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  • Prednisolone and budesonide for short- and long-term treatment of microscopic colitis: systematic review and meta-analysis.

Prednisolone and budesonide for short- and long-term treatment of microscopic colitis: systematic review and meta-analysis.

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (2011-06-28)
Michael J Stewart, Cynthia H Seow, Martin A Storr
ABSTRACT

The incidence of microscopic colitis and its disease burden are increasing, yet there is limited systematic information addressing the use of conventional corticosteroids and budesonide in microscopic colitis. We performed a systematic review and meta-analysis on the short- and long-term efficacy of corticosteroids in treatment of microscopic colitis. Randomized controlled trials that met predetermined selection criteria were included. Articles were identified through MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, proceedings of major gastroenterology meetings, and reference lists of trials and review articles. Eight randomized trials were identified. A total of 248 patients were randomized to corticosteroid versus placebo. The intervention was budesonide in 7 trials and prednisolone in 1 trial. Budesonide was significantly more effective than placebo for short-term clinical response (risk ratio [RR], 3.07; 95% confidence interval [CI], 2.06-4.57) and long-term clinical response (RR, 3.22; 95% CI, 1.05-9.89). Prednisolone was not superior to placebo for short-term clinical response (RR, 2.00; 95% CI, 0.38-10.58). Histologic improvement was seen with both short- and long-term budesonide (RR, 3.76; 95% CI, 2.00-7.06, and RR, 2.50; 95% CI, 1.25-4.98, respectively). Symptom relapse occurred in 46%-80% of patients within 6 months of treatment cessation. Withdrawal because of adverse effects occurred in 4.4% of patients, with no difference between study groups (P = .55). Both short- and long-term treatment with budesonide is effective and well-tolerated for microscopic colitis. However, the rate of symptom relapse once budesonide is discontinued is high. Further studies are needed to determine optimal treatment duration, dose, and withdrawal procedure.

MATERIALS
Product Number
Brand
Product Description

Prednisolone for system suitability, European Pharmacopoeia (EP) Reference Standard
Prednisolone, European Pharmacopoeia (EP) Reference Standard
Supelco
Budesonide, Pharmaceutical Secondary Standard; Certified Reference Material
Sigma-Aldrich
Prednisolone, ≥99%
Sigma-Aldrich
Budesonide, ≥99%
Supelco
Prednisolone, VETRANAL®, analytical standard
Supelco
Prednisolone, Pharmaceutical Secondary Standard; Certified Reference Material
Budesonide, European Pharmacopoeia (EP) Reference Standard
Prednisolone for peak identification, European Pharmacopoeia (EP) Reference Standard