A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment

Abstract

Objective Helicobacter pylori ( H. pylori ) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication. Methods We conducted a randomized, open‐label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4‐8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). Results Altogether 658 participants were consecutively enrolled. An intention‐to‐treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per‐protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre‐established margin of noninferiority, at −10% (the lower bounds of the 95% CI were −7.66% and −9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies. Conclusion The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14‐day BA‐based quadruple therapy is noninferior to the TF‐based therapy.

A Survey of Helicobacter pylori Antibiotic-Resistant Genotypes and Strain Lineages by Whole-Genome Sequencing in China

“…Furazolidone is widely used as an antibiotic in China for the eradication of H. pylori . Its efficacy and safety have also been well demonstrated ( 67 – 70 ). There were five furazolidone-resistant strains among our isolates, and the previously described mutations in the porD and oorD genes associated with furazolidone resistance were not found ( 46 ).…”

Efficacy and safety of high-dose esomeprazole–amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial

“…[ 21 , 22 ] According to a previous study by our group, tetracycline- and furazolidone-based quadruple therapy, which has an 85% eradication rate by PP analysis, is an ideal rescue strategy in patients with a previous eradication treatment failure. [ 23 ] Owing to adverse drug reactions [ 24 , 25 ] and difficulty with accessibility, the clinical use of tetracycline and furazolidone in the treatment of H. pylori has been severely limited. Our results demonstrated that HDDT consisting of esomeprazole plus amoxicillin achieved an eradication rate similar to that of bismuth quadruple therapy containing tetracycline and furazolidone and is an effective alternative for H. pylori rescue treatment.…”

Identifying the best regimen for primary eradication of Helicobacter pylori: analysis of 240 cases

“…The average antibiotics resistance rates in Beijing were 0.3% (amoxicillin), 37.2% (clarithromycin), 1.7% (furazolidone), 63.9% (metronidazole), 1.2% (tetracycline), 50.3% (levofloxacin), and 61.9% (moxifloxacin), as in most parts of China (Gao et al, 2010; Hu et al, 2017). Although furazolidone and tetracycline are effective antibiotics, they have several side effects and are always not available (Chen et al, 2016; Zhang et al, 2014, 2020; Zhuge et al, 2018). China's food and drug agency announced in 2018 (no.…”