Double blind trial oforal fluticasone propionate v prednisolone inthetreatmentofactive ulcerative colitis

Fluticasone propionate isacorticosteroid with thepotential fortopical treatment ofulcerative colitis because oflowsystemic bioavailability. Thedrugwascompared withprednisolone in themanagement ofactive left sided ortotal ulcerative colitis. Two hundredandfive patients werestudied inthemulticentre four weekdouble blind study. Prednisolone was given inadoseof40mgdaily orally, reducing overfourweeksto10or20mg.Fluticasone propionate wasgiven inanoral daily doseof 20mg.Theprimary endpoint wastheinvestigator's overall assessment of response. Patient's assessment, sigmoidoscopic appearance, andhistology werealso studied. Patients improved morerapidly withprednisolone. Differences between thetwogroupswere significant attwoweeks. Atfour weeksdifferenceswerenotsignificant, butthere wasa trend infavour ofprednisolone. Corticosteroid sideeffects wereminimal inthefluticasone propionate group, andthere wasminimal suppression ofthehypothalamic pituitary adrenal axis. Fluticasone propionate 20mgdaily isnot aseffective inthetreatment ofactive ulcerative colitis asprednisolone tapering from40mg daily to10or20mg.Thecomplete absence of suppression ofthecorticoadrenal axisby fluticasone propionate wasencouraging, however, andahigher dosage schedule should be assessed. (Gut1993; 34:125-128)