Display options
Share it on

Curr Ther Res Clin Exp. 2005 Nov;66(6):486-500. doi: 10.1016/j.curtheres.2005.12.002.

Effects of the addition of high-dose vitamin C to polyethylene glycol solution for colonic cleansing: A pilot study in healthy volunteers.

Current therapeutic research, clinical and experimental

Stéphane Mouly, Isabelle Mahé, Anne-Laure Knellwolf, Guy Simoneau, Jean-François Bergmann

Affiliations

  1. Unit of Therapeutic Research, Department of Internal Medicine, Lariboisière Hospital, Paris, France.

PMID: 24678071 PMCID: PMC3965999 DOI: 10.1016/j.curtheres.2005.12.002

Abstract

BACKGROUND: Polyethylene glycol (PEG) solutions, with or without osmotic agents, are used to empty the large intestine before procedures such as colonoscopy or colonic surgery. Data concerning the effectiveness of vitamin C as an ingredient in colonic preparations are scant.

OBJECTIVE: The aim of this article was to assess the effectiveness, acceptability, and tolerability of 6 preparations of a standard PEG electrolyte solution containing different doses of PEG, vitamin C (as an osmotic agent), and sodium sulfate in colonic cleansing.

METHODS: This double-blind, randomized, 2-period crossover study was conducted at the Lariboisière Hospital, Paris, France. Healthy adult volunteers were randomly assigned to receive 2 of 6 colonic cleansing preparations, each containing different doses of PEG (100 or 125 g/L), vitamin C (0, 5, or 10 g/L, in the form of sodium ascorbate, ascorbic acid, or a mixture of both), and sodium sulfate (5 or 7.5 g/L), diluted in water to a volume of 2 L. Study drug administration was separated by a washout period of 7 to 15 days, after which the volunteers received an alternate preparation. Stools were collected for 10 hours after the start of solution ingestion. The primary efficacy end point was stool volume. Secondary end points included acceptability of taste, assessed using a 100-mm visual analog scale (VAS) (0 = excellent to 100 = execrable), taste criteria (saltiness, acidity, and sweetness, assessed on a 4-point Likert-type scale [0 = very pleasant to 3 = intolerable]) and tolerability (clinical effects [changes in body weight, blood pressure, heart rate, and nausea and vomiting] and biologic effects [changes in serum electrolytes, creatinine, hematocrit, and ascorbic acid]).

RESULTS: Thirty volunteers (15 men, 15 women; mean [SD] age, 29.8 [8.2] years [range, 20-45 years]) were enrolled and completed the study. Mean (SD) stool volume obtained with preparations containing 10 g/L of vitamin C did not differ significantly from the volume obtained without vitamin C (2.54 [0.54] L vs 1.93 [0.62] L; 95% CI, -0.13 to 1.47). Mean (SD) VAS scores for acceptability of taste ranged from 54.4 (25.0) (preparation E) to 74.4 (20.1) (preparation C) (P = 0.03 preparation E vs all other preparations). The only significant difference in taste criteria was in acidity, with preparation A being the least acidic according to patients' ratings on the VAS (1.4 [0.7] vs 1.8 [0.4] [mean of the other 5 preparations combined]; P = 0.04 preparation A vs all other preparations). Mild dehydration occurred in 6 subjects (1 for each preparation). No clinical or biological adverse effects were found.

CONCLUSIONS: In this study of 6 colonic cleansing preparations in healthy volunteers, the use of high-dose vitamin C as an osmotic agent in addition to PEG did not significantly increase stool output. All 6 preparations were well tolerated.

Keywords: acceptability; ascorbate; ascorbic acid; colonic preparation; polyethylene glycol solution; stool output; taste; vitamin C

References

  1. J Surg Res. 1994 Aug;57(2):284-8 - PubMed
  2. Int J Vitam Nutr Res. 1999 Mar;69(2):67-82 - PubMed
  3. Biopharm Drug Dispos. 1993 Jul;14(5):429-42 - PubMed
  4. N Engl J Med. 2002 Jan 3;346(1):40-4 - PubMed
  5. Dis Colon Rectum. 1995 Jun;38(6):594-9 - PubMed
  6. Gastrointest Endosc. 1996 May;43(5):463-6 - PubMed
  7. Br J Nutr. 2002 Feb;87(2):97-100 - PubMed
  8. Postgrad Med. 1996 Aug;100(2):203-4, 207-12, 214 - PubMed
  9. Dis Colon Rectum. 1994 Mar;37(3):229-33; discussion 233-4 - PubMed
  10. Dis Colon Rectum. 2000 Nov;43(11):1568-71 - PubMed
  11. Zhonghua Yi Xue Za Zhi (Taipei). 1989 Jul;44(1):45-56 - PubMed
  12. Aust N Z J Surg. 1998 Dec;68(12):856-8 - PubMed
  13. Gastrointest Endosc. 2001 Dec;54(6):705-13 - PubMed
  14. Am J Gastroenterol. 1993 Aug;88(8):1218-23 - PubMed
  15. Gastrointest Endosc. 1995 May;41(5):485-9 - PubMed
  16. Nutr Rev. 1993 Nov;51(11):313-26 - PubMed
  17. Endoscopy. 1996 Sep;28(7):555-8 - PubMed
  18. J Gastroenterol Hepatol. 1996 Feb;11(2):103-7 - PubMed
  19. Rev Hosp Clin Fac Med Sao Paulo. 1999 Nov-Dec;54(6):187-92 - PubMed
  20. Endoscopy. 1990 Jul;22(4):168-70 - PubMed
  21. Gastrointest Endosc. 1998 Sep;48(3):276-82 - PubMed
  22. Gastroenterol Jpn. 1992 Dec;27(6):728-33 - PubMed
  23. Gastrointest Endosc. 2000 Aug;52(2):218-22 - PubMed
  24. Aliment Pharmacol Ther. 2001 May;15(5):605-11 - PubMed
  25. J Bacteriol. 2002 Jan;184(1):302-6 - PubMed
  26. Gastroenterol Clin Biol. 2001 Jan;25(1):29-34 - PubMed
  27. Endoscopy. 1987 Sep;19(5):198-200 - PubMed

Publication Types