Budesonide foam as a new therapeutic concept in the therapy of distal ulcerative colitis in comparison to mesalazine enemas. An open, controlled, randomized and prospective multicenter pilot study

Budesonide is a locally acting steroid with a high first-pass metabolism in the liver and low systemic effects. We performed the first pilot study com paring budesonide foam (1 mg/50 ml b.i.d.) with mesalazine enemas (4 g/60 m l o.d.). 33 patients from 3 centres were enrolled in this open randomized c linical trial. 16 patients got budesonide foam and 17 got mesalazine enemas . The drugs were administered for 4 weeks. Histological index (HI) and endo scopic index (EI) were assessed at day 1 and day 28, clinical activity inde x (CAI) at day 1, 14 and 28. For patients with left-sided colitis and proct osigmoiditis improvement was defined as decrease in CAI of greater than or equal to 2 points. For patients with proctitis improvement was defined as d ecrease in HI of greater than or equal to 1 point. The primary efficacy eva luation was performed with the intention to treat population (n = 32). Impr ovement was found in 67% of the patients in the budesonide group compared t o 71% in the mesalazine group. There was no statistically significant diffe rence between the groups. Adverse events were mild and rare in both groups. Both treatments had no significant influence on plasma cortisol. In this p ilot study for distal ulcerative colitis budesonide foam is as safe and eff ective as mesalazine enema.