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A comparative study evaluating the efficacy and safety of once daily versus three times daily mesalazine in ulcerative colitis

Hiba Salam, Bhagyalekshmi Narayanapillai, Ramesh Mohan.




Abstract

Background: Ulcerative Colitis (UC) is an inflammatory disease affecting the colonic mucosa. Oral Mesalazine is one of the established treatments for UC and the conventional dosing regimen is 3 times a day. However, medical management favors lesser dosing frequency and the evidence of once daily dosing efficacy is not established by randomized controlled trials.

Aim and Objective: Aim and objective of the study was to assess the efficacy and safety of once daily versus 3 times daily Mesalazine in UC.

Materials and Methods: This prospective study was carried out in a sample of patients newly diagnosed with mild to moderately active UC. Patients were grouped into to once daily and 3 times daily groups. Outcomes were measured by Partial Mayo score, Individual Symptom Assessment, endoscopy and Histological score at the end of 8th week. Primary endpoint was proportion of patients achieving clinical remission and response with Partial Mayo score at the end of 8th week from start of treatment. Analysis was done using Epi Info Version 7.

Results: Sixty patients were assessed (31 patients in OD group and 29 patients in TID group). 61.3% patients in OD group and 62.1% in TID group achieved remission, whereas 71% in the OD group and 58.6% in the TID group achieved clinical response to treatment at the end of 8th week with Partial Mayo score.

Conclusion: The study concludes that once daily dosing regimen of Mesalazine is as efficacious and safe as 3 times daily dosing regimen in inducing remission in mild to moderate UC.

Key words: Oral Mesalazine; Ulcerative Colitis; Once Daily Dose; Three Times Daily Dose






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