A randomized, controlled trial of oral sulfate solution plus polyethylene glycol as a bowel preparation for colonoscopy.

Abstract

BACKGROUND:

No bowel preparation for colonoscopy is optimal with regard to efficacy, safety, and tolerability. New options for bowel preparation are needed.

OBJECTIVE:

To compare a new hybrid preparation consisting of a reduced dose of oral sulfate solution (OSS) plus 2 L of sulfate-free electrolyte lavage solution (SF-ELS) with 2 low-volume preparations based on polyethylene glycol electrolyte lavage solution (PEG-ELS).

DESIGN:

Two randomized, controlled trials.

SETTING:

Twenty-four U.S. centers.

PATIENTS:

A total of 737 outpatients undergoing colonoscopy.

INTERVENTIONS:

In study 1, OSS plus SF-ELS was given as a split dose, and in study 2, OSS plus SF-ELS was given in its entirety the evening before colonoscopy. In study 1, the active control was 2 L of PEG-ELS plus ascorbic acid (PEG-EA) given as a split dose. In study 2, the control was 10 mg of bisacodyl plus 2 L of SF-ELS taken the evening before colonoscopy.

MAIN OUTCOME MEASUREMENTS:

Rates of successful (good or excellent) bowel preparation.

RESULTS:

In study 1, the rates of successful (excellent or good) preparation with OSS plus SF-ELS and PEG-EA were identical at 93.5% for split-dose preparation. OSS plus SF-ELS was noninferior to PEG-EA (P < .001). In study 2, OSS plus SF-ELS resulted in successful preparation in 89.8% of patients compared with 83.5% with bisacodyl plus SF-ELS in a same-day preparation regimen. OSS plus SF-ELS was noninferior to bisacodyl plus SF-ELS (P <.001). In study 1, vomiting was more frequent with OSS plus SF-ELS (13.5% vs 6.7%; P = .042), and bloating was rated worse with PEG-EA (P = .025). In study 2, overall discomfort was rated worse with OSS plus SF-ELS (mean score 2.1 vs 1.8; P = .032). There were no deaths in either study and no serious adverse events considered related to the preparation.

LIMITATIONS:

Bowel cleansing was not scored by colon segment. Adenoma detection was not compared between the regimens.

CONCLUSION:

OSS plus SF-ELS is a new, safe, and effective bowel preparation for colonoscopy.

• Authors: Douglas K Rex, John McGowan, Mark vB Cleveland, Jack A Di Palma
• Journal: Gastrointestinal endoscopy (Gastrointest Endosc) Vol. 80 Issue 3 Pg. 482-91 (Sep 2014) ISSN: 1097-6779 [Electronic] United States
• PMID: 24830577 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

Chemical References

• Cathartics
• Electrolytes
• Sulfates
• sodium sulfate
• Bisacodyl
• potassium sulfate
• Polyethylene Glycols
• Magnesium Sulfate
• polyethylene glycol 3350
• Ascorbic Acid

Topics

• Aged
• Ascorbic Acid (therapeutic use)
• Bisacodyl (therapeutic use)
• Cathartics (therapeutic use)
• Colonoscopy (methods)
• Electrolytes (therapeutic use)
• Female
• Humans
• Magnesium Sulfate (therapeutic use)
• Male
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Single-Blind Method
• Sulfates (therapeutic use)