Low‐dose cimetidine in the acute treatment of duodenal ulcer. Comparison of a single nocturnal dose regimen with a twice daily regimen

Abstract

A 0.5 g daily dose of cimetidine was as effective as a 1 g dose in the acute treatment of duodenal ulcer patients in Hong Kong. The aims of the present study were, first, to determine whether low-dose cimetidine treatment was as effective as standard doses in acute duodenal ulcer treatment of patients in Singapore, and second, to compare a single nocturnal dosage regimen with a twice daily regimen. In this single centre, double-blind, controlled trial, 282 patients with endoscopically proven duodenal ulcer were randomized to receive four weeks' treatment with cimetidine using one of three dosage regimens: (A) 800 mg at night; (B) 400 mg at night; or (C) 400 mg twice daily. Two hundred and forty-seven patients were evaluated. The incidences of healing at four weeks were: (A) 40/80 (50%), (B) 39/88 (44%); and (C) 48/79 (61%); (B vs C: P less than 0.05; A vs C: NS; 95% confidence limits: -5% to 27%; A vs B: NS, 95% confidence limits: -6% to 21%). Of 183 patients who had antral biopsies taken, 176 (96%) had histological gastritis, while 167 (91%) were positive for Helicobacter-like organisms. The occurrence of gastritis or Helicobacter-like organisms had no influence on ulcer healing. A 400 mg dose of cimetidine is therefore suboptimal for the treatment of duodenal ulcer in patients in Singapore. A single nocturnal dosage regimen may be less effective than a twice daily regimen.