Omeprazole 20 mg uid and ranitidine 150 mg bid in the treatment of benign gastric ulcer. Italian Cooperative Group on Omeprazole.
The primary aim of this double-blind, randomized Italian multicenter trial was to compare the healing rates in patients with benign gastric ulcers after 4-8 weeks treatment with either omeprazole 20 mg uid or ranitidine 150 mg bid. Secondary aims were to compare the healing rates in a subgroup of patients after two weeks and to study symptom relief and frequency of adverse events. One hundred and sixty-seven (167) patients were randomized to treatment with either omeprazole (84) or ranitidine (83). Four and three patients in the omeprazole and ranitidine groups, respectively, were found to have malignant gastric ulcers, and were therefore excluded from the analysis. Protocol healing rates were significantly higher in the omeprazole group (35%, 74% and 96%) than in the ranitidine group (9%, 53% and 85%) after two (p = 0.004), four (p = 0.015) and eight weeks (p = 0.04) of treatment (chi 2 test). Relief of both daytime and nocturnal epigastric pain, as reported on clinic visits, was more rapid in the omeprazole group than in the ranitidine group. Diary card reports of nocturnal and day pain during the first two weeks showed a similar pattern, with somewhat faster relief of pain in the omeprazole group. Both omeprazole and ranitidine were well tolerated, and only few adverse events were reported. No changes in the laboratory tests were considered to be clinically important.
D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009853:Omeprazole / Q000627:therapeutic use*; D011899:Ranitidine / Q000627:therapeutic use*; D013276:Stomach Ulcer / Q000188:drug therapy*; D013997:Time Factors; D014945:Wound Healing
D011899:Ranitidine; D009853:Omeprazole