Feb. 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 Health System.
“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 study 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.”
This study is published in The American Journal of Gastroenterology.
<b>About The American Journal of Gastroenterology</b>
The American Journal of Gastroenterology, the official publication of the American College of Gastroenterology, is THE clinical journal for all practicing gastroenterologists, hepatologists and GI endoscopists. With an impact factor of 4.172, it is the authoritative clinical source in the field of gastroenterology. With a broad-based, rigorous, interdisciplinary approach, the journal presents the latest important information in the field of gastroenterology including original manuscripts, meta-analyses and reviews, health economic papers, debates and consensus statements of clinical relevance in gastroenterology. The reports will highlight new observations and original research, results with innovative treatments and all other topics relevant to clinical gastroenterology. Case reports highlighting disease mechanisms or particularly important clinical observations and letters on articles published in the Journal are included.
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