Scientific publications

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

Oct 1, 2015 | Magazine: International Journal of Colorectal Disease

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).


PURPOSE:
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.

CITATION  Int J Colorectal Dis. 2015 Oct;30(10):1407-16. doi: 10.1007/s00384-015-2307-6. Epub 2015 Jul 16