Efficacy and Safety of Tegoprazan-Containing Versus Proton Pump Inhibitor-Containing Regimens for First Line Helicobacter pylori Eradication-An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Abstract

Effective acid-suppressing treatment is of vital importance for the successful eradication of Helicobacter pylori (H. pylori). Tegoprazan, which is a potassium-competitive acid blocker (P-CAB), has been evaluated as a substitute for proton pump inhibitors (PPIs) in first-line eradication therapy, but updated evidence from randomized controlled trials (RCTs) remains limited. To evaluate and compare the first-line treatment regimens containing tegoprazan with those containing PPIs in terms of efficacy and safety for the eradication of H. pylori infection. We searched the literature in PubMed, Embase, Web of Science, CENTRAL, CNKI, Wanfang, and CBM databases for all available years until November 2025. Randomized trials enrolling treatment-naïve adults receiving first-line eradication therapy were eligible. The primary outcome was the rate of eradication success based on an intention-to-treat (ITT) population analysis, while adverse events and treatment adherence were assessed as secondary outcomes. A pooled analysis was conducted using the risk ratio (RR) and its 95% confidence interval (CI), and the reliability of the evidence was rated on the basis of the Grading of Recommendations Assessment, Development and Evaluation (GRADE). Data were available from 11 randomized trials, including 3872 participants and 14 treatment comparisons. In ITT analyses, tegoprazan-containing regimens were associated with higher eradication success than PPI-containing regimens, but the magnitude of benefit was small (85.7% vs. 81.1%; RR = 1.06, 95% CI: 1.03-1.09, p < 0.0001, I² = 31%; moderate-certainty evidence). The subgroup finding was most favorable for 14-day treatment and quadruple therapy (RR = 1.07, 95% CI: 1.04-1.11; RR = 1.10, 95% CI: 1.05-1.15). Fewer adverse events were reported in tegoprazan groups than in comparator groups (27.1% vs. 30.5%; RR = 0.90, 95% CI: 0.82-0.99, p = 0.03; low-certainty evidence). Treatment adherence was high in both groups, with a small between-group difference and substantial heterogeneity (low-certainty evidence). Tegoprazan-containing first-line therapy may provide a small improvement in H. pylori eradication compared with PPI-containing therapy, particularly in 14-day quadruple regimens. Current evidence does not establish a clinically meaningful advantage in safety or adherence, and the findings should be interpreted in light of clinical heterogeneity, geographic limitations, and limited evidence in refractory or special populations. Further well-designed randomized trials are needed. PROSPERO registration ID: CRD420261290197.