Background and Aim: Concomitant therapy is a recommended first-line treatment for Helicobacter pylori infection in most national or international consensuses. Reverse hybrid therapy is a modified 14-day concomitant therapy without clarithromycin and metronidazole in the final 7 days. This study aims to test whether 14-day reverse hybrid therapy is non-inferior to 14-day concomitant therapy in the first-line treatment of H. pylori infection. Methods: Helicobacter pylori-infected adult patients were randomly assigned to receive either reverse hybrid therapy (dexlansoprazole 60 mg o.d. plus amoxicillin 1 g b.d. for 14 days, and clarithromycin 500 mg plus metronidazole 500 mg b.d. for initial 7 days) or concomitant therapy (dexlansoprazole 60 mg once o.d. plus amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg b.d. for 14 days). H. pylori status was assessed 6 weeks after the end of treatment. Results: Helicobacter pylori-infected participants (n = 248) were randomized to receive either 14-day reverse hybrid therapy (n = 124) or 14-day concomitant therapy (n = 124). Intention-to-treat analysis demonstrated that the two therapies had comparable eradication rate (95.2% vs 93.5%; 95% confidence interval, À4.0% to 7.4%; P = 0.582). However, reverse hybrid therapy had a much lower frequency of adverse events than concomitant therapy (20.2% vs 38.7%, P = 0.001). The two therapies exhibited comparable drug adherence (93.5% vs 87.9%, P = 0.125). Conclusions: Fourteen-day reverse hybrid therapy and 14-day concomitant therapy are equivalent in efficacy for the first-line treatment of H. pylori infection. However, reverse hybrid therapy has fewer adverse events compared with concomitant therapy.
PCR is the most accurate method among the biopsy-based tests to detect H pylori infection in patients with bleeding peptic ulcers. Blood may reduce the sensitivities of all biopsy-based tests.
Background
The Maastricht V/Florence Consensus Report recommends amoxicillin‐fluoroquinolone triple or quadruple therapy as a second‐line treatment for Helicobacter pylori infection. An important caveat of amoxicillin‐fluoroquinolone rescue therapy is poor eradication efficacy in the presence of fluoroquinolone resistance. The study aimed to investigate the efficacies of tetracycline‐levofloxacin (TL) quadruple therapy and amoxicillin‐levofloxacin (AL) quadruple therapy in the second‐line treatment of H. pylori infection.
Methods
Consecutive H. pylori‐infected subjects after the failure of first‐line therapies were randomly allocated to receive either TL quadruple therapy (tetracycline 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) or AL quadruple therapy (amoxicillin 500 mg QID, levofloxacin 500 mg QD, esomeprazole 40 mg BID, and tripotassium dicitrato bismuthate 300 mg QID) for 10 days. Post‐treatment H. pylori status was assessed 6 weeks after the end of therapy.
Results
The study was early terminated after an interim analysis. In the TL quadruple group, 50 out of 56 patients (89.3%) had successful eradication of H. pylori infection. Cure of H. pylori infection was achieved only in 39 of 52 patients (69.6%) receiving AL quadruple therapy. Intention‐to‐treat analysis showed that TL quadruple therapy achieved a markedly higher eradication rate than AL quadruple therapy (95% confidence interval: 4.8% to 34.6%; p = 0.010). Further analysis revealed that TL quadruple therapy had a high eradication rate for both levofloxacin‐susceptible and resistant strains (100% and 88.9%). In contrast, AL quadruple therapy yielded a high eradication for levofloxacin‐susceptible strains (90.9%) but a poor eradication efficacy for levofloxacin‐resistant strains (50.0%). The two therapies exhibited comparable frequencies of adverse events (37.5% vs 21.4%) and drug adherence (98.2% vs 94.6%).
Conclusions
Ten‐day TL quadruple therapy is more effective than AL quadruple therapy in the second‐line treatment of H. pylori infection in a population with high levofloxacin resistance.
Current international consensuses on Helicobacter pylori eradication therapy recommend that only regimens that reliably produce eradication rates of ⩾90% should be used for empirical treatment. The Real-world Practice & Expectation of Asia-Pacific Physicians and Patients in Helicobacter Pylori Eradication Survey also showed that the accepted minimal eradication rate in H. pylori-infected patients was 91%. According to efficacy prediction model, the per-protocol eradication rates of 7-day and 14-day standard triple therapies fall below 90% when clarithromycin resistance rate ⩾5%. Several strategies including bismuth-containing, non-bismuth-containing quadruple therapies (including sequential, concomitant, hybrid and reverse hybrid therapies), high-dose dual therapy and vonoprazan-based triple therapy have been proposed to increase the eradication rate of H. pylori infection. According to efficacy prediction model, the eradication rate of 14-day concomitant therapy, 14-day hybrid therapy and 7-day vonoprazan-based triple therapy is less than 90% if the frequency of clarithromycin-resistant strains is higher than 90%, 58% and 23%, respectively. To meet the recommendation of the consensus report and patients’ expectation, local surveillance networks for resistance of H. pylori to clarithromycin are required to select appropriate eradication regimens in each geographic region. In areas with low (<5%) clarithromycin resistance (e.g. Sweden, Philippine, Myanmar and Bhutan), 7-day and 14-day standard triple therapies can be adopted for the first-line treatment of H. pylori infection with eradication rates of ⩾90%. In areas with high (⩾5%) clarithromycin resistance (most other countries worldwide) or unknown clarithromycin resistance, 14-day hybrid, 14-day reverse hybrid, 14-day concomitant and 10- to 14-day bismuth quadruple therapy can be used to treat H. pylori infection.
Background and Aim: Most consensuses recommend culture-guided therapy as third-line Helicobacter pylori treatment. This study aimed to investigate the efficacies of culture-guided therapy and empirical therapy with high-dose proton pump inhibitor (PPI) in the H. pylori third-line treatment. Methods: Between August 2012 and October 2021, H. pylori-infected patients with at least two failed eradication attempts received anti-H. pylori therapy according to the results of antimicrobial sensitivity tests plus high-dose rabeprazole and/or bismuth. They were categorized into three groups: patients who had positive results of culture with equal to or more than three susceptible antibiotics were treated by culture-guided non-bismuth quadruple therapy, patients who had positive results of culture with one or two susceptible antibiotics were treated by culture-guided bismuth-containing therapy, and patients who had a negative result of culture were treated by an empirical therapy with high-dose rabeprazole plus amoxicillin, tetracycline and levofloxacin. A post-treatment assessment was conducted at week 8.
Results:We recruited 126 patients. The eradication rates of culture-guided non-bismuth quadruple therapy (n = 50), culture-guided bismuth-containing therapy (n = 46) and empirical therapy (n = 30) were 84.0%, 87.0%, and 66.7% (95% confidence interval: 73.8-94.2%, 77.3-96.7%, and 49.8-83.6%), respectively. Overall, culture-guided therapy achieved a higher eradication rate than empirical therapy (85.4% vs 66.7%; 95% confidence interval, 0.4% to 37.0%, P = 0.022). Conclusions: Culture-guided therapy with high-dose PPI achieves a higher eradication rate than empirical therapy with high-dose PPI in the third-line treatment of H. pylori infection. The eradication rate of rescue therapy with bismuth plus two susceptible antibiotics is not inferior to that with three susceptible antibiotics.
The study aimed to compare the efficacies and safety of 14-day hybrid therapy, 14-day high-dose dual therapy, and 10-day bismuth quadruple therapy in the first-line treatment of Helicobacter pylori infections.
METHODS:In this multicenter, open-label, randomized trial, we recruited adult H. pylori-infected patients from 9 centers in Taiwan. Subjects were randomly assigned (1:1:1) to 14-day hybrid therapy, 14-day high-dose dual therapy, or 10-day bismuth quadruple therapy. Eradication status was determined by the 13 C-urea breath test. The primary outcome was the eradication rate of H. pylori assessed in the intention-to-treat population.
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