BACKGROUND A low-volume polyethylene glycol(PEG) solution that combines ascorbic acid with PEG-based electrolyte solution(PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and impro...BACKGROUND A low-volume polyethylene glycol(PEG) solution that combines ascorbic acid with PEG-based electrolyte solution(PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and improved taste.Although several reports showed that bowel preparation with PEG-ASC volume lower than 2.0 L with laxative agents could be an alternative to traditional preparation regimen, the cleansing protocols have not been fully investigated.AIM To evaluate the cleansing efficacy of 1.2 L PEG-ASC solution comparing with 2.0 L PEG electrolyte(PEG-ELS) for bowel preparations.METHODS A randomized, single-blinded, open-label, single-center, non-inferiority study was conducted. In total, 312 Japanese adult patients(aged > 18 years) who underwent colonoscopy were enrolled. Patients were randomly allocated to bowel lavage with either 1.2 L of PEG-ASC solution with at least 0.6 L of an additional clear fluid(1.2 L PEG-ASC group) or 2.0 L of PEG-ELS(PEG-ELS group). Then, 48 mg of sennoside was administered at bedtime on the day before colonoscopy, and the designated drug solution was administered at the hospital on the day of colonoscopy. Bowel cleansing was evaluated using the Boston Bowel Preparation Scale(BBPS). The volume of fluid intake and required time for bowel preparation were evaluated. Furthermore, compliance, patient tolerance,and overall acceptability were evaluated using a patient questionnaire, which was assessed using a visual analog scale.RESULTS In total, 291 patients(1.2 L PEG-ASC group, 148; PEG-ELS group, 143) completed the study. There was no significant difference in successful cleansing, defined as a BBPS score ≥ 2 in each segment, between the two groups(1.2 L PEG-ASC group, 91.9%; PEG-ELS group, 90.2%; 95%CI:-0.03-0.09). The required time for bowel preparation was significantly shorter(164.95 min ± 68.95 min vs 202.16 min± 68.69 min, P < 0.001) and the total fluid intake volume was significantly lower(2.23 L ± 0.55 L vs 2.47 L ± 0.56 L, P < 0.001) in the 1.2 L PEG-ASC group than in the PEG-ELS group. Palatability, acceptability of the volume of solution, and overall acceptability evaluated using a patient questionnaire, which was assessed by the visual analog scale, were significantly better in the 1.2 L PEG-ASC group than in the PEG-ELS group(7.70 cm ± 2.57 cm vs 5.80 cm ± 3.24 cm, P < 0.001). No severe adverse event was observed in each group.CONCLUSION The 1.2 L PEG-ASC solution was non-inferior to the 2.0 L PEG-ELS solution in terms of cleansing efficacy and had better acceptability among Japanese patients.展开更多
文摘BACKGROUND A low-volume polyethylene glycol(PEG) solution that combines ascorbic acid with PEG-based electrolyte solution(PEG-ASC) is gaining mainstream acceptance for bowel preparation due to reduced volume and improved taste.Although several reports showed that bowel preparation with PEG-ASC volume lower than 2.0 L with laxative agents could be an alternative to traditional preparation regimen, the cleansing protocols have not been fully investigated.AIM To evaluate the cleansing efficacy of 1.2 L PEG-ASC solution comparing with 2.0 L PEG electrolyte(PEG-ELS) for bowel preparations.METHODS A randomized, single-blinded, open-label, single-center, non-inferiority study was conducted. In total, 312 Japanese adult patients(aged > 18 years) who underwent colonoscopy were enrolled. Patients were randomly allocated to bowel lavage with either 1.2 L of PEG-ASC solution with at least 0.6 L of an additional clear fluid(1.2 L PEG-ASC group) or 2.0 L of PEG-ELS(PEG-ELS group). Then, 48 mg of sennoside was administered at bedtime on the day before colonoscopy, and the designated drug solution was administered at the hospital on the day of colonoscopy. Bowel cleansing was evaluated using the Boston Bowel Preparation Scale(BBPS). The volume of fluid intake and required time for bowel preparation were evaluated. Furthermore, compliance, patient tolerance,and overall acceptability were evaluated using a patient questionnaire, which was assessed using a visual analog scale.RESULTS In total, 291 patients(1.2 L PEG-ASC group, 148; PEG-ELS group, 143) completed the study. There was no significant difference in successful cleansing, defined as a BBPS score ≥ 2 in each segment, between the two groups(1.2 L PEG-ASC group, 91.9%; PEG-ELS group, 90.2%; 95%CI:-0.03-0.09). The required time for bowel preparation was significantly shorter(164.95 min ± 68.95 min vs 202.16 min± 68.69 min, P < 0.001) and the total fluid intake volume was significantly lower(2.23 L ± 0.55 L vs 2.47 L ± 0.56 L, P < 0.001) in the 1.2 L PEG-ASC group than in the PEG-ELS group. Palatability, acceptability of the volume of solution, and overall acceptability evaluated using a patient questionnaire, which was assessed by the visual analog scale, were significantly better in the 1.2 L PEG-ASC group than in the PEG-ELS group(7.70 cm ± 2.57 cm vs 5.80 cm ± 3.24 cm, P < 0.001). No severe adverse event was observed in each group.CONCLUSION The 1.2 L PEG-ASC solution was non-inferior to the 2.0 L PEG-ELS solution in terms of cleansing efficacy and had better acceptability among Japanese patients.
