Rescue H. pylori Therapy in the Clinical Setting

Abstract

Purpose:Helicobacter pylori (Hp) is increasingly more resistant to ‘current standard triple therapy' of amoxicillin, clarithromycin and omeprazole1. We report the response of a novel dose ramped-up rifabutin-based combination therapy used as ‘rescue therapy'. The unique aspect of this report is the use of this combination in ‘real life' clinical practice to remove the artificial restraints of a Randomised Controlled Trial (RCT) which may result in excessively high Hp eradication compared with real clinical practice for which the trial is designed2. This is a prospective study of referred patients with failed Hp therapy whose doctors were given the protocol to prescribe to be followed by Urea Breath Test(UBT) without other interference from the consultant. This reflects clinical practice and should probably be used as the real measure of clinical efficacy in situations of unequivocal outcomes eg Hp positive vs Hp negative. Methods: Patients who had failed initial treatment with the ‘current standard triple therapy' were prescribed ‘rescue therapy' of amoxicillin (4.5 g/d), rifabutin (240 mg/d final dose ramped up over 3 days), omeprazole (120 mg/d) for a period of 14 days. They were given a protocol to follow with an information leaflet. A total of 56 patients were offered treatment. Eradication was determined by follow up urea breath test approximately 4-6 weeks post last dosage. Results: We report 55 patients who completed >80% ‘rescue therapy' (12/14 day treatment). To date, 52 were available for review with 49/52 (PP=94%) cured of Hp as judged by post treatment UBT, with three remaining positive. Two patients have yet to undergo repeat UBT. 1 patient chose not to complete >80% of the therapy (ITT=92%). Conclusion: 1. Higher dose, ramped-up rifabutin protocol achieves high eradication in treating recrudescent Hp that had remained despite first line triple therapy. A 94% efficacy ‘locally' conforms to best clinical practice and possibly exceeds it for failed Hp3. 2. Unequivocal trial results remove ‘noise from signal' and so preclude need for RCT where placebo almost universally fails4 saving unnecessary placebo arms. Such ‘Clinical Setting' trials in Hp should be used more.