Graduate Institute of Acupuncture Science, China Medical University, Taichung, 40402, Taiwan.
Department of Colorectal Surgery, China Medical University Hospital, Taichung, 40447, Taiwan.
Sci Rep. 2020 Mar 27;10(1):5604. doi: 10.1038/s41598-020-62120-w.
Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.
肠道清洁对于成功进行结肠镜检查至关重要,但理想的清洁剂和剂量仍有待确定。小剂量清洁剂对于患者的依从性很重要。本研究旨在比较 300 毫升小剂量聚乙二醇钠/柠檬酸镁(PSMC)制剂 Bowklean 与一种 2 升聚乙二醇(PEG)/比沙可啶-Klean-Prep/Dulcolax 制剂在相同饮食建议下的肠道清洁效果、安全性、耐受性和可接受性。这是一项多中心、随机、平行组、预先指定的非劣效性研究,共纳入 631 名计划接受结肠镜检查的门诊患者(Bowklean = 316 例,Klean-Prep/Dulcolax = 315 例)。肠道准备后,一位独立的评估员在不知道患者治疗分配的情况下,对结肠清洁质量进行盲法评估。使用 Aronchick 量表和渥太华肠道准备量表(OPBS)评估疗效。通过监测不良事件评估安全性。通过患者问卷评估耐受性和可接受性。总体而言,Bowklean 不比 Klean-Prep/Dulcolax 更有效,但与更好的准备质量相关。值得注意的是,与 Klean-Prep/Dulcolax 相比,Bowklean 与肠道准备的耐受性和可接受性显著提高相关。两组的安全性特征无显著差异。我们的数据表明,在结肠镜检查前,Bowklean 是一种比 Klean-Prep/Dulcolax 更有效且更耐受的肠道清洁准备方法。因此,Bowklean 可能会增加对结肠镜检查的积极态度和参与率。