ABSTRACT
BACKGROUND AND AIM: Sodium picosulfate plus magnesium citrate (SP + MC) is a well-tolerated bowel preparation agent. However, Japan currently approves only two methods of taking SP + MC: the day-before and split-dose preparation, without approval of same-day preparations. This study aimed to evaluate the efficacy and safety of same-day SP + MC preparations. METHODS: This was a multicenter, single-arm, nonrandomized, open-label study. We enrolled 145 Japanese patients between June and December 2023. The patients received two sachets of SP + MC dissolved in 300 ml of water and 1200 mL or more of clear liquid on the day of colonoscopy. Bowel cleansing efficacy, adverse events (AEs), and patient satisfaction were evaluated. RESULTS: Of the enrolled patients, 137 underwent colonoscopy according to our protocol. Bowel preparation was adequate in 133 patients (97.1%). The mean total Boston Bowel Preparation Score was 8.3 ± 1.2. Five patients experienced AEs (3.6%): two (1.5%), abdominal pain; one (0.73%), ischemic enteritis; one (0.73%), vomiting or nausea; and one (0.73%), headache. All AEs were treated conservatively. None of the patients exhibited abnormal blood test results or clinical symptoms after receiving SP + MC. Regarding patient satisfaction, all patients were able to take SP + MC as directed; 136 (99.2%) expressed a preference for this bowel preparation for future colonoscopies. CONCLUSION: The same-day SP + MC preparation showed high bowel-cleansing efficacy and satisfaction in Japanese patients without serious AEs.
Subject(s)
Cathartics , Citrates , Citric Acid , Colonoscopy , Organometallic Compounds , Patient Satisfaction , Picolines , Humans , Cathartics/administration & dosage , Cathartics/adverse effects , Picolines/administration & dosage , Picolines/adverse effects , Male , Female , Organometallic Compounds/administration & dosage , Organometallic Compounds/adverse effects , Citrates/administration & dosage , Citrates/adverse effects , Middle Aged , Citric Acid/administration & dosage , Citric Acid/adverse effects , Aged , Adult , Treatment Outcome , Drug Administration Schedule , JapanABSTRACT
Objective To compare the effectiveness of lactulose oral solution combined with PEG-4000 electrolyte lavage solution with PEG-4000 electrolyte lavage solution only in colonoscopy preparation.Methods A total of 121 patients preparing for colonoscopy were randomly divided into two groups:61 patients in lactulose oral solution combined with PEG-4000 electrolyte lavage solution group (the experimental group =group A),and 60 patients in PEG-4000 electrolyte lavage solution group(the control group =group B).During the colonoscopy,the endoscopist blindly scored the cleanness of the bowel,and recorded any adverse event to assess the safety.Results According to the Boston bowel preparation scale,the experimental group scored 7.07 ±0.79,and the control group scored 6.18 ± 1.03,which showed significant significance(P =0.000).There was no significant difference in the time of accessing rectum between the two groups[(8.80 ± 1.74) min VS(9.22 ± 1.94) min,P =0.220].Polyp detection rate in group A was higher than that in group B,with no significant difference (22.95％ VS 15.00％,P ＞ 0.05).The small polyp (≤0.5 cm)detection rate in group A was higher than that in group B with significant significance(P =0.038).No adverse event was recorded in either group.Conclusion The bowel preparation with lactulose oral solution combined with PEG-4000 electrolyte lavage solution is more effective than that with PEG-4000 electrolyte lavage solution alone.It will enhance the detection rate of small polyps with no evident adverse reactions.