EFFECT OF 15(R)-15-METHYL PROSTAGLANDIN-E2 (ARBAPROSTIL) ON THE HEALING OF DUODENAL-ULCER - A DOUBLE-BLIND MULTI-CENTER STUDY

  • 1 January 1982
    • journal article
    • research article
    • Vol. 83  (2) , 357-363
Abstract
A multicenter study was conducted on 173 patients with active, endoscopically proven duodenal ulcers (158 men, 15 women). They were randomly assigned, in a double-blind manner, to 2 groups: those receiving placebo capsules (91 patients) and those receiving capsules containing 100 .mu.g of 15(R)-15-methyl prostaglandin E2 (arbaprostil) (82 patients). Each drug was ingested 4 times a day (1 h before meals and at bedtime) for 28 days. Endoscopy was performed on days 0, 14, and 28 after the trial began. At each examination, the ulcer size was measured and whether the ulcer had healed was recorded. Arbaprostil increased the incidence of ulcer healing to approximately the same degree as reported in most extensive studies with cimetidine. At 14 days, 3 times as many patients were totally healed in the arbaprostil-treated as in the placebo-treated group (37% vs. 12%, P < 0.001). At 28 days, 67% of patients receiving arbaprostil were healed compared with 39% in the group receiving placebo (P < 0.001). Similarly, the ulcer size, measured endoscopically, was much smaller after arbaprostil administration than in the group receiving placebo after both 14 and 28 days (P < 0.001). Side effects attributable to treatment consisted primarily of loose stools and diarrhea (34%). Smoking retarded healing in the placebo-treated group (P < 0.05), but did not significantly retard healing in patients treated with arbaprostil. Arbaprostil markedly accelerates the healing rate of active duodenal ulcers. This effect may be due to inhibition of acid secretion as well as to gastric cytoprotection.

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