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Clinical Trial
. 2002 Apr 27;324(7344):999-1002.
doi: 10.1136/bmj.324.7344.999.

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  1 , L S Murray, D Gillen, A Walker, A Wirz, J Fletcher, C Mowat, E Henry, A Kelman, A Dickson
Affiliations
Clinical Trial

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 et al. BMJ. .

Erratum in

  • BMJ 2002 Aug 31;325(7362):479
  • BMJ 2002 Sep 14;325(7364):580

Abstract

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.

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Figures

Figure 1
Figure 1
Flow chart of recruitment
Figure 2
Figure 2
Box and whisker plots showing range, quarters, and median scores for concern about missed pathology at one year in the two groups, subdivided according to quarter (Q1-Q4) of concern at initial assessment. Points denote outliers. In some cases, minimum, Q1, and median are all 0. BT=non-invasive breath test for Helicobacter pylori; E=endoscopy plus H pylori testing
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