Randomized clinical trial comparing fixed-time split dosing and split dosing of oral Picosulfate regimen for bowel preparation

AIM To compare the efficacy of fixed-time split dose and split dose of an oral sodium picosulfate for bowel preparation.METHODS This is study was prospective, randomized controlled study performed at a single Institution(2013-058). A total of 204 subjects were assigned to receive one of two sodium picosulfate regimens(i.e., fixed-time split or split) prior to colonoscopy. Main outcome measurements were bowel preparation quality and subject tolerability.RESULTS There was no statistical difference between the fixedtime split dose regimen group and the split dose regimen group(Ottawa score mean 2.57 ± 1.91 vs 2.80 ± 2.51, P = 0.457). Cecal intubation time and physician’s satisfaction of inspection were not significantly different between the two groups(P = 0.428, P = 0.489). On subgroup analysis, for afternoon procedures, the fixed-time split dose regimen was equally effective as compared with the split dose regimen(Ottawa score mean 2.56 ± 1.78 vs 2.59 ± 2.27, P = 0.932). There was no difference in tolerability or compliance between the two groups. Nausea was 21.2% in the fixed-time split dose group and 14.3% in the split dose group(P = 0.136). Vomiting was 7.1% and 2.9%(P = 0.164), abdominal discomfort 7.1% and 4.8%(P = 0.484), dizziness 1% and 4.8%(P = 0.113), cold sweating 1% and 0%(P = 0.302) and palpitation 0% and 1%(P = 0.330), respectively. Sleep disturbance was two(2%) patients in the fixed-time split dose group and zero(0%) patient in the split dose preparation(P = 0.143) group.CONCLUSION A fixed-time split dose regimen with sodium picosulfate is not inferior to a split dose regimen for bowel preparation and equally effective for afternoon colonoscopy.