Lee and colleagues designed a randomized double blind multicentre clinical trial to compare the effect of ranitidine 300 mg single night-time dose and ranitidine 150 mg twice daily in the acute treatment of duodenal ulcers. The study was conducted in the UK and Ireland.

A total of 594 patients with endoscopically confirmed duodenal ulcer were included in the study. Of these, 424 patients had complete endoscopic findings on which healing rates at four weeks were assessed.

Patients received either ranitidine 150 mg twice daily or 300 mg at night with a placebo tablet in the morning. Initially, the treatment was given for four weeks, and if the ulcer was not healed by this time, treatment was continued for additional four weeks and endoscopy was conducted again at eight weeks.

• At four weeks, 78% patients (156 of 201) had healing with ranitidine 300 mg nocte, compared with 83% (186 of 223) of those who were given ranitidine 150 mg twice daily (p = 0.28).
• After eight weeks, 97% of the patients in each group had healed.
• The healing rates did not differ significantly for smokers and non-smokers at either four or eight weeks.
• Both the treatment regimens were found to be equally effective in reducing day and night-time pain.
• Adverse events were reported in 23 patients and 12 were withdrawn from the study.
• There were minor abnormalities in liver function tests in three patients.

It was concluded that a single dose of ranitidine 300 mg at night is a safe and effective alternative to twice daily ranitidine 150 mg for the acute treatment of duodenal ulcers.

Source: Lee FI, Reed PI, Crowe JP, et al. Acute treatment of duodenal ulcer: a multicentre study to compare ranitidine 150 mg twice daily with ranitidine 300 mg once at night. Gut 1986;27:1091-95.