Gastroenterology 2002; 122:20-25

Budesonide in Collagenous Colitis: A Double-Blind Placebo-Controlled Trial With Histologic Follow-Up FILIP

Filip Baert, Alain Schmit, Geert D'haens, Franceska Dedeurwaerdere, Edouard Louis, Marc Cabooter, Martine De Vos, Fernand Fontaine, Serge Naegels, Piet Schurmans, Hedwig Stals, Karel Geboes, And Paul Rutgeerts, for the Belgian Ibd Research Group and Codali Brussels, Belgium.

BACKGROUND & AIMS: Collagenous colitis (CC) is a welldescribed entity causing chronic diarrhea and characteristic histologic Þndings. Several treatment options have been suggested, but no controlled data are available. We conducted a placebo-controlled trial to show the clinical and histologic effects of budesonide in CC.
METHODS: Twenty-eight patients were randomly assigned to receive placebo (n 5 14) or budesonide 9 mg daily (n 5 14) for 8 weeks. Patients were evaluated clinically, and blinded biopsy specimens were analyzed from Þxed locations at weeks 0 and 8. Clinical response was de-Þned as a decrease of at least 50% in the disease activity score (number of bowel movements in the last 7 days). At week 8, nonresponders received open-label budesonide for the next 8-week period; responders discontinued treatment and were followed up. 
RESULTS: 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 (P 5 0.05) after 8 weeks of blinded therapy, together with improved stool consistency.
Histologically, there was no change in the mean thickness of the collagen band but a signiÞcant decrease of the lamina propria inÞltrate in the budesonide group (P < 0.001). 
CONCLUSIONS: Budesonide is efÞcacious in inducing short-term clinical response in CC with signiÞcant reduction of the histologic inÞltrate in the lamina propria.