Comparison of tailored Helicobacter pylori eradication versus modified bismuth quadruple therapy in Korea: a randomized controlled trial

ABSTRACT

Objectives

We aimed to compare the success rate, adverse drug events, and cost-effectiveness of tailored Helicobacter pylori eradication and modified bismuth-containing quadruple therapy.

Methods

The diagnosis of H. pylori infection was randomly based on either rapid urease test (RUT) or dual priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) in 1:1 ratio. According to the presence of point mutations that cause clarithromycin resistance, patients in the tailored therapy (TT) group received standard triple therapy or classic bismuth quadruple therapy. Patients with positive RUT results received 40 mg pantoprazole, 1000 mg amoxicillin, 750 mg metronidazole, and 600 mg bismuth subcitrate twice daily for 14 days (PAM-B therapy).

Results

Between the TT (n = 141) and PAM-B groups (n = 141), H. pylori eradication rate did not differ significantly according to intention-to-treat (TT: 80.9% vs. PAM-B: 85.8%, P = 0.262), modified intention-to-treat (TT: 89.1% vs. PAM-B: 91.0%, P = 0.606), and per-protocol (TT: 89.0% vs. PAM-B: 93.5%, P = 0.198) analyses. The average cost for successful eradication was higher in the TT group than in the PAM-B group ($340.7 vs. $263.9 per patient).

Conclusion

PAM-B therapy exhibits similar efficacy and improved cost-effectiveness compared to TT based on the results of DPO-PCR tests.

Clinical trial registration

www.clinicaltrials.gov identifier is NCT05002595

KEYWORDS:

• Helicobacter pylori
• eradication
• clarithromycin resistance
• bismuth
• metronidazole

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This work was supported by the Soonchunhyang University Research Fund (grant number: 10210045).