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Sulphasalazine and Prednisone Compared with Sulphasalazine for Treating Active Crohn Disease: A Double-Blind, Randomized, Multicenter Trial

Marno C. M. Rijk, MD; Ruud A. van Hogezand, MD, PhD; Henk J. J. van Lier, MSc; and Jan H. M. van Tongeren, MD, PhD
[+] Article and Author Information

Requests for Reprints: Marno C. M. Rijk, MD, Department of Internal Medicine, Ziekenhuis de Baronie, P.O. Box 90157, 4800 RL Breda, The Netherlands.

Current Author Addresses: Dr. Rijk: Department of Internal Medicine, Ziekenhuis de Baronie, P.O. Box 90157, 4800 RL Breda, The Netherlands.

Dr. van Tongeren: Department of Gastrointestinal and Liver Diseases, University Hospital Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.

Dr. van Hogezand: Medisch Spectrum Twente, Haakbergerstraat 55, 7513 ER Enschede, The Netherlands.

Mr. van Lier: Medisch Statistische Adviesafdeling, University Hospital Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands.


From the University Hospital Nijmegen and the University of Nijmegen, Nijmegen, The Netherlands. For current author addresses, see end of text.*The multicenter group included: M.C.M. Rijk, R.A. van Hogezand, P.A.M. van Hees, J.H.M. van Tongeren, H.J.J, van Lier, and Ph. van Eiteren, Nijmegen; W.M.M. Driessen, A.A.M. Masclee, and CT. Postma, Eindhoven; J. Scherpenisse, H.A. Sonneveldt, and R.J.Th.M. Ypma, Enschede; P.H.E. Berghuis, Helmond; J.H.E. Custers, A. M. Smit, E.W. van der Hoek, 's-Hertogenbosch; O.J.J. Cluysenaer, Amersfoort; A.M. de Vlaam, Eindhoven; L.P. Bos and L.G.J.B. Engels, Stittard; G. Bëtius, Breda; and J. Ferwerda, Haarlem, The Netherlands.


© 1991 American College of PhysiciansAmerican College of Physicians


Ann Intern Med. 1991;114(6):445-450. doi:10.7326/0003-4819-114-6-445
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Objective: To determine whether sulphasalazine plus prednisone is more effective than sulphasalazine alone in treating active Crohn disease.

Design: Randomized, double-blind, placebo-controlled trial.

Setting: Multicenter trial in one university hospital and nine general hospitals.

Patients: Patients with active Crohn disease and a Van Hees Activity Index of 140 or more. Of 71 patients who were randomly assigned, 60 completed treatment and were analyzed.

Interventions: For 16 weeks, 30 patients received sulphasalazine, 6 g/d (or 4 g/d if adverse effects occurred) and prednisone, 30 mg/d initially. Prednisone therapy was tapered in increments of 5 mg/2 wk to 10 mg/d after 8 weeks. Thirty other patients received sulphasalazine and a placebo.

Measurements and Main Results: In the first 6 weeks of treatment, the Van Hees Activity Index decreased to a median of 70% (interquartile range, 57% to 81%) of the initial value in patients treated with sulphasalazine and prednisone and to a median of 87% (interquartile range, 70% to 94%) in patients treated with sulphasalazine alone (P = 0.001). In the last 4 weeks of treatment, the corresponding figures were 63% (interquartile range, 40% to 75%) and 70% (interquartile range, 54% to 90%) (P = 0.10). The Crohn's Disease Activity Index decreased in the first 6 weeks to a median of 65% (interquartile range, 57% to 86%) in patients receiving sulphasalazine and prednisone and to a median of 75% (interquartile range, 58% to 101%) in patients receiving sulphasalazine alone (P = 0.13). In the last 4 weeks of treatment, the corresponding figures were 65% (interquartile range, 42% to 90%) and 76% (interquartile range, 49% to 110%) (P = 0.19).

Conclusions: The use of prednisone in addition to sulphasalazine in patients with active Crohn disease results in a significantly faster initial improvement, but not in a significantly better result after 16 weeks of treatment, when disease activity is measured by the Van Hees Activity Index.

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