Treatment of Crohn's disease (CD) in clinical remission is still a debated issue. Previous studies have shown a high risk of relapse for patients with CD in clinical remission (CDAI<150) but with some abnormally high laboratory parameters as well as a possible beneficial role of low-dosage steroid treatment in this group of patients. Furthermore, good results have been reported on the efficacy of 5-aminosalicylic acid (5-ASA) in moderately active CD. In our study we verified the efficacy of a slow-release oral 5-ASA preparation in preventing relapses in a group of patients in clinical remission but with raised laboratory parameters. Forty-four patients were randomized in a double-blind manner to receive either 5-ASA (2 g/day) or placebo for four months. Location of disease and previous steroid treatment were similar in both groups. One patient in the 5-ASA group discontinued the drug because of uterine bleeding. During the study period, 13 of 22 placebo-treated patients and 11 of 21 5-ASA-treated patients relapsed (corrected chi square=NS). Considering the location of disease, three of 10 patients in the 5-ASA group and six of nine patients in the placebo group with ileal CD relapsed (therapeutic gain with 5-ASA: 36.6%; 95% allowance for error from -6% to 79.2%). Moreover, in seven patients with ileal CD who remained in remission, we found a statistically significant decrease in α1 acid glycoprotein and C-reactive protein from the second month of the study. In conclusion, although results with 5-ASA in CD seem disappointing, the possible benefit of higher dosages of 5-ASA in selected subgroups of CD patients is discussed. © 1992 Plenum Publishing Corporation.

Brignola C., Iannone P., Pasquali S., Campieri M., Gionchetti P., Belluzzi A., et al. (1992). Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn's disease. DIGESTIVE DISEASES AND SCIENCES, 37(1), 29-32 [10.1007/BF01308338].

Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn's disease

Brignola C.;Iannone P.;Campieri M.;Gionchetti P.;Belluzzi A.;Miglioli M.;Barbara L.
1992

Abstract

Treatment of Crohn's disease (CD) in clinical remission is still a debated issue. Previous studies have shown a high risk of relapse for patients with CD in clinical remission (CDAI<150) but with some abnormally high laboratory parameters as well as a possible beneficial role of low-dosage steroid treatment in this group of patients. Furthermore, good results have been reported on the efficacy of 5-aminosalicylic acid (5-ASA) in moderately active CD. In our study we verified the efficacy of a slow-release oral 5-ASA preparation in preventing relapses in a group of patients in clinical remission but with raised laboratory parameters. Forty-four patients were randomized in a double-blind manner to receive either 5-ASA (2 g/day) or placebo for four months. Location of disease and previous steroid treatment were similar in both groups. One patient in the 5-ASA group discontinued the drug because of uterine bleeding. During the study period, 13 of 22 placebo-treated patients and 11 of 21 5-ASA-treated patients relapsed (corrected chi square=NS). Considering the location of disease, three of 10 patients in the 5-ASA group and six of nine patients in the placebo group with ileal CD relapsed (therapeutic gain with 5-ASA: 36.6%; 95% allowance for error from -6% to 79.2%). Moreover, in seven patients with ileal CD who remained in remission, we found a statistically significant decrease in α1 acid glycoprotein and C-reactive protein from the second month of the study. In conclusion, although results with 5-ASA in CD seem disappointing, the possible benefit of higher dosages of 5-ASA in selected subgroups of CD patients is discussed. © 1992 Plenum Publishing Corporation.
1992
Brignola C., Iannone P., Pasquali S., Campieri M., Gionchetti P., Belluzzi A., et al. (1992). Placebo-controlled trial of oral 5-ASA in relapse prevention of Crohn's disease. DIGESTIVE DISEASES AND SCIENCES, 37(1), 29-32 [10.1007/BF01308338].
Brignola C.; Iannone P.; Pasquali S.; Campieri M.; Gionchetti P.; Belluzzi A.; Basso O.; Miglioli M.; Barbara L.
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/876344
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