Background: Budesonide is a synthetic glucocorticoid used in the Crohns's disease (CD) and ulcerative colitis (UC). The aim of the study was to evaluate its efficacy in inducing and maintaining remission of CD in oral administration and in inducing endoscopic and histologic remission in distal UC when was given as enema.
Material and method: Systematic review of controlled clinical trials was made and meta-analysis were performed using the Peto method. Eight studies provided data regarding CD (4 in induction of remission and 4 in maintenance therapy) and 4 regarding UC.
Results: CD-inducing remission: in total 560 patients were involved; 280 received 9 mg/d of budesonide and 280 received 40-46 mg/d of prednisolone. Clinical remission was similar in both groups [0.76 (0.54-1.06)] [0R (CI 95%)] and adverse events were more frequent in patients treated with prednisolone [0.42 (0.30-0.58)]. Plasma cortisol was evaluated in 292 patients (146 each group); values were significantly lower in prednisolone group [0.32 (0.20-0.50)]. CD-maintaining remission: in total 449 patients were enrolled; 174 and 90 received 3 mg/d or 6 mg/d of budesonide respectively and 185 received placebo. There were not significant differences between placebo and budesonide 3 mg/d [1.04 (0.56-1.92)]. Budesonide 6 mg/d was also similar to placebo group [0.91 (0.59-1.39)]. UC: 325 patients were included, 156 received budesonide and 169 were given conventional glucocorticoids. No significant differences were found between both groups in endoscopic remission rates [1.15 (0.71-1.88)].
Conclusions: Budesonide is as useful as prednisolone in treatment of active CD and it has a lower impact in serum cortisol levels. Nevertheless, at evaluated dose, it is not useful for maintenance therapy. In UC is as effective as conventional glucocorticoids.