BERLIN — A new bowel-cleansing formula was more effective and had better patient acceptance than did a conventional bowel-preparation solution in a controlled study with 356 patients.
The Moviprep formulation of polyethylene glycol, ascorbic acid, and other electrolytes was rated substantially higher for colon cleansing than was the comparator, Fleet Phospho-soda, while also cutting in half the volume of liquid required during the prep. Moviprep needed at least 2 L of water, compared with a minimum of 4 L with the Fleet prep, Dr. Christian Ell said at the 14th United European Gastroenterology Week.
“This is a milestone for colon-cancer screening,” said Dr. Ell, a gastroenterologist at Dr. Horst Schmidt Hospital in Wiesbaden, Germany.
But Dr. Ralf Kiesslich, chief of endoscopy at the Johannes Gutenberg University Mainz (Germany), was more cautious, suggesting that the superiority of Moviprep should be confirmed in a second study.
He was skeptical of the Fleet prep's performance in the study, because it usually doesn't seem so ineffective. But the results do suggest that Moviprep is at least as good and easier to use, Dr. Kiesslich said in an interview.
The study investigators randomized people who were undergoing screening colonoscopy at any of 12 German centers to treatment using either the Moviprep preparation or the Fleet regimen on a two-to-one basis.
The study was sponsored by Norgine, a German company that markets Moviprep in the United Kingdom. In August, Moviprep received marketing approval from the Food and Drug Administration. Sales by the U.S. licensee, Salix Pharmaceuticals Inc., are scheduled to start before the end of 2006.
The 242 people who used Moviprep and the 114 who received a Fleet prep were similar by gender and by average age and weight.
The quality of the bowel prep was rated by the gastroenterologist for each case, as well as on a blinded basis by a second gastroenterologist from a study panel.
Bowel appearance was scored on a scale of 0–4, in which 4 corresponded to completely empty and clean, 3 meant that clear liquid remained in the colon, and a 2 indicated patches of brown liquid or semisolid stool. Each of the cases was scored for each of five segments of the colon: ascending, transverse, descending, sigmoid, and rectum.
In addition, every case was rated for efficacy as a function of the score in each of the five segments. An A rating meant a score of 4 or 3 in each segment; a B rating meant at least one score of 2; a C meant at least one score was 1; and a D rating meant that at least one score was 0.
Experts rated results as A or B for 93% of participants in the Moviprep group (20% received an A and 73% got a B); individual gastroenterologists gave an A or B to 95%, Dr. Ell reported.
In the Fleet prep group, experts rated the results as A or B for 23%, and participating physicians gave these grades to 46% of patients, which were significantly lower rates than those in the Moviprep group. The superiority of Moviprep was consistent in every segment of the colon, Dr. Ell reported.
The incidence of adverse effects, such as malaise, nausea, and abdominal pain, was similar in the two subgroups. The taste of Moviprep was rated acceptable, and 88% of patients said that they were willing to take it again, compared with a 78% rate in the people treated with the comparator regimen. Three-quarters of the people using Moviprep said that they had no problems drinking the entire 2 liters, he said.
People who had the Moviprep regimen were able to continue eating their usual diet until the evening before their colonoscopy. In contrast, people who use a conventional bowel prep have to fast the entire day before their procedure.