Mar. 4, 2005 ANN ARBOR, Mich. – 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.
To learn how much information endoscopies contribute to the measurement of disease activity, each endoscopic index was analyzed to determine how well it predicted disease activity with and without the endoscopic item. The prediction of disease activity was nearly as good (only 3 percent less accurate) without the endoscopic information. The St. Mark's Index and the UCDAI endoscopy items correlated with patient-reported stool frequency and stool blood, which are already measured in the indices through survey questions.
These findings suggest endoscopy is not a necessary component to determine disease activity and that less expensive, noninvasive indices may be reasonable alternatives for measuring disease activity for ulcerative colitis, says Higgins.
"Our data support a common clinical practice of following the self-reported symptoms of patients with ulcerative colitis, rather than assessing patients with endoscopy each time symptoms flare," says Higgins. "
Adds co-author Ellen Zimmermann, M.D., associate professor of Internal Medicine at UMHS: "While endoscopy is still necessary to diagnose ulcerative colitis and to evaluate a patient for early signs of cancer, patients may be more willing to participate in clinical trials of new treatments if there are not so many colonoscopies involved."
Although the study favors the use of noninvasive indices to measure ulcerative colitis activity, Higgins feels that the SCCAI and Seo index could still be improved by including additional non-endoscopic components to further enhance the measurement of ulcerative colitis activity in patients.
In addition to Higgins and Zimmermann, the study was co-authored by Marc Schwartz, M.D., a fellow in gastroenterology at the University of Chicago, and John Mapili, M.D., a house officer in Family Practice at Wayne State University.
The research investigators for this study were supported by grants from the National Institutes of Health, the U-M Medical School and the Department of Internal Medicine at the U-M Health System.
Reference: American Journal of Gastroenterology, February 2005, Vol. 100, No. 2, pp. 355-361.
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