A prospective randomized clinical study evaluating the efficacy and compliance of oral sulfate solution and 2-L ascorbic acid plus polyethylene glycol

Abstract

Background/Aims: Oral sulfate solution (OSS) is an emerging cleansing agent for bowel preparation. However, data comparing OSS to other conventional bowel preparations in Asian patients are limited. Therefore, the objective of this study was to compare the efficacy and tolerability of OSS to ascorbic acid plus polyethylene glycol (AA + PEG) in Asian patients. Methods: This was a prospective, randomized, parallel, investigator-blind study performed in two university hospitals in Korea. Bowel preparation efficacy was evaluated using both the Ottawa Bowel Preparation Scale (OBPS) and Boston Bowel Preparation Scale (BBPS). Results: Among 173 patients, 86 received OSS while 87 received AA + PEG for bowel preparation. Total OBPS score was 2.80 ± 2.48 in the OSS group and 4.49 ± 3.08 in the AA + PEG group, indicating significantly (p < 0.001) better efficacy with OSS. Total BBPS was higher in the OSS group (7.43 ± 1.49 vs. 6.51 ± 1.76, p < 0.001), indicating superior bowel preparation quality with OSS. Preparation-related adverse events were generally acceptable. Patients receiving OSS had more nausea (1.92 ± 0.94 vs. 1.54 ± 0.76, p = 0.004) and abdominal cramping (1.45 ± 0.78 vs. 1.17 ± 0.51, p = 0.006) than those receiving AA + PEG. However, overall satisfaction and taste were similar between the two groups. Conclusions: OSS had a non-inferior bowel cleansing efficacy than AA + PEG regardless of colon segment.

Comparison of Four Bowel Cleansing Agents for Colonoscopy and the Factors Affecting their Efficacy. A Prospective, Randomized Study

“…Similar to our study, a recent European multicentric study found that patient compliance with OSS administration was excellent regardless of administration (i.e., same-day or split-dose) and that the most frequent adverse symptoms for OSS were nausea and abdominal pain [35]. In another study, the same symptoms were significantly more frequent in the OSS group compared to the 2-L PEG/Asc group [25]. In contrast, Kim et al [21] described no differences in adverse events among patients receiving OSS or 2L-PEG/Asc.…”

“…In our study, 82% of patients accepted the split-dose regimen, which, according to previous studies, significantly improves the quality of bowel cleansing [23]. A recent study performed by Rostom et al [25] found that PEG was superior to MCSP via a split dose regimen (p=0.007) [24] while Kwon et al [25] demonstrated better efficiency of OSS than 2-L PEG/ Asc in an Asian population (p=0.06). Yoo et al [19] reported more frequent excellent preparation (BBPS > 8) in patients administered MCSP as compared to patients given 2-L PEG/ Asc (p=0.003).…”

“…Many studies comparing quality of bowel preparation have already been published. There is a high degree of heterogeneity among the studies because of the different study designs, including different types of compared agents, administration, and evaluation scales [17][18][19][20][21][22][23][24][25][26]. The present study was a prospective, randomized, unicentric, and investigator-blinded study.…”

Efficacy and safety of oral sulfate solution for bowel preparation in Japanese patients undergoing colonoscopy: Noninferiority‐based, randomized, controlled study

“…The split-dose regimen has a higher patient acceptance because of the lower fluid intake required each day. A phase III trial conducted in the United States 10 and some South Korean studies 11,12 confirmed the noninferiority of OSS to PEG-ASC. OSS has also been used in Europe and certain Latin American territories.…”

Oral sulfate solution versus low‐volume polyethylene glycol for bowel preparation: Meta‐analysis of randomized controlled trials

“…10 10 Four studies had participants in both arms on a low-residue diet. [11][12][13][14] Two studies had different precolonoscopy diets for each arm (OSS arm had light breakfast followed by clears; PEG + Asc had normal breakfast followed by light lunch). 5 All studies recorded the frequency of patients reporting some combination of nausea, vomiting, abdominal pain, and abdominal bloating.…”