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Well-controlled data on the effectiveness of budesonide for lymphocytic colitis are sparse. In the current industry-funded, multicenter European trial, investigators sought to demonstrate the superiority of budesonide or mesalamine — a therapy commonly used to treat this condition — over placebo.
Fifty-seven patients were randomized to receive 9 mg budesonide, 3 g mesalamine, or placebo once daily for 8 weeks. The primary endpoint was clinical remission, defined as ≤21 loose stools in the last 7 days of treatment.
In the intention-to-treat analysis, a higher percentage of the budesonide group met the primary endpoint compared with the placebo group (79% vs. 42%). There was no difference between the mesalamine (63%) and placebo groups (P=0.09)…