Comparative Evaluation of the Efficacy of Polyethylene Glycol With Ascorbic Acid and an Oral Sulfate Solution in a Split Method for Bowel Preparation: A Randomized, Multicenter Phase III Clinical Trial.

Abstract

An adequate level of bowel preparation before colonoscopy is important. The ideal agent for bowel preparation should be effective and tolerable. The purpose of this study was to compare the clinical efficacy and tolerability of polyethylene glycol with ascorbic acid and oral sulfate solution in a split method for bowel preparation. This was a prospective, multicenter, randomized controlled clinical trial. Outpatients at the specialized clinics were included. A total of 186 subjects were randomly assigned. After exclusions, 84 subjects in the polyethylene glycol with ascorbic acid group and 83 subjects in the oral sulfate solution group completed the study and were analyzed. Polyethylene glycol with ascorbic acid or oral sulfate solution in a split method was the included intervention. The primary end point was the rate of successful bowel preparation, which was defined as being excellent or good on the Aronchick scale. Tolerability and adverse events were also measured. Success of bowel preparation was not different between 2 groups (91.7% vs 96.4%; p = 0.20), and the rate of adverse GI events (abdominal distension, pain, nausea, vomiting, or abdominal discomfort) was not significantly different between the 2 groups. In contrast, the mean intensity of vomiting was higher in the oral sulfate solution group than in the polyethylene glycol with ascorbic acid group (1.6 ± 0.9 vs 1.9 ± 1.1; p = 0.02). All of the colonoscopies were performed in the morning, and the subjects were offered enhanced instructions for bowel preparation. In addition, the results of tolerability and adverse effect may have a type II error, because the number of cases was calculated for confirming the efficacy of bowel preparation. Oral sulfate solution is effective at colonoscopy cleansing and has acceptable tolerability when it is compared with polyethylene glycol with ascorbic acid. The taste and flavor of oral sulfate solution still need to be improved to enhance tolerability.