Carbon-13 urea breath test for Helicobacter pylori infection in patients with uninvestigated ulcer-like dyspepsia: An evidence-based analysis

Background Dyspepsia is a condition defined by chronic pain or discomfort in the upper gastrointestinal tract that can be caused by Helicobacter pylori. The carbon-13 urea breath test (¹³C UBT) is a non-invasive test to detect H. pylori. Objectives We aimed to determine the diagnostic accuracy and clinical utility of the ¹³C UBT in adult patients with ulcer-like dyspepsia who have no alarm features. Data Sources A literature search was performed using Ovid MEDLINE, Ovid MEDLINE In-Process and Other Non-Indexed Citations, Ovid Embase, the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published between 2003 and 2012. Review Methods We abstracted the sensitivity and specificity, which were calculated against a composite reference standard. Summary estimates were obtained using bivariate random effects regression analysis. Results From 19 diagnostic studies, the ¹³C UBT summary estimates were 98.1% (95% confidence interval [CI], 96.3-99.0) for sensitivity and 95.1% (95% CI, 90.3-97.6) for specificity. In 6 studies that compared the ¹³C UBT with serology, the 1¹³C UBT sensitivity was 95.0% (95% CI, 90.1-97.5) and specificity was 91.6% (95% CI, 81.3-96.4). The sensitivity and specificity for serology were 92.9% (95% CI, 82.6-97.3) and 71.1% (95% CI, 63.8-77.5), respectively. In 1 RCT, symptom resolution, medication use, and physician visits were similar among the ¹³C UBT, serology, gastroscopy, or empirical treatment arms. However, patients tested with ¹³C UBT reported higher dyspepsia-specific quality of life scores. Limitations Processing of the ¹³C UBT results can vary according to many factors. Further, the studies showed significant heterogeneity and used different composite reference standards. Conclusions The ¹³C UBT is an accurate test with high sensitivity and specificity. Compared with serology, it has higher specificity. There is a paucity of data on the ¹³C UBT beyond test accuracy.