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. 1997 Aug;41(2):209–214. doi: 10.1136/gut.41.2.209

Oral budesonide is as effective as oral prednisolone in active Crohn's disease

M Campieri 1, A Ferguson 1, W Doe 1, T Persson 1, L Nilsson 1, G the 1
PMCID: PMC1891473  PMID: 9301500

Abstract

Background—The use of corticosteroids in active Crohn's disease often becomes limited by side effects. Budesonide is a potent corticosteroid with low systemic bioavailability due to an extensive first pass liver metabolism. 
Aims—To compare the efficacy and safety of two dosage regimens of budesonide and prednisolone in patients with active Crohn's disease affecting the ileum and/or the ascending colon. 
Patients and methods—One hundred and seventy eight patients were randomised to receive budesonide controlled ileal release (CIR) capsules 9 mg once daily or 4.5 mg twice daily, or prednisolone tablets 40 mg once daily. The treatment period was 12 weeks. The primary efficacy variable was clinical remission, defined as a Crohn's Disease Activity Index (CDAI) of 150 or less. 
Results—After eight weeks of treatment, remission occurred in 60% of patients receiving budesonide once daily or prednisolone and in 42% of those receiving budesonide twice daily (p=0.062). The presence of glucocorticoid associated side effects was similar in all groups; however, moon face was more common in the prednisolone group (p=0.0005). The highest frequency of impaired adrenal function, as measured by a short ACTH test, was found in the prednisolone group (p=0.0023). 
Conclusions—Budesonide CIR, administered at 9 mg once daily or 4.5 mg twice daily, is comparable to prednisolone in inducing remission in active Crohn's disease. The single dose administration is as promptly effective as prednisolone and represents a simpler and safer therapeutic approach, with a considerable reduction in side effects. 



Keywords: adrenal function; CDAI; glucocorticoid; glucocorticoid associated side effects

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Figure 1 .

Figure 1

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: Mean (SE) proportion of patients in remission after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone. 


Figure 2 .

Figure 2

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: Mean (SE) CDAI score at randomisation and after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone. 


Figure 3 .

Figure 3

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: Mean (SE) morning plasma cortisol at randomisation and after two, four, eight, and 12 weeks of treatment with budesonide or prednisolone. 


Selected References

These references are in PubMed. This may not be the complete list of references from this article.

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