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

World J Gastroenterol. 2017 Aug 28;23(32):5986-5993. doi: 10.3748/wjg.v23.i32.5986.

Abstract

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.

Keywords: Bowel preparation; Colonoscopy; Ottawa Bowel Preparation Scale; Sodium picosulfate; Split dose preparation.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Cathartics / administration & dosage*
  • Cathartics / adverse effects
  • Cecum / diagnostic imaging
  • Cecum / drug effects
  • Citrates / administration & dosage*
  • Citrates / adverse effects
  • Colonoscopy / adverse effects
  • Colonoscopy / methods*
  • Dizziness / chemically induced
  • Dizziness / epidemiology
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Middle Aged
  • Nausea / chemically induced
  • Nausea / epidemiology
  • Organometallic Compounds / administration & dosage*
  • Organometallic Compounds / adverse effects
  • Picolines / administration & dosage*
  • Picolines / adverse effects
  • Prospective Studies
  • Time Factors
  • Treatment Outcome
  • Vomiting / chemically induced
  • Vomiting / epidemiology

Substances

  • Cathartics
  • Citrates
  • Organometallic Compounds
  • Picolines
  • picosulfate sodium