Published online Aug 28, 2017. doi: 10.3748/wjg.v23.i32.5954
Peer-review started: January 27, 2017
First decision: March 16, 2017
Revised: March 25, 2017
Accepted: June 1, 2017
Article in press: June 1, 2017
Published online: August 28, 2017
Processing time: 217 Days and 1.1 Hours
To determine the sensitivity and specificity of the 13C-urea breath test (UBT) in patients taking proton pump inhibitors (PPIs), using a new test meal Refex.
One hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative, were included in the study. The patients were then given esomeprazole 40 mg for 29 consecutive days, and the 13C-UBT with the new test meal was performed the next morning.
The sensitivity of the 13C-UBT with a cut off 2.5‰ was 92.45% (95%CI: 81.79%-97.91%) by per-protocol (PP) analysis and 78.13% (95%CI: 66.03%-87.49%) by intention-to-treat (ITT) analysis. The specificity of the 13C-UBT test was 96.00% in the ITT population (95%CI: 86.29%-99.51%) and 97.96% in the PP population (95%CI: 89.15%-99.95%).
The new test meal based 13C-UBT is highly accurate in patients on PPIs and can be used in those unable to stop their PPI treatment.
Core tip: The urea breath test (UBT) with new test meal Reflex (5.5 g powder mixture of citric, malic and tartaric acid) was tested in one hundred and fourteen consecutive patients with dyspepsia, 53 Helicobacter pylori (H. pylori) positive, 49 H. pylori negative. After being on esomeprazole 40 mg for 29 consecutive days, the 13C-UBT was performed the next morning. The sensitivity of the 13C-UBT (cut off 2.5‰) was 92.45% by per-protocol (PP) analysis and 78.13% by intention-to-treat (ITT) analysis. The specificity of the 13C-UBT test was 96.00% in the ITT population and 97.96% in the PP population.