Running head: BUDESONIDE VS MESALAMINE TO INDUCE REMISSION IN ULCERATIVE COLITIS
Evidenced Based Critically Appraised Topic
Budesonide versus Mesalamine to Induce Remission in Ulcerative Colitis
Erica Wald, RN, FNP-S
University of Mary
Nursing 568
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BUDESONIDE VS MESALAMINE TO INDUCE REMISSION IN ULCERATIVE COLITIS
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Evidenced Based Critically Appraised Topic
Budesonide versus Mesalamine to Induce Remission in Ulcerative Colitis
Erica Wald, RN, FNP-S
Date: March 8, 2014
Clinical Scenario
A 28 year old male presents to the clinic with a 1 week history of exacerbation of ulcerative
colitis (UC). He complains of 6-8 bloody stools per day. He has been using mesalamine to
induce remission. Would budesonide, a synthetic steroid with low systemic absorption, instead
of mesalamine, a 5-aminosalicylic acid (5-ASA), be a better treatment option for this individual?
Clinical Question
In adult patients (over the age of 18) diagnosed with UC, is oral budesonide a more effective
medication to induce remission in active UC versus oral mesalamine?
Articles
Iborra, M., Alvarez-Sotomayor, D., & Nos, P. (2014). Long-term safety and efficacy of
budesonide in the treatment of ulcerative colitis. Clinical and Experimental
Gastroenterology, 7, 39-46. doi:http://dx.doi.org/10.2147/CEG.S34715
Sherlock, M.E., Seow, C.H., Steinhart, A.H., & Griffiths, A.M. (2010). Oral budesonide for
induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews,
2011(8), 1-42. doi:10.1002/14651858.CD007698.pub2
Summary and Appraisal of Key Evidence
Study 1
Sherlock, Seow, Steinhart, & Griffith (2010) systematically reviewed the results of three
randomized controlled studies (RCTs) that evaluated: budesonide versus prednisolone;
budesonide versus mesalamine; and budesonide versus placebo. This review provides Level I,
Grade A evidence. The primary objective was to evaluate the efficacy and safety of oral
budesonide for the induction of remission in ulcerative colitis. Adult patients with a confirmed
diagnosis of active UC, using a combination of clinical symptoms and signs, radiologic,
endoscopic and histologic criteria, were included in the review. Data was extracted and quality
was assessed by 2 independent investigators. A meta-analysis could not be performed due to the
heterogeneity of the studies reviewed. A total of 368 potential studies were narrowed to three
eligible RCTs. The first RCT compared budesonide and prednisolone. It found that both
medications improved endoscopic and histologic scores; it did not specifically examine induction
of remission. This was a small, low powered, low quality study which did not adequately
demonstrate a difference between the medications. The second RCT compared budesonide with
mesalamine. Mesalamine performed significantly better at inducing remission; this was a high
BUDESONIDE VS MESALAMINE TO INDUCE REMISSION IN ULCERATIVE COLITIS
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quality study. The third RCT compared budesonide-multimatrix system (MMX) with placebo
and found no significant difference in clinical remission in the treatment groups. This was a
small, underpowered, but high quality study. Only two of the studies reviewed met the primary
outcomes of this review. The authors concluded that budesonide is inferior to mesalamine for
treatment of active colitis.
Study 2
Iborra, Alvarez-Sotomayor, & Nos (2014) reviewed the long term safety and efficacy of
budesonide in the treatment of UC, providing Level I evidence. A discussion of study 1’s RCTs
was included in this review and similar findings were reported. However, this review examined
a recent randomized, double-blind, double-dummy, placebo controlled trial to evaluate the
efficacy of budesonide-MMX for induction of remission in UC. A group of 509 adult patients
with active, mild to moderate UC were randomly assigned to groups and given budesonide
MMX (9mg or 6mg), mesalamine (2.4g), or placebo for 8 weeks. The remission rates at 8 weeks
are as follows: 17.9% (9mg budesonide), 13.2% (6mg budesonide), 12.1% (mesalamine), and
7.4% (placebo). Clinical improvement at week 8 was 33.3%, 30.6%, 33.69%, and 24.8% for 9
mg budesonide, 6mg budesonide, mesalamine and placebo respectively. Budesonide MMX 9mg
was determined to be more effective and safe compared to placebo, but no better than
mesalamine. The reviewers called for additional controlled trials that compare budesonide with
effective induction doses of mesalamine, in order to confirm budesonide’s efficacy.
Results
The results from both studies determined that budesonide is not as effective as mesalamine for
inducing remission in active UC. However, budesonide MMX has been shown to be an
effective treatment in active left sided UC. Study 1’s weaknesses were the heterogeneity in the
defined disease activity of the participants and small size of two RCTs reviewed. The scarcity of
literature on the use of oral budesonide in UC is a possible bias in both studies. Study 1 was
funded by the Canadian Institutes of Health Research Knowledge Translation Branch; there were
no conflicts. Study 2 denied conflicts of interest.
Clinical Bottom Line
Evidence from these two articles suggests that mesalamine is superior to budesonide in inducing
remission in active UC. The reader should be aware that few studies compare the two
medications and that further research is needed. Additionally, new formulations of budesonide
MMX appear to be more effective than placebo; and have potential treatment benefit in left sided
UC. RCTs demonstrated a remission rate of 40% using budesonide MMX; this was determined
not to be statistically significant, but could have clinical importance.
Implications for Practice
I would recommend that oral mesalamine be utilized initially to induce remission in UC. All
patients may not respond to mesalamine. Oral budesonide MMX might be an option for these
non-responder patients, particularly if they have left sided mild to moderate active UC.
BUDESONIDE VS MESALAMINE TO INDUCE REMISSION IN ULCERATIVE COLITIS
References
Iborra, M., Alvarez-Sotomayor, D., & Nos, P. (2014). Long-term safety and efficacy of
budesonide in the treatment of ulcerative colitis. Clinical and Experimental
Gastroenterology, 7, 39-46. doi:http://dx.doi.org/10.2147/CEG.S34715
Sherlock, M.E., Seow, C.H., Steinhart, A.H., & Griffiths, A.M. (2010). Oral budesonide for
induction of remission in ulcerative colitis. Cochrane Database of Systematic Reviews,
2011(8), 1-42. doi:10.1002/14651858.CD007698.pub2
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