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


OBJECTIVE
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.


CONCLUSIONS
The use of PEG + Asc resulted in better colon cleansing and higher adenoma detection rates compared with PEG + Bis.
Cohen
L B
LB
Department of Medicine, The Mount Sinai School of Medicine, New York, NY 10029, USA. lawrence.cohen@nyga.md
Sanyal
S M
SM
Von Althann
C
C
Bodian
C
C
Whitson
M
M
Bamji
N
N
Miller
K M
KM
Mavronicolas
W
W
Burd
S
S
Freedman
J
J
Aisenberg
J
J
D000328:Adult; D000368:Aged; D002400:Cathartics / Q000008:administration & dosage*; D003113:Colonoscopy / Q000379:methods*; D004304:Dosage Forms; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011092:Polyethylene Glycols / Q000008:administration & dosage*; D016037:Single-Blind Method; D012996:Solutions; D013223:Statistics as Topic; D007507:Therapeutic Irrigation / Q000379:methods*
D002400:Cathartics; D004304:Dosage Forms; D012996:Solutions; D011092:Polyethylene Glycols