Clinical trial: 2-L polyethylene glycol-based lavage solutions for colonoscopy preparation - a randomized, single-blind study of two formulations

Aliment Pharmacol Ther. 2010 Sep;32(5):637-44. doi: 10.1111/j.1365-2036.2010.04390.x.

Abstract

Background: The 2-L polyethylene glycol (PEG) lavage solutions provide efficacy similar to that of standard 4-L PEG formulations in spite of the reduced volume. The comparative efficacy and tolerability of two formulations of 2-L PEG solution remain unknown.

Aims: To assess the efficacy, safety and tolerability of PEG + Bis compared with PEG + Asc, and to study the effect of bowel cleansing quality on adenoma detection rates.

Methods: Patients were randomized to receive either 2-L PEG with ascorbic acid (PEG + Asc) or 2-L PEG plus bisacodyl 10 mg (PEG + Bis). The primary endpoint was overall colon cleansing score, assessed by blinded investigators using a validated four-point scale. Secondary endpoints included adenoma detection rate, patient tolerability and compliance and adverse events.

Results: Fifty-two patients received PEG + Asc and 55 patients received PEG + Bis. Overall colon cleansing scores (+/-s.d.) were 1.40 +/- 0.69 and 1.75 +/- 0.70 (P < 0.003) in the PEG + Asc and PEG + Bis groups, respectively. Excellent and good ratings were recorded in 69% and 23% receiving PEG + Asc compared to 38% and 51% (P = 0.01) of patients receiving PEG + Bis. More adenomas were detected in colonoscopies performed with PEG + Asc (39%) than in those performed with PEG + Bis (20%) (P = 0.04). Patient tolerability and safety were similar with both preparations.

Conclusion: The use of PEG + Asc resulted in better colon cleansing and higher adenoma detection rates compared with PEG + Bis.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Cathartics / administration & dosage*
  • Colonoscopy / methods*
  • Dosage Forms
  • Female
  • Humans
  • Male
  • Middle Aged
  • Polyethylene Glycols / administration & dosage*
  • Single-Blind Method
  • Solutions
  • Statistics as Topic
  • Therapeutic Irrigation / methods*

Substances

  • Cathartics
  • Dosage Forms
  • Solutions
  • Polyethylene Glycols