Omeprazole 20 or 40 mg daily for healing of duodenal ulcer? A double-blind comparative study

Objective: To determine whether omeprazole 40 mg daily for 2-8 weeks was superior to omeprazole 20 mg daily in healing duodenal ulcers and to assess whether ulcer healing occurred in all patients if treatment was prolonged for a further 4-8 weeks. Design: Double-blind randomized parallel group study. Setting: Outpatient referrals in 70 centres in 16 countries. Patients: The study included 1004 consenting patients. Interventions: Omeprazole either one 20 mg or one 40 mg capsule in the morning for 2, 4, or 8 weeks until healing was confirmed endoscopically. Placebos were provided so that all patients received both sizes of capsules. Patients with an unhealed ulcer after 8 weeks of treatment were treated with omeprazole 40 mg daily for another 4-8 weeks. Compliance was monitored by capsule counts. Main outcome measures: Endoscopic evidence of accelerated healing. Results: The cumulative healing rates in the 20 mg group at 2, 4 and 8 weeks were 66.0, 93.3 and 96.7%, respectively. In the 40 mg group, these figures were 71.6, 97.1 and 99.8%. Although statistically significant, the differences may be only of minor clinical importance. After 8 weeks of treatment, only 1.5% (13 patients in the 20 mg group and one in the 40 mg group) had an unhealed ulcer and ulcers healed in all patients who continued on omeprazole (40 mg daily) for a further 4-8 weeks. Ulcer size, but not age, gender, duration of the disease, smoking or use of NSAIDs, was predictive of ulcer healing at 2 weeks. Rapid relief of symptoms occurred in both groups and both doses were well tolerated. Conclusions: Omeprazole 20 mg daily is an appropriate dosage for most patients with duodenal ulcer. In the few patients with an unhealed ulcer after 8 weeks of treatment, a dose increase to 40 mg of omeprazole may be considered.