Long-term budesonide treatment of collagenous colitis: a randomised, double-blind, placebo-controlled trial

Objective:To evaluate the efficacy and safety of long-term budesonide therapy for the maintenance of clinical remission in patients with collagenous colitis.Design:Randomised, placebo-controlled study with a 24-week, blinded follow-up period without any treatment.Setting:Three gastroenterology clinics in Denmark.Patients:Forty-two patients with histologically confirmed collagenous colitis and diarrhoea (more than three stools/day).Interventions:Patients in clinical remission after 6 weeks’ open-label therapy with oral budesonide (Entocort CIR capsules, 9 mg/day) received 24 weeks’ double-blind maintenance therapy with budesonide 6 mg/day or placebo. Thereafter, patients entered the 24-week, blinded follow-up period.Main Outcome Measure:The proportion of patients in clinical remission (three or fewer stools/day) at the end of maintenance therapy.Findings:A total of 34 patients in remission at week 6 were randomly assigned to budesonide 6 mg/day (n = 17) or placebo (n = 17). After 24 weeks’ maintenance treatment, the proportions of patients in clinical remission were 76.5% (13 of 17) with budesonide and 12% (2 of 17) with placebo (p