Abstract
Seven quality-of-life parameters were assessed in a trial of mesalamine in Crohn's disease. The results with regard to efficacy and safety have been previously published. A total of 310 patients were enrolled in this double-blind, parallel trial and randomized to receive placebo, or 1, 2, or 4 g/day of mesalamine in controlled-release capsules for 16 weeks. Results revealed that mesalamine at the dose of 4 g/day resulted in significant (P<0.03) improvements from baseline in all quality-of-life parameters. A significant (P<0.02) linear trend between increasing doses of mesalamine and increasing response was also noted. The 1- and 2-g/day doses of mesalamine also resulted in an improvement in quality of life, however, with the exception of 2 g/day of mesalamine on the hobby and recreational activities parameter, these changes were not significantly different from placebo.
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Grant support for this trial was provided by Marion Merrell Dow Inc.
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Singleton, J.W., Hanauer, S. & Robinson, M. Quality-of-life results of double-blind, placebo-controlled trial of mesalamine in patients with Crohn's disease. Digest Dis Sci 40, 931–935 (1995). https://doi.org/10.1007/BF02064179
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DOI: https://doi.org/10.1007/BF02064179