Single-day sodium picosulfate and magnesium citrate versus split-dose polyethylene glycol for bowel cleansing prior to colonoscopy: A prospective randomized endoscopist-blinded trial

2015 ◽  
Vol 30 (11) ◽  
pp. 1627-1634 ◽  
Author(s):  
Peter Klare ◽  
Anne Poloschek ◽  
Benjamin Walter ◽  
Ina-Christine Rondak ◽  
Soher Attal ◽  
...  
2020 ◽  
Vol Volume 13 ◽  
pp. 449-457
Author(s):  
Antonio Afonso de Miranda Neto ◽  
Diogo Turiani Hourneaux de Moura ◽  
Kelly E Hathorn ◽  
Francisco Tustumi ◽  
Eduardo Guimarães Hourneaux de Moura ◽  
...  

2016 ◽  
Vol 25 (3) ◽  
pp. 295-302 ◽  
Author(s):  
Christian Schulz ◽  
Joachim Müller ◽  
Joachim Sauter ◽  
Stephan Miehlke ◽  
Christoph Schmöcker ◽  
...  

Background & Aims: Split-dose regimens are generally recommended for bowel cleansers. However, other regimens still remain in the summary of product characteristics of some bowel cleansers in Europe. The aim of this study is to compare the efficacy and safety of a split-dose regimen of sodium picosulfate/magnesium citrate (SPMC) with a prior-day schedule (AM/PM). Methods: Multicenter, randomized (EudraCT no. 2013-001620-20), endoscopist-blinded, parallel study, carried out in subjects 18 years or older undergoing elective colonoscopy. The primary endpoint was the bowel cleansing assessment using a binary transformation (adequate/inadequate) of the Global Preparation Assessment (GPA) scale. Additional parameters analyzed were the segmental assessment of bowel cleansing (RSS), the adenoma detection rate and safety evaluations. Results: 315 subjects comprised the ITT set. A significantly higher proportion of patients in the split-dose regimen had an adequate bowel preparation (AM/PM: 30.8% vs split-dose: 79.9%; p<0.0001). The mean global RSS was significantly lower in the split-dose group (AM/PM: 5.0 [SD: 2.91] vs split-dose: 2.6 [SD: 2.14]; p<0.0001). Flat polyps were detected in a higher proportion of subjects in the split-dose group compared with the AM/PM group (AM/PM: 16.0% vs split-dose: 22.0%). Both regimens were equally safe and well tolerated, with no serious treatment-emergent adverse events or discontinuations due to adverse events. Conclusion: A split-dose regimen of SPMC is superior to the AM/PM regimen administered the day before colonoscopy. Split regimen of SPMC should be considered the standard of use. Abbreviations: CTCAE: Common Terminology Criteria for Adverse Events; eGFR: Glomerular filtration rate; mITT: modified intent-to-treat; RSS: Residual Stool Score; SA: safety analysis; SAE: serious adverse event; SmPC: summary of product characteristics; SPMC: sodium picosulfate-magnesium citrate.


2014 ◽  
Vol 23 (2) ◽  
pp. 141-146 ◽  
Author(s):  
Vladimir Kojecky ◽  
Jiri Dolina ◽  
Bohuslav Kianicka ◽  
Miroslav Misurec ◽  
Michal Varga ◽  
...  

Background & Aims: To compare the eficacy and tolerance of sodium picosulphate/magnesium citrate(PMC) and polyethylene glycol (PEG) in a single or split dose regimen for colonoscopy bowel preparation.Methods: A prospective, randomized, endoscopist-blinded, multicenter study. The patients were randomly assigned to receive PMC (PMC4/0) or PEG (PEG4/0) in a single dose 4L day before colonoscopy or a split dose 2+2L PMC (PMC2/2) or 3+1L PEG (PEG3/1) one day before and in the morning before the colonoscopy. Each patient was interviewed to determine his/her subjective tolerance of the preparation before the procedure. The quality of bowel cleansing was assessed in a blinded test performed by multiple endoscopists using the Aronchick scale.Results: A total of 600 patients were enrolled, 88.2% were included in the analysis. Satisfactory bowel cleansing (Aronchick score 1 and 2) was signicantly more frequent when a split dose was used irrespective of the solution type (81.6% PMC2/2, 87.3% PEG3/1 vs. 73.0% PEG4/0, p = 0.024). In single dose regimens, PMC performed better than PEG (82.6% vs. 73.0%). Single or split dose PMC preparations were comparable. A PMC based solution was generally better tolerated than PEG regardless of the regimen used (p < 0.001). Nausea was reported mostly after the 4L PEG (32.8%, p < 0.001), incontinence after a split PMC dose (34.4%, p = 0.002), and bloating after the 4L PEG (38.0%, p < 0.001). There was no significant difference in the prevalence of vomiting.Conclusion: Colonic preparation with PMC yields similar results as a split PEG dose, regardless of whether PMC is administered in single or separate doses. PMC is better tolerated than any PEG-based preparation. A single 4L PEG the day before the colonoscopy is less appropriate for bowel cleansing.


2020 ◽  
Vol 2020 ◽  
pp. 1-6
Author(s):  
Amit Kumar Jaiswal ◽  
Shatdal Chaudhary

Introduction. Colonoscopy is considered as a gold standard investigation for screening of colorectal cancer and other lower gastrointestinal pathologies. Adequate bowel preparation is absolutely necessary for a fruitful colonoscopy. Various bowel cleansing agents are being used for his purpose. The aim of the present study was to compare the two bowel cleansing agents: a single dose of Polyethylene Glycol (PEG) solution and a split dose of Sodium Picosulfate (Na PICOSUL) tablet with regards to cleansing efficacy and tolerability among the patients scheduled for colonoscopy. Methods. It is an open-label hospital-based observational study. A total of sixty-four patients were grouped randomly into two groups of bowel cleansing agents that are PEG and Na PICOSUL during the study period between 1st December 2015 and 30th November 2016. Patients’ tolerability was evaluated using a structured questionnaire, and the bowel cleansing efficacy was evaluated using the Aronchick Bowel Preparation Scale (ABPS). Results. The group that received PEG solution was found to have better efficacy than that which received Na PICOSUL tablet (63.3% versus 29.4%, respectively, with a P value < 0.028) with excellent grade as per ABPS. The Na PICOSUL group was found better in terms of tolerability than the PEG group as nausea/vomiting was encountered significantly higher in the PEG group than in the Na PICOSUL group (43.3% versus 11.8%, respectively, with a P value < 0.01). Conclusions. Colonic preparation with a split dose of Na PICOSUL tablet was better tolerated than the evening before regimen of PEG solution. However, PEG solution was found to be more efficacious in bowel cleansing, but procedural performance and lesion detection were similar for both agents.


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