Randomized trial of oral sulfate solution versus polyethylene glycol–ascorbic acid for bowel cleansing in elderly people

• Published in: Journal of gastroenterology and hepatology 2022-02, Vol.37 (2), p.319-326
• Main Authors: Nam, Seung‐Joo, Park, Sung Chul, Lee, Sung Joon, Lee, Sang Hoon, Kim, Ji Hyun, Bang, Chang Seok, Seo, Hyun Il
• Format: Article
• Language: English
• Subjects: Administration, Oral; Aged; Aged, 80 and over; Ascorbic acid; Ascorbic Acid - administration & dosage; Ascorbic Acid - adverse effects; Cathartics; Cathartics - administration & dosage; Cathartics - adverse effects; Colon; Colonoscopy; Humans; Intestine; Older people; Polyethylene glycol; Polyethylene glycols; Polyethylene Glycols - administration & dosage; Polyethylene Glycols - adverse effects; Prospective Studies; Sulfate; Sulfates - administration & dosage; Sulfates - adverse effects; Thirst; Treatment Outcome; Vomiting
• ISSN: 0815-9319; 1440-1746
• DOI: 10.1111/jgh.15696

Background and Aim The efficacy and safety of the recently introduced low‐volume purgatives in elderly people are not well known. Therefore, in this trial, we aimed to evaluate and compare the efficacy of two low‐volume agents, oral sulfate solution (OSS) and 2‐L polyethylene glycol with ascorbic acid (PEG‐Asc), in elderly people. Methods A prospective, randomized, single‐blinded, multicenter, non‐inferiority trial was performed at three university‐affiliated hospitals in South Korea. Outpatients aged 65–80 years, who underwent elective colonoscopy, were enrolled. The primary outcome was the rate of adequate bowel preparation assessed using the Boston Bowel Preparation Scale. Results A total of 199 subjects were randomized into the OSS (n = 99) or the 2‐L PEG‐Asc (n = 100) group. Of them, 189 subjects were included in the analysis of the primary outcome (OSS group 95 vs PEG‐Asc group 94). The proportion of adequate bowel preparation was 89.5% (85/95) in the OSS group and 93.6% (88/94) in the 2‐L PEG‐Asc group. OSS was not inferior to 2‐L PEG‐Asc according to the prespecified non‐inferiority margin of −15% (95% confidence interval for the difference, −12.1 to 3.8). Vomiting (11.6% vs 2.1%) and thirst (24.2% vs 11.7%) were more common in the OSS group than in the 2‐L PEG‐Asc group. Conclusions OSS is an effective low‐volume purgative that is non‐inferior to 2‐L PEG‐Asc in elderly people. Both the low‐volume agents were identified to be well tolerated and safe in the healthy elderly population.