Controlled, open, randomized multicenter trial comparing the effects of treatment on quality of life, safety and efficacy of budesonide foam and betamethasone enemas in patients with active distal ulcerative colitis
Hammond, A.; Andus, T.; Gierend, M.; Ecker, K-Walter.; Scholmerich, J.; Herfarth, H.
Hepato-Gastroenterology 51(59): 1345-1349
2004
ISSN/ISBN: 0172-6390 PMID: 15362749 Document Number: 2197
Background/Aims: There is evidence of a higher quality of life with foams as compared with enemas. The purpose of this study was to assess the effect of treatment with budesonide foam or betamethasone enema on the quality of life and the clinical outcome in patients with distal ulcerative colitis. Methodology: In an open multicenter trial, patients with active distal ulcerative colitis were randomized to receive 2mg/50mL budesonide foam or 5mg/100mL betamethasone enema. Primary outcome variable was the change in the mean Life Quality Index. Therapeutic efficacy was determined by clinical activity, endoscopical and histological indices. Results: 38 patients were included in the study. The decrease of the mean Life Quality Index was more pronounced in the budesonide group. No significant difference in the efficacy of treatment was observed for both groups. Betamethasone suppressed the plasma cortisol level in the majority of the patients (87%) compared to only 22% of the patients receiving budesonide. Conclusions: The quality of life is not significantly different in patients during treatment with budesonide foam or betamethasone enema for active distal ulcerative colitis. However, while having comparable clinical efficacy budesonide foam has less effect on the plasma cortisol level thus potentially minimizing steroid side effects.
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