Efficacy, tolerability and safety of a split-dose bowel cleansing regimen of magnesium citrate with sodium picosulfate: A phase IV clinical observational study

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: two hundred and thirty-three 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 in 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.