Year 2021 / Volume 113 / Number 9
Original
Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate – a phase IV clinical observational study

635-642

DOI: 10.17235/reed.2020.7073/2020

Renáta Bor, Mária Matuz, Anna Fabián, Zoltán Szepes, Kata Szántó, Klaudia Farkas, Mariann Rutka, Ágnes Milassin, Daniella Pigniczki, Anita Bálint, Tibor Tóth, Tamás Molnár,

Abstract
Background: There are contradictory results about the effect of magnesium citrate plus sodium picosulfate bowel cleansing agents on the fluid and electrolyte balance. Therefore, this study aimed to determine the efficacy, tolerability and safety of this medication in colonoscopy preparation. Methods: 233 patients were enrolled in this phase IV prospective observational study. The effectiveness of bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS). Adequate cleansing was defined as BBPS ≥ 6 and excellent cleansing as BBPS > 7. Tolerability was examined using a standardized questionnaire. In the safety analysis, the change of serum electrolytes levels and renal function during bowel cleansing was assessed. Results: Adequate and excellent bowel cleansing were achieved 94.85% and 72.96% of cases, respectively. None or very mild symptoms were reported in 47.21% of cases. Statistically significant changes occurred in serum potassium (4.38±0.43 vs. 4.25±0.43 mmol/L, p<0.0001), urea (4.86±1.37 vs. 3.84±1.43 mmol/L, p<0.0001) and creatinine (male: 81.07±16.02 vs. 84.54±15.11 μmol/L; female: 69.32±12.22 vs. 72.96±12.11 μmol/L, p<0.0001) levels during the colonoscopy preparation. However, the number of patients with values outside of the normal range increased significantly only in the case of serum urea (3.95% vs. 26.97%, p<0.0001). Conclusion: Magnesium citrate with sodium picosulfate is outstandingly effective, well tolerated and a safe agent in colonoscopy preparation. It caused significant, but non-clinically relevant changes in serum electrolytes levels and renal function.
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Bor R, Matuz M, Fabián A, Szepes Z, Szántó K, Farkas K, et all. Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate – a phase IV clinical observational study. 7073/2020


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Publication history

Received: 25/03/2020

Accepted: 15/11/2020

Online First: 29/12/2020

Published: 07/09/2021

Article revision time: 227 days

Article Online First time: 279 days

Article editing time: 531 days


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