Dp. Jewell et Je. Lennardjones, ORAL CYCLOSPORINE FOR CHRONIC ACTIVE CROHNS-DISEASE - A MULTICENTER CONTROLLED TRIAL, European journal of gastroenterology & hepatology, 6(6), 1994, pp. 499-505
Objective: To determine the role of oral cyclosporin in the management
of patients with chronic active Crohn's disease. Design: Double-blind
, placebo-controlled study of oral cyclosporin (5 mg/kg) versus placeb
o in combination with prednisolone over an initial period of 3 months.
Patients: The trial included 147 patients with chronic active Crohn's
disease. Criteria for entry were as follows: patients with active dis
ease requiring greater-than-or-equal-to 10 mg prednisolone daily and/o
r azathioprine to control symptoms, and patients relapsing within 4 we
eks of finishing one of these treatments. No case record form was comp
leted for one patient. The data were analysed on an intention-to-treat
basis for 146 patients. Outcome measures: Clinical response was defin
ed as the resolution of symptoms or a significant improvement on withd
rawal or reduction of prednisolone. Disease activity was also assessed
by the Harvey-Bradshaw Activity Index and laboratory indicators of ac
tivity (erythrocyte sedimentation rate, C-reactive protein). Results:
No significant differences were observed between the two groups with r
espect to clinical outcome, corticosteroid dosage required, or changes
in the indices of activity over the 3-month trial period. Adverse rea
ctions in the cyclosporin-treated patients were not uncommon, but none
were serious or prolonged. Conclusion: This trial does not support th
e value of oral cyclosporin (5 mg/kg) for the management of chronic ac
tive Crohn's disease.