title: Budesonide enema in distal ulcerative colitis. A randomized dose-response trial with prednisolone enema as positive control. The Danish Budesonide Study Group.
abstract: The effect of budesonide, 1, 2, and 4 mg/100 ml in daily enemas, on active distal ulcerative colitis was compared with that of prednisolone disodium phosphate enemas, 25 mg/100 ml, in a multicentre, randomized, group-comparative trial. A total of 146 patients with active disease were treated for 2 weeks. Data from 139 were valid for statistical analyses. Bowel habits, proctoscopy findings, and histologic pictures were evaluated, and plasma cortisol was determined for measurement of influence on the hypothalamic-pituitary-adrenal axis. Clinical symptoms and proctoscopy findings improved within all treatment groups. The improvement of these effect variables tended to be less after treatment with the lowest dose of budesonide, 1 mg/100 ml, than after the other treatments. Plasma cortisol did not change in any of the budesonide groups, whereas a mean reduction of 30% (P = 0.07) was observed after prednisolone. It can be concluded that budesonide enemas of 2 mg/100 ml constitute an attractive alternative to prednisolone enemas for topical treatment of distal ulcerative colitis.
mesh_terms: D000287:Administration, Topical; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D019819:Budesonide; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004733:Enema; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D008297:Male; D011239:Prednisolone / Q000008:administration & dosage* / Q000627:therapeutic use; D011282:Pregnenediones / Q000008:administration & dosage* / Q000627:therapeutic use
chemical_list: D000893:Anti-Inflammatory Agents; D005938:Glucocorticoids; D011282:Pregnenediones; D019819:Budesonide; D011239:Prednisolone