Efficacy, tolerability, and safety of oral sulfate tablet versus 2 L-polyethylene glycol/ascorbate for bowel preparation in older patients: prospective, multicenter, investigator single-blinded, randomized study
- Authors
- Kang, Ho Suk; Na, Soo-Young; Yoon, Jin Young; Jung, Yunho; Seo, Geom Seog; Cha, Jae Myung
- Issue Date
- May-2024
- Publisher
- SPRINGER JAPAN KK
- Keywords
- Aged; Cathartics; Colonoscopy; Efficacy; Safety
- Citation
- JOURNAL OF GASTROENTEROLOGY, v.59, no.5, pp 402 - 410
- Pages
- 9
- Journal Title
- JOURNAL OF GASTROENTEROLOGY
- Volume
- 59
- Number
- 5
- Start Page
- 402
- End Page
- 410
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/26397
- DOI
- 10.1007/s00535-024-02089-9
- ISSN
- 0944-1174
1435-5922
- Abstract
- Background: We compared the efficacy, tolerability, and safety of oral sulfate tablets (OST, which contains simethicone) and 2 L-polyethylene glycol/ascorbate (2 L-PEG/Asc) with a split-dosing regimen in older individuals aged >= 70 years who underwent scheduled colonoscopy. Methods: This prospective, randomized, investigator-blinded, multicenter study was conducted between June 2022 and October 2023. Participants aged >= 70 years were randomized at a ratio of 1:1 to the OST or 2 L-PEG/Asc groups. Results: In total, 254 patients were evaluated using a modified full analysis set. Successful overall bowel preparation was excellent and similar between the OST and 2 L-PEG/Asc groups for the Boston Bowel Preparation Scale (BBPS) (96.5% vs. 96.6%) and Harefield Cleansing Scale (HCS) (96.5% vs. 97.4%). The overall high-quality preparation rate was higher in the OST group than in the 2 L-PEG/Asc group (BBPS: 55.7% vs. 28.4%, P < 0.001; HCS: 66.1% vs. 38.8%, P < 0.001). The overall adenoma detection rate (54.8% vs. 35.3, P = 0.003) was superior in the OST group compared to the 2 L-PEG/Asc group. Tolerability scores, including overall satisfaction, were generally higher in the OST group than in the 2 L-PEG/Asc group. The incidence of major solicited adverse events was comparable between the two groups (55.7% vs. 68.1, P = 0.051), and there were no clinically significant changes in the serum laboratory profiles on the day of or 7 days after colonoscopy. Conclusions: OST is an effective and safe low-volume agent for colonoscopy, with better tolerance than 2 L-PEG/Asc, in older individuals aged >= 70 years.
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