A steroid enema, budesonide, lacking systemic effects for the treatment of distal ulcerative colitis or proctitis

Abstract

The aim of this study was to evaluate whether budesonide enema (2 mg/100 ml) had a significantly better effect than placebo in the treatment of distal ulcerative colitis or proctitis. The trial was of controlled, randomized, double-blind design and included 41 treated patients. The treatment time was 4 weeks, with revisits after 2 and 4 weeks. If no improvement was seen, the patient could be switched over to open-label therapy with budesonide enema. Sigmoidoscopy, histology, blood chemistry, and diary cards were used for estimating the effect of treatment. The results showed that budesonide was superior to placebo. Sigmoidoscopy and biopsy scores improved significantly (p less than 0.01) in budesonide-treated patients compared with placebo. Significantly more patients switched over to open budesonide treatment in the placebo group owing to lack of efficacy compared with budesonide (p less than 0.001). No drug-related adverse experiences occurred, and there was no decrease in endogenous morning plasma cortisol levels. It is concluded that budesonide enema appears to be an effective and safe treatment for distal ulcerative colitis and proctitis.