Journal
ZEITSCHRIFT FUR GASTROENTEROLOGIE
Volume 38, Issue 4, Pages 287-293Publisher
GEORG THIEME VERLAG KG
DOI: 10.1055/s-2000-14869
Keywords
budesonide foam; ulcerative colitis; mesalazine enemas
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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 comparing budesonide foam (1 mg/50 ml b.i.d.) with mesalazine enemas (4 g/60 ml o.d.). 33 patients from 3 centres were enrolled in this open randomized clinical trial. 16 patients got budesonide foam and 17 got mesalazine enemas. The drugs were administered for 4 weeks. Histological index (HI) and endoscopic index (EI) were assessed at day 1 and day 28, clinical activity index (CAI) at day 1, 14 and 28. For patients with left-sided colitis and proctosigmoiditis improvement was defined as decrease in CAI of greater than or equal to 2 points. For patients with proctitis improvement was defined as decrease in HI of greater than or equal to 1 point. The primary efficacy evaluation was performed with the intention to treat population (n = 32). Improvement was found in 67% of the patients in the budesonide group compared to 71% in the mesalazine group. There was no statistically significant difference between the groups. Adverse events were mild and rare in both groups. Both treatments had no significant influence on plasma cortisol. In this pilot study for distal ulcerative colitis budesonide foam is as safe and effective as mesalazine enema.
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