Article
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
A Heaneya, J S A Collinsa, R G P Watsonb, R J McFarlandc, K B Bamfordd, T C K Thamc
a Royal Victoria
Hospital, Belfast, N Ireland, UK, b Department of Medicine, Queen's
University, Belfast, N Ireland, UK, c Ulster Hospital, Dundonald, N
Ireland, UK, d Department
of Microbiology and Immunology, Queen's University, Belfast, N Ireland, UK
Correspondence to: Dr A Heaney, Royal Victoria Hospital, Belfast BT12 6BA, N Ireland, UK.
Accepted for publication 25 February 1999
BACKGROUND
Management of dyspepsia
remains a controversial area. Although the European
Helicobacter pylori study group has advised
empirical eradication therapy without oesophagogastroduodenoscopy (OGD) in young H pylori positive dyspeptic
patients who do not exhibit alarm symptoms, this strategy has not been
subjected to clinical trial.
AIMS
To compare a "test and
treat" eradication policy against management by OGD.
PATIENTS
Consecutive subjects were
prospectively recruited from open access OGD and outpatient referrals.
METHODS
H
pylori status was assessed using the carbon-13 urea breath test.
H pylori positive patients were randomised
to either empirical eradication or OGD. Symptoms and quality of life
scores were assessed at baseline and subsequent reviews over a 12 month period.
RESULTS
A total of 104 H pylori positive patients aged under 45 years were recruited. Fifty two were randomised to receive empirical eradication therapy and 52 to OGD. Results were analysed using an
intention to treat policy. Dyspepsia scores significantly improved in
both groups over 12 months compared with baseline; however, dyspepsia
scores were significantly better in the empirical eradication group.
Quality of life showed significant improvements in both groups at 12 months; however, physical role functioning was significantly improved
in the empirical eradication group. Fourteen (27%) in the empirical
eradication group subsequently proceeded to OGD because of no
improvement in dyspepsia.
CONCLUSIONS
This randomised study
strongly supports the use of empirical H
pylori eradication in patients referred to secondary practice; it is estimated that 73% of OGDs in this group would have been avoided
with no detriment to clinical outcome.
Keywords: Helicobacter pylori; dyspepsia; management strategies
© 1999 by Gut
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