Both high-dose dual therapy (HDDT) and bismuth quadruple therapy (BQT) were able to achieve high Helicobacter pylori (H pylori) eradication rates, according to study results presented at Digestive Disease Week 2021.
BQT has been recommended as a standard first-line or rescue regimen for H pylori eradication. However, a high rate of adverse events with BQT may reduce its compliance and effectiveness. Conversely, HDDT is a simpler regimen with low antibiotic resistance and potentially high efficacy.
Researchers compared the efficacy, adverse events, and compliance of HDDT with BQT as first-line or rescue regimens. In addition, investigators explored factors that may influence H pylori eradication.
A total of 2672 patients were evaluated, and 1020 patients with H pylori infections were enrolled in the study. Prior to treatment, all study participants had upper endoscopy with biopsy for histological and culture/antibiotic sensitivity testing (E-test).
In this multi-center, randomized control study, patients in both first-line therapy (n=576) and rescue therapy (n=444) were randomized to receive HDDT (20 mg of rabeprazole 4 times daily and 750 mg of amoxicillin 4 times daily for 14 days) or BQT (20 mg of rabeprazole 2 times daily, 300 mg of tripotassium dicitrate bismuthate 4 times daily, 250 mg of metronidazole 4 times daily, and 500 mg of tetracycline 4 times daily for 10 days).
To minimize dropouts due to adverse events, a 10-day BQT regimen was selected. All patients were requested to complete a set of standardized questionnaires. These questionnaires included dietary habits, adverse events, and drug compliance. Investigators used polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) to analyze CYP 2C19 genotypes. They used C13-urea breath tests 4-8 weeks following treatment to determine H pylori eradication.
The intention-to-treat (ITT) eradication rates for first-line therapies were 95.8% (276/288; 95% CI, 93.5-98.1) with HDDT and 91.7 (264/288; 95% CI, 88.5-94.9) with BQT. The ITT eradication rates for the rescue treatments were 91.0% (202/222; 95% CI, 87.2-94.7) with HDDT and 88.3% (196/222; 95% CI, 84.1-92.5) with BQT.
The investigators observed significant differences in adverse events among the two groups (HDDT 27% vs. BQT 65%; P <.001).
The resistance rates (first-line vs rescue groups) to amoxicillin, metronidazole, tetracycline, clarithromycin, and levofloxacin were the following: 0.6% vs 0.9%, 30% vs 41%, 0.6% vs 0.9%, 18% vs 75%, and 19% vs 39%, respectively.
The efficacy of HDDT was significantly reduced by amoxicillin resistance and high-acid diet (ie, consumption of high acid and spicy foods, heavy alcohol or tea consumption during treatment). In contrast, the treatment outcomes of BQT were significantly affected by metronidazole resistance, tetracycline resistance, and poor drug compliance.
The study authors concluded that both HDDT and BQT were able to achieve high H pylori eradication rates. However, HDDT was better tolerated and more available worldwide compared with BQT. Thus, HDDT is an excellent first-line or rescue regimen option for H pylori infection. Nevertheless, a high-acid diet may significantly reduce HDDT efficacy.
Tung CC, Hu CT, Lin CJ, et al. Efficacy of high-dose dual therapy and bismuth quadruple therapy in first-line and rescue helicobacter pylori eradication – a final report of multi-center, randomized control study. Presented at: Digestive Disease Week Annual Meeting; May 21-23, 2021. Abstract 594.
This article originally appeared on Gastroenterology Advisor