title: Budesonide foam for mild to moderate distal ulcerative colitis: A systematic review and meta-analysis.
abstract: OBJECTIVE
  Budesonide is a second-generation steroid with prominent topical effects and minimal systemic activity for patients with ulcerative colitis (UC). We perform a systematic review and meta-analysis of randomized placebo-controlled trials to assess the efficacy and safety of budesonide foam in mild-to-moderate distal UC.
  
  
  METHODS
  Comprehensive searches were performed to identify all eligible studies. Outcome measures were clinical remission, endoscopic improvement, elimination of rectal bleeding, and adverse events. The risk ratio (RR) with 95% confidence interval (CI) was estimated for each outcome. All statistical analyses were performed in STATA 12.0.
  
  
  RESULTS
  Three randomized placebo-controlled trials recruiting 711 patients with mild-to-moderate distal UC were included in this study. No significant bias and heterogeneity was identified. Pooled analyses showed that budesonide foam was significantly superior to placebo for induction of clinical remission (RR = 1.83, 95%CI: 1.41, 2.37; P < 0.001) and endoscopic improvement (RR = 1.44, 95%CI: 1.23, 1.68; P < 0.001), and eliminating rectal bleeding at week 2 (RR = 2.00, 95%CI: 1.50, 2.66; P < 0.001), week 4 (RR = 1.73, 95%CI: 1.42, 2.12; P < 0.001), and week 6 (RR = 1.76, 95%CI: 1.45, 2.14; P < 0.001). No statistically significant difference was observed in the incidence of treatment-related adverse events and therapeutic discontinuation because of adverse events between budesonide foam and placebo.
  
  
  CONCLUSIONS
  Budesonide foam is well tolerated and superior to placebo in inducing clinical remission and endoscopic improvement, and eliminating rectal bleeding for mild-to-moderate distal UC.
authors.affiliation: Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Jian
authors.initials: J
authors.lastname: Zeng
authors.affiliation: Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Lin
authors.initials: L
authors.lastname: Lv
authors.affiliation: Department of Gastroenterology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.
authors.forename: Zhe-Chuan
authors.initials: ZC
authors.lastname: Mei
mesh_terms: D000328:Adult; D019819:Budesonide / Q000008:administration & dosage*; D003093:Colitis, Ulcerative / Q000188:drug therapy*; D004304:Dosage Forms; D004311:Double-Blind Method; D004339:Drug Compounding; D005260:Female; D006801:Humans; D008297:Male; D015337:Multicenter Studies as Topic; D015990:Placebo Effect; D016032:Randomized Controlled Trials as Topic; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D004304:Dosage Forms; D019819:Budesonide
keywords: budesonide foam; meta-analysis; systematic review; ulcerative colitis