Randomized clinical trial comparing ten day concomitant and sequential therapies for Helicobacter pylori eradication in a high clarithromycin resistance area.

Background Currently only a few studies compare sequential and concomitant non-bismuth Helicobacter pylori therapies referring to high antibiotic resistance populations. Materials and methods This multicenter prospective randomized clinical trial included 353 H. pylori positive, treatment naïve, patients. All patients had positive CLO-test and/or histology and culture. They received sequential (esomeprazole 40 mg, amoxicillin 1 g/bid for 5 days, followed by 5 days of esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg bid), or concomitant treatment (all drugs taken concomitantly bid for 10 days). Eradication was confirmed by 13 C-urea breath test or histology 4–6 weeks after treatment. Adverse events and adherence were evaluated. Results Allocated to concomitant were 175 (72F/103M, mean 52.3 years, 38.3% smokers, 25.7% ulcer disease) and 178 (87F/91M, mean 52 years, 31% smokers, 19.1% ulcer disease) patients to sequential treatment. There were 303/353 (85.8%) positive cultures, with the following resistances: 34% metronidazole, 27.7% clarithromycin, and 7.9% dual. Eradication rates were, respectively, 89.1% (156/175) vs. 78.7% (140/178) by intention to treat ( p = 0.01, 95% CI = 2.7–18) and 93.4%(156/167) vs. 82.8% (140/169) per protocol ( p = 0.004, 95% CI = 3.6–17.6). Overall, adherence was (98.9%, 95% CI = 97–100). Eradication rates according to resistance were the following: dual susceptible strains 67/69 (97.1%), 62/67 (92%) ( p = 0.4), metronidazole single resistant 38/39 (97.4%), 31/39 (79.5%) ( p = 0.03, 95% CI = 3.5–33), clarithromycin single resistant 25/28 (89.3%), 26/31 (83.9%) ( p = 0.8), and dual resistant 9/12 (75%), 4/11 (36.4%) ( p = 0.1) for concomitant and sequential regimens, respectively. Side effects were comparable among regimens, except from diarrhea being more frequent among patients treated with concomitant treatment. Conclusions Concomitant treatment eradication rate overcomes 90% per protocol and has a significant advantage over sequential therapy. This is probably due to its better efficacy on metronidazole resistant strains. Both regimens were well tolerated and safe. [ABSTRACT FROM AUTHOR]