Omeprazole, amoxycillin and metronidazole for the cure of Helicobacter pylori infection

Objective In two studies, different regimens of omeprazole-amoxycillin-metr onidazole were assessed for the eradication of Helicobacter pylori. Design Randomized, international, multicentre studies with parallel groups, Setting The studies were performed at centres in Canada, Czech Republic, Fr ance, Germany, Hungary, Sweden and UK. Participants and interventions H. pylori-positive patients with duodenal ul cer disease (active or in remission) were randomized to 7-day treatment wit h: omeprazole 40 mg once daily, amoxycillin 500 mg three times daily and me tronidazole 400 mg three times daily (OAMtid; n = 242); omeprazole 20 mg tw ice daily, amoxycillin 1000 mg twice daily and metronidazole 800 mg twice d aily (OAM800; n = 247); or omeprazole 20 mg twice daily, amoxycillin 1000 m g twice daily and metronidazole 400 mg twice daily (OAM400; n=127). Main ou tcome measures Eradication of H. pylori. Results Intention-to-treat analysis revealed H. pylori eradication rates of 76% (184/242) with OAMtid, 80% (198/247) with OAM800, and 76% (97/127) wit h OAM400, There was considerable variation in the levels of primary resista nce to metronidazole in different countries. The overall eradication rate i n patients infected with metronidazole-sensitive H, pylori strains was 85% (313/370), compared with 60% (56/94) in patients harbouring metronidazole-r esistant strains (P < 0.001). All regimens were generally well tolerated, w ith mild adverse events occurring in 4-26% of patients (mainly diarrhoea, r eversible increase in liver enzymes and headache). Conclusion The OAM combination is effective in curing H, pylori infection. Primary metronidazole resistance may reduce its effectiveness, but an incre ased daily dosing of metronidazole may partly overcome this problem. Eur J Gastroenterol Hepatol 11 (suppl 2):S19-S22 (C) 1999 Lippincott Williams & W ilkins.