ORAL FLUTICASONE PROPIONATE COMPARED WITH PREDNISOLONE IN TREATMENT OF ACTIVE CROHNS-DISEASE - A RANDOMIZED DOUBLE-BLIND MULTICENTER STUDY

Objective: An oral corticosteroid with low systemic bioavailability could allow treatment of active Crohn's disease without side effects. The efficacy of fluticasone propionate, a halogenated corticosteroid of this type, was tested against prednisolone. Design: A randomized double-blind multicentre trial. Setting: A multicentre study among outpatients of 28 specialist gastroenterological departments in five countries. Patients: Three hundred and fifty-six patients with mild to moderately active Crohn's disease judged to need oral corticosteroid treatment. Intervention: Fluticasone propionate 20 mg daily for 4 weeks was compared with prednisolone 40, 30, 20 and 15 mg daily in divided doses over 4 successive weeks. Main outcome measures: Physician's overall assessment at 2 and 4 weeks, the Harvey-Bradshaw clinical index and the erythrocyte sedimentation rate (ESR). Results: One hundred and eighty-three patients received fluticasone propionate and 173 prednisolone; the groups were well matched. Fewer patients receiving fluticasone propionate were in remission at 2 weeks [33 out of 177 (19%) compared with 58 out of 167 (35%), P < 0.001] and 4 weeks [69 out of 175 (39%) compared with 75 out of 161 (47%), P = 0.002]. The Harvey-Bradshaw index decreased less in the fluticasone propionate group at 2 weeks (8 +/- 4 to 4 +/- 4 compared with 8 +/- 4 to 3 +/- 3, P = 0.035) but there was no significant difference at 4 weeks. The ESR fell in both groups but the decrease was less in the fluticasone propionate group (P < 0.001). The site of disease had an effect on outcome; among patients with ileitis, results were similar whereas in patients with ileo-colitis (P < 0.001) or colitis (P < 0.002), prednisolone was superior. Steroid-type effects were reported by only two patients in the fluticasone propionate group but by 17 in the prednisolone group. Conclusion: In the doses used, prednisolone gave better overall results than fluticasone propionate; this poorly absorbed steroid may be more effective in ileal than colonic disease.