Ulcer healing (intention-to-treat) was greater than 90% in all groups. The differences in the eradication and relapse rat es between 0 vs. OMC and 0 vs, OAC were statistically significant (all, P < 0.001). Treatment was well tolerated and compliance was high, Conclusion: The OMC and OAC 1-week treatment regimens are safe and effectiv e for eradication, healing and the prevention of relapse in duodenal ulcer patients.