Is it best to give budesonide for acute flares of Crohn's disease?
Steroids continue to play a central role in inducing remission in active Crohn's disease. However, their use comes at a price of significant adverse effects when used repeatedly or for extended periods. Newer steroid agents with limited systemic bioavailability offer a tantalising option, if they can be shown to be efficacious and safer than conventional steroids. Budesonide is the main alternative steroid currently available in an enteric formulation. Our objective was to evaluate the effectiveness of oral budesonide and the adverse effect profile.
We searched the following sources for relevant papers and trials.
· A computer-assisted search of the online bibliographic database Medline from 1986 onwards.
· Hand searching the reference lists of trials and review articles identified by means of the computer- assisted search.
· Proceedings from major gastrointestinal meetings from 1990 onwards.
· Contact with the relevant pharmaceutical companies that have been involved in the development of budesonide.
Potentially relevant articles were reviewed in an independent unblinded fashion by two authors to determine if they met our criteria of study population, methodology (randomised double blind controlled trials) with clinical remission the outcome measure of interest.
Eight studies were deemed eligible for review. Budesonide was superior to placebo for induction of remission with a pooled odds ratio for the two placebo-controlled trials of 2.85 (95 per cent CI 1.67-4.87).
A single trial comparing budesonide with mesalazine demonstrated an odds ratio of 2.80 (95% CI 1.50-5.20) in favour of budesonide over mesalazine for induction of remission in active Crohn's disease. However, budesonide was inferior to conventional steroids (prednisone or prednisolone) for induction of remission with a pooled odds ratio for the five trials of 0.69 (95 per cent CI 0.5 - 0.95).
The two trials comparing budesonide versus placebo (Greenberg 1994; Tremaine 2002) showed no difference between study groups for proportion of reported steroid-
related adverse effects with the pooled odds ratio for both trials of 0.98 (95 per cent CI 0.58-1.67). Five trials comparing budesonide versus prednisone showed the budesonide study group had fewer reported steroid-
related adverse effects than the prednisone study group (pooled odds ratio was 0.38 (95 per cent CI 0.28 - 0.53).
With disease in the ileum or ascending colon, budesonide offers an effective therapy which
is somewhat less efficacious but with fewer
adverse effects than conventional steroids
(eg, prednisone, prednisolone,
Otley A, Steinhart AH. Budesonide for induction of remission in Crohn's disease. The Cochrane Database of Systematic Reviews
2005, Issue 4
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