Quality-of-life results of double-blind, placebo-controlled trial of mesalamine in patients with Crohn's disease.
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.
Singleton
J W
JW
University of Colorado Health Science Center, Gastroenterology Division, Denver 80262, USA.
Hanauer
S
S
Robinson
M
M
D000328:Adult; D000636:Aminosalicylic Acids / Q000008:administration & dosage / Q000627:therapeutic use*; D000704:Analysis of Variance; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003424:Crohn Disease / Q000188:drug therapy* / Q000453:epidemiology / Q000523:psychology; D003692:Delayed-Action Preparations; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D019804:Mesalamine; D011788:Quality of Life; D018434:Sickness Impact Profile
D000636:Aminosalicylic Acids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D003692:Delayed-Action Preparations; D019804:Mesalamine