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

Background-Management of dyspepsia remains a controversial area. Although t he European Helicobacter pylori study group has advised empirical eradicati on therapy without oesophagogastroduodenoscopy (OGD) in young H-pylori posi tive dyspeptic patients who do not exhibit alarm symptoms, this strategy ha s 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 s ubsequent 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 thera py and 52 to OGD. Results were analysed using an intention to treat policy. Dyspepsia scores significantly improved in both groups over 12 months comp ared with baseline; however, dyspepsia scores were significantly better in the empirical eradication group. Quality of life showed significant improve ments in both groups at 12 months; however, physical role functioning was s ignificantly improved in the empirical eradication group. Fourteen (27%) in the empirical eradication group subsequently proceeded to OGD because of n o improvement in dyspepsia. Conclusions-This randomised study strongly supports the use of empirical H pylori eradication in patients referred to secondary practice; it is estima ted that 73% of OGDs in this group would have been avoided with no detrimen t to clinical outcome.