We conducted a clinical trial to compare the efficacy and safety profile of two
prostaglandin analogues,
enprostil (35 micrograms twice daily) and
misoprostol (200 micrograms four times daily) in the treatment of acute
duodenal ulcers in 214 patients. The two agents healed approximately 80% and in excess of 90% of
duodenal ulcers after 4 and 6 weeks'
therapy, respectively. There was a significantly lower
ulcer healing rate in both treatment groups in smokers compared with non-smokers (P < 0.05). However, daytime and nighttime
ulcer pain relief was achieved in fewer than 50% of patients by either agent.
Diarrhea, which occurred in more than 40% of patients, was the predominant side effect, and occurred mainly during the first 2 weeks of
therapy with either agent. Nevertheless, this side effect was mild and self-limiting in the majority of patients. Both agents were found to be safe and well tolerated by the majority of patients. We conclude that these
prostaglandin analogues are safe and effective
duodenal ulcer healing agents. Furthermore, there was very little difference between
enprostil and
misoprostol. The limiting factors, however, for their routine use as
ulcer healing agents are their low efficacy with regard to
ulcer pain relief and the high incidence of
diarrhea.