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In quadruple therapy for Helicobacter pylori (H.pylori) rescue therapy, both berberine
plus amoxicillin (BA)-based therapy and tetracycline plus furazolidone
(TF)-based therapy display satisfactory efficacy.
A study depicted that for H.pylori rescue treatment, the efficacy of both BA-based therapy and TF-based therapy is adequate. However, the 14-day BA-based quadruple therapy is non-inferior to TF-based therapy.
A randomized, open-label, multicenter, noninferiority trial was carried out to explore the safety and efficacy of a brand-new quadruple regimen with BA vs TF in rescue therapy for H. pylori eradication in patients who had previously failed eradication therapy at least once.
From July 2018 to August 2019, 658 patients with previous treatment failures were recruited from five centers in China. Participants were randomly assigned (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group, n=329) or tetracycline and furazolidone (the TF group, n=329) for 14 days.
Their H. pylori infection status was evaluated four-eight weeks after completion of therapy. The eradication rate was the primary endpoint ascertained. The rates of symptom improvement, compliance, and adverse events were the secondary outcome parameters.
In both intention-to-treat analysis and per-protocol analysis, the two regimens achieved a similar eradication rate as shown in the following table:
In the BA group, the H.pylori eradication rate reached was more compared to the pre-established margin of noninferiority at −10%. Compared to the TF group, the rate of adverse events was lower in the BA group. Both the groups displayed similar rates of compliance and symptom improvement, as shown below:
Thus, both BA and TF-based rescue therapy have satisfactory efficacy. However, 14-day BA-based quadruple therapy is non-inferior to TF-based quadruple therapy.
Journal of Digestive Diseases
A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment
Jian Zhang et al.
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