Combination Corticosteroids+5-aminosalicylic Acids Compared to Corticosteroids Alone (for Ulcerative Colitis).
Status:
Completed
Trial end date:
2021-05-11
Target enrollment:
Participant gender:
Summary
The role of steroids in the treatment of severe ulcerative colitis (UC) exacerbation is well
established and recommended by professional societies. Similarly, 5-aminosalycilates (5-ASA)
agents in the form of mesalamine/mesalzine are well established proven therapy in
mild-moderate UC, and the combination of oral 5-ASA with topical (per-rectal enema) 5-ASA was
shown to be superior to oral 5ASA alone in patients with mild moderate UC. Thus, in most
cases, when a patient with UC experiences a flare while taking 5-ASA therapy, treatment is
usually optimized by maximizing the oral dose to 4gr/day and adding topical therapy until the
flare is controlled. If this is unhelpful, or if the flare is severe to begin with,
corticosteroids are usually prescribed. However, there are very scarce data comparing
steroids versus 5-ASA in the treatment of severe UC exacerbation.
The aim of this study is to compare the efficacy of steroids alone vs. combination of
steroids + 5-ASA in the treatment of moderate-severe UC exacerbation.