Augmentation with pre-emptive macrogol-based osmotic laxative does not significantly improve standard bowel preparation in unselected patients

A randomized trial

Dileep Mangira, Shara Ket, Jeremy Dwyer, Robyn Secomb, John Reynolds, Gregor Brown

Research output: Contribution to journalArticleResearchpeer-review

Abstract

Background and Aim The addition of a laxative prior to a standard bowel preparation (BP) has shown variable results in efficacy, safety, and tolerability of the BP. This study compared the efficacy and tolerability of a macrogol-augmented BP (M-BP) with standard BP for routine colonoscopy in unselected patients. Methods Adults undergoing outpatient colonoscopy were randomized to either M-BP (one sachet of macrogol-based osmotic laxative (MBOL) twice daily for eight doses prior to standard preparation) or BP (split-dose of polyethylene glycol and sodium picosulfate). Bowel cleansing was assessed using the Ottawa BP scale. Risk factors for poor BP, patient satisfaction, and tolerance were recorded. Results This randomized trial was stopped due to futility after 14?months; at that point, 92 subjects were randomized to the study arm and 102 to the control arm. M-BP had a success rate of 71.7% (95% CI: 58.5?82.7%), while the BP had a success rate of 67.7% (95% CI: 54.9?78.8%), with a Pearson ?2 test P-value of 0.639, which exceeded the cut-off for futility (0.313). In subgroup analyses, there were statistically significant decreases in the rates of successful BP in patients taking regular opioids and regular laxatives. Both preparations were well tolerated, with no difference between groups (BP ? 5.3% and M-BP ? 6.6% P = 0.66). Conclusion The addition of MBOL prior to a standard BP in unselected subjects does not significantly improve bowel cleanliness at routine colonoscopy. The role of this laxative in patients at high risk of poor preparation warrants further investigation.
Original languageEnglish
Number of pages7
JournalJGH Open
DOIs
Publication statusAccepted/In press - 4 Apr 2019

Keywords

  • augmentation
  • macrogol
  • osmotic laxative

Cite this

@article{b5a0cbee0d144dd8b971b052588c3a0d,
title = "Augmentation with pre-emptive macrogol-based osmotic laxative does not significantly improve standard bowel preparation in unselected patients: A randomized trial",
abstract = "Background and Aim The addition of a laxative prior to a standard bowel preparation (BP) has shown variable results in efficacy, safety, and tolerability of the BP. This study compared the efficacy and tolerability of a macrogol-augmented BP (M-BP) with standard BP for routine colonoscopy in unselected patients. Methods Adults undergoing outpatient colonoscopy were randomized to either M-BP (one sachet of macrogol-based osmotic laxative (MBOL) twice daily for eight doses prior to standard preparation) or BP (split-dose of polyethylene glycol and sodium picosulfate). Bowel cleansing was assessed using the Ottawa BP scale. Risk factors for poor BP, patient satisfaction, and tolerance were recorded. Results This randomized trial was stopped due to futility after 14?months; at that point, 92 subjects were randomized to the study arm and 102 to the control arm. M-BP had a success rate of 71.7{\%} (95{\%} CI: 58.5?82.7{\%}), while the BP had a success rate of 67.7{\%} (95{\%} CI: 54.9?78.8{\%}), with a Pearson ?2 test P-value of 0.639, which exceeded the cut-off for futility (0.313). In subgroup analyses, there were statistically significant decreases in the rates of successful BP in patients taking regular opioids and regular laxatives. Both preparations were well tolerated, with no difference between groups (BP ? 5.3{\%} and M-BP ? 6.6{\%} P = 0.66). Conclusion The addition of MBOL prior to a standard BP in unselected subjects does not significantly improve bowel cleanliness at routine colonoscopy. The role of this laxative in patients at high risk of poor preparation warrants further investigation.",
keywords = "augmentation, macrogol, osmotic laxative",
author = "Dileep Mangira and Shara Ket and Jeremy Dwyer and Robyn Secomb and John Reynolds and Gregor Brown",
year = "2019",
month = "4",
day = "4",
doi = "10.1002/jgh3.12170",
language = "English",
journal = "JGH Open",
issn = "2397-9070",
publisher = "John Wiley & Sons",

}

TY - JOUR

T1 - Augmentation with pre-emptive macrogol-based osmotic laxative does not significantly improve standard bowel preparation in unselected patients

T2 - A randomized trial

AU - Mangira, Dileep

AU - Ket, Shara

AU - Dwyer, Jeremy

AU - Secomb, Robyn

AU - Reynolds, John

AU - Brown, Gregor

PY - 2019/4/4

Y1 - 2019/4/4

N2 - Background and Aim The addition of a laxative prior to a standard bowel preparation (BP) has shown variable results in efficacy, safety, and tolerability of the BP. This study compared the efficacy and tolerability of a macrogol-augmented BP (M-BP) with standard BP for routine colonoscopy in unselected patients. Methods Adults undergoing outpatient colonoscopy were randomized to either M-BP (one sachet of macrogol-based osmotic laxative (MBOL) twice daily for eight doses prior to standard preparation) or BP (split-dose of polyethylene glycol and sodium picosulfate). Bowel cleansing was assessed using the Ottawa BP scale. Risk factors for poor BP, patient satisfaction, and tolerance were recorded. Results This randomized trial was stopped due to futility after 14?months; at that point, 92 subjects were randomized to the study arm and 102 to the control arm. M-BP had a success rate of 71.7% (95% CI: 58.5?82.7%), while the BP had a success rate of 67.7% (95% CI: 54.9?78.8%), with a Pearson ?2 test P-value of 0.639, which exceeded the cut-off for futility (0.313). In subgroup analyses, there were statistically significant decreases in the rates of successful BP in patients taking regular opioids and regular laxatives. Both preparations were well tolerated, with no difference between groups (BP ? 5.3% and M-BP ? 6.6% P = 0.66). Conclusion The addition of MBOL prior to a standard BP in unselected subjects does not significantly improve bowel cleanliness at routine colonoscopy. The role of this laxative in patients at high risk of poor preparation warrants further investigation.

AB - Background and Aim The addition of a laxative prior to a standard bowel preparation (BP) has shown variable results in efficacy, safety, and tolerability of the BP. This study compared the efficacy and tolerability of a macrogol-augmented BP (M-BP) with standard BP for routine colonoscopy in unselected patients. Methods Adults undergoing outpatient colonoscopy were randomized to either M-BP (one sachet of macrogol-based osmotic laxative (MBOL) twice daily for eight doses prior to standard preparation) or BP (split-dose of polyethylene glycol and sodium picosulfate). Bowel cleansing was assessed using the Ottawa BP scale. Risk factors for poor BP, patient satisfaction, and tolerance were recorded. Results This randomized trial was stopped due to futility after 14?months; at that point, 92 subjects were randomized to the study arm and 102 to the control arm. M-BP had a success rate of 71.7% (95% CI: 58.5?82.7%), while the BP had a success rate of 67.7% (95% CI: 54.9?78.8%), with a Pearson ?2 test P-value of 0.639, which exceeded the cut-off for futility (0.313). In subgroup analyses, there were statistically significant decreases in the rates of successful BP in patients taking regular opioids and regular laxatives. Both preparations were well tolerated, with no difference between groups (BP ? 5.3% and M-BP ? 6.6% P = 0.66). Conclusion The addition of MBOL prior to a standard BP in unselected subjects does not significantly improve bowel cleanliness at routine colonoscopy. The role of this laxative in patients at high risk of poor preparation warrants further investigation.

KW - augmentation

KW - macrogol

KW - osmotic laxative

U2 - 10.1002/jgh3.12170

DO - 10.1002/jgh3.12170

M3 - Article

JO - JGH Open

JF - JGH Open

SN - 2397-9070

ER -