Edible colon preparation (ECP) was found to be at least as effective and safe as currently available colonoscopy preparation formulations, and it was preferred with high satisfaction, according to study results presented at the American College of Gastroenterology 2016 Annual Scientific Meeting.1,2
Although colonoscopy is the gold standard for identifying colon cancer at early stage, approximately 40% of people who ought to undergo screening colonoscopy avoid the procedure frequently citing the preparation required as their reason for avoiding it. Better patient-friendly preparations are needed to improve patients’ willingness to undergo the screening.
In this phase 2, dual-center, randomized, single blind study, researchers compared edible colon prep (ECP) with FDA-approved active comparators to determine which ECP formulaton is most effective. Participants were randomized to use 1 of 6 formulations or 1 of 2 active comparators to prepare for colonoscopy.
The edible colon preparation consisted of meal kit menus of nutritionally balanced bars and beverage incorporating PEG 3350, the standard purgative active ingredient, in different doses. Patients are instructed to consume the edible colon prep in the 24 hours before the colonoscopy. The kits are designed to be good-tasting, do not require fasting, and have lower fluid requirements compared with standard preparations.
Outcomes measured were endoscopic visibility (rating of excellent or good using the Aronchick scale and segment-by-segment visibility using the Ottawa scale), safety, tolerability, and reports of patients’ experience.
For the study, 51 participants prepared for colonoscopy using the ECP (median age 62 years, 55% female) and 14 used active comparators. Participants were age 40 to 75 years, had undergone a prior colonoscopy, and the current procedure was for colon cancer screening or surveillance.
Endoscopic visibility ratings were excellent or good for 29 of 32 (90.6%) participants who used 1 of the top 3 most effective ECP formulations, with a rating of excellent or good for 14 of 15 (93.3%) participants undergoing colonoscopies who used the lead formulations. Forty of 45 (88.9%) colon segments were rated as excellent or good on the Ottawa scale.
Twelve of 14 (85.7%) of participants using the comparators had a rating of excellent or good on the Aronchick scale.
No serious adverse events were reported from any of the treatment groups. Of the participants using the lead formulation, 64.3% reported their experience as satisfied or extremely satisfied, compared with 33.3% of those using the comparators.
In a nod to the Cancer Moonshot Blue Ribbon Panel’s and the National Colorectal Cancer Roundtable’s goal of 80% screening rate by 2018, the researchers hope that making the preparation for colonoscopy easier will reduce patient resistance, thereby ensuring this important public health goal is achieved.
1. Knuth D, Allio MK, Stern HB, Siegel CA, Rex DK. Edible colon preparation shows excellent efficacy and tolerability in a phase 2, randomized trial. Oral presentation at: American College of Gastroenterology 2016 Annual Scientific Meeting; October 14-19, 2016; Las Vegas, NV.
2. Novel ‘patient-friendly’ colonoscopy prep shows excellent efficacy and safety [news release]. EurekAlert! web site. https://www.eurekalert.org/pub_releases/2016-10/b-nc101216.php. Accessed October 18, 2016.