BACKGROUND: Therapy for active left-sided ulcerative colitis usually involves topical application of mesalazine (mesalamine) or budesonide. AIM: To compare the efficacy and safety of budesonide enema and mesalazine enema in the treatment of active left-sided ulcerative colitis. METHODS: A total of 237 patients with mild-moderate ulcerative colitis were randomized open 1:1 to receive either budesonide (n = 118) or mesalazine enemas (n = 119) for 8 weeks. Efficacy variables were clinical activity index, endoscopic, histological index and IBDQ scores after 4 and 8 weeks. RESULTS:Clinical remission (intention-to-treat analysis) at week 4 was 63.5% for budesonide enemas and 77.2% for mesalazine enemas (P < 0.05). The respective values for the per protocol population (PP) were 59.9% examined in the budesonide group and 77.5% in the mesalazine group (P < 0.02). At the final visit (W8), clinical remission was diagnosed in the ITT analysis for 64.4% of the budesonide group and 77.4% of the mesalazine group (P < 0.05). The respective values for the PP analysis were 59.5% in the budesonide group and 75.3% in the mesalazine group (P < 0.02). CONCLUSIONS: Compared with budesonide, mesalazine enema was associated with a significantly higher remission rate; this was supported by favourable trends in endoscopic, histological remission rates and the IBDQ score.
RCT Entities:
BACKGROUND: Therapy for active left-sided ulcerative colitis usually involves topical application of mesalazine (mesalamine) or budesonide. AIM: To compare the efficacy and safety of budesonide enema and mesalazine enema in the treatment of active left-sided ulcerative colitis. METHODS: A total of 237 patients with mild-moderate ulcerative colitis were randomized open 1:1 to receive either budesonide (n = 118) or mesalazine enemas (n = 119) for 8 weeks. Efficacy variables were clinical activity index, endoscopic, histological index and IBDQ scores after 4 and 8 weeks. RESULTS: Clinical remission (intention-to-treat analysis) at week 4 was 63.5% for budesonide enemas and 77.2% for mesalazine enemas (P < 0.05). The respective values for the per protocol population (PP) were 59.9% examined in the budesonide group and 77.5% in the mesalazine group (P < 0.02). At the final visit (W8), clinical remission was diagnosed in the ITT analysis for 64.4% of the budesonide group and 77.4% of the mesalazine group (P < 0.05). The respective values for the PP analysis were 59.5% in the budesonide group and 75.3% in the mesalazine group (P < 0.02). CONCLUSIONS: Compared with budesonide, mesalazine enema was associated with a significantly higher remission rate; this was supported by favourable trends in endoscopic, histological remission rates and the IBDQ score.
Authors: Cynthia W Ko; Siddharth Singh; Joseph D Feuerstein; Corinna Falck-Ytter; Yngve Falck-Ytter; Raymond K Cross Journal: Gastroenterology Date: 2018-12-18 Impact factor: 22.682
Authors: Jonathan Blackwell; Christian Selinger; Tim Raine; Gareth Parkes; Melissa A Smith; Richard Pollok Journal: Frontline Gastroenterol Date: 2020-04-02
Authors: Axel Dignass; Robert Schnabel; Jacek Romatowski; Vladimir Pavlenko; Andrey Dorofeyev; Jelena Derova; Laimas Jonaitis; Karin Dilger; Tanju Nacak; Roland Greinwald Journal: United European Gastroenterol J Date: 2017-03-30 Impact factor: 4.623
Authors: H Sales-Campos; P J Basso; V B F Alves; M T C Fonseca; G Bonfá; V Nardini; C R B Cardoso Journal: Braz J Med Biol Res Date: 2014-11-28 Impact factor: 2.590