Budesonide in collagenous colitis: a double-blind placebo-controlled trial with histologic follow-up.
OBJECTIVE
Collagenous colitis (CC) is a well-described entity causing chronic diarrhea and characteristic histologic findings. 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 = 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). 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 = 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 significant decrease of the lamina propria infiltrate in the budesonide group (P < 0.001).


CONCLUSIONS
Budesonide is efficacious in inducing short-term clinical response in CC with significant reduction of the histologic infiltrate in the lamina propria.
Baert
Filip
F
Imelda Hospital Bonheiden, Belgium.
Schmit
Alain
A
D'Haens
Geert
G
Dedeurwaerdere
Franceska
F
Louis
Edouard
E
Cabooter
Marc
M
De Vos
Martine
M
Fontaine
Fernand
F
Naegels
Serge
S
Schurmans
Piet
P
Stals
Hedwig
H
Geboes
Karel
K
Rutgeerts
Paul
P
D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001706:Biopsy; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D002908:Chronic Disease; D003092:Colitis / Q000188:drug therapy* / Q000473:pathology; D003967:Diarrhea / Q000188:drug therapy / Q000473:pathology; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
D000893:Anti-Inflammatory Agents; D019819:Budesonide