title: Lubiprostone plus PEG electrolytes versus placebo plus PEG electrolytes for outpatient colonoscopy preparation: a randomized, double-blind placebo-controlled trial.
abstract: Bowel preparation using large volume of polyethylene glycol (PEG) solutions is often poorly tolerated. Therefore, there are ongoing efforts to develop an alternative bowel cleansing regimen that should be equally effective and better tolerated. The aim of this study was to assess the efficacy of lubiprostone (versus placebo) plus PEG as a bowel cleansing preparation for colonoscopy. Our study was a randomized, double-blind placebo-controlled design. Patients scheduled for screening colonoscopy were randomized 1:1 to lubiprostone (group 1) or placebo (group 2) plus 1 gallon of PEG. The primary endpoints were patient's tolerability and endoscopist's evaluation of the preparation quality. The secondary endpoint was to determine any reduction in the amount of PEG consumed in the lubiprostone group compared with the placebo group. One hundred twenty-three patients completed the study and were included in the analysis. There was no difference in overall cleanliness. The volume of PEG was similar in both the groups. The volume of PEG approached significance as a predictor of improved score for both the groups (P = 0.054). Lubiprostone plus PEG was similar to placebo plus PEG in colon cleansing and volume of PEG consumed. The volume of PEG consumed showed a trend toward improving the quality of the colon cleansing.
authors.affiliation: 1Division of Gastroenterology, Department of Medicine, University of Toledo Medical Center, Toledo, OH; and 2Department of Gastroenterology, Henry Ford Health System, Detroit, MI.
authors.forename: Aijaz A
authors.initials: AA
authors.lastname: Sofi
authors.forename: Ali T
authors.initials: AT
authors.lastname: Nawras
authors.forename: Chetan
authors.initials: C
authors.lastname: Pai
authors.forename: Qiana
authors.initials: Q
authors.lastname: Samuels
authors.forename: Ann L
authors.initials: AL
authors.lastname: Silverman
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D003113:Colonoscopy / Q000379:methods*; D004311:Double-Blind Method; D004573:Electrolytes / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D000068238:Lubiprostone / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010045:Outpatients; D011092:Polyethylene Glycols / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D012996:Solutions; D016896:Treatment Outcome
chemical_list: D004573:Electrolytes; D012996:Solutions; D011092:Polyethylene Glycols; D000068238:Lubiprostone