Non-inferiority between two low-volume agents (Sodium picosulfate/magnesium citrate vs. sodium sulfate/potassium/magnesium) to prepare the bowel for diagnostic procedures: An observational study

Abstract

Introduction: Colorectal cancer is a public health problem; however, early detection reduces morbidity and mortality. Colonoscopy is the procedure of choice for detecting precancerous lesions, and success depends on proper bowel cleansing. Objective: To evaluate the performance of two low-volume agents used in a high-level hospital. Materials and methods: Prospective study in adults who underwent colonoscopy at the Fundación Santa Fe in Bogotá, Colombia. Preparations were evaluated using the Boston Bowel Preparation Scale. A score ≥6 points indicated adequate preparation. A logistic regres-sion analysis was carried out to establish the effectiveness of the medicines with a non-inferiority ratio of 3-5%. Results: 598 patients were evaluated. 49% (293) received sodium picosulfate/magnesium citrate and 51% (305) received sodium sulfate/potassium/magnesium, with an average Boston score of 6.98±1.86 (78% Boston ≥6) and 7.39±1.83 (83%), respectively (p=0.649). According to the analysis of the presence and frequency of unwanted symptoms, picosulfate was better tolerated (p < 0.001). Conclusions: Bowel preparation studies in patients from a real-life scenario are scarce. Low-volume agents had similar overall and segmental effectiveness in the colon, confirming non-inferiority; sodium picosulfate/magnesium citrate was better tolerated. A cost-effectiveness study could establish the best option according to the needs of the study population.