BMJ  2003;327:E116-E117 (4 October), doi:10.1136/bmjusa.02060002 (published 23 August 2002)

BMJ USA: Editorial

Bugs, drugs, and dyspepsia in primary care

The role of "test and treat" has its limits

This article originally appeared in BMJ USA

Dyspepsia is defined as pain or discomfort centered in the upper abdomen, and it is estimated that 2-6% of patients presenting to family physicians have dyspepsia as their presenting complaint.^{1 2} Two articles in this issue (BMJ USA p 319 and p 324) provide further proof that non-invasive testing for Helicobacter pylori, followed by treatment (the "test and treat" strategy) of those who test positive, is effective in alleviating symptoms, reducing the need for endoscopic investigations, and decreasing the overall cost of managing this common condition.

Until recently, the diagnostic test for H pylori recommended for use in primary care was serology. This low-cost test is widely available and is inexpensive, allowing primary care physicians to perform H pylori testing in their offices. As the prevalence of H pylori has fallen in developed countries, the predictive value of the serologic test for H pylori has declined along with the pre-test probability of infection. This is because the serologic tests measure H pylori antibody levels, which can remain high even after successful eradication has occurred, leading to false positive tests. The Canadian study demonstrates that 33% of serologic tests were false positives, and the authors suggest that these tests should be replaced by more accurate alternatives. Two non-invasive tests are recommended in this setting: the urea breath test and the stool antigen test. Both have been shown to be very accurate in the initial diagnosis of H pylori infection and in the confirmation of eradication.^{3 4} Both tests are widely available in Europe. However, breath tests are still not widely available in many parts of the United States, and the stool antigen test may be useful in these areas because it can be ordered through large national laboratory services. In Europe both tests are inexpensive but in the United States, the breath test generally costs more than the stool test.⁵ Serologic tests are no longer recommended in developed countries.⁶ Serology may still have a role in countries with high prevalence rates of H pylori infection and where stool or breath tests are not available.⁶

The Canadian study differs from the Scottish study in that it included patients with predominant symptoms of heartburn. Although heartburn is present in some patients with peptic ulcer disease and improves after eradication of H pylori, many experts would not include patients with classic symptoms of gastroesophageal reflux disease in an empirical treatment plan for dyspepsia, preferring to treat these patients with acid inhibitory agents. A recent consensus guideline recommends that test and treat strategies for H pylori in dyspepsia exclude patients presenting with predominant symptoms of gastroesophageal reflux disease.⁶ This remains a reasonable strategy in clinical practice settings where reflux disease is common and the prevalence of H pylori is low. Cost-effectiveness models suggest that an empirical trial of acid suppression may be less expensive than testing and treatment.⁷

Test and treat strategies for H pylori have generally not been used in older patients because of concerns that an underlying malignancy might be missed. While most patients with upper gastrointestinal malignancies present with "alarm" symptoms (eg, dysphagia, gastrointestinal bleeding, weight loss), a recent study has shown that, among patients older than 55 years, 4% of those with upper gastrointestinal malignancies present with uncomplicated dyspepsia.⁸ The Scottish study limited entry of patients to those who were under 55 years of age. The Canadian study did not set an upper age limit and included patients older than 55 years of age. Therein lies a cautionary tale. A 69-year-old man entered into the Canadian dyspepsia trial was diagnosed with esophageal malignancy three months after being enrolled and died a month later. While an earlier diagnosis might not have changed his outcome, failure to diagnose an underlying malignancy is a common cause for litigation in the United States and deserves consideration. Current guidelines recommend that a local age cutoff be determined for the test and treat strategy based on the epidemiology of upper gastrointestinal malignancies in the region and that patients with "alarm" symptoms be referred for early endoscopy.⁶ This is a prudent strategy.

While the test and treat strategy for H pylori is clearly effective and reduces costs, a substantial proportion of patients who have successful eradication of H pylori remain symptomatic. In the Canadian study, 50% of the original population randomized to H pylori eradication did not achieve symptomatic cure. How should these patients be managed? Some current guidelines recommend that these patients should be referred for endoscopy.⁹ However, a recent cost analysis has suggested that a strategy of testing and treating for H pylori followed by an empirical trial of acid suppression for non-responders before endoscopy might further reduce the need for endoscopy, leading to a substantial reduction in the cost of managing dyspepsia.⁴ The latter strategy will need testing in a clinical trial before it is widely adopted.

University of Wisconsin Medical School, Madison, WI and Marquette University College of Health Sciences, Milwaukee WI ( nvakil{at}wisc.edu)

University of Bologna, Bologna, Italy.

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Papers BMJ USA pp 319, 324

References

1. Talley NJ, Stanghellii V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ. Functional gastroduodenal disorders. Gut 1999;45(Suppl II):II37-II42 [Abstract/Free Full Text]
2. Morrell DC, Gage HG, Robinson NA. Symptoms in general practice. J R Coll Gen Pract 1971;21:32-43 [Medline]
3. Vaira D, Vakil N, Menagatti M, van Hoff B, Ricci C, Gatta L, Gasbarini G, Quina M, Pajares Garcia J, van der Ende A, van der Hulst R, Anti M, Duarte C, Gisbert J, Mignoli M, Tytgat G. The stool antigen test for detection of H pylori after eradication therapy. Ann Intern Med 2002;136:280-287 [Abstract/Free Full Text]
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5. Vakil N, Rhew D, Soll A, Ofman J. The Cost-Effectiveness of Diagnostic Testing Strategies for H. Pylori. Am J Gastroenterol 2000;95:1691-1698 [ISI][Medline]
6. Malfertheiner P, Megraud F, Omorain C, Hungin A, Jones R, Axon A, Graham D, Tytgat G, the European H pylori study group. Current concepts in the management of Helicobacter pylori infection-The Maastricht 2-2000 Consensus report. Aliment Pharmacol Ther 2002;16:167-180 [ISI][Medline]
7. Spiegel B, Vakil N, Ofman J. Dyspepsia Management strategies in primary care: a decision analysis of competing strategies. Gastroenterology 2002;122:1270-1285 [CrossRef][ISI][Medline]
8. Canga C, Vakil N. Upper GI malignancy, uncomplicated dyspepsia and the age threshold for early endoscopy. Am J Gastroenterol 2002;97:600-603 [CrossRef][ISI][Medline]
9. American Gastroenterological Association. American Gastroenterological Association Position Statement: evaluation of dyspepsia. Gastroenterology 1998;114:579-581 [CrossRef][ISI][Medline]

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