Background/Aim: To investigate patient-reported health-related quality of life (HRQoL) in data collected from a multinational randomized double-blind controlled trial comparing oral mesalazine (4 g) + topical mesalazine enema (1 g) to oral mesalazine alone (4 g). Methods: HRQoL was collected using the EQ-5D at baseline and weeks 2, 4 and 8. The EQ-5D assesses mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Scores from each dimension were reported individually, and converted into a weighted health state which reflects an individual’s perception of their health condition. Results: At week 4, a significant HRQoL improvement was observed for patients on mesalazine enemas compared to placebo enemas, with EQ-5D scores of 0.906 and 0.838, respectively (p < 0.05). Mesalazine enema was found to reduce the probability of impairment at week 4 for mobility (p = 0.049) and anxiety/depression (p = 0.048), and was of borderline significance for pain/discomfort (p = 0.053); there was also an increased probability of influencing HRQoL changes for mobility (p < 0.005), usual activities (p < 0.005), pain/discomfort (p < 0.005) and anxiety/depression (p < 0.005), based on reported HRQoL problems at baseline. Conclusions: Including 1 g mesalazine enemas with 4 g oral mesalazine significantly improved HRQoL in patients with active ulcerative colitis. The improvement in QoL of patients with UC preceded clinical remission, and this underlines the importance of including QoL instruments in clinical studies.

Ghosh S, Shand A, Ferguson A: Ulcerative colitis. BMJ 2000;320:1119&ndash;1123.
Su C, Lewis JD, Goldberg B, Brensinger C, Lichtenstein GR: A meta-analysis of the placebo rates of remission and response in clinical trials of active ulcerative colitis. Gastroenterology 2007;132:516&ndash;526.
Ansari R, Attari F, Razjouyan H, Etemadi A, Amjadi H, Merat S, Malekzadeh R: Ulcerative colitis and irritable bowel syndrome: relationships with quality of life. Eur J Gastroenterol Hepatol 2008;20:46&ndash;50.
Hjortswang H, Str&ouml;m M, Almer S: Health-related quality of life in Swedish patients with ulcerative colitis. Am J Gastroenterol 1998;93:2203&ndash;2211.
Reinisch W, Sandborn WJ, Bala M, Yan S, Feagan BG, Rutgeerts P, Radford-Smith G, Xu S, Eisenberg D, Olson A, Colombel JF: Response and remission are associated with improved quality of life, employment and disability status, hours worked, and productivity of patients with ulcerative colitis. Inflamm Bowel Dis 2007;13:1135&ndash;1140.
Travis SPL, Stange EF, L&eacute;mann M, &Oslash;resland T, Bemelman WA, Chowers Y, et al: European evidence-based consensus on the management of ulcerative colitis: current management. J Crohns Colitis 2008;2:24&ndash;62.
Clemett D, Markham A: Prolonged-release mesalazine: a review of its therapeutic potential in ulcerative colitis and Crohn&rsquo;s disease. Drugs 2000;59:929&ndash;956.
Kane SV: Systematic review: adherence issues in the treatment of ulcerative colitis. Aliment Pharmacol Ther 2006;23:577&ndash;585.
Gionchetti P, Amadini C, Rizzello F, Venturi A, Campieri M: Review article: treatment of mild to moderate ulcerative colitis and pouchitis. Aliment Pharmacol Ther 2002;16:13&ndash;19.
Marteau P, Probert CS, Lindgren S, Gassul M, Tan TG, Dignass A, Befrits R, Midhagen G, Rademaker J, Foldager M: Combined oral and enema treatment with Pentasa (mesalazine) is superior to oral therapy alone in patients with extensive mild/moderate active ulcerative colitis: a randomized, double blind, placebo controlled study. Gut 2005;54:960&ndash;965.
National Institute for Health and Clinical Excellence (NICE): Guide to the Methods of Technology Appraisal. May 2004. (accessed 8 October 2008).
EuroQol Group: EuroQol &ndash; a new facility for the measurement of health-related quality of life. Health Policy 1990;16:199&ndash;208.
Kind P, Dolan P, Gudex C, Williams A: Variations in population health status: results from a United Kingdom national questionnaire survey. BMJ 1998;316:736&ndash;741.
Vickers AJ, Altman DG: Analysing controlled trials with baseline and follow up measurements. BMJ 2001;323:1123&ndash;1124.
Campieri M, Gionchetti P, Belluzzi A, Brignola C, Tampieri M, Iannone P, Miglioli M, Barbara L: Optimum dosage of 5-aminosalicylic acid as rectal enemas in patients with active ulcerative colitis. Gut 1991;32:929&ndash;931.
Suarez-Almazor ME, Conner-Spady B, Kendall CJ, Russell AS, Skeith K: Lack of Congruence in the ratings of patients&rsquo; health status by patients and their physicians. Med Decis Making 2001;21:113&ndash;121.
Montgomery AA: How do patients&rsquo; treatment preferences compare with those of clinicians? Qual Health Care 2001;10:i39&ndash;i43.
D&rsquo;Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR: A review of activity indices and efficacy points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology 2007;132:763&ndash;786.
Cooney RM, Warren BF, Altman DG, Abreu MT, Travis SPL: Outcome measurement in clinical trials for ulcerative colitis: towards standardization. Trials 2007;8:17. DOI: 10.1186/1745-6215-8-17.
Poole CD, Nielsen SK, Currie CJ, Marteau P: Establishing the relationship between the Ulcerative Colitis Disease Activity Instrument (UCDAI) and patient health-related quality of life from a large randomised controlled trial. Gut 2008;57(suppl II):A141.
Walsh AJ, Brain O, Keshav S, Buchel OC, Merrin B, Rolinski M, Thomas S, White L, von Berbay A, Warren B, Altman DG, Travis S: Which activity index for ulcerative colitis (UC)? Evaluation of inter-observer variation in clinical, endoscopic and composite indices. Gut 2009;58(suppl I):A1&ndash;A156.
Travis S, Sandborn WJ, Hanauer SB, Lemann M, Sands BE, Marteau P, Colombel JF, Abreu MT, Lichtenstein GR, Feagan BG, Altman DG, Mary JY, Schnell D, Yacyshyn B, Krzeski P, Bernhardt CA: Identification of items to be included in an ulcerative colitis endoscopic index of severity (UCEIS). DDW oral presentation 2009; abstract 1049.
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