Comparison of the efficacy and safety of an oral sulfate solution and 3-L polyethylene glycol on bowel preparation before colonoscopy: a phase III multicenter randomized controlled trial

Post written by Peng Pan, MD, from the Department of Gastroenterology, Changhai Hospital, Naval Military Medical University, Shanghai, China.

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The oral sulfate solution (OSS) split-dose regimen has been evaluated in several trials by comparing 2-L polyethylene glycol (PEG) plus ascorbic acid or 4-L PEG using the split-dose or same-day method. These studies showed that OSS was not inferior to 4-L PEG or 2-L PEG plus ascorbic acid in the quality of bowel preparation, but OSS was not compared with 3-L PEG, which is commonly used in clinical practice in China.

OSS has been available for many years, but no studies have verified its safety and effectiveness in a Chinese population, and this has limited its use in China. Therefore, we conducted this phase III clinical study to compare the safety and efficacy of OSS versus PEG.

In conclusion, the split-dose OSS regimen was not inferior to the split-dose 3-L PEG regimen for an adequate bowel preparation rate in a Chinese adult population. No safety concerns were observed after the ingestion of OSS. The safety and acceptability of the 2 groups were similar.

To our knowledge, this study is the first to report the safety and efficacy of OSS in a Chinese population and the first to compare the safety and efficacy of OSS with the split-dose 3-L PEG regimen, providing evidence for the clinical use of OSS in a Chinese population. Next, we will pay attention to the real-world performance and adverse effects of OSS in clinical use.

This randomized, multicenter, phase III clinical trial compared the safety and efficacy of PEG and OSS, and the results showed that the safety and efficacy of OSS are not inferior to PEG, which can provide an alternative method for bowel preparation for colonoscopy in a Chinese population.

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Graphical Abstract

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