Positive diagnostic strategy non-inferior to exclusion in IBS
Luise M. Begtrup, M.D., from Odense University in Denmark, and colleagues conducted a non-inferiority trial comparing a positive diagnostic strategy with a strategy of exclusion for patients' HRQOL. Participants included 302 patients (aged 18 to 50 years) from primary care who fulfilled the Rome III criteria for IBS with no alarm signals. They were randomized to groups to be assessed by exclusion (analyses of blood, stool samples for intestinal parasites, and sigmoidoscopies with biopsies) or a positive strategy involving blood cell count and C-reactive protein. From baseline to one year, the difference in the change of HRQOL was assessed.
The researchers found that a positive strategy was non-inferior to an exclusion strategy (difference, 0.64). Lower direct costs were incurred with the positive diagnostic strategy. Similar effects on symptoms, satisfaction, and subsequent use of health resources were observed with each approach. There were no cases found of inflammatory bowel disease, colorectal cancer, or celiac disease.
"In diagnosing IBS in primary care, use of a positive diagnostic strategy is non-inferior to using a strategy of exclusion with regard to the patients' HRQOL," the authors write. "Our findings support the current guideline recommendations."
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