title: Comparative Evaluation of the Efficacy of Polyethylene Glycol With Ascorbic Acid and an Oral Sulfate Solution in a Split Method for Bowel Preparation: A Randomized, Multicenter Phase III Clinical Trial.
abstract: BACKGROUND
  An adequate level of bowel preparation before colonoscopy is important. The ideal agent for bowel preparation should be effective and tolerable.
  
  
  OBJECTIVE
  The purpose of this study was to compare the clinical efficacy and tolerability of polyethylene glycol with ascorbic acid and oral sulfate solution in a split method for bowel preparation.
  
  
  METHODS
  This was a prospective, multicenter, randomized controlled clinical trial.
  
  
  METHODS
  Outpatients at the specialized clinics were included.
  
  
  METHODS
  A total of 186 subjects were randomly assigned. After exclusions, 84 subjects in the polyethylene glycol with ascorbic acid group and 83 subjects in the oral sulfate solution group completed the study and were analyzed.
  
  
  METHODS
  Polyethylene glycol with ascorbic acid or oral sulfate solution in a split method was the included intervention.
  
  
  METHODS
  The primary end point was the rate of successful bowel preparation, which was defined as being excellent or good on the Aronchick scale. Tolerability and adverse events were also measured.
  
  
  RESULTS
  Success of bowel preparation was not different between 2 groups (91.7% vs 96.4%; p = 0.20), and the rate of adverse GI events (abdominal distension, pain, nausea, vomiting, or abdominal discomfort) was not significantly different between the 2 groups. In contrast, the mean intensity of vomiting was higher in the oral sulfate solution group than in the polyethylene glycol with ascorbic acid group (1.6 ± 0.9 vs 1.9 ± 1.1; p = 0.02).
  
  
  CONCLUSIONS
  All of the colonoscopies were performed in the morning, and the subjects were offered enhanced instructions for bowel preparation. In addition, the results of tolerability and adverse effect may have a type II error, because the number of cases was calculated for confirming the efficacy of bowel preparation.
  
  
  CONCLUSIONS
  Oral sulfate solution is effective at colonoscopy cleansing and has acceptable tolerability when it is compared with polyethylene glycol with ascorbic acid. The taste and flavor of oral sulfate solution still need to be improved to enhance tolerability.
authors.affiliation: 1 Center for Colorectal Cancer, National Cancer Center, Goyang, Korea 2 Department of Surgery, Daehang Hospital, Seoul, Korea.
authors.forename: Bun
authors.initials: B
authors.lastname: Kim
authors.forename: Seong Dae
authors.initials: SD
authors.lastname: Lee
authors.forename: Kyung Su
authors.initials: KS
authors.lastname: Han
authors.forename: Byung Chang
authors.initials: BC
authors.lastname: Kim
authors.forename: Eui-Gon
authors.initials: EG
authors.lastname: Youk
authors.forename: Myung Jin
authors.initials: MJ
authors.lastname: Nam
authors.forename: Doo Han
authors.initials: DH
authors.lastname: Lee
authors.forename: Dae Kyung
authors.initials: DK
authors.lastname: Sohn
mesh_terms: D015746:Abdominal Pain / Q000139:chemically induced; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D001205:Ascorbic Acid / Q000627:therapeutic use*; D002400:Cathartics / Q000627:therapeutic use*; D003113:Colonoscopy; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011300:Preoperative Care / Q000379:methods*; D016037:Single-Blind Method; D013431:Sulfates / Q000627:therapeutic use*; D013501:Surface-Active Agents / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D002400:Cathartics; D013431:Sulfates; D013501:Surface-Active Agents; D011092:Polyethylene Glycols; D001205:Ascorbic Acid