{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,7]],"date-time":"2026-11-07T05:16:04Z","timestamp":1794028564418,"version":"4.8.0"},"reference-count":32,"publisher":"BMJ","issue":"6666","license":[{"start":{"date-parts":[[1989,1,14]],"date-time":"1989-01-14T00:00:00Z","timestamp":600739200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/www.bmj.com\/company\/legal-information\/terms-conditions\/legal-information\/tdm-licencepolicy"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BMJ"],"published-print":{"date-parts":[[1989,1,14]]},"abstract":"<jats:p>OBJECTIVE--To assess the safety and efficacy of a preparation of mesalazine (5-aminosalicylic acid) coated with a pH dependent resin (Eudragit L) as compared with sulphasalazine in patients with active mild to moderate ulcerative colitis. DESIGN--Eight week randomised double blind parallel group study. SETTING--Forty six gastroenterology outpatient clinics in seven countries. PATIENTS--Two hundred and twenty patients aged 18-70 who met the following criteria: clinical activity index greater than or equal to 6 and endoscopic index greater than or equal to 4; no concomitant treatment for ulcerative colitis; no hypersensitivity to salicylates or sulphonamides. Of the 164 patients eligible for efficacy analysis, 87 received the coated preparation of mesalazine and 77 sulphasalazine. Most of the remaining patients (28 in each group) were ineligible for the efficacy analysis because of treatment with steroid enemas. All pretrial characteristics were comparable in the two treatment groups. INTERVENTIONS--Coated mesalazine (Mesasal) 1.5 g daily or sulphasalazine 3.0 g daily for eight weeks. Compliance monitored by pill counts. END POINT--Clinical and endoscopic remission. MEASUREMENTS AND MAIN RESULTS--Clinical activity measured by daily diary cards, assessment by investigators, and laboratory findings. Endoscopic evaluation at week 8. After four weeks 50 of 70 patients (71%) taking coated mesalazine and 38 of 58 (66%) taking sulphasalazine had achieved remission of their disease by eight weeks remission rates were 74% (37\/50 patients) and 81% (35\/43) in the two treatment groups respectively. Endoscopic remission at eight weeks was recorded in 20 of 41 patients (49%) taking coated mesalazine and 18 of 38 (47%) taking sulphasalazine. There was a higher incidence of adverse events among patients taking sulphasalazine (25\/105; 24%) than among those taking coated mesalazine (16\/115; 14%). CONCLUSION--Mesalazine coated with Eudragit L is a safe, logical alternative to sulphasalazine.<\/jats:p>","DOI":"10.1136\/bmj.298.6666.82","type":"journal-article","created":{"date-parts":[[2009,4,2]],"date-time":"2009-04-02T15:19:55Z","timestamp":1238685595000},"page":"82-86","source":"Crossref","is-referenced-by-count":868,"title":["Coated mesalazine (5-aminosalicylic acid) versus sulphasalazine in the treatment of active ulcerative colitis: a randomised trial."],"prefix":"10.1136","volume":"298","author":[{"given":"D.","family":"Rachmilewitz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[1989,1,14]]},"reference":[{"key":"ref_1","first-page":"465","article-title":"The treatment of 124 cases of ulcerative colitis with Salazopyrin and attempts at desensitization in cases of hypersensitivity tt) sulfa. Acia Mde1 Scand","volume":"206","author":"Svartz, N.","year":"1948","unstructured":"Svartz N. The treatment of 124 cases of ulcerative colitis with Salazopyrin and attempts at desensitization in cases of hypersensitivity tt) sulfa. Acia Mde1 Scand 1948;206 suppl):465-71."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"923","DOI":"10.1136\/gut.14.12.923","article-title":"A controlled therapeutic trial of long-ternm maintenance trcatment of ulcerative colitis with sulphasalazine tSalazopyrin)","volume":"14","author":"Dissanavake, A.S.; Truelove, S.C.","year":"1973","unstructured":"Dissanavake AS, Truelove SC. A controlled therapeutic trial of long-ternm maintenance trcatment of ulcerative colitis with sulphasalazine tSalazopyrin). Gut 1973;14:923-6.","journal-title":"Gut"},{"key":"ref_3","first-page":"833","article-title":"Sulfasalazine-adserse effects and desensitization","volume":"28","author":"Taffet, S.L.; Das, K.M.","year":"1983","unstructured":"Taffet SL, Das KM. 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The value of 5-aminosalicylic acid in inflammatory bowel disease for patients intolerant or allergic to sulphasalazine. Postgrad Med.7 1985;61:1047-8.","journal-title":"Postgrad Med.7"},{"key":"ref_26","first-page":"1240","article-title":"Sulphasalazine-induced infertility reversed on transfer to 5-aminosalicylic acid","volume":"i:","author":"Schaffer, J.L.; Kershaw, A.; Berrisford, M.H.","year":"1984","unstructured":"Schaffer JL, Kershaw A, Berrisford MH. Sulphasalazine-induced infertility reversed on transfer to 5-aminosalicylic acid. Lancet 1984;i: 1240.","journal-title":"Lancet"},{"key":"ref_27","article-title":"Treatment of ulcerativ e colitis with oral 5-aminosalicylic acid in patients unable to take sulphasalazine","author":"Dew, A.J.; Harries, A.D.; Evans, N.; Evans, B.K.; Rhodes, J.","year":"1983","unstructured":"Dew AJ, Harries AD, Evans N, Evans BK, Rhodes J. Treatment of ulcerativ e colitis with oral 5-aminosalicylic acid in patients unable to take sulphasalazine. 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