title: A comparison of oral sulfate solution with sodium picosulfate: magnesium citrate in split doses as bowel preparation for colonoscopy.
abstract: BACKGROUND
  There are few data comparing U.S. Food and Drug Administration-approved low-volume bowel preparations for colonoscopy.
  
  
  OBJECTIVE
  To compare oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) for bowel cleansing efficacy.
  
  
  METHODS
  Single-blind, randomized, controlled trial.
  
  
  METHODS
  Ten U.S. centers.
  
  
  METHODS
  Outpatients undergoing colonoscopy for routine indications.
  
  
  METHODS
  Patients were randomized to undergo bowel preparation with OSS or SP+MC. Both preparations were given in split doses.
  
  
  METHODS
  Cleansing efficacy on a 4-point scale from excellent (4) to poor (1).
  
  
  RESULTS
  Among 338 randomized patients who took preparation, OSS resulted in a higher rate of successful (excellent or good) preparation (94.7% vs 85.7%; P = .006) and more excellent preparations (54% vs 26%; P < .001) compared with SP+MC. There was no difference between OSS and SP+MC in treatment-emergent adverse events. SP+MC had better scores for nausea, but the differences were small.
  
  
  CONCLUSIONS
  The preparation grading scale has been used in previous studies and has regulatory acceptance but has not been formally validated.
  
  
  CONCLUSIONS
  The U.S. Food and Drug Administration-approved split-dose regimen of OSS provides superior bowel cleansing compared with the approved split-dose regimen of SP+MC. (
  
  
  BACKGROUND
  NCT01786629.).
authors.affiliation: Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana.
authors.forename: Douglas K
authors.initials: DK
authors.lastname: Rex
authors.affiliation: Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, Alabama.
authors.forename: Jack A
authors.initials: JA
authors.lastname: DiPalma
authors.affiliation: Braintree Laboratories, Braintree, Massachusetts, USA.
authors.forename: John
authors.initials: J
authors.lastname: McGowan
authors.affiliation: Braintree Laboratories, Braintree, Massachusetts, USA.
authors.forename: Mark vB
authors.initials: Mv
authors.lastname: Cleveland
mesh_terms: D000368:Aged; D002400:Cathartics / Q000627:therapeutic use*; D002951:Citrates / Q000627:therapeutic use*; D019343:Citric Acid / Q000627:therapeutic use*; D003113:Colonoscopy / Q000379:methods*; D005260:Female; D006801:Humans; D008278:Magnesium Sulfate / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000627:therapeutic use*; D010847:Picolines / Q000627:therapeutic use*; D016037:Single-Blind Method; D013431:Sulfates / Q000627:therapeutic use*
chemical_list: D002400:Cathartics; D002951:Citrates; D009942:Organometallic Compounds; D010847:Picolines; D013431:Sulfates; C012036:sodium sulfate; C031512:potassium sulfate; D019343:Citric Acid; D008278:Magnesium Sulfate; C005701:picosulfate sodium; C110422:magnesium citrate