Decision analysis of histamine H-2-receptor antagonist maintenance therapyversus Helicobacter pylori eradication therapy - A randomised controlled trial in patients with continuing pain after duodenal ulcer

Background: Much has been published on the efficacy and cost effectiveness of Helicobacter pylori eradication treatment as an alternative to histamine H-2-receptor antagonist maintenance treatment in peptic ulcer disease. How ever, most studies have analysed and emphasised H. pylori eradication rates rather than management/control of symptoms and the associated cost savings . Although H. pylori eradication therapy is very successful in clearing the infection, dyspeptic symptoms may persist and management of these can be e xpensive. Objective: The aim of this study was to assess the cost implications in con trolling symptoms using either H-2-receptor antagonist maintenance therapy or H. pylori eradication therapy in patients with duodenal ulcer disease. Design: This was a non-blind, prospective, randomised, parallel-group study comparing maintenance H-2-receptor antagonist treatment using ranitidine w ith H. pylori eradication therapy, with a 1-year follow-up. Setting: This was a study of outpatients from general practices in Dundee, Scotland, or the Nine wells Hospital, Dundee, gastroenterology clinic. Patients and participants: 119 patients with confirmed duodenal ulcer, free from active ulceration at study entry but positive for H. pylori infection , who were receiving maintenance H-2-receptor antagonist therapy. Interventions: Patients were randomised to receive either continuing mainte nance therapy with ranitidine (initially 150 mg daily; 58 patients) or H. p ylori eradication therapy using an omeprazole/amoxicillin/metronidazole reg imen (or omeprazole/clarithromycin if allergic to penicillin). Main outcome measures and results: Overall, ii. pylori eradication rates we re 100% per protocol and 95.1% intention-to-treat. At completion of 1 year of follow-up, 12 of the 61 (19.7%) patients successfully eradicated of H. p ylori were still dependent on acid suppression for symptom relief. H. pylor i eradication treatment was the least-cost strategy in managing/controlling symptoms at 1 year (pound 168 vs pound 210 per patient; 1996 values). Howe ver, over time, post-eradication treatment costs were greater than H-2-rece ptor antagonist therapy costs. Any potential savings were directly related to the proportion of patients needing further treatment post-eradication, t he cost of endoscopy and the urea breath test. Conclusions: If dyspepsia persists long term, H. pylori eradication treatme nt may not be the least-cost option for patients with duodenal ulcer.