ORAL CORTICOSTEROIDS IN ULCERATIVE COLITIS: NO GAIN WITHOUT PAIN

Rhodes JM, Robinson R, Beales I, . Clinical trial: oral prednisolone metasulfobenzoate (Predocol) vs. oral prednisolone for active ulcerative colitis. Aliment Pharmaol Ther 2008;27:228–40.

It would be nice to treat active ulcerative colitis (UC) with an oral corticosteroid that was topically effective but without significant systemic absorption. Previous studies with fluticasone (Gut 1993;34:125) and budesonide (Gastroenterology 1996;110:1713) have not shown as much benefit as oral prednisolone, particularly in distal disease. Prednisolone metasulfobenzoate is clinically effective as an enema in UC but is poorly absorbed from the colon and when given orally with a Eudragit S coating has little absorption and no adrenal suppression. Is it as effective as oral prednisolone in UC?

This double-blind controlled UK trial recruited 181 patients with active UC (sigmoidoscopy Baron score ⩾1 and disease extending at least to the descending colon) to receive either prednisolone metasulfobenzoate 40 mg or 60 mg daily or prednisolone 40 mg daily. The prednisolone metasulfobenzoate groups stayed on the same dose for 6 months but the prednisolone group started tapering after 2 weeks and stopped at 8 weeks, then took placebo for up to 6 months. Patients with severe UC were excluded. The primary end point was a patient’s global visual analogue scale (VAS) assessment of side effects. Efficacy was a secondary …