Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER), Mayo Clinic, Rochester, Minnesota, USA.
Indiana University, Indianapolis, Indiana, USA.
Gut. 2017 Sep;66(9):1611-1622. doi: 10.1136/gutjnl-2016-311835. Epub 2016 Jun 10.
To compare efficacy of pharmacotherapies for chronic idiopathic constipation (CIC) based on comparisons to placebo using Bayesian network meta-analysis.
We conducted searches (inception to May 2015) of MEDLINE, EMBASE, Scopus and Cochrane Central, as well as original data from authors or drug companies for the medications used for CIC.
Phase IIB and phase III randomised, placebo-controlled trials (RCT) of ≥4 weeks' treatment for CIC in adults with Rome II or III criteria for functional constipation; trials included at least one of four end points.
Two investigators independently evaluated all full-text articles that met inclusion criteria and extracted data for primary and secondary end points, risk of bias and quality of evidence.
Primary end points were ≥3 complete spontaneous bowel movements (CSBM)/week and increase over baseline by ≥1 CSBM/week. Secondary end points were change from baseline (Δ) in the number of SBM/week and Δ CSBM/week.
Twenty-one RCTs (9189 patients) met inclusion and end point criteria: 9 prucalopride, 3 lubiprostone, 3 linaclotide, 2 tegaserod, 1 each velusetrag, elobixibat, bisacodyl and sodium picosulphate (NaP). All prespecified end points were unavailable in four polyethylene glycol studies. Bisacodyl, NaP, prucalopride and velusetrag were superior to placebo for the ≥3 CSBM/week end point. No drug was superior at improving the primary end points on network meta-analysis. Bisacodyl appeared superior to the other drugs for the secondary end point, Δ in number of SBM/week.
Current drugs for CIC show similar efficacy. Bisacodyl may be superior to prescription medications for Δ in the number of SBM/week in CIC.
采用贝叶斯网状meta 分析比较安慰剂,评估治疗慢性特发性便秘(CIC)的药物疗效。
我们检索了 MEDLINE、EMBASE、Scopus 和 Cochrane Central(均从建库至 2015 年 5 月),并向作者或制药公司索取了治疗 CIC 的药物的原始数据。
纳入了符合罗马 II 或 III 功能性便秘标准的成年患者,进行为期至少 4 周的 CIC 治疗的 IIB 期和 III 期安慰剂对照随机临床试验(RCT);试验至少包含以下 4 个终点中的 1 个。
2 位研究者独立评估了所有符合纳入标准的全文文章,并提取了主要和次要终点、偏倚风险和证据质量的数据。
21 项 RCT(9189 例患者)符合纳入和终点标准:9 项普芦卡必利、3 项鲁比前列酮、3 项利那洛肽、2 项替加色罗、1 项维鲁司他、埃洛比司他、比沙可啶和聚乙二醇(PEG)。在 4 项 PEG 研究中,所有预先指定的终点均不可用。比沙可啶、PEG、普芦卡必利和维鲁司他在每周 ≥3 次完全自发性排便(CSBM)的终点优于安慰剂。网状meta 分析未显示任何药物在主要终点方面具有优势。比沙可啶在改善每周 CSBM 数量这一次要终点方面似乎优于其他药物。
目前治疗 CIC 的药物疗效相似。在 CIC 中,比沙可啶可能在每周 SBM 数量的变化方面优于处方药物。