A research team, from Germany and Switzerland, investigated the effect of budesonide on symptoms and histology in patients with collagenous colitis.
The team used a randomized, double-blind, placebo-controlled multicenter trial.
In the study, 51 patients with chronic diarrhea and histologically-proven collagenous colitis received either oral budesonide 9 mg/day for 6 weeks or placebo. Of these, 45 patients were available for per protocol analysis.
The researchers performed a complete colonoscopy both before and after treatment.
- 61% in budesonide group
- 5% in placebo group
Histopathology was assessed, using a single pathologist who was unaware of each patient's treatment.
In addition, the team assessed clinical symptoms by using standardized questionnaires.
It was found that the rate of clinical remission was significantly higher in the budesonide group (p < 0.001), than in the placebo group.
Furthermore, the team observed histologic improvement in 61% of patients in the budesonide group, but in only 5% of patients in the placebo group (p < 0.001).
Dr Stephan Miehlke, from the Technical University Hospital, Dresden, concluded on behalf of his colleagues, "Oral budesonide is an effective and safe treatment modality for patients with collagenous colitis".
However, "Long-term follow-up of these patients is necessary to investigate whether clinical and histologic remission is sustained".