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Oral versus combination mesalazine therapy in active ulcerative colitis: a double-blind, double-dummy, randomized
M Vecchi1, G Meucci, P Gionchetti
1Gastroenterology and Gastrointestinal Endoscopy Service, Department of Internal Medicine, IRCCS Ospedale Policlinico, Milan, Italy. gastro@polic.cilea.it
Alimentary Pharmacology & Therapeutics
|January 10, 2001
Summary
For mild ulcerative colitis, oral mesalazine and combined oral/topical mesalazine show similar efficacy in achieving remission. Both treatments are effective for managing active disease.
Area of Science:
- Gastroenterology
- Pharmacology
- Clinical Medicine
Background:
- Oral and topical mesalazine are established treatments for active ulcerative colitis.
- Limited data exist on the comparative efficacy of combined oral and topical mesalazine therapy.
Purpose of the Study:
- To compare the effectiveness of oral mesalazine versus a combination of oral and topical mesalazine.
- To evaluate treatment outcomes in patients with mild to moderate active ulcerative colitis.
Main Methods:
- Randomized controlled trial involving 130 patients with ulcerative colitis (Clinical Activity Index [CAI] 4-12).
- Patients received either 4g oral mesalazine with placebo enema or 2g oral mesalazine with 2g mesalazine enema for 6 weeks.
- Primary endpoints included clinical remission (CAI < 4) and clinical remission/improvement rates at 6 weeks.
Main Results:
- Clinical remission rates were 82% for oral and 87% for combined treatment (P=0.56).
- Rates of clinical remission/improvement were 85% and 91% (P=0.503), respectively.
- Endoscopic remission rates were 58% and 71% (P=0.21) for oral and combined groups, respectively.
Conclusions:
- Mesalazine 4g orally and 2g orally plus 2g enema demonstrate comparable efficacy in inducing remission for mild ulcerative colitis.
- Both treatment strategies are equally effective for patients with mild active ulcerative colitis.