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
Muñoz-Navas M (1), Calleja JL (2), Payeras G (3), Hervás AJ (4), Abreu LE (5), Orive V (6), Menchén PL (7), Bordas JM (8), Armengol JR (9), Carretero C (1), Beltrán VP (10), Alonso-Abreu I (11), Manteca R (12), Parra-Blanco A (13,14), Carballo F (15), Herrerías JM (16), Badiola C (17).
(1) Instituto de Investigación Sanitaria de Navarra (Idisna), Clínica Universidad de Navarra, Pamplona, Spain.
(2) Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain. email@example.com.
(3) Hospital Infanta Elena Valdemoro, Madrid, Spain.
(4) Hospital General Universitario Reina Sofía, Córdoba, Spain.
(5) Department of Gastroenterology, IDIPHIM, Hospital Universitario Puerta de Hierro, Joaquin Rodrigo 2, Majadahonda, 28222, Madrid, Spain.
(6) Hospital Basurto, Bilbao, Spain.
(7) Hospital General Universitario Gregorio Marañón, Madrid, Spain.
(8) Hospital Clínic de Barcelona, Barcelona, Spain.
(9) Hospital Universitari Vall d'Hebrón, Barcelona, Spain.
(10) Hospital Universitari i Politècnic la Fe, Valencia, Spain.
(11) Hospital Universitario de Canarias, La Laguna, Spain.
(12) Hospital Regional Universitario Carlos Haya, Málaga, Spain.
(13) Hospital Universitario Central de Asturias, Oviedo, Spain.
(14) School of Medicine of Pontificia, Universidad Católica de Chile, Santiago, Chile.
(15) Hospital Universitario Virgen de la Arrixaca, Murcia, Spain.
(16) Hospital Virgen Macarena, Sevilla, Spain.
(17) Laboratorios Casen Recordati S.L., Zaragoza, Spain.
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.
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.
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.
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.
CITATION Int J Colorectal Dis. 2015 Oct;30(10):1407-16. doi: 10.1007/s00384-015-2307-6. Epub 2015 Jul 16