One hundred twenty-seven patients with endoscopically diagnosed active duodenal, pyloric, or prepyloric
ulcers participated in this multicenter, double-blind, randomized, controlled trial comparing placebo with
enprostil 35 micrograms twice daily for up to four weeks. Cumulative endoscopic healing for the
enprostil and placebo treatment groups, respectively, was 25% (15 of 59) and 12% (7 of 60) at two weeks (P = 0.060) and 59% (34 of 58) and 33% (19 of 57) at four weeks (P = 0.005). Excluding prepyloric
ulcers, cumulative healing for the
enprostil and placebo groups, respectively, was 22% (9 of 41) and 7% (3 of 44) at two weeks (P = 0.104) and 56% (23 of 41) and 24% (10 of 42) at four weeks (P = 0.002). A greater percentage of prepyloric
ulcers healed on
enprostil than placebo, but the difference was not significant. Mean
antacid use in both groups was identical, averaging only two or less
tablets per day in each group throughout the study. Daytime
pain was relieved more quickly in the
enprostil group, while median time to relief of nighttime
pain was essentially identical in both groups. The most common side effect in the
enprostil treatment group,
diarrhea, was mostly mild to moderate in intensity and was generally self-limiting, requiring no specific
therapy; no patient withdrew because of this complaint. Other symptoms and laboratory profiles were similar in the two groups. These results indicate that
enprostil 35 micrograms taken twice daily for four weeks is effective and safe for the treatment of prepyloric, pyloric channel, and
duodenal ulcers.