Douglas K Rex1, Jack A DiPalma2, John McGowan3, Mark vB Cleveland3. 1. Division of Gastroenterology and Hepatology, Indiana University School of Medicine, Indianapolis, Indiana. 2. Division of Gastroenterology, University of South Alabama College of Medicine, Mobile, Alabama. 3. Braintree Laboratories, Braintree, Massachusetts, USA.
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.).
RCT Entities:
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.).
Authors: Ala I Sharara; Jean M Chalhoub; Maya Beydoun; Rani H Shayto; Hamed Chehab; Ali H Harb; Fadi H Mourad; Fayez S Sarkis Journal: Clin Transl Gastroenterol Date: 2017-01-05 Impact factor: 4.488
Authors: Jaroslaw Regula; Manon C W Spaander; Stepan Suchanek; Anne Kornowski; Valerie Perrot; Wolfgang Fischbach Journal: Endosc Int Open Date: 2020-02-21