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

摘要

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 fixed-time 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.