Department of Gastroenterology, Ningbo First Hospital, Ningbo, 315010, China.
College of Medicine, Ningbo University, Ningbo, 315211, China.
Trials. 2022 Aug 26;23(1):709. doi: 10.1186/s13063-022-06658-2.
An optimal bowel preparation can result in an improved colonoscopy. This study was to compare the effectiveness and safety of the use of a sports drink (Mizone) plus polyethylene glycol (PEG) solution with a water plus PEG solution in bowel preparations.
This was a randomised controlled study. All of the included patients were randomly divided into the following two groups: the PEG + Mizone group and the PEG + water group. The palatability of the solution was measured through the use of questionnaires. Additionally, bowel cleanliness was evaluated according to the Ottawa Bowel Preparation Scale (OBPS, 0-14, with higher values indicating worse cleanliness), as well as with the aid of colonoscopy videos.
A total of 270 patients were enrolled. The rate of adequate bowel preparation was 74.8% in the PEG + Mizone group and 68.9% in the PEG + water group, with a risk difference of 5.9% (95% CI: - 4.8-16.6%), which indicated noninferiority (noninferiority margin: - 9.5% < - 4.8%). However, patients rated the palatability (65.9% vs 44.4%, P < 0.001) and willingness to recommend or repeat (88.9% vs 75.6%, P = 0.004) the administration of the PEG + Mizone preparation as being better than those of the PEG + water preparation. The rates of adverse events during the bowel preparations were not significantly different between the two groups, except for bloating (PEG + Mizone vs PEG + water, 4.4% vs 13.3%, P = 0.010).
The concomitant use of PEG + Mizone was a well tolerated and effective bowel preparation, compared with the PEG + water treatment.
ClinicalTrials.gov NCT04247386 . Registered on 30 Jan 2020.
理想的肠道准备可提高结肠镜检查的效果。本研究旨在比较运动饮料(Mizone)加聚乙二醇(PEG)溶液与水加 PEG 溶液在肠道准备中的效果和安全性。
这是一项随机对照研究。所有纳入的患者均随机分为以下两组:PEG+Mizone 组和 PEG+水组。通过问卷调查评估溶液的口感。此外,根据渥太华肠道准备量表(OBPS,0-14 分,分数越高表示清洁度越差)以及结肠镜视频评估肠道清洁度。
共纳入 270 例患者。PEG+Mizone 组和 PEG+水组的充分肠道准备率分别为 74.8%和 68.9%,风险差异为 5.9%(95%CI:-4.8-16.6%),表明非劣效性(非劣效性边界:-9.5%<−4.8%)。然而,患者对 PEG+Mizone 制剂的口感(65.9%比 44.4%,P<0.001)和推荐或重复使用的意愿(88.9%比 75.6%,P=0.004)评价均优于 PEG+水制剂。两组肠道准备期间不良事件的发生率无显著差异,除腹胀外(PEG+Mizone 比 PEG+水,4.4%比 13.3%,P=0.010)。
与 PEG+水治疗相比,PEG+Mizone 联合应用是一种耐受性良好且有效的肠道准备方法。
ClinicalTrials.gov NCT04247386 。2020 年 1 月 30 日注册。