Study finds new colon-cleansing prep safer, more effective
December 10th, 2009 by Jennifer Walker-Journey
A randomized clinical study evaluating the safety and efficacy of a new, reduced-volume oral sulfate colon-cleansing preparation for colonoscopy has proven well tolerated and effective in bowel preparation, according to the December 2009 issue of the Journal of the American Academy of Physician Assistants Patient-Oriented Evidence that Matters report.
The study looked at two different laxative solutions – polyethylene glycol (PEG) and oral sodium phosphate (OSP). PEG includes products such as Miralax but can be poorly tolerated when taken in large volumes to prepare the bowel for procedures such as colonoscopy. OSP is sold under prescription brands Visicol and Osmo Prep and OTC under brands such as Fleet Phospho-soda. OSPs have been linked to a serious kidney injury known as acute phosphate nephropathy and carry a black box warning issued by the Food and Drug Administration (FDA).
The authors of the clinical trial focused their study on an alternative solution, a 960-mL oral sulfate solution, compared with two liters of PEG in two similarly designed clinical trials. The first trial involved 387 patients who took the entire preparation the day before their colonoscopy. The second study included 364 patients who took half the preparation the day before the procedure and the second half the morning before the exam.
Colonoscopists described the preparations as adequate 94 percent of the time for sulfate and 95 percent of the time for PEG in patients who took the entire preparation the day before the exam. In the second study that split the preparation over two days, colonoscopists rated the preparations adequate 99 percent of the time for both groups.
Adverse events during the study were rare and were unlikely to be related to the preparation. Authors also reported no clinically significant changes in patients’ electrolyte levels or renal functions. Patients receiving sulfate also reported having slightly higher vomiting scores but the difference was likely not clinically meaningful, according to the study’s authors.