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

Abstract

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.

Plain language summary: Breath test for detecting bacteria in patients with ulcer-like symptoms. Dyspepsia is a condition that causes long-term pain or discomfort in the upper abdomen. Symptoms can include heartburn, burping, bloating, nausea, or slow digestion. Dyspepsia can be caused by a bacterium that also causes ulcers and stomach cancer. Half of the world's people are believed to be infected with these bacteria. A test has been developed to detect the bacteria in a breath sample. Our review determined the accuracy of this breath test in adults with ulcer-like symptoms. From 19 studies, the breath test correctly identified 98% of patients with the bacteria and 95% of patients without the bacteria, as determined by a reference standard. Six studies compared the breath test to a blood test that is currently used. Both the breath and blood tests performed well in correctly identifying patients with the bacteria. However, the blood test was incorrectly positive in 20 more patients who did not have the bacteria according to the breath test. This means that more patients would have received unnecessary treatment. Thus, the breath test is an accurate test to detect the bacteria in adult patients who have ulcer-like symptoms. But the many differences among the studies in our review included several steps taken to perform the breath test and the reference standards used to compare a blood test with the breath test.

Figure 1:. Citation Flow Chart

Figure 2:. Sensitivity Estimates from 19 Diagnostic Studies of Carbon-13 Urea Breath Test

Figure 3:. Specificity Estimates from 19 Diagnostic Studies of Carbon-13 Urea Breath Test