Published References on Urea Breath Test Method for Detection of Helicobacter pylori

•  McColl KE et al . Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H pylori testing alone in the management of dyspepsia. British Medical J. 2002 Apr 27;324(7344):999-1002.

A prospective, randomized, controlled trial (n=708) was conducted in which the efficacy of noninvasive testing for H. pylori was compared to that of endoscopic evaluation and testing in patients with dyspepsia. The two treatment groups consisted of patients all under the age of 55 who had either endoscopy in addition to breath testing (n=352) or breath testing alone (n=356). The study found that no potentially serious pathology requiring treatment other than H. pylori eradication was missed. It was concluded that noninvasive testing (UBT) is as safe and effective as endoscopy in this population.

•  Lassen AT et al . Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial. Lancet 2000 Aug 5;356(9228):455-60.

In another randomized study of 500 patients with dyspepsia, the efficacy and safety of H. pylori test-and-eradicate strategy (n=250) was assessed compared with prompt endoscopy (n=250). Patients in the test-and-eradicate group were tested with 13C-labeled urea. The authors concluded that the test-and-eradicate strategy was as effective as endoscopy with regard to outcome measures of symptoms, hospital admissions and quality of life.

•  Carlo A. et. al ., The urea breath tests for Helicobacter pylori infection: taking the wind out of the sails of endoscopy, Can. Medical Assoc. J 2000, 162, 371 – 372.

Carlo states that numerous variations of the UBT have been successfully tested and validated, with a sensitivity and specificity of about 95%. It is the noninvasive test of choice for diagnosing active H. pylori infection and for confirming eradication after treatment. Indeed, the UBT may be considered the gold standard for H. pylori detection because it avoids the potential sampling error present with endoscopic biopsy of this sometimes patchy gastric infection.

•  P Moayyedi , Helicobacter pylori test and treat strategy for young dyspeptic patients: new data. Gut 2002; 50 :iv47-iv50.

Four trials evaluating the H pylori test and treat strategy for uncomplicated dyspeptics who are 45 years of age or younger were conducted which resulted in construction of a more accurate decision analysis model. The trials found that a H pylori test and treat strategy was at least as effective as prompt endoscopy and the model indicates that it is more cost effective. Thus, it should be the new "gold standard" against which other strategies are compared.

•  Smellie W.S.A. et. al ., Best practice in primary care pathology: review 1, J of Clinical Pathology 2005, 58(10), 1016 – 1024.

European dyspepsia guidelines and those from the National Institute for Clinical Excellence (NICE) say that patients with persistent or recurrent uncomplicated dyspepsia should have a non-invasive Helicobacter pylori test and, if the test is positive, receive triple therapy. The urea breath test is the most accurate with 95% sensitivity and specificity.