Novel Budesonide Suppository and Standard Budesonide Rectal Foam Induce High Rates of Clinical Remission and Mucosal Healing in Active Ulcerative Proctitis: a Randomised, Controlled, Non-inferiority Trial.

BACKGROUND AND AIMS: Proctitis is the least extensive type of ulcerative colitis, for which rectal therapy is rarely studied and is underused. This study evaluated the efficacy, safety, and patient's preference of a novel formulation of budesonide suppository 4 mg, compared with a commercially available budesonide rectal foam 2 mg, for the treatment of mild to moderate ulcerative proctitis. METHODS: This was a randomised, double-blind, double-dummy, active-controlled trial. Patients were randomly assigned in a 1:1 ratio to receive either budesonide 4 mg suppository or budesonide 2 mg foam once daily for 8 weeks. The co-primary endpoints were changes from baseline to Week 8 in clinical symptoms, for which clinical remission was defined as having a modified Ulcerative Colitis-Disease Activity Index [UC-DAI] subscore for stool frequency of 0 or 1 and a subscore for rectal bleeding of 0, and mucosal healing, defined as having a modified UC-DAI subscore for mucosal appearance of 0 or 1. Using a more stringent criterion, we additionally analysed deepened mucosal healing, which was defined as a mucosal appearance subscore of 0. Patient's preference, physician's global assessment, and quality of life were also assessed and analysed. RESULTS: Overall, 286 and 291 patients were included in the 4 mg suppository and 2 mg foam groups, respectively. Budesonide 4 mg suppository met the prespecified criterion for non-inferiority to the 2 mg foam in both co-primary endpoints of clinical remission and mucosal healing. Secondary endpoints consistently supported the non-inferiority of the suppository. Trends in favour of the suppository were observed in the subgroup of mesalazine non-responders. More patients reported a preference for the suppository over rectal foam. CONCLUSIONS: In patients with ulcerative proctitis, budesonide 4 mg suppository was non-inferior to budesonide 2 mg foam in efficacy, and both were safe and well tolerated.

The impact of mirror therapy on body schema perception in patients with complex regional pain syndrome after distal radius fractures.

INTRODUCTION: Mirror therapy requires a minimum of equipment, is relatively simple to perform and effective for various pathological conditions. The effect of mirror therapy on body schema disturbances registered in complex regional pain syndrome type I (CRPS I) patients has not yet been determined. METHODS: The study is based on the analysis of the treatment results of 30 patients with CRPS I, developed as a result of the distal radius fractures, with help of mirror therapy together with exercise therapy and medications. The control group consisted of 20 patients with CRPS I developed as a result of the distal radius fractures treated only with exercise therapy and medications. We evaluated the results before the treatment, after 3 days and after 6 weeks of treatment according to The Bath CRPS Body Perception Disturbance Scale. RESULTS: A total of 83.33% patients experienced the positive effect of mirror therapy on the perception of the 'body schema' after 6 weeks of treatment, and 35% underwent standard treatment without mirror therapy. The positive effect was statistically significant for the first five points of the Bath scale after 6 weeks of treatment compared to the control group. Improvements observed in some patients after 3 days of treatment were less pronounced and statistically insignificant. CONCLUSION: Mirror therapy can improve the perception of the body schema as an element of integrated treatment of CRPS I developed after fractures of the distal radius less than 3 years duration.