Comparison of the Efficacy and Safety Between Oral Sulphate Solution (OSS) and Polyethylene Glycol Electrolyte (PGE-E) as Bowel Cleansing Agent

Aims In China, Polyethylene Glycol Electrolyte (PEG-E) is the primary recommended bowel cleansing agent but patient compliance may be influenced by poor taste and large volume (3-4L). This study aimed to compare the efficacy and safety of oral sulphate solution (OSS, a low volume agent with fruit favor) to PEG-E on bowel cleansing before colonoscopy in Chinese population.

Methods This was a phase III, multicenter, randomized, controlled, non-inferiority, investigator/assessor-blinded trial (NCT03562884). 294 subjects were randomized, 283 subjects received OSS (Eziclen, 3L, n = 143) or PEG-E (Fortrans, n = 140) via split-dosing regimen. The primary outcome was the proportion of subjects with successful preparation (BBPS global score ≥ 6 by central assessment). The secondary outcomes included BBPS global and segmental score, lesion detection rate, proportion of fully compliant, investigator satisfaction score (5-point Likert scale score) and safety evaluations. Farrington-Manning method was used to compare the difference.

Results Proportion of subjects with successful cleansing was 100 % for OSS and 99.3 % for PEG-E (adjusted difference 0.7 %, 95 % CI [-5.3 %, 6.7 %], p<0.0001 for non-inferiority, mITT population). BBPS score by central assessment was significantly higher in OSS including global and segmental scores. Detailed results in [Table 1]. Investigator satisfaction score was significantly higher for OSS (2.6 vs 2.3, p=0.0005). The proportion of fully compliant was not statistically different (88.1 % in OSS vs 83.1 % in PEG-E, p=0.2252). No significant difference was noted on adenomas (4.2 % in OSS vs 5.6 % in PEG-E, p=0.5787) and polyps (16.5 % in OSS vs 22.8 % in PEG-E, p=0.1832) detection rate. All drug-related AEs were mild to moderate with no significant differences and no SAEs.

Table 1 BBPS comparison between OSS and PEG-E

Item	OSS N=143 Mean (95 % CI)	PGE-E N=140 Mean (95 % CI)	P-value
BBPS global score	8.1 (7.9-8.3)	7.7 (7.5-7.9)	< 0.0001
Left colon BBPS score	2.8 (2.7-2.9)	2.7 (2.6-2.8)	0.0067
Transverse colon BBPS score	2.8 (2.7-3.0)	2.7 (2.6-2.8)	0.0177
Right colon BBPS score	2.4 (2.3-2.6)	2.3 (2.1-2.4)	0.0022

Note: P-value is calculated using Kruskal-Wallis test.

Conclusions OSS had at least equal efficacy to PEG-E and higher BBPS score overall and by segments with similar safety and compliance. Investigator satisfaction was also significantly higher.

Citation: Ye Z, Fandong M, Yongdong W etal. eP289 COMPARISON OF THE EFFICACY AND SAFETY BETWEEN ORAL SULPHATE SOLUTION (OSS) AND POLYETHYLENE GLYCOL ELECTROLYTE (PGE-E) AS BOWEL CLEANSING AGENT. Endoscopy 2021; 53: S193.

Publication History

Article published online:
19 March 2021