- Design
- Multicentre, randomised, three-arm controlled trial
- Population
- Korean adults with clarithromycin-resistant H. pylori
- Primary outcome
- Eradication rate after 14 days of therapy
- Effect
- ITT 84.8% PAM-B vs 68.2% PAM (p = 0.024) vs 81.8% PBMT; nausea 6.8% vs 25.0% PBMT
A multicentre Korean trial randomised patients with confirmed clarithromycin-resistant Helicobacter pylori to 14 days of PPI, amoxicillin and metronidazole (PAM); the same with bismuth (PAM-B); or classic bismuth quadruple therapy with PPI, bismuth, metronidazole and tetracycline (PBMT).
Intention-to-treat eradication was 68.2% with PAM, 84.8% with PAM-B and 81.8% with PBMT. Per protocol, the figures were 75.4%, 96.5% and 94.6%. PAM-B and PBMT did not differ, but nausea and vomiting were much less frequent with PAM-B (6.8% against 25.0%).
Tetracycline is often hard to obtain, and tolerability limits the classic quadruple regimen. This supports bismuth plus amoxicillin and metronidazole as a practical alternative where clarithromycin resistance is common, which includes much of India. The trial was modest in size, regional and registered retrospectively, so it confirms a direction rather than settling the choice.
- Avoid clarithromycin-based triple therapy where resistance is high or unknown
- Use 14 days, not 7 or 10
- Add bismuth to an amoxicillin–metronidazole regimen
- Confirm eradication with a urea breath or stool antigen test at least 4 weeks after treatment, off PPI for 2 weeks
Why it matters
It gives a better-tolerated route to quadruple-level eradication where tetracycline is scarce.
Don't overread it
Numbers per arm were small and the trial was registered after it ran; it is not a definitive comparison of the two bismuth regimens.
The statistics, in plain English
The intention-to-treat analysis counts everyone randomised, including those who stopped early, so it reflects real practice; per-protocol counts only completers, so it is higher. The 17-point gain from adding bismuth was significant (p = 0.024). 'Comparable' between PAM-B and PBMT means no significant difference was found, not that equivalence was proven.
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