A Comparison of Two Different Doses of Omeprazole Versus Ranitidine in Treatment of Duodenal Ulcers

In a study involving three centers, 105 patients with duodenal ulcer proven by endoscopy were randomly assigned to treatment with either the H+, K+, ATPase inhibitor omeprazole (20 mg or 40 mg taken as a single morning dose), or ranitidine (150 mg morning and night). It was a double-blind study using a double-dummy technique. Clinical assessment and laboratory investigations were carried out at 2,4, and 8 weeks; endoscopy was done at 2 weeks, and if not healed, at 4 and 8 weeks. The patients in the three treatment groups were well matched. Significantly more patients treated with omeprazole healed compared with ranitidine at 2 weeks (p = 0.007) and at 4 weeks (p = 0.007), but there was no statistically significant difference between the two omeprazole groups. Pain was of similar severity at the start in all groups, but patients treated with omeprazole had fewer days with pain (median values being omeprazole 20 mg: 2 days; omeprazole 40 mg: I day; ranitidine: 7 days). The difference between the combined omeprazole groups and ranitidine was significant (p < 0.02). There was also a tendency towards less severe daytime pain on omeprazole during the first week. The difference was statistically significant between omeprazole (40 mg) and ranitidine for days 2–7 (p < 0.01). No change in laboratory screen attributable to drug treatment occurred. After healing, 79 patients entered a 6-month follow-up study with endoscopy at 3 and 6 months or whenever symptoms occurred. After 6 months relapses occurred in 14/24, 19/23, and 15/25 after 20 mg omeprazole, 40 mg omeprazole, and ranitidine, respectively. There was thus no significant difference in relapse rate between the treatment regimens. Median time to relapse was 157, 84, and 84 days, respectively, for all patients followed after omeprazole (20 mg, 40 mg) and ranitidine. In conclusion, omeprazole given once daily is superior to 150 mg ranitidine twice daily for both duodenal ulcer healing and symptom relief and seems to be equivalent with regard to ulcer relapse.