Omeprazole and ranitidine in duodenal ulcer healing and subsequent relapse: A randomized double-blind study with weekly endoscopic assessment

Abstract

To investigate the efficacy of standard and low dosage of omeprazole in the healing of duodenal ulcer, 270 patients with endoscopically active duodenal ulcer were randomized to receive omeprazole, 10 mg or 20 mg every morning, or ranitidine, 150 mg twice daily, using the double-dummy technique. Forty-six potential prognostic factors for healing including clinical, acid-secretory, and endoscopic characteristics were prospectively obtained and healing was assessed by endoscopy at weekly intervals for up to 4 weeks. The cumulative healing rates in the 4 weeks wete 43%, 77%, 94% and 95% for omeprazole,10 mg (n=83); 49%, 86%, 93% and 96% for omeprazole, 20 mg (n=87); and 29%, 63%, 83% and 93% for ranitidine (n=84), respectively. Life-table analysis showed P<0.03 for omeprazole, 10 mg versus ranitidine and P<0.002 for omeprazole, 20 mg versus ranitidine. Life-table analysis also showed that in omeprazole groups, healing rates were lower in smokers than in non-smokers (P<0.001), in late- than in early-onset patients (symptoms starting after or before the age of 30 years, respectively, P<0.02), in those with less than 5 months than in those with more than 5 months of remission (P<0.05), and in those with increased maximal acid output than in those with normal output (P<0.05). Patients with healed ulcer were interviewed at 2-month intervals and endoscoped at 4-month intervals or whenever symptoms recurred. The cumulative ulcer relapse rates in 1 year were not significantly different between omeprazole and ranitidine groups. It is concluded that (i) omeprazole, 10 mg daily or 20 mg daily, heals duodenal ulcer significantly faster than ranitidine, 150 mg twice daily; (ii) despite potent acid inhibition, ulcer healing by omeprazole is adversely affected by cigarette smoking in the population studied; and (iii) ulcers healed with omeprazole or ranitidine relapsed at similar rates.