Treatment of duodenal ulcer with rioprostil: a randomized multicentre double-blind study.

ABSTRACT

The effectiveness of rioprostil, 300 micrograms b.d. is evaluated in evolutive duodenal ulcer in a double-blind study in five French and North African centres. A total of 115 patients are included in the study (57 in the rioprostil group and 58 in the placebo group). After a 4-week treatment period, a significantly higher endoscopic healing rate is observed in the rioprostil group (57%) compared with the placebo group (33%) (p less than 0.01). The mean time with abdominal pain is significantly lower in the rioprostil group (5.6 +/- 4.4 days) compared to the placebo group (12.7 +/- 5 days) (p less than 0.001). Clinical and biological tolerance is excellent. The only side effect is diarrhoea (3.5% in the rioprostil group). In only one case does diarrhoea necessitate cessation of treatment. Rioprostil, 300 micrograms b.d., is thus effective in the treatment of developing duodenal ulcer.