Budesonide in inflammatory bowel disease: a meta-analysis

BACKGROUND: Budesonide is a synthetic glucocorticoid used in the Crohns's d isease (CD) and ulcerative colitis (UC), The aim of the study was to evalua te its efficacy in inducing and maintaining remission of CD in oral adminis tration and in inducing endoscopic and histologic remission in distal UC wh en was given as enema. MATERIAL AND METHOD: Systematic review of controlled clinical trials was ma de and meta-analysis were performed using the Peto method. Eight studies pr ovided 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 re ceived 9 mg/d of budesonide and 280 received 40-46 mg/d of prednisolone. cl inical remission was similar in both groups [0.76 (0.54-1.06)] [OR (CI 95%) ] and adverse events were more frequent in patients treated with prednisolo ne [0.42 (0.30-0.58)]. Plasma cortisol was evaluated in 292 patients (146 e ach group); values were significantly lower in prednisolone group [0.32 (0. 20-0.50)] CD-maintaining remission: in total 449 patients were enrolled; 17 4 and 90 received 3 mg/d or 6 mg/d of budesonide respectively and 185 recei ved placebo. There were not significant differences between placebo and bud esonide 3 mg/d [1.04 (0.56-1.92)]. Budesonide 6 mg/d was also similar to pl acebo 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 ev aluated dose, it is not useful for maintenance therapy, In UC is as effecti ve as conventional glucocorticoids.