Comparable Efficacy of a 1-L PEG and Ascorbic Acid Solution Administered with Bisacodyl versus a 2-L PEG and Ascorbic Acid Solution for Colonoscopy Preparation: A Prospective, Randomized and Investigator-Blinded Trial

PLoS One. 2016 Sep 2;11(9):e0162051. doi: 10.1371/journal.pone.0162051. eCollection 2016.

Abstract

Background: Two liters of polyethylene glycol (PEG) solution administered with ascorbic acid (Asc) can provide efficacy similar to that of a 4-L PEG solution for colonoscopy preparation. In addition, oral bisacodyl (Bis) has been shown to reduce the volume of PEG needed for a bowel preparation with comparable efficacy. This study aimed to compare the efficacy, tolerability and safety of a 2-L PEG solution mixed with Asc versus the combination of Bis, Asc and a 1-L PEG solution.

Methods: This was a prospective, randomized, multi-centre, single-blind, non-inferiority trial. Participants who were scheduled for colonoscopy were included and randomized to receive either 2-L PEG and Asc (2L PEG/Asc group) or 1-L PEG, Asc and 20 mg Bis (1L PEG/Asc + Bis group). The quality of bowel preparation was assessed using the Boston Bowel Preparation Scale. Data regarding tolerance, compliance and adverse events were also gathered.

Results: A total of 187 participants were analyzed; 96 were allocated to the 2L PEG/Asc group and 91 to the 1L PEG/Asc + Bis group. Bowel preparation was adequate in 87.5% (84/96) of patients in the 2L PEG/Asc group and 94.5% of the 1L PEG/Asc + Bis group (86/91, p = 0.10). There was no significant difference between the two groups with respect to compliance, tolerability or safety. The patients allocated to the 1L PEG/Asc + Bis group expressed more willingness to repeat the procedure than patients in the 2L PEG/Asc group (p = 0.01).

Conclusions: Bowel preparation with Bis and a 1-L PEG/Asc solution is as effective, well-tolerated, and safe as a 2-L PEG/Asc solution.

Trial registration: ClinicalTrials.gov NCT 01745835; Clinical Research Information Service (CRiS) KCT0000708.

Trial registration: ClinicalTrials.gov NCT01745835.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Ascorbic Acid / administration & dosage*
  • Bisacodyl / administration & dosage*
  • Cathartics / administration & dosage*
  • Colonoscopy / methods*
  • Female
  • Humans
  • Male
  • Middle Aged
  • Patient Satisfaction*
  • Polyethylene Glycols / administration & dosage*
  • Single-Blind Method
  • Young Adult

Substances

  • Cathartics
  • Bisacodyl
  • Polyethylene Glycols
  • Ascorbic Acid

Associated data

  • ClinicalTrials.gov/NCT01745835

Grants and funding

The work was funded by TaeJoon Pharmaceuticals and the funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. All aspects of the analysis and its writing were carried out by the authors.