Comparator choice in Helicobacter pylori eradication: Tegoprazan-amoxicillin dual therapy vs. an optimised bismuth-containing quadruple therapy in a randomised trial and meta-analysis.

OBJECTIVES

Given the variable eradication efficacy of bismuth-containing quadruple therapies (BcQT), comparator choice is critical in randomised controlled trials (RCTs) of Helicobacter pylori (H. pylori) eradication. This study compared the efficacy and safety of tegoprazan-amoxicillin dual therapy (TADT) versus esomeprazole-amoxicillin-tetracycline bismuth-containing quadruple therapy (EBQT) as first-line treatment.

METHODS

In this non-inferiority RCT conducted at Qilu Hospital of Shandong University from March 2023 to January 2024, treatment-naïve H. pylori-infected patients were randomised to receive TADT or EBQT for 14 days. The primary outcome was eradication rate in the intention-to-treat (ITT), modified ITT (mITT) and per-protocol (PP) analyses. Secondary outcomes were adverse events and compliance. A meta-analysis of RCTs comparing TADT with BcQT for first-line eradication was also performed.

RESULTS

A total of 258 patients were randomised. Eradication rates were 82.95% vs 90.70% (P = 0.066) in ITT, 84.25% vs 91.41% (P = 0.080) in mITT, and 89.17% vs 95.80% (P = 0.052) in PP analysis for TADT and EBQT, respectively. Although eradication rates were comparable, TADT failed to demonstrate non-inferiority to EBQT. Adverse events (20.16% vs 26.36%, P = 0.238), and compliance (96.12% vs 95.35%, P = 0.758) were similar. Seven groups were included in the meta-analysis. In the ITT subgroup analysis by antibiotic combination, TADT showed a significantly lower eradication rate than amoxicillin- and tetracycline/metronidazole-containing BcQT (RR = 0.90, 95% CI: 0.84-0.97; P = 0.006).

CONCLUSIONS

TADT showed comparable eradication rates to EBQT but was not non-inferior, with similar safety and compliance. Comparator choice is critical in RCTs.