Budesonide Foam For Mild To Moderate Distal Ulcerative Colitis: A Meta-analysis

Objective: To study the efficacy and safety of budesonide foam in distal ulcerative colitis.Method: According to Cochrane systematic review guideline,The Cochrane Central Register of Controlled Trials,MEDLINE and EMBASE were searched to identify all relevant trials which studied the efficacy and safety of budesonide foam in mild-to-moderate distal ulcerative colitis,including proctitis,sigmoiditis and proctosigmoiditis,from the database establishment up to July 2016.All eligible studies were identified depending on the eligibility criteria,and the risk of bias in the studies was assessed according to the Cochrane Collaboration handbook.Outcome measures were the assessments for therapeutic efficacy and safety.We calculated the relative risk(RR)with 95% confidence intervals(CI)by using the STATA 12.0 software.Funnel plots,Begg's and Egger's test were designed to evaluate publication bias.Results: Three high-quality trials recruiting 711 patients with active,mild to moderate distal ulcerative colitis were included in this study.No significant bias and heterogeneity was identified.Their outcome measureswere clinical remission,endoscopic improvement,elimination of rectal bleeding and adverse effects.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 effects between budesonide foam and placebo.Conclusions: Budesonide foam is an effective and safe therapy in inducing clinical remission and endoscopic improvement,and eliminating rectal bleeding for mild-to-moderate distal ulcerative colitis.More randomized controlled trials with high-quality,large sample sizes,and multiregional cooperation are required to verify our conclusions.