Papers

Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H pylori testing alone in the management of dyspepsia

K E L McColl, professor of gastroenterology, ^a L S Murray, statistician, ^a D Gillen, consultant gastroenterologist, ^a A Walker, health economist, ^b A Wirz, research sister, ^a J Fletcher, consultant gastroenterologist, ^a C Mowat, specialist registrar in gastroenterology, ^a E Henry, specialist registrar in gastroenterology, ^a A Kelman, physicist, ^a A Dickson, study manager. ^a

^a University Department of Medicine and Therapeutics, Western Infirmary, Glasgow G11 6NT, ^b Robertson Institute, University of Glasgow, Glasgow G12 8QQ

Correspondence to: K McColl K.E.L.McColl{at}clinmed.gla.ac.uk

Objective: To compare the efficacy of non-invasive testing for Helicobacter pylori with that of endoscopy (plus H pylori testing) in the management of patients referred for endoscopic investigation of upper gastrointestinal symptoms.
Design: Randomised controlled trial with follow up at 12 months.
Setting: Hospital gastroenterology unit.
Participants: 708 patients aged under 55 referred for endoscopic investigation of dyspepsia, randomised to non-invasive breath test for H pylori or endoscopy plus H pylori testing.
Main outcome measure: Glasgow dyspepsia severity score at one year. Use of medical resources, patient oriented outcomes, and safety were also assessed.
Results: In 586 patients followed up at 12 months the mean change in dyspepsia score was 4.8 in the non-invasive H pylori test group and 4.6 in the endoscopy group (95% confidence interval for difference -0.7 to 0.5, P=0.69). Only 8.2% of patients followed up who were randomised to breath test alone were referred for subsequent endoscopy. The use of non-endoscopic resources was similar in the two groups. Reassurance value, concern about missed pathology, overall patient satisfaction, and quality of life were similar in the two groups. The patients found the non-invasive breath test procedure less uncomfortable and distressing than endoscopy with or without sedation. No potentially serious pathology requiring treatment other than eradication of H pylori was missed.
Conclusion: In this patient group, non-invasive testing for H pylori is as effective and safe as endoscopy and less uncomfortable and distressing for the patient. Non-invasive H pylori testing should be the preferred mode of investigation.

What is already known on this topic Endoscopy is a commonly used investigation for upper gastrointestinal symptoms, but its effectiveness has been questioned Non-invasive testing for Helicobacter pylori has been shown to predict endoscopic diagnosis in patients with dyspepsia What this study adds In patients less than 55 years of age with uncomplicated dyspepsia, non-invasive testing for H pylori is as effective and as safe as endoscopy Non-invasive H pylori testing is as reassuring to the patient as endoscopy and is less uncomfortable and distressing