Background and aims: Oral aminosalicylates are well established in the treatment of active mild/moderate ulcerative colitis (UC) when the disease is extensive (that is, beyond the splenic flexure). The majority of clinical sym-ptoms relate to disease activity in the distal part of the colon and therefore this study was designed to investigate if adding a mesalazine enema to oral mesalazine has additional benefit for patients with extensive mild/moderate active UC. Methods: A randomised double blind study was performed in 127 ambulatory patients. All received 4 g/ day (twice daily dosing) oral mesalazine for eight weeks. During the initial four weeks, they additionally received an enema at bedtime containing 1 g of mesalazine or placebo. Disease activitywas assessed using the ulcerative colitis disease activity index, with clinical and endoscopic signs at four and eight weeks. Results: Remission was obtained in 44%(95%confidence interval (CI) 31%, 58%) of the mesalazine enema group (Me) and in 34%(95%CI 21%, 49%) of the placebo enema group (PI) at four weeks (p = 0.31) and in 64%(95%CI 50%, 76%) of the Me group versus 43%(95%CI 28%, 58%) of the PI group at eight weeks (p = 0.03). Improvement was obtained in 89%(95%CI 78%, 96%) of the Me group versus 62%(95%CI 46%, 75%) of the PI group at four weeks (p = 0.0008) and in 86%(95%CI 75%, 94%) of the Me group versus 68%(95%CI 53%, 81%) of the PI group at eight weeks (p = 0.026). Conclusion: In patients with extensive mild/moderate active UC, the combination therapy is superior to oral therapy. It is safe, well accepted, and may be regarded as firstline treatment.
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