NIZATIDINE IN THE TREATMENT OF REFLUX ESOPHAGITIS - AN ITALIAN MULTICENTER STUDY

objective: To evaluate the various doses and administration schedules of nizatidine in the treatment of reflux oesophagitis. Design and methods: Two hundred and forty patients with erosive-ulcerative oesophagitis were randomly allocated to a 6-week treatment regimen with nizatidine 150 mg three times daily (group A, n = 79), 150 + 150 + 300 mg (group B, n = 79) and 300 mg twice daily (group C, n = 82). Clinical evaluation was performed at entry and after 3 and 6 weeks, whereas endoscopy and laboratory tests were performed only at entry and at the end of the study. Results: Reflux symptoms were significantly reduced in all three groups after 6 weeks. The patients on three times daily regimens (groups A and B) improved some of their symptoms faster than those in group C. Oesophagitis healed with similar frequency in the three groups (A = 81.1%, B = 79.2% and C = 67.6%). Adverse events were rare and mild. Conclusions: High-dose nizatidine is safe and effective in relieving the symptoms and healing the lesions of oesophagitis.