A new mesalazine gel enema in the treatment of left-sided ulcerative colitis: a randomized controlled multicentre trial

Background: A new mesalazine rectal gel preparation (without propellant gas ) has been recently developed to improve topical treatment in distal ulcera tive colitis. Aim: To evaluate the efficacy, safety and patient tolerability of mesalazin e gel enema compared with mesalazine foam enema in the treatment of patient s with acute left-sided ulcerative colitis. Methods: In a randomized multicentre investigator-blind parallel group tria l, 103 patients with mild to moderate left-sided colitis or proctosigmoidit is were randomly allocated to mesalazine 2 g gel enema (n = 50 evaluable pa tients) and mesalazine 2 g foam enema (n = 53 evaluable patients) for 4 wee ks. Clinical symptoms, endoscopic and histological findings were assessed a t entry, 2 and 4 weeks, Patients' evaluation of treatment tolerability and acceptability was assessed at 2 and 4 weeks. Results: After 4 weeks of treatment, clinical remission was achieved by 76% of mesalazine gel enema-treated patients and 69% of patients treated with mesalazine foam enema (P = 0.608). Endoscopic remission rates at week 4 wer e 51 and 52% for the mesalazine gel and foam enemas, respectively (P = 0.92 5), Histological remission was achieved by 30% of patients in both groups. Patients reported that the new mesalazine gel preparation was significantly better tolerated than the foam enema, Patients in the foam group had signi ficantly more difficulty in retention (25% vs. 6%, P < 0.05), abdominal blo ating (50% vs. 26%, P < 0.005) and discomfort during administration (48% vs , 26%, P < 0.05). Conclusion: The new mesalazine gel enema is efficacious and significantly b etter tolerated than the mesalazine foam enema.