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

Abstract

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. A prospective, randomized, single-blinded, multicenter, non-inferiority trial was performed at three university-affiliated hospitals in South Korea. Outpatients aged 65-80years, who underwent elective colonoscopy, were enrolled. The primary outcome was the rate of adequate bowel preparation assessed using the Boston Bowel Preparation Scale. 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. 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.