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Noninvasive Helicobacter pylori testing was as effective as endoscopy for managing dyspepsia
  1. Brendan Delaney, MD, FRCP, MRCGP
  1. University of Birmingham
 Birmingham, UK

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 QUESTION: In patients with upper gastrointestinal symptoms presenting for investigation of dyspepsia, is treatment based on a urea breath test for Helicobacter pylori alone as effective as endoscopy and urea breath testing?

    Design

    Randomised {allocation concealed*}, unblinded,* controlled trial with 1 year of follow up.

    Setting

    A gastroenterology clinic in Glasgow, UK.

    Patients

    708 patients (mean age 37 y, 53% men) who were referred by their general practitioners for investigation of upper gastrointestinal symptoms. Exclusion criteria were age >55 years, nonsteroidal anti-inflammatory drugs, or sinister symptoms. Follow up was 83%.

    Intervention

    Patients were allocated to endoscopy plus the noninvasive 14C-urea breath test (n=352) or the breath test alone (n=356) for determination of H pylori status. Patients were informed of their status after the test, and patients with positive results were prescribed a 7 day course of H pylori eradication treatment with omeprazole, 20 mg twice daily; clarithromycin, 250 mg 3 times daily; and amoxicillin, 500 mg (or metronidazole, 400 mg) 3 times daily.

    Main outcome measures

    Change from baseline on the Glasgow Dyspepsia Severity Score (GDSS). Secondary outcomes were use of medical resources, patient assessment of the procedures, and safety.

    Main results

    Analysis was by intention to treat. At 1 year, the mean change from baseline on the GDSS was similar between groups (p=0.69) (table). The study had 90% power to detect a difference in mean change on the GDSS of 1.03 and 1.41 between the groups that were positive and negative for H pylori, respectively. The mean reduction in GDSS was 46% in the endoscopy group and 45% in the breath test alone group. Groups did not differ for resolution of dyspepsia (14% v 11%, p=0.25). More patients who received the breath test alone were referred for further endoscopy than were those who received the breath test and endoscopy (8.2% v 1.7%, p<0.001). Groups did not differ for further nonendoscopic investigations.

    Conclusion

    In patients with upper gastrointestinal symptoms presenting for investigation of dyspepsia, a urea breath test for Helicobacter pylori was as effective as endoscopy plus breath test for managing dyspepsia.

    Commentary

    Patients with dyspeptic symptoms should be managed with 2 goals in mind: early detection of malignant disease and cost-effective relief of symptoms. Patients <55 years of age without “alarm features” (eg, weight loss, dysphagia, and anaemia) are at very low risk of malignancy and do not require endoscopic investigation. The question of management then turns on the relative costs and effectiveness of endoscopy, noninvasive tests, and eradication of H pylori and empiric acid suppression.1

    The trials by McColl and Chiba and their colleagues provide important information for physicians managing patients presenting with uninvestigated dyspepsia. The study by McColl et al adds to 2 previous studies2–3 that confirm the cost effectiveness of a secondary care based H pylori test and treat service compared with endoscopy based management. All 3 trials of test and treat compared with endoscopy based management showed equivalent effectiveness, but costs were reduced because fewer patients had endoscopy. The trial by McColl et al showed a rate of endoscopy in the year of follow up in the test and treat group of only 8%, whereas Heaney2 and Lassen3 showed rates nearer 30%. Patients positive for H pylori in both groups of the trial by McColl et al received eradication treatment. Thus, any differences caused by the eradication treatment itself were abolished. The trial can therefore be considered to address the question, “Is the cost of endoscopy warranted by the effect on symptoms, quality of life, and patient satisfaction of having the investigation?” The answer is “no”.

    The trial by Chiba et al (CADET-Hp) takes the McColl et al trial 2 steps further. Firstly, patient recruitment and the intervention took place in a primary care setting. Secondly, test and treat was compared with acid suppression alone. In contrast to the trial by McColl et al, CADET-Hp was designed to examine the effect of eradication treatment on dyspeptic symptoms, and found a substantial improvement in the proportion of patients with dyspeptic symptoms at the end of the trial. However, the difference in costs was small and not statistically significant.

    The reason for the difference in effects and costs between CADET-Hp and McColl et al lies in the use of eradication treatment for H pylori. In CADET-Hp the control group patients did not receive eradication treatment and were therefore at risk of recurrent peptic ulcers that had healed initially with omeprazole

    Furthermore, patients with nonulcer dyspepsia may also benefit from H pylori eradication. A Cochrane review of 9 placebo controlled trials of H pylori eradication treatment in patients without peptic ulcers or oesophagitis at endoscopy found a number needed to treat of 15.4

    The CADET-Hp trial does not show conclusively that H pylori test and treat is more cost effective in primary care than omeprazole alone, because it was only done in H pylori–positive patients. The cost effectiveness of this strategy needs to be tested by randomising patients with dyspepsia, both positive and negative for H pylori, before noninvasive testing for H pylori, to determine the effect of the management strategy on the whole group. It does, however, lend more support to the eradication of H pylori in all patients known to be infected.

    References

    Noninvasive 14C-urea breath test v endoscopy plus breath test for dyspepsia at 1 year‡

    
 
 QUESTION: In patients with upper gastrointestinal symptoms presenting for investigation of dyspepsia, is treatment based on a urea breath test for Helicobacter pylori alone as effective as endoscopy and urea breath testing?

    View Abstract

    Footnotes

    • Source of funding: NHS Executive Research and Development Technology Assessment Programme.

    • For correspondence: Dr K McColl, Western Infirmary, Glasgow, UK. K.E.L.McColl{at}clinmed.gla.ac.uk

    • Abstract and commentary published in ACP Journal Club

    • * See glossary.

    • Information provided by author.

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