Randomized Trial of Gatorade/Polyethylene Glycol With or Without Bisacodyl and NuLYTELY for Colonoscopy Preparation

David P Gerard, John L Holden, Diane B Foster, Manfred W Raiser, David P Gerard, John L Holden, Diane B Foster, Manfred W Raiser

Abstract

Objectives: We assessed the safety, efficacy, and tolerability of a new preparation of Gatorade and polyethylene glycol (PEG) for colonoscopy with or without bisacodyl compared with NuLYTELY.

Methods: We performed an investigator-blinded, placebo-controlled, randomized trial of 64 oz of Gatorade and 306 g of PEG (G/PEG) with or without 10 mg of bisacodyl and NuLYTELY. A total of 600 outpatients consumed their preparation the day before a morning colonoscopy. The primary endpoint was colon cleanliness assessed by the Boston Bowel Preparation Scale (BBPS). Tolerability was assessed using a subject questionnaire, and safety was assessed from a basic metabolic profile drawn before the colonoscopy.

Results: Adding bisacodyl to G/PEG caused more abdominal bloating/cramps (P<0.01) and did not result in a cleaner colon (P=0.66) compared with G/PEG without bisacodyl. The BBPS scores in both the G/PEG arms and NuLYTELY arm were not significantly different (P=0.19). Compared with subjects in the NuLYTELY arm, subjects in the G/PEG without bisacodyl arm had less nausea (P<0.04), vomiting (P<0.02), abdominal pain (P<0.02), bloating (P<0.005), difficulty drinking the liquid (P<0.0001), and found the overall preparation easier to tolerate (P<0.0001). Subjects in the combined G/PEG arms had a lower serum sodium (P<0.0007), chloride (P<0.007), and BUN (P<0.0001) levels than those in the NuLYTELY arm, but this did not cause any clinical symptoms.

Conclusions: Bisacodyl added to G/PEG for colon lavage caused more side effects and did not result in a cleaner colon. The G/PEG preparations cleansed the colon as well as NuLYTELY, were far better tolerated, and were equally safe.

References

    1. Richardson LC, Rim SH, Plescia M. Vital signs: colorectal cancer screening among adults aged 50-75 - United States, 2008. Morb Mortal Wkly Rep. 2010;59:808–812.
    1. Harewood GC, Wiersema MJ, Melton LJ., III A prospective, controlled assessment of factors influencing acceptance of screen colonoscopy. Am J Gastroenterol. 2002;97:3186–3194.
    1. Davis GR, Santa Ana CA, Morawski SG, et al. Development of a lavage solution associated with minimal water and electrolyte absorption or secretion. Gastroenterology. 1980;78:991–995.
    1. ASGE A consensus document on bowel preparation before colonoscopy: prepared by a Tast Force from the ASCRS, the ASGE, and the SAGES. Gastrointest Endosc. 2006;63:894–909.
    1. DiPalma JA, Marshall JB. Comparison of a new sulfate-free polyethylene glycol electrolyte lavage solution versus a standard solution for colonoscopy cleansing. Gastrointest Endosc. 1990;36:285–289.
    1. Markowitz GS, Stokes MB, Radhakrishnon J, et al. Acute phosphate nephropathy following oral sodium phosphate bowel purgative: an underrecognized cause of chronic renal failure. J Am Soc Nephrol. 2005;15:3389–3396.
    1. Rex DK, Vanner SJ. Colon cleansing before colonoscopy: does oral sodium phosphate solution still make sense. Can J Gastroenterol. 2009;23:210–214.
    1. Belsey J, Epstein O, Herebach D. Systematic review: oral bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2007;25:373–384.
    1. Enestvedt BK, Fennerty MB, Eisen GM. Randomized clinical trial: PEG vs. GoLYTELY - a controlled study of efficacy and patient tolerability in bowel preparation for colonoscopy. Aliment Pharmacol Ther. 2011;33:33–40.
    1. Hjelkrem M, Stengel J, Jones DP, et al. MiraLAX is not as effective as GoLYTELY in bowel cleaning before screening colonoscopy. Clin Gastroenterol Hepatol. 2011;9:326–332.
    1. Lai EJ, Calderwood AH, Doros G, et al. The Boston Bowel Preparation scale: a valid and reliable instrument for colonoscopy oriented research. Gastrointest Endosc. 2009;69:620–625.
    1. Rostom A, Jolicoeur E. Validation of a new scale for the assessment of bowel preparation quality. Gastrointest Endosc. 2004;59:482–486.
    1. Bardy CE, III, Dipalma JA, Beck DE. Effect of bisacodyl on gut lavage cleaning for colonoscopy. Ann Clin Res. 1987;19:34–38.
    1. DiPalma JA, McGowan J, Cleveland V. Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy. Aliment Pharmacol Ther. 2007;26:1113–1119.
    1. DiPalma JA, Wolff BG, Meagher A, et al. Comparison of reduced volume versus four liters sulfate-free electrolyte lavage solutions for colonoscopy colon cleansing. Am J Gastroenterol. 2003;98:2187–2191.
    1. Rex DK, DiPalma JA, Rodriguez R, et al. A randomized clinical study comparing reduced-volume oral sulfate solution with standard 4-liter sulfate-free electrolyte lavage solution as preparation for colonoscopy. Gastrointest Endosc. 2010;72:328–336.
    1. Nagler J, Poppers D, Turetz M. Severe hyponatremia and seizure following a polyethylene glycol-based bowel preparation for colonoscopy. J Clin Gastroenterol. 2006;40:558–559.
    1. Lewis J, Schoenfeld P. Severe hyponatremia and MiraLax-Gatorade bowel preparation (abstract) Am J Gastroenterol. 2011;106:S582.
    1. Rex DK, Johnson DA, Anderson JC, et al. American College of Gastroenterology Guidelines for Colorectal Cancer Screening 2009. Am J Gastroenterol. 2009;104:739–750.
    1. Aoun E, Abdul-Baki H, Azar C, et al. A randomized single-blind trial of split-dose PEG-electrolyte solution without dietary restrictions compared to whole dose PEG-electrolyte solution with dietary restriction for colonoscopy preparation. Gastrointest Endosc. 2005;62:213–218.
    1. Abdul-Baki H, Hashash JG, ElHajj II, et al. A randomized, controlled, double-blind trail of the adjunct use of tegaserod in whole-dose or split-dose polyethylene glycol electrolyte solution for colonoscopy preparation. Gastrointest Endosc. 2008;68:294–300.
    1. Adams WJ, Meaghher AP, Lubowski DZ, et al. Bisacodyl reduces the volume of polyethylene glycol solution required for bowel preparation. Dis Colon Rectum. 1994;37:229–234.
    1. Sharma VK, Chockalingham SK, Ugheoke EA, et al. 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. 1998;47:167–171.
    1. Ker TS. Comparison of reduced volume versus four-liter electrolyte lavage solutions for colon cleansing. Am Surg. 2006;72:909–911.
    1. Ker TS. Prospective comparison of three bowel preparation regimens: Fleet Phosphosoda, two-liter and four liter electrolyte lavage solutions. Am Surg. 2008;74:1030–1032.
    1. Siddiqui AA, Yang K, Spechler SJ, et al. Duration of the interval between the completion of bowel preparation and the start of colonoscopy predicts bowel-preparation quality. Gastrointest Endosc. 2009;69:700–706.

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