Researchers from Belgium investigated the clinical and histologic effects of budesonide in collagenous colitis (CC).
A total of 28 patients were randomly assigned to receive placebo (n = 14) or budesonide 9 mg daily (n = 14) for 8 weeks.
Patients were evaluated clinically, and blinded biopsy specimens were analyzed from fixed locations at weeks 0 and 8.
Clinical response was defined as a decrease of at least 50% in the disease activity score (number of bowel movements in the last 7 days).
| Gastroenterology |
At week 8, nonresponders received open-label budesonide for the next 8-week period; responders discontinued treatment and were followed up.
Three patients discontinued the study prematurely.
Intention-to-treat analysis showed clinical response in 8 of 14 patients in the budesonide group compared with 3 of 14 responders for placebo after 8 weeks of blinded therapy, together with improved stool consistency.
Histologically, the team found that there was no change in the mean thickness of the collagen band. However, there was a significant decrease of the lamina propria infiltrate in the budesonide group.
Author Filip Baert concluded on behalf of the group, "Budesonide is efficacious in inducing short-term clinical response in CC, with significant reduction of the histologic infiltrate in the lamina propria."