In regions where Helicobacter pylori has a high (>20%) rate of resistance to clarithromycin and bismuth is unavailable, a 10-day quadruple concomitant scheme remained the most effective treatment, according to results from a randomized study published in the Journal of Clinical Gastroenterology.

To investigate the efficacy of the newly proposed standard treatment of H pylori with a 14-day quadruple nonbismuth concomitant regimen by the Guidelines and Consensus Statements, investigators from the Army Share Fund Hospital and Paleo Faliron Hospital in Greece conducted a randomized trial. Patients who tested positive for H pylori in 2017 were randomly prescribed to a 10-day (n=172) or 14-day (n=169) concomitant scheme of twice-daily 20 mg esomeprazole, 500 mg clarithromycin, 1000 mg amoxicillin, and 500 mg metronidazole.

The investigators reported high eradication rates in their intention-to-treat (87.9% vs 87.4%; P > .99 and per protocol (93% vs 94.1%; P =.859) analyses of 10-day vs 14-day schemes, respectively. Within the 14-day treatment group, patients aged 55 years or younger had higher eradication rates when compared with older patients in the intention-to-treat analysis (95.2% vs 83.2%; P =.036), but not in the per protocol analysis (96.8% vs 92.5%; P =.328).


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The patients had high compliance rates (99.5% vs 96.2%; P =.067) for the 10-day and 14-day cohorts, respectively. Serious adverse effects were reported by 1 patient in the 10-day group vs 4 patients in the 14-day group (0.5% vs 2.2%, respectively; P >.05). Moderate adverse effects such as diarrhea, metallic taste, and abdominal pain were similar in both treatment groups.

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A limitation of this study is that the H pylori strains were not tested for antibiotic resistance. It is unknown whether clarithromycin resistance was present in any of the participants, and to what extent the results were affected.

The study concluded that the newly recommended 14-day concomitant nonbismuth quadruple regimen was not more effective than the previous first-line treatment recommendation. Therefore, in Greece, a region with high clarithromycin resistance where bismuth is unavailable, the 10-day esomeprazole, clarithromycin, amoxicillin, and metronidazole therapy remained the most efficient strategy for H pylori eradication.

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Reference

Apostolopoulos P, Ekmektzoglou K, Georgopoulos S, et al. 10-day versus 14-day quadruple concomitant nonbismuth therapy for the treatment of Helicobacter pylori infection results from a randomized prospective study in a high clarithromycin resistance country [published online February 5]. J Clin Gastroenterol. doi:10.1097/MCG.0000000000001328