A comparison of oral sulfate solution with sodium picosulfate

Magnesium citrate in split doses as bowel preparation for colonoscopy

Douglas Rex, Jack A. Dipalma, John McGowan, Mark Vb Cleveland

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Background There are few data comparing U.S. Food and Drug Administration-Approved low-volume bowel preparations for colonoscopy.

Objective To compare oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) for bowel cleansing efficacy.

Design Single-blind, randomized, controlled trial.

Setting Ten U.S. centers.

Patients Outpatients undergoing colonoscopy for routine indications.

Interventions Patients were randomized to undergo bowel preparation with OSS or SP+MC. Both preparations were given in split doses.

Main Outcome Measurements Cleansing efficacy on a 4-point scale from excellent (4) to poor (1).

Results Among 338 randomized patients who took preparation, OSS resulted in a higher rate of successful (excellent or good) preparation (94.7% vs 85.7%; P =.006) and more excellent preparations (54% vs 26%; P <.001) compared with SP+MC. There was no difference between OSS and SP+MC in treatment-emergent adverse events. SP+MC had better scores for nausea, but the differences were small.

Limitations The preparation grading scale has been used in previous studies and has regulatory acceptance but has not been formally validated.

Conclusion The U.S. Food and Drug Administration-Approved split-dose regimen of OSS provides superior bowel cleansing compared with the approved split-dose regimen of SP+MC. (Clinical trial registration number: NCT01786629.).

Original languageEnglish
Pages (from-to)1113-1123
Number of pages11
JournalGastrointestinal Endoscopy
Volume80
Issue number6
DOIs
StatePublished - Dec 1 2014

Fingerprint

Colonoscopy
Sulfates
United States Food and Drug Administration
Nausea
Outpatients
Randomized Controlled Trials
magnesium citrate
picosulfate sodium
Clinical Trials

ASJC Scopus subject areas

  • Gastroenterology
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

A comparison of oral sulfate solution with sodium picosulfate : Magnesium citrate in split doses as bowel preparation for colonoscopy. / Rex, Douglas; Dipalma, Jack A.; McGowan, John; Cleveland, Mark Vb.

In: Gastrointestinal Endoscopy, Vol. 80, No. 6, 01.12.2014, p. 1113-1123.

Research output: Contribution to journalArticle

@article{f7445d43d9f8405e9d2a141caa6550a5,
title = "A comparison of oral sulfate solution with sodium picosulfate: Magnesium citrate in split doses as bowel preparation for colonoscopy",
abstract = "Background There are few data comparing U.S. Food and Drug Administration-Approved low-volume bowel preparations for colonoscopy.Objective To compare oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) for bowel cleansing efficacy.Design Single-blind, randomized, controlled trial.Setting Ten U.S. centers.Patients Outpatients undergoing colonoscopy for routine indications.Interventions Patients were randomized to undergo bowel preparation with OSS or SP+MC. Both preparations were given in split doses.Main Outcome Measurements Cleansing efficacy on a 4-point scale from excellent (4) to poor (1).Results Among 338 randomized patients who took preparation, OSS resulted in a higher rate of successful (excellent or good) preparation (94.7{\%} vs 85.7{\%}; P =.006) and more excellent preparations (54{\%} vs 26{\%}; P <.001) compared with SP+MC. There was no difference between OSS and SP+MC in treatment-emergent adverse events. SP+MC had better scores for nausea, but the differences were small.Limitations The preparation grading scale has been used in previous studies and has regulatory acceptance but has not been formally validated.Conclusion The U.S. Food and Drug Administration-Approved split-dose regimen of OSS provides superior bowel cleansing compared with the approved split-dose regimen of SP+MC. (Clinical trial registration number: NCT01786629.).",
author = "Douglas Rex and Dipalma, {Jack A.} and John McGowan and Cleveland, {Mark Vb}",
year = "2014",
month = "12",
day = "1",
doi = "10.1016/j.gie.2014.05.329",
language = "English",
volume = "80",
pages = "1113--1123",
journal = "Gastrointestinal Endoscopy",
issn = "0016-5107",
publisher = "Mosby Inc.",
number = "6",

}

TY - JOUR

T1 - A comparison of oral sulfate solution with sodium picosulfate

T2 - Magnesium citrate in split doses as bowel preparation for colonoscopy

AU - Rex, Douglas

AU - Dipalma, Jack A.

AU - McGowan, John

AU - Cleveland, Mark Vb

PY - 2014/12/1

Y1 - 2014/12/1

N2 - Background There are few data comparing U.S. Food and Drug Administration-Approved low-volume bowel preparations for colonoscopy.Objective To compare oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) for bowel cleansing efficacy.Design Single-blind, randomized, controlled trial.Setting Ten U.S. centers.Patients Outpatients undergoing colonoscopy for routine indications.Interventions Patients were randomized to undergo bowel preparation with OSS or SP+MC. Both preparations were given in split doses.Main Outcome Measurements Cleansing efficacy on a 4-point scale from excellent (4) to poor (1).Results Among 338 randomized patients who took preparation, OSS resulted in a higher rate of successful (excellent or good) preparation (94.7% vs 85.7%; P =.006) and more excellent preparations (54% vs 26%; P <.001) compared with SP+MC. There was no difference between OSS and SP+MC in treatment-emergent adverse events. SP+MC had better scores for nausea, but the differences were small.Limitations The preparation grading scale has been used in previous studies and has regulatory acceptance but has not been formally validated.Conclusion The U.S. Food and Drug Administration-Approved split-dose regimen of OSS provides superior bowel cleansing compared with the approved split-dose regimen of SP+MC. (Clinical trial registration number: NCT01786629.).

AB - Background There are few data comparing U.S. Food and Drug Administration-Approved low-volume bowel preparations for colonoscopy.Objective To compare oral sulfate solution (OSS) with sodium picosulfate plus magnesium citrate (SP+MC) for bowel cleansing efficacy.Design Single-blind, randomized, controlled trial.Setting Ten U.S. centers.Patients Outpatients undergoing colonoscopy for routine indications.Interventions Patients were randomized to undergo bowel preparation with OSS or SP+MC. Both preparations were given in split doses.Main Outcome Measurements Cleansing efficacy on a 4-point scale from excellent (4) to poor (1).Results Among 338 randomized patients who took preparation, OSS resulted in a higher rate of successful (excellent or good) preparation (94.7% vs 85.7%; P =.006) and more excellent preparations (54% vs 26%; P <.001) compared with SP+MC. There was no difference between OSS and SP+MC in treatment-emergent adverse events. SP+MC had better scores for nausea, but the differences were small.Limitations The preparation grading scale has been used in previous studies and has regulatory acceptance but has not been formally validated.Conclusion The U.S. Food and Drug Administration-Approved split-dose regimen of OSS provides superior bowel cleansing compared with the approved split-dose regimen of SP+MC. (Clinical trial registration number: NCT01786629.).

UR - http://www.scopus.com/inward/record.url?scp=84920110160&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84920110160&partnerID=8YFLogxK

U2 - 10.1016/j.gie.2014.05.329

DO - 10.1016/j.gie.2014.05.329

M3 - Article

VL - 80

SP - 1113

EP - 1123

JO - Gastrointestinal Endoscopy

JF - Gastrointestinal Endoscopy

SN - 0016-5107

IS - 6

ER -