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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.
Dino Vaira
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Talley NJ, Stanghellii V, Heading RC, Koch KL, Malagelada JR, Tytgat GNJ.
Functional gastroduodenal disorders.
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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.
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| 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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