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

• Published in: Alimentary pharmacology & therapeutics Vol. 32; no. 5; pp. 637 - 644
• Main Authors: Cohen, L. B., Sanyal, S. M., Von Althann, C., Bodian, C., Whitson, M., Bamji, N., Miller, K. M., Mavronicolas, W., Burd, S., Freedman, J., Aisenberg, J.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01.09.2010; Blackwell
• Subjects: Adult; Aged; Biological and medical sciences; Cathartics - administration & dosage; Colonoscopy - methods; Digestive system; Dosage Forms; Female; Gastroenterology. Liver. Pancreas. Abdomen; Humans; Male; Medical sciences; Middle Aged; Pharmacology. Drug treatments; Polyethylene Glycols - administration & dosage; Single-Blind Method; Solutions; Statistics as Topic; Therapeutic Irrigation - methods; Ethylene oxide polymer; Human; Randomization; Colonoscopy; Formulation; Preparation; Clinical trial; Endoscopy
• ISSN: 0269-2813; 1365-2036
• DOI: 10.1111/j.1365-2036.2010.04390.x

Aliment Pharmacol Ther 2010; 32: 637–644 Summary 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.