The GU-MACH study: the effect of 1-week omeprazole triple therapy on Helicobacter pylori infection in patients with gastric ulcer

Aims: To study the efficacy of omeprazole triple therapy in the eradication of Helicobacter pylori in patients with active gastric ulcer, and to asses s healing and relapse of gastric ulcer. Methods: A double-blind, randomized study was carried out in 18 centres in Germany, Hungary and Poland. Patients (n = 160) with gastric ulcer and a po sitive H. pylori screening test were randomized to a 7-day twice daily trea tment with omeprazole 20 mg, clarithromycin 500 mg and amoxycillin 1000 mg (OAC) or omeprazole 20 mg, clarithromycin 250 mg and metronidazole 400 mg ( OMC), or with omeprazole 20 mg once daily (O). After completion of this 1-w eek treatment, patients were treated with omeprazole until healing (maximum 12 weeks), and followed for 6 months. H. pylori was assessed by urea breat h test (UBT) and histology. Results: Eradication rates ITT were OAC 79% (95% CI: 65-90%), OMC 86% (95% CI: 73-94%) and O 4% (95% CI: 0-14%). Eradication rates PP were OAC 83% (95 % CI: 68-93%), OMC 93% (95% CI: 80-98%) and O 3% (95% CI: 0-13%). Gastric u lcer relapses occurred in 5, 0 and 11 patients in the groups, respectively. Conclusions: The results from the study demonstrate that OMC and OAC 1-wee k regimens are safe and effective for eradication of H. pylori in gastric u lcer patients, and that ulcer relapse is infrequent after successful eradic ation.