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 compare the efficacy and safety of Eudragit-L coated oral 5-aminosalicylic acid (5-ASA) (Salofalk; lnterfalk) 3 g per day to a 'standard' oral prednisone therapeutic regimen in a 12 week treatment period of uncomplicated attacks of...
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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Wiley
1990-01-01
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| Series: | Canadian Journal of Gastroenterology |
| Online Access: | http://dx.doi.org/10.1155/1990/659079 |
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| Summary: | A multicencre randomized controlled trial was designed to compare
the efficacy and safety of Eudragit-L coated oral 5-aminosalicylic acid
(5-ASA) (Salofalk; lnterfalk) 3 g per day to a 'standard' oral prednisone therapeutic
regimen in a 12 week treatment period of uncomplicated attacks of
Crohn's ileitis and ileocolitis. Fifty patients with active Crohn's disease (Crohn's
disease activity index [CDAI] 200 to 450) were randomized to receive either four
250 mg Eudragit-L-100 coated 5-ASA tablets three times a day for 12 weeks or
oral prednisone ( 4 mg tablets) at a sustained 40 mg per day for two weeks followed
by a 4 mg/day weekly dose reduction for the 10 subsequent weeks. Efficacy was
determined by changes in the calculated CDAI and, as a novel assessment, the
McMaster University quality of life index at two, four, six, eight, 10 and 12 weeks.
Standard blood and urine values were obtained and physician's assessment
completed at each two week visit. Clinical remission was obtained in 12 of 26
patients (46%) in the prednisone group and in nine of 19 (47%) in the 5-ASA
group. Treatment failure was observed in three patients in each group. All other
patients improved during the treatment period. Patients on prednisone reduced
their CDAI scores significantly more rapidly during the first four weeks, but the
reduction and maintenance of CDAI scores were similar in both groups for the
remainder of the study period. In patients with ileocolitis, prednisone was
significantly better than 5-ASA. Quality of life assessment parallelled the changes
in CDAI, and appear a valid index. The two therapeutic regimens appear safe
and did not disclose any unexpected adverse events or side effects. No significant
biological 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 appears
effective treatment for active Crohn's disease, and it is proposed chat higher doses
may be beneficial in more extensive disease (ileocolitis) and during the first four
weeks of treatment. |
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| ISSN: | 0835-7900 |