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

Ji Eun Kwon, Jung Won Lee, Jong Pil Im, Ji Won Kim, Su Hwan Kim, Seong-Joon Koh, Byeong Gwan Kim, Kook Lae Lee, Sang Gyun Kim, Joo Sung Kim, Hyun Chae Jung, Ji Eun Kwon, Jung Won Lee, Jong Pil Im, Ji Won Kim, Su Hwan Kim, Seong-Joon Koh, Byeong Gwan Kim, Kook Lae Lee, Sang Gyun Kim, Joo Sung Kim, Hyun Chae Jung

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.

Conflict of interest statement

The work was funded by TaeJoon Pharmaceuticals. This does not alter our adherence to PLOS ONE policies on sharing data and materials.

Figures

Fig 1. Study flow chart.
Fig 1. Study flow chart.
Asc; ascorbic acid, PEG; polyethylene glycol, Bis; bisacodyl.
Fig 2. Bowel Preparation Protocols.
Fig 2. Bowel Preparation Protocols.
Asc; ascorbic acid, PEG; polyethylene glycol, Bis; bisacodyl.

References

    1. Burke CA, Church JM (2007) Enhancing the quality of colonoscopy: the importance of bowel purgatives. Gastrointest Endosc 66: 565–573.
    1. Froehlich F, Wietlisbach V, Gonvers JJ, Burnand B, Vader JP (2005) Impact of colonic cleansing on quality and diagnostic yield of colonoscopy: the European Panel of Appropriateness of Gastrointestinal Endoscopy European multicenter study. Gastrointest Endosc 61: 378–384.
    1. Lee HS, Byeon JS (2014) Bowel preparation, the first step for a good quality colonoscopy. Intest Res 12: 1–2. 10.5217/ir.2014.12.1.1
    1. Collazo TH, Jandorf L, Thelemaque L, Lee K, Itzkowitz SH (2015) Screening Colonoscopy among Uninsured and Underinsured Urban Minorities. Gut Liver 9: 502–508. 10.5009/gnl14039
    1. Cha JM (2014) Colonoscopy Quality is the Answer for the Emerging Issue of Interval Cancer. Intest Res 12: 110–116. 10.5217/ir.2014.12.2.110
    1. Rosenfeld G, Krygier D, Enns RA, Singham J, Wiesinger H, Bressler B (2010) The impact of patient education on the quality of inpatient bowel preparation for colonoscopy. Can J Gastroenterol 24: 543–546.
    1. Harewood GC, Sharma VK, de Garmo P (2003) Impact of colonoscopy preparation quality on detection of suspected colonic neoplasia. Gastrointest Endosc 58: 76–79.
    1. Adams WJ, Meagher AP, Lubowski DZ, King DW (1994) Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation. Dis Colon Rectum 37: 229–233; discussion 233–224.
    1. Johnson DA, Barkun AN, Cohen LB, Dominitz JA, Kaltenbach T, Martel M, et al. (2014) Optimizing adequacy of bowel cleansing for colonoscopy: recommendations from the US multi-society task force on colorectal cancer. Gastroenterology 147: 903–924. 10.1053/j.gastro.2014.07.002
    1. Cohen LB, Sanyal SM, Von Althann C, Bodian C, Whitson M, Bamji N, et al. (2010) Clinical trial: 2-L polyethylene glycol-based lavage solutions for colonoscopy preparation—a randomized, single-blind study of two formulations. Aliment Pharmacol Ther 32: 637–644. 10.1111/j.1365-2036.2010.04390.x
    1. Sharma VK, Chockalingham SK, Ugheoke EA, Kapur A, Ling PH, Vasudeva R, et al. (1998) Prospective, randomized, controlled comparison of the use of polyethylene glycol electrolyte lavage solution in four-liter versus two-liter volumes and pretreatment with either magnesium citrate or bisacodyl for colonoscopy preparation. Gastrointest Endosc 47: 167–171.
    1. Kamm MA, Mueller-Lissner S, Wald A, Richter E, Swallow R, Gessner U (2011) Oral bisacodyl is effective and well-tolerated in patients with chronic constipation. Clin Gastroenterol Hepatol 9: 577–583. 10.1016/j.cgh.2011.03.026
    1. Bharucha AE (2012) High amplitude propagated contractions. Neurogastroenterol Motil 24: 977–982. 10.1111/nmo.12019
    1. Brahmania M, Ou G, Bressler B, Ko HK, Lam E, Telford J, et al. (2014) 2 L versus 4 L of PEG3350 + electrolytes for outpatient colonic preparation: a randomized, controlled trial. Gastrointest Endosc 79: 408–416 e404. 10.1016/j.gie.2013.08.035
    1. Mittal S (2010) The Boston bowel preparation scale: reliable not only for colonoscopy-oriented research but clinical practice also. Gastrointest Endosc 71: 221.
    1. Jeon SR, Kim HG, Lee JS, Kim JO, Lee TH, Cho JH, et al. (2015) Randomized controlled trial of low-volume bowel preparation agents for colonic bowel preparation: 2-L polyethylene glycol with ascorbic acid versus sodium picosulfate with magnesium citrate. Int J Colorectal Dis 30: 251–258. 10.1007/s00384-014-2066-9
    1. Siddiqui AA, Yang K, Spechler SJ, Cryer B, Davila R, Cipher D, et al. (2009) Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc 69: 700–706. 10.1016/j.gie.2008.09.047
    1. Kim TK, Kim HW, Kim SJ, Ha JK, Jang HH, Hong YM, et al. (2014) Importance of the time interval between bowel preparation and colonoscopy in determining the quality of bowel preparation for full-dose polyethylene glycol preparation. Gut Liver 8: 625–631. 10.5009/gnl13228
    1. Calderwood AH, Schroy PC 3rd, Lieberman DA, Logan JR, Zurfluh M, Jacobson BC (2014) Boston Bowel Preparation Scale scores provide a standardized definition of adequate for describing bowel cleanliness. Gastrointest Endosc 80: 269–276. 10.1016/j.gie.2014.01.031
    1. Clark BT, Protiva P, Nagar A, Imaeda A, Ciarleglio MM, Deng Y, et al. (2016) Quantification of Adequate Bowel Preparation for Screening or Surveillance Colonoscopy in Men. Gastroenterology 150: 396–405. 10.1053/j.gastro.2015.09.041
    1. Lai EJ, Calderwood AH, Doros G, Fix OK, Jacobson BC (2009) The Boston bowel preparation scale: a valid and reliable instrument for colonoscopy-oriented research. Gastrointest Endosc 69: 620–625. 10.1016/j.gie.2008.05.057
    1. Ell C, Fischbach W, Bronisch HJ, Dertinger S, Layer P, Rünzi M, et al. (2008) Randomized trial of low-volume PEG solution versus standard PEG + electrolytes for bowel cleansing before colonoscopy. Am J Gastroenterol 103: 883–893. 10.1111/j.1572-0241.2007.01708.x
    1. Repici A, Cestari R, Annese V, Biscaglia G, Vitetta E, Minelli L, et al. (2012) Randomised clinical trial: low-volume bowel preparation for colonoscopy—a comparison between two different PEG-based formulations. Aliment Pharmacol Ther 36: 717–724. 10.1111/apt.12026
    1. Ell C, Fischbach W, Keller R, Dehe M, Mayer G, Schneider B, et al. (2003) A randomized, blinded, prospective trial to compare the safety and efficacy of three bowel-cleansing solutions for colonoscopy (HSG-01*). Endoscopy 35: 300–304.
    1. Aronchick CA, Lipshutz WH, Wright SH, Dufrayne F, Bergman G (2000) A novel tableted purgative for colonoscopic preparation: efficacy and safety comparisons with Colyte and Fleet Phospho-Soda. Gastrointest Endosc 52: 346–352.
    1. Radaelli F, Meucci G, Imperiali G, Spinzi G, Strocchi E, Terruzzi V, et al. (2005) High-dose senna compared with conventional PEG-ES lavage as bowel preparation for elective colonoscopy: a prospective, randomized, investigator-blinded trial. Am J Gastroenterol 100: 2674–2680.
    1. Bae SE, Kim KJ, Eum JB, Yang DH, Ye BD, Byeon JS, et al. (2013) A Comparison of 2 L of Polyethylene Glycol and 45 mL of Sodium Phosphate versus 4 L of Polyethylene Glycol for Bowel Cleansing: A Prospective Randomized Trial. Gut Liver 7: 423–429. 10.5009/gnl.2013.7.4.423
    1. Kao D, Lalor E, Sandha G, Fedorak RN, van der Knoop B, Doornweerd S, et al. (2011) A randomized controlled trial of four precolonoscopy bowel cleansing regimens. Can J Gastroenterol 25: 657–662.
    1. Brady CE 3rd, Dipalma JA, Beck DE (1987) Effect of bisacodyl on gut lavage cleansing for colonoscopy. Ann Clin Res 19: 34–38.
    1. Wang HS, Lin JK (2003) A randomized prospective trial of bowel preparation for colonoscopy with Fortrans compared with bisacodyl. J Chin Med Assoc 66: 364–369.
    1. Klaschik E, Nauck F, Ostgathe C (2003) Constipation—modern laxative therapy. Support Care Cancer 11: 679–685.
    1. Ajani S, Hurt RT, Teeters DA, Bellmore LR (2012) Ischaemic colitis associated with oral contraceptive and bisacodyl use. BMJ Case Rep 2012.
    1. Baudet JS, Castro V, Redondo I (2010) Recurrent ischemic colitis induced by colonoscopy bowel lavage. Am J Gastroenterol 105: 700–701. 10.1038/ajg.2009.637

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