High‐dose amoxicillin‐proton pump inhibitor dual therapy as first‐line treatment for Helicobacter pylori infection in Northwest China: A prospective, randomised controlled trial

Abstract

Aims We aimed to assess the eradication efficacy and factors that influencing it of high‐dose dual therapy (HDDT) in Gansu region, Northwest China. Methods A total of 216 treatment‐naive patients with Helicobacter pylori infection were randomly assigned to two groups for the 14‐day eradication treatment: the HDDT group (amoxicillin 750 mg q.i.d. and esomeprazole 40 mg t.i.d.) and the amoxicillin and clarithromycin‐containing bismuth quadruple therapy group (ACBQT: esomeprazole 20 mg, bismuth potassium citrate 2 g, amoxicillin 1 g, and clarithromycin 500 mg; b.i.d.). The eradication rates, adverse effects and patient compliance of these two groups were compared. Eradication efficacy was determined by 13C urea breath test (13C UBT) 4–8 weeks after finishing treatment. Antibiotic resistance was determined by the Epsilometer testing (E‐test) method. Results The eradication rates for the HDDT and ACBQT groups were 71.0% and 74.7% (P = .552) by per‐protocol analysis, and 65.7% and 68.5% (P = .664) by intention‐to‐treat analysis. The overall adverse event rates in the HDDT and ACBQT groups were 2.0% and 43.4% (P < .001), respectively. The resistance rates to amoxicillin, clarithromycin, tetracycline, levofloxacin and metronidazole were 15.2%, 42.0%, 5.4%, 35.7% and 83.0%, respectively. Amoxicillin resistance and delta over baseline (DOB) of 13C UBT ≥ 20 before treatment significantly reduced the eradication rate in 112 participants with H. pylori cultured. Conclusion The HDDT as first‐line treatment for H. pylori was unsatisfactory in Gansu. Amoxicillin resistance and DOB of 13C UBT ≥ 20 before treatment were significantly correlated with H. pylori eradication failure.

High-dose dual therapy versus bismuth-containing quadruple therapy for Helicobacter pylori eradication: a systematic review and meta-analysis with trial sequential analysis

“…All included studies were published between 2003 and 2022, of which six were multicenter RCTs 17,18,22,25,26,29 and eight were single-center RCTs. 19–21,23,24,27,28,30 Among these included studies, 11 studies were performed in China, 18,19,21–26,28–30 one in Germany and Austria, 17 one in Turkey, 20 and one in Colombia. 27 Concerning publication language, 12 studies were published in English, 17–20, 22–26 , 28–30 one in Chinese, 21 and one in Spanish.…”

“…19–21,23,24,27,28,30 Among these included studies, 11 studies were performed in China, 18,19,21–26,28–30 one in Germany and Austria, 17 one in Turkey, 20 and one in Colombia. 27 Concerning publication language, 12 studies were published in English, 17–20, 22–26 , 28–30 one in Chinese, 21 and one in Spanish. 27 Among these studies, three of which were published as conference abstracts.…”

“…As to H. pylori eradication treatment experience, two studies were rescue therapy 17,22 and these remaining studies were initial therapy. Two studies 17,30 performed antibiotic susceptibility tests, two studies 23,24 conducted antibiotic susceptibility tests and CYP2C19 gene polymorphism analysis simultaneously. With regard to HDDT regimen, the types of PPI are mainly esomeprazole or rabeprazole, and only one early study 17 used omeprazole to eradicate H. pylori ; the total dose of amoxicillin was 3000 mg, administered three or four times daily.…”

“…Supplemental Figures S1 and S2 show the details of risk of bias assessment. Among these 14 studies, nine studies 17,19,20,23,24,26,27,29,30 reported sufficient random sequence generation methods (computer-generated randomization and randomized digital table) and were judged as low risk, while the other five studies were judged as unclear risk of randomization. Only two studies 24,26 provided sufficient data for allocation concealment and were judged as low risk.…”

“…Only two studies 24,26 provided sufficient data for allocation concealment and were judged as low risk. With regard to blinding participants and personnel, seven studies were open trial, 19,23,24,26,28–30 and the remaining seven studies 17,18,20–22,25,27 were judged as unclear risk due to insufficient information. All these studies showed low risk in blinding of outcome assessment, incomplete outcome data, and other bias.…”