A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy

Worthington, J.; Thyssen, M; Chapman, George; Chapman, R W; Geraint, Mike

doi:10.1185/030079908x260844

Cited by 69 publications

(57 citation statements)

References 9 publications

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“…These percentages are higher in randomized controlled trials, ranging from 91 to 99%, 5,[13][14][15] but the definition of compliance is rarely given and the specific setting of randomized trials does not reflect real life.…”

Section: Discussionmentioning

confidence: 99%

“…It has been shown that the quality of bowel cleansing is inversely proportional to the waiting time between the information provided and the colonoscopy. 19 Randomized trials comparing the various colon preparations gave conflicting results, some demonstrating the superiority of PNa over PEG, 20 with others showing opposite 13,21 or similar efficacy, 15 or heterogeneous results, depending on the time of colonoscopy 6 or the criteria used. 22 Two recent meta-analyses of randomized published studies also showed conflicting results, one showing that PNa tablets resulted in better preparation and completion rates than PEG 23 and the other showing similar results, except in some subgroups in favour of PEG.…”

Section: Discussionmentioning

confidence: 99%

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Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study

et al. 2014

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Background: The factors associated with inadequate bowel cleansing leading to colonoscopy failure are not well known. Objective: We conducted a multicentre, prospective, observational case-control study in order to identify these factors. Methods: Investigators included one patient with colonoscopy failure due to inadequate bowel cleansing (failure group) and the following patient with complete colonoscopy (success group). Data related to demographics, medical history, and preparation were collected and compared. Factors associated with bowel cleansing failure were identified by multivariate logistical regression analysis. Results: A total of 101 gastroenterologists included 202 patients from 1 November 2009 to 15 January 2010. There was no difference between both groups with regards to baseline characteristics. In univariate analysis, factors significantly associated with bowel cleansing failure were vomiting during preparation (p ¼ 0.0007), incomplete intake of the preparation (p ¼ 0.002), and constipation (p ¼ 0.02). Type and timing of preparation were not significantly different between groups. In multivariate analysis, incomplete intake of the preparation (OR 4.5, 95% CI 1.2-17.3), constipation (OR 4.2, 95% CI 1.2-14.9), and treatment with neuroleptics or antidepressants (OR 9.9 (95% CI 1.4-71.0) were independent predictors of colonoscopy failure. Conclusions: Factors associated with bowel cleansing failure were incomplete intake of the preparation, constipation, and treatment with psychotropic drugs. Interventions to reduce poor colonoscopy preparations should be targeted at these at-risk patients.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study

et al. 2014

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“…However, the authors compared various doses and duration of the preparation (3L of PEG in the a ernoon and 3 sachets of PMC from the morning the day before the colonoscopy). In another study, Worthington et al evaluated PMC and 2L of PEG containing ascorbic acid [12]. is formula is distinct from the PEG solution used in the present study, and thus, a comparison is not possible.…”

Section: Discussionmentioning

confidence: 99%

A Single or Split Dose Picosulphate/Magnesium Citrate Before Colonoscopy: Comparison Regarding Tolerance and Eficacy with Polyethylene Glycol. A Randomized Trial

Kojecký

Dolina

Kianička

et al. 2014

JGLD

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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.

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“…This result differs from the results published in earlier reports with this regimen. In general, between 50% and 80% of patients receiving the AM/PM regimen of SPMC for colonoscopy rendered a satisfactory bowel cleansing [5,20,21]. We identified several reasons for such poor results for the AM/ PM treatment group in this study.…”

Section: Discussionmentioning

confidence: 68%

“…Sodium picosulfate-magnesium citrate (SPMC) is a lowvolume bowel cleansing powder packed in a sachet for oral solution. Recently published clinical studies on SPMC have shown a successful bowel cleansing rate in 73% to 93% of subjects [5,6].…”

Section: Introductionmentioning

confidence: 99%

Superiority of a Split-dose Regimen of Sodium Picosulfate/ Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

Schulz

Müller²,

Sauter

et al. 2016

JGLD

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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.

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A randomised controlled trial of a new 2 litre polyethylene glycol solution versus sodium picosulphate + magnesium citrate solution for bowel cleansing prior to colonoscopy

Cited by 69 publications

References 9 publications

Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study

Factors related to bowel cleansing failure before colonoscopy: Results of the PACOME study

A Single or Split Dose Picosulphate/Magnesium Citrate Before Colonoscopy: Comparison Regarding Tolerance and Eficacy with Polyethylene Glycol. A Randomized Trial

Superiority of a Split-dose Regimen of Sodium Picosulfate/ Magnesium Citrate (SPMC) in Comparison to a Prior-day Schedule (AM/PM) for Colonoscopy Preparation. A Randomized Single-blinded Study

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