Oral 5-ASA Versus Prednisone in Short Term Treatment of Crohn's Disease: A Multicentre Controlled Trial

A multicencre randomized controlled trial was designed to comparethe efficacy and safety of Eudragit-L coated oral 5-aminosalicylic acid(5-ASA) (Salofalk; lnterfalk) 3 g per day to a 'standard' oral prednisone therapeuticregimen in a 12 week treatment period of uncomplicated attacks ofCrohn's ileitis and ileocolitis. Fifty patients with active Crohn's disease (Crohn'sdisease activity index [CDAI] 200 to 450) were randomized to receive either four250 mg Eudragit-L-100 coated 5-ASA tablets three times a day for 12 weeks ororal prednisone ( 4 mg tablets) at a sustained 40 mg per day for two weeks followedby a 4 mg/day weekly dose reduction for the 10 subsequent weeks. Efficacy wasdetermined by changes in the calculated CDAI and, as a novel assessment, theMcMaster University quality of life index at two, four, six, eight, 10 and 12 weeks.Standard blood and urine values were obtained and physician's assessmentcompleted at each two week visit. Clinical remission was obtained in 12 of 26patients (46%) in the prednisone group and in nine of 19 (47%) in the 5-ASAgroup. Treatment failure was observed in three patients in each group. All otherpatients improved during the treatment period. Patients on prednisone reducedtheir CDAI scores significantly more rapidly during the first four weeks, but thereduction and maintenance of CDAI scores were similar in both groups for theremainder of the study period. In patients with ileocolitis, prednisone wassignificantly better than 5-ASA. Quality of life assessment parallelled the changesin CDAI, and appear a valid index. The two therapeutic regimens appear safeand did not disclose any unexpected adverse events or side effects. No significantbiological abnormalities were detected in either treatment group. In conclusion,in this small trial, it was found that Salofalk at a dose of 3 g per day appearseffective treatment for active Crohn's disease, and it is proposed chat higher dosesmay be beneficial in more extensive disease (ileocolitis) and during the first fourweeks of treatment