Background: Helicobacter pylori resistance to amoxicillin remains rare in many regions. Proton pump inhibitor-amoxicillin-containing high dose dual therapy (HDDT) has been proposed to treat H. pylori infection. We aimed to assess the effectiveness and safety of PPI-amoxicillin HDDT for treatment of H. pylori infection in comparison with other regimens. Methods: Databases, including PubMed, Embase, and the Cochrane Register of Controlled Trials, were searched to find relevant publications. Randomized controlled trials comparing HDDT with control regimens for H. pylori eradication in adult patients were included. The primary outcome was eradication rate by intention-to-treat analysis. Adverse events were analyzed as second outcome. Results: A total of 15 trials with 3818 patients qualified for inclusion. The eradication rate of HDDT was neither significantly inferior nor superior to the recommended regimens such as triple therapy, bismuth quadruple therapy, and non-bismuth quadruple therapy [relative risk (RR): 1.00, 95% confidence interval (CI): 0.96–1.05, p = 0.870]. This finding was robust through subgroup analyses and sensitivity analyses. Trial sequential analysis showed that HDDT was equivalent to control regimens, and further similar trials were unlikely to alter the conclusions of this analysis. The frequency of adverse events was significantly lower in HDDT group (RR: 0.48, 95% CI: 0.37–0.64, p < 0.001). Conclusion: HDDT was equivalent to recommended first-line or rescue regimens with fewer adverse effects. The evidence from this meta-analysis supports the use of HDDT as first-line or rescue treatment for H. pylori infection. Trial registration: PROSPERO CRD42019133002
Background Inconsistent eradication rates for Helicobacter pylori have been reported worldwide with dual therapy, perhaps owing to the difference in dose administration and treatment duration. This retrospective study aimed to determine whether high‐dose dual therapy (HDDT) with different regimens leads to different eradication rates. The study compares the efficacy and safety of HDDT 10‐day vs 14‐day and investigates the factors that might affect the eradication rates. Materials and Methods Two comparable treatment groups were based on propensity score matching (PSM). Patients were divided into two groups based on the therapy they underwent: 10‐day HDDT and 14‐day HDDT (20 mg esomeprazole and 750 mg amoxicillin, administered four times daily). The eradication rates, adverse events (AEs), patient compliance, CYP2C19 gene polymorphisms, and antibiotic resistance rates of the two groups were compared. Results The intention to treat (ITT) analysis showed that the eradication rates for 10‐day and 14‐day groups were 78.4% (95% CI 69.6%–87.2%) and 89.7% (95% CI 83.3%–96.2%; p = .039), respectively, while the per‐protocol (PP) eradication rates were 80.0% (95% CI 71.3%–88.7%) and 92.9% (95% CI 87.4%–98.5%; p = .014), respectively. The corresponding drug‐related AEs were 6.8% (6/88) and 5.7% (5/88; p = .755). No significant differences were observed between the compliance rates of the two groups. The CYP2C19 gene polymorphism had no effect on the eradication rates of the two groups. Conclusion The results showed that the 14‐day HDDT affords a higher H. pylori eradication rate than the 10‐day HDDT.
Objective The prevalence of Helicobacter pylori resistance to amoxicillin was less than 5% in most countries. Proton pump inhibitor (PPI)-amoxicillin dual therapy dosing four times daily (q.i.d.) for 14 days could achieve an eradication rate of more than 85%. It is unclear whether dual therapy with shorter treatment duration or lower dosing frequency could also attain a satisfactory cure rate. We conducted a randomized controlled trial to assess the efficacy and safety of two modified esomeprazole-amoxicillin dual therapies, 10-day q.i.d. and 14-day three times daily (t.i.d.) dual therapy, and investigate the factors that might affect the eradication rates. Participants and methods A total of 253 patients were screened for eligibility and 208 patients were randomly assigned to 10-day dual therapy (esomeprazole 20 mg and amoxicillin 750 mg, all given four times daily) or 14-day dual therapy (esomeprazole 20 mg and amoxicillin 1000 mg, all given three times daily). Results In the intention-to-treat analysis, the eradication rates for 10-day and 14-day groups were 79.8% [95% confidence interval (CI): 70.2–87.4%] and 83.5% (95% CI: 74.3–90.5%) as first-line therapies; and 80% (95% CI: 44.4–97.5%) and 76.9% (95% CI: 46.2–95.0%) as rescue therapies. The adverse event rates were 5.9% and 5.0% for 10-day and 14-day groups, respectively. Smoking and compliance significantly affected the efficacy of PPI-amoxicillin dual therapies. Conclusion The eradication rate of 10-day q.i.d. dual therapy was unacceptable, while that of the 14-day t.i.d. dual therapy was borderline acceptable for first-line therapy. The two dual therapies were well tolerated with few adverse effects.
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