High rate of post‐therapeutic resistance after failure of macrolide–nitroimidazole triple therapy to cure Helicobacter pylori infection: impact of two second‐line therapies in a randomized study

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Abstract
Background: The optimal second‐line treatment after failed Helicobacter pylori therapy has not been established. Aims: To ascertain whether quadruple therapy or triple therapy with omeprazole, clarithromycin and amoxicillin is the superior re‐treatment after triple therapy containing a macrolide and a nitroimidazole, and to determine the impact of microbial in vitro resistance. Methods: Patients after failed triple therapy were randomly allocated to one of two 1‐week second‐line treatments: omeprazole, 40 mg, clarithromycin, 500 mg, and amoxicillin, 1 g, all b.d.; or omeprazole, 20 mg b.d., bismuth subsalicylate, 600 mg q.d.s., metronidazole, 400 mg t.d.s., and tetracycline, 500 mg q.d.s. Post‐therapeutic Helicobacter pylori status was assessed by 13C‐urea breath test at least 4 weeks after treatment. Results: The study was terminated after including 84 patients. H. pylori cure rates differed significantly: omeprazole–clarithromycin–amoxicillin: intention‐to‐treat, 43%; per protocol, 50%; omeprazole–bismuth subsalicylate–metronidazole–tetracycline: intention‐to‐treat, 68%; per protocol, 69%. The frequencies of resistance after first‐line therapy were: metronidazole, 90%; clarithromycin, 71%; both combined, 68%. For clarithromycin resistance, H. pylori cure with omeprazole–clarithromycin–amoxicillin was 30% vs. 83% for clarithromycin susceptibility. Conclusions: Omeprazole–bismuth subsalicylate–metron‐ idazole–tetracycline was superior to omeprazole–clarithromycin–amoxicillin, but both therapies yielded unsatisfactory results. The high rate of post‐therapeutic dual resistance has a negative impact on omepraz‐ ole–clarithromycin–amoxicillin, and probably also on omeprazole–bismuth subsalicylate–metronidazole–tetracycline, and limits the choice for second‐line treatment.

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