Controlled clinical trials of omeprazole in the long-term management of reflux disease.

Reflux oesophagitis is a chronic relapsing disorder. When treatment is stopped after successful short-term healing of oesophagitis, high relapse rates (80% within 6 months) indicate that prolonged treatment is necessary in order to maintain remission. The results of three long-term, multicentre, controlled, double-blind clinical trials comparing different regimens of omeprazole with ranitidine are reviewed. Omeprazole, 20 mg daily, was found to be a highly effective maintenance therapy in patients with ulcerative oesophagitis, keeping 67-89% of patients in remission for 1 year, compared with 10-25% of patients treated with ranitidine, 150 mg twice daily. Weekend omeprazole therapy, 20 mg daily every Friday, Saturday and Sunday, was, as with daily ranitidine, relatively ineffective. All treatment regimens were well tolerated and gastric mucosal biopsies showed no qualitative changes in gastric enterochromaffin-like cells.