ABSTRACT
In the USSR, uncomplicated duodenal ulcer is usually managed in an inpatient setting. A double-blind, randomized, double-dummy, multiclinic, comparative trial examined the safety and efficacy of oral misoprostol (200 micrograms qid) and intramuscular dalargin (1 mg bid) in duodenal ulcer healing. Dalargin, an enkephalin peptide with gastric antisecretory and cytoprotective properties, is commonly used in the USSR for treating peptic ulcer. The trial characteristics and monitoring were performed in accordance with US standards. Consenting patients of either sex, aged 18 to 70 years, who had a duodenal ulcer of 0.3 to 2.5 cm in diameter were enrolled. Endoscopy, physical examination, and laboratory assessments were performed on entry and after 4 weeks of treatment. The effects of the treatments on complete ulcer healing, dyspeptic symptoms, antacid consumption, adverse drug reactions, and safety were determined. Both treatment groups were well matched for demographic characteristics. The majority of patients were smokers and alcohol users and had a history of recurrent peptic ulcers. Misoprostol was significantly more effective than dalargin in inducing duodenal ulcer healing, both in the intent-to-treat cohort (P = .001) and in the evaluable cohort (P = .0001). Both regimens were well tolerated, and no patients were withdrawn from the study because of adverse reactions. Mild, self-limiting diarrhea was reported more frequently in patients receiving misoprotol (9.4% incidence) than those receiving dalargin (1.9%). The disparity in ulcer healing between the two groups suggests that hospitalization alone is not an optimum treatment in this high-risk patient population.
