People living with fatigue, abdominal discomfort and bloody diarrhea caused by the chronic inflammation of ulcerative colitis may no longer need to undergo frequent and uncomfortable endoscopies, a new study shows.
Researchers at the University of Michigan Health System found that disease severity in patients with ulcerative colitis can be evaluated accurately in clinical practice and research trials without frequent lower endoscopies. The results from the study are published in the February 2005 issue of the American Journal of Gastroenterology.
This new finding will spare patients the discomfort of undergoing regular endoscopies to monitor disease activity, and save researchers the expense of using endoscopy as part of clinical trials, says lead author Peter D.R. Higgins, M.D., Ph.D., lecturer in the Division of Gastroenterology and Hepatology in the Department of Internal Medicine at the University of Michigan Medical School.
"Currently, common disease activity indices require an endoscopy every time a patient with ulcerative colitis is evaluated to measure disease activity and monitor the effectiveness of new therapies," says Higgins. "However, this study suggests that endoscopy does not provide physicians with enough new information about the activity of the patient's disease to make it necessary for patients to have to undergo the discomfort of an endoscopy."
Several disease activity measurement scales have been developed – some requiring endoscopy and some not – to monitor the activity of ulcerative colitis, an inflammatory bowel disease that affects more than one million Americans and causes inflammation and bleeding of the colon and rectum. Since none of the scales have been rigorously tested, experts in the field, especially those in clinical research, tend to use multiple disease activity indices, including those requiring endoscopy, to assess patients.
With no gold standard in place to measure disease activity, Higgins and his colleagues set out to determine if endoscopy is truly needed to accurately measure disease activity in ulcerative colitis.
For the comparative study, 66 ulcerative colitis patients with scheduled lower endoscopy appointments at the U-M Health System's Medical Procedures Unit were evaluated using two indices requiring endoscopy and two non-endoscopic measures of disease activity.
The patient sample, gathered over a five-month period, included both very ill inpatients and healthy outpatients with less active disease, a range that is representative of patients participating in clinical trials.
Prior to their scheduled endoscopy, patients completed a 50-question survey and provided a blood sample to collect data to compare the invasive indices (the St. Marks's Index and the Ulcerative Colitis Disease Activity Index) and the noninvasive indices (the Simple Clinical Colitis Activity Index and the Seo Index).
As part of the St. Mark's and the UCDAI measures, patients undergo a physician assessment and endoscopy, while the SCCAI and the Seo index use a six-question symptom survey and a two-question survey with blood tests, respectively, to measure ulcerative colitis.