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.
Hepatogastroenterology
; 51(59): 1345-9, 2004.
Article
in En
| MEDLINE
| ID: mdl-15362749
ABSTRACT
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 2 mg/50 mL budesonide foam or 5 mg/100 mL 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.
Search on Google
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Quality of Life
/
Betamethasone
/
Colitis, Ulcerative
/
Budesonide
/
Anti-Inflammatory Agents
Type of study:
Clinical_trials
/
Observational_studies
Aspects:
Patient_preference
Limits:
Adolescent
/
Adult
/
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Language:
En
Journal:
Hepatogastroenterology
Year:
2004
Document type:
Article
Affiliation country:
Alemania