Managing uninvestigated dyspepsia in primary care

Abstract

Test and treat for Helicobacter pylori is still as good as proton pump inhibitors first

In their accompanying paper, Delaney and colleagues report a randomised controlled trial of 699 people with uninvestigated dyspepsia, which compares the strategy of “test and treat” for Helicobacter pylori infection against empirical acid suppression using a proton pump inhibitor.¹ The test and treat group was tested for H pylori infection and positive patients were given eradication treatment, whereas negative patients were given proton pump inhibitors. Previous studies have looked at people who were H pylori positive² or H pylori negative,³ but none has used test and treat as an overall strategy—instead, if patients were H pyloripositive they were randomised to eradication treatment or placebo; if they were negative they were randomised to proton pump inhibitors, other drugs, or placebo.

Dyspepsia is a common symptom complex of epigastric pain or discomfort—which includes symptoms of heartburn, acid regurgitation, excessive belching, increased abdominal bloating, nausea, feeling of abnormal or slow digestion, or early satiety—for which patients seek medical care.⁴ Upper gastrointestinal endoscopy should be performed in patients with alarm symptoms such as weight loss, vomiting, or overt bleeding. However, most patients can be safely managed with empirical treatment.^{2 3 5 6} Patients who present to primary care with dyspepsia usually have several symptoms, but the symptoms do not predict the diagnosis.⁶ Recent algorithms for the management of dyspepsia have been published in the United Kingdom,⁷ Canada,⁴ and the United States.⁸

In the UK, the National Institute for Health and Clinical Excellence (NICE) recommends that patients with epigastric pain and heartburn should be managed in the same way, rather than arbitrarily considering that epigastric pain represents dyspepsia (which is not a diagnosis) and that heartburn diagnoses gastro-oesophageal reflux disease.⁷ In Canada, it is recommended that patients with uninvestigated dyspepsia who have mainly reflux symptoms should be treated as if they have gastro-oesophageal reflux disease and given empirical proton pump inhibitors.⁴ In patients with non-heartburn predominant symptoms of dyspepsia, H pylori can be tested for non-invasively and eradicated if the result is positive. It is not cost effective to perform endoscopy before treatment.⁹ In the Canadian CADET-Hp study, patients with uninvestigated dyspepsia who were H pylori positive were given H pylori eradication treatment or empirical treatment with a proton pump inhibitor.² Treatment was successful—a final score of 1-2 (none or minimal) on a seven point Likert scale—in 50% of patients who had eradication treatment compared with 36% in those given a proton pump inhibitor (P=0.02). The number needed to treat over one year was seven for one treatment success. This strategy was also cost effective.¹⁰ In a post hoc subgroup analysis, patients with predominant reflux symptoms who had H pylori eradication had 43% treatment success compared with 32% treatment success in those who received placebo antibiotics (P=0.08). Dyspepsia did not seem to worsen in this group of patients.¹¹

Delaney and colleagues followed the NICE guidelines and studied patients with dyspepsia who had epigastric pain, heartburn, or both.¹ This was a pragmatic trial that allowed the practitioner to manage the patient according to their discretion during the next year. At 12 months, the patients in the two treatment groups did not differ significantly in terms of dyspeptic symptoms, quality adjusted life years, or costs. The test and treat arm had higher initial costs, but over the course of the year there was a trend towards reduced use of resources (for example, fewer ultrasound scans, endoscopies, primary care consultations), although the only significant reduction was in H pylori testing. Delaney and colleagues’ trial lasted one year, so if H pylori was responsible for dyspepsia in some patients, cost effectiveness might have improved over a longer time period. However, this might be offset by the large numbers of patients with ongoing symptoms who need continued drug treatment.

Eradicating H pylori can be beneficial; for example, it can cure ulcers. Eradication may reduce the potential risk of developing gastric adenocarcinoma or mucosa associated lymphoid tissue (MALT) lymphoma in some patients. Eradication may also provide a small benefit in people with investigated or functional dyspepsia.¹² Primary care patients at first presentation could have any of the above diagnoses, so the strategy of eradicating H pylori as a first line strategy continues to have merit.

The prevalence of H pylori is declining in the general population. Delaney and colleagues’ study indicates that the prevalence of H pylori in the UK is about 30%, which is comparable to that seen in Canada.² Where the prevalence of H pylori is lower, empirical treatment with proton pump inhibitors may be more cost effective, whereas test and treat may be better when the prevalence of H pylori is higher. Delaney and colleagues pointed out that it was difficult to recruit for their study as so many patients with dyspepsia had already been treated for H pylori.

So what strategy should we use? Although this study suggests that the test and treat strategy and the policy of giving proton pump inhibitors first are equally effective, practitioners can choose which strategy to use according to the predominant symptom complex. Delaney and colleagues’ study included patients with both predominant heartburn and epigastric pain. Simply having heartburn does not mean that the patient has gastro-oesophageal reflux disease. Indeed, some patients with heartburn and epigastric pain might respond well to H pylori eradication. The good news is, if the prevalence of H pylori is high enough, we cannot go wrong with either strategy. If H pylori test and treat is used, a reliable method such as urea breath test or stool antigen must be used because H pylori serology is unreliable. In uninvestigated patients without alarm symptoms, the initial choice of treatment still depends on individual considerations for each patient.