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Randomized Controlled Trial
. 2020 Sep 2;11(5):1314-1323.
doi: 10.1080/19490976.2020.1754118. Epub 2020 May 2.

Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection

Chang Seok Bang  1   2   3 , Hyun Lim  1   2 , Hae Min Jeong  1   2 , Woon Geon Shin  1   2 , Jae Ho Choi  3 , Jae Seung Soh  1   2 , Ho Suk Kang  1   2 , Young Joo Yang  1   2 , Ji Taek Hong  1   2 , Suk Pyo Shin  1   2 , Ki Tae Suk  1   2 , Jae Jun Lee  3   4 , Gwang Ho Baik  1   2 , Dong Joon Kim  1   2
Affiliations
Randomized Controlled Trial

Amoxicillin or tetracycline in bismuth-containing quadruple therapy as first-line treatment for Helicobacter pylori infection

Chang Seok Bang et al. Gut Microbes. .

Abstract

Aim: To compare the efficacy and safety between modified quadruple- and bismuth-containing quadruple therapy as first-line eradication regimen for Helicobacter pylori infection.

Methods: This study was a multicenter, randomized-controlled, non-inferiority trial. Subjects endoscopically diagnosed with H. pylori infection were randomly allocated to receive modified quadruple- (rabeprazole 20 mg bid, amoxicillin 1 g bid, metronidazole 500 mg tid, bismuth subcitrate 300 mg qid [elemental bismuth 480 mg]; PAMB) or bismuth-containing quadruple therapy (rabeprazole 20 mg bid, bismuth subcitrate 300 mg qid, metronidazole 500 mg tid, tetracycline 500 mg qid; PBMT) for 14 days. Rates of eradication success and adverse events were investigated. Antibiotic resistance was determined using the agar dilution and DNA sequencing of the clarithromycin resistance point mutations in the 23 S rRNA gene of H. pylori.

Results: In total, 233 participants were randomized, 27 were lost to follow-up, and four violated the protocol. Both regimens showed an acceptable eradication rate in the intention-to-treat (PAMB: 87.2% vs. PBMT: 82.8%, P = .37), modified intention-to-treat (96.2% vs. 96%, P > .99), and per-protocol (96.2% vs. 96.9%, P > .99) analyses. Non-inferiority in the eradication success between PAMB and PBMT was confirmed. The amoxicillin-, metronidazole-, tetracycline-, clarithromycin-, and levofloxacin-resistance rates were 8.3, 40, 9.4, 23.5, and 42.2%, respectively. Antimicrobial resistance did not significantly affect the efficacy of either therapy. Overall compliance was 98.1%. Adverse events were not significantly different between the two therapies.

Conclusion: Modified quadruple therapy comprising rabeprazole, amoxicillin, metronidazole, and bismuth is an effective first-line treatment for the H. pylori infection in regions with high clarithromycin and metronidazole resistance.

Keywords: Helicobacter pylori; bismuth; disease eradication; drug resistance; metronidazole.

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Figures

Figure 1.
Figure 1.
Patient enrollment flow chart. ITT, intention-to-treat; PP, per-protocol; n, number.
See this image and copyright information in PMC

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