title: A randomized trial to compare the efficacy and tolerability of sodium picosulfate-magnesium citrate solution vs. 4 L polyethylene glycol solution as a bowel preparation for colonoscopy.
abstract: OBJECTIVE
  The purpose of this study is to compare the efficacy and acceptability of an evening-before regimens of sodium picosulfate/magnesium citrate (SPMC) and polyethylene glycol (PEG) as bowel cleansers and to explore the results of a same-day regimen of SPMC.
  
  
  METHODS
  Multicenter, randomized, observer-blinded, parallel study carried out in subjects who were 18-80 years old and were undergoing diagnostic colonoscopy for the first time. The primary outcome was treatment success, which was a composite outcome defined by (1) the evaluation of the overall preparation quality as "excellent" or "good" by two blinded independent evaluators with the Fleet(®) Grading Scale for Bowel Cleansing and (2) a subject's acceptability rating of "easy to take" or "tolerable." The primary outcome was analyzed using a logistic regression with site, gender, and age group (age ≥65 years and <65 years) as factors.
  
  
  RESULTS
  Four hundred ninety subjects were included in the efficacy evaluation. Although treatment success was significantly higher in subjects assigned to the evening-before regimen of SPMC vs. subjects assigned to the evening-before PEG, when evaluating the two individual components for treatment success, there were significant differences in the ease of completion but not in the quality of preparation. The same-day SPMC regimen was superior to both the evening-before regimen of SPMC and PEG in terms of the quality of preparation, especially regarding the proximal colon.
  
  
  CONCLUSIONS
  An evening-before regimen of SPMC is superior to an evening-before regimen of PEG in terms of subject's acceptability. The same-day SPMC regimen provides better cleansing levels in the proximal colon.
authors.affiliation: Instituto de Investigación Sanitaria de Navarra (Idisna), Clínica Universidad de Navarra, Pamplona, Spain.
authors.forename: Miguel
authors.initials: M
authors.lastname: Muñoz-Navas
authors.affiliation: Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain. joseluis.calleja@uam.es.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Calleja
authors.affiliation: Hospital Infanta Elena Valdemoro, Madrid, Spain.
authors.forename: Guillermo
authors.initials: G
authors.lastname: Payeras
authors.affiliation: Hospital General Universitario Reina Sofía, Córdoba, Spain.
authors.forename: Antonio José
authors.initials: AJ
authors.lastname: Hervás
authors.affiliation: Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain.
authors.forename: Luis Esteban
authors.initials: LE
authors.lastname: Abreu
authors.affiliation: Hospital Basurto, Bilbao, Spain.
authors.forename: Víctor
authors.initials: V
authors.lastname: Orive
authors.affiliation: Hospital General Universitario Gregorio Marañón, Madrid, Spain.
authors.forename: Pedro L
authors.initials: PL
authors.lastname: Menchén
authors.affiliation: Hospital Clínic de Barcelona, Barcelona, Spain.
authors.forename: José María
authors.initials: JM
authors.lastname: Bordas
authors.affiliation: Hospital Universitari Vall d'Hebrón, Barcelona, Spain.
authors.forename: José Ramón
authors.initials: JR
authors.lastname: Armengol
authors.affiliation: Instituto de Investigación Sanitaria de Navarra (Idisna), Clínica Universidad de Navarra, Pamplona, Spain.
authors.forename: Cristina
authors.initials: C
authors.lastname: Carretero
authors.affiliation: Hospital Universitari i Politècnic la Fe, Valencia, Spain.
authors.forename: Vicente Pons
authors.initials: VP
authors.lastname: Beltrán
authors.affiliation: Hospital Universitario de Canarias, La Laguna, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Alonso-Abreu
authors.affiliation: Hospital Regional Universitario Carlos Haya, Málaga, Spain.
authors.forename: Román
authors.initials: R
authors.lastname: Manteca
authors.affiliation: Hospital Universitario Central de Asturias, Oviedo, Spain.|School of Medicine of Pontificia, Universidad Católica de Chile, Santiago, Chile.
authors.forename: Adolfo
authors.initials: A
authors.lastname: Parra-Blanco
authors.affiliation: Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
authors.forename: Fernando
authors.initials: F
authors.lastname: Carballo
authors.affiliation: Hospital Virgen Macarena, Sevilla, Spain.
authors.forename: Juan Manuel
authors.initials: JM
authors.lastname: Herrerías
authors.affiliation: Laboratorios Casen Recordati S.L., Zaragoza, Spain.
authors.forename: Carlos
authors.initials: C
authors.lastname: Badiola
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002400:Cathartics / Q000008:administration & dosage / Q000009:adverse effects; D002951:Citrates / Q000008:administration & dosage / Q000009:adverse effects; D019343:Citric Acid / Q000008:administration & dosage / Q000009:adverse effects; D003113:Colonoscopy / Q000379:methods*; D004334:Drug Administration Schedule; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009942:Organometallic Compounds / Q000008:administration & dosage / Q000009:adverse effects; D017060:Patient Satisfaction; D010847:Picolines / Q000008:administration & dosage / Q000009:adverse effects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D055815:Young Adult
chemical_list: D002400:Cathartics; D002951:Citrates; D009942:Organometallic Compounds; D010847:Picolines; D019343:Citric Acid; D011092:Polyethylene Glycols; C005701:picosulfate sodium; C110422:magnesium citrate
keywords: Bowel cleansing colonoscopy; Polyethylene glycol; Randomized trial; Same-day bowel preparation; Sodium picosulfate/magnesium citrate