Comparison of four different regimens against Helicobacter pylori as a first-line treatment: A prospective, cross-sectional, comparative, open trial in Chinese children

Abstract

Backgrounds: Due to the decreasing eradication rate of Helicobacter pylori, some novel alternatives have been developed, such as bismuth-containing quadruple therapy and non-bismuth-containing quadruple therapy (sequential and concomitant treatment). Little is known about whether a success rate above 90% can be achieved with these regimens in Chinese children. Methods: In this prospective, open, comparative cross-sectional study, we recruited treatment-naïve children (aged between 6 and 18 years) with H pylori infection. The patients were assigned either standard triple therapy, sequential therapy, bismuth-based quadruple therapy, or concomitant therapy at the discretion of the prescribing physician. H pylori infection was evaluated at least 4 weeks after the completion of the treatment. A negative urea breath test (UBT) indicated successful eradication. The primary endpoint was the eradication frequency of H pylori in the full analysis set (FAS), which included all children who received at least one dose of the treatment and with available follow-up data. Results: Between September 2017 and December 2018, 228 patients were finally included in the FAS analyses. The eradication rates were 74.1% for standard triple therapy (43/58, [95% CI: 62.8%-85.5%]), 69.5% for sequential therapy (41/59, [95% CI: 57.8%-81.2%]), 89.8% for bismuth-based quadruple therapy (53/59, [95% CI: 82.1%-97.5%]), and 84.6% for concomitant therapy (44/52, [95% CI: 74.8%-94.4%]). Bismuth-based therapy was superior to triple therapy, while sequential therapy and concomitant therapy were not superior to triple therapy. The frequency of adverse events was 12.1% (7/58) in standard triple therapy, 6.8% (4/59) in sequential therapy, 15.3% (9/59) in bismuth-based therapy, and 15.4% (8/52) in concomitant therapy. The rate of adverse events was similar among the four groups. Conclusion: Bismuth quadruple therapy can achieve an eradication rate of 89.8% as first-line treatment and is safe and well tolerated. Bismuth could be a promising alternative as a first-line regimen in Chinese children.