Current issues of ACP Journal Club are published in Annals of Internal Medicine


Therapeutics

Noninvasive Helicobacter pylori testing was as effective as endoscopy for managing dyspepsia

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ACP J Club. 2002 Jan-Feb;136:16. doi:10.7326/ACPJC-2003-138-1-016

Related Content in this Issue
• Companion Abstract and Commentary: Helicobacter pylori eradication improved dyspepsia symptoms


Source Citation

McColl KE, Murray LS, Gillen D, et al. Randomised trial of endoscopy with testing for Helicobacter pylori compared with non-invasive H. pylori testing alone in the management of dyspepsia. BMJ. 2002;324:999-1002. [PubMed ID: 11976239]


Abstract

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

Randomized {allocation concealed*}†, unblinded,* controlled trial with 1-year follow-up.

Setting

A gastroenterology clinic in Glasgow, Scotland, 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% vs 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% vs 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.

*See Glossary.

†Information provided by author.

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

For correspondence: Dr. K. McColl, Western Infirmary, Glasgow, Scotland, UK. E-mail K.E.L.McColl@clinmed.gla.ac.uk.


Table. Noninvasive 14C urea breath test vs endoscopy plus breath test for dyspepsia at 1 year‡

Outcome Breath test (baseline) Endoscopy plus breath (baseline) Difference in mean change from baseline (95% CI)
Glasgow Dyspepsia Severity Score 5.6 (10.2) 5.4 (10.2) 0.2 (−0.7 to 0.5)

‡CI defined in Glossary.


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” (e.g., weight loss, dysphagia, and anemia) are at very low risk for 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 a (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 and colleagues adds to 2 previous studies (2, 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 and colleagues showed a rate of endoscopy in the year of follow-up in the test-and-treat group of only 8%, whereas Heaney (2) and Lassen (3) showed rates nearer 30%. Patients positive for H. pylori in both groups of the trial by McColl and colleagues received eradication therapy. Thus, any differences caused by the eradication therapy 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 and colleagues (CADET-Hp) takes the McColl and colleagues’ trial 2 steps further. First, patient recruitment and the intervention took place in a primary care setting. Second, test-and-treat was compared with acid suppression alone. In contrast to the trial by McColl and colleagues, CADET-Hp was designed to examine the effect of eradication therapy 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 and colleagues lies in the use of eradication therapy for H. pylori. In CADET-Hp, the control-group patients did not receive eradication therapy and were therefore at risk for 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 therapy in patients without peptic ulcers or esophagitis 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 randomizing 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.

Brendan Delaney, MD, FRCP, MRCGP
University of Birmingham
Birmingham, England, UK


References

1. Delaney BC, Innes MA, Deeks J, et al. Initial management strategies for dyspepsia. Cochrane Database Syst Rev. 2001;(3):CD001961. [PubMed ID: 11687004]

2. Heaney A, Collins JS, Watson RG, et al. A prospective randomised trial of a “test and treat” policy versus endoscopy based management in young Helicobacter pylori positive patients with ulcer-like dyspepsia, referred to a hospital clinic. Gut. 1999;45:186-90. [PubMed ID: 10403729]

3. Lassen AT, Pedersen FM, Bytzer P, Schaffalitzky de Muckadell OB.Helicobacter pylori test-and-eradicate versus prompt endoscopy for management of dyspeptic patients: a randomised trial. Lancet. 2000;356:455-60. [PubMed ID: 10981888]

4. Moayyedi P, Soo S, Deeks J, et al. Eradication of Helicobacter pylori for non-ulcer dyspepsia. Cochrane Database Syst Rev. 2001;(1):CD002096. [PubMed ID: 11279751]