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. 2025 Dec;11(1):2527539.
doi: 10.1080/20565623.2025.2527539. Epub 2025 Jul 10.

Comparison of bismuth and concomitant therapy for H. pylori eradication: a prospective, randomized clinical trial

A Oueslati  1   2 , G Mohamed  1   2 , S Bostani  1   2 , K Boughoula  1   2 , S Bizid  1   2 , H Ben Abdallah  1   2 , R Bouali  1   2 , M N Abdelli  1   2
Affiliations

Comparison of bismuth and concomitant therapy for H. pylori eradication: a prospective, randomized clinical trial

A Oueslati et al. Future Sci OA. 2025 Dec.

Abstract

Background: In Tunisia, concomitant quadruple therapy (QTC) has been the standard first-line treatment for Helicobacter pylori (H. pylori) infection. However, increasing resistance to clarithromycin (28%) has raised concerns about its long-term efficacy. Bismuth-based quadruple therapy (QTB) offers an alternative, yet its higher cost and safety profile remain debated. This study aimed to compare the efficacy, safety, and cost of both regimens.

Methods: We conducted a prospective, randomized, open-label study enrolling 200 patients naïve to any anti-HP treatment. Patients were randomized to either 10 days of bismuth therapy (QTB: potassium bismuth subcitrate, metronidazole, and tetracycline hydrochloride, omeprazole) or 14 days of concomitant quadruple therapy (QTC: amoxicillin, clarithromycin, metronidazole, esomeprazole). H. pylori eradication as defined by a negative urea breath test 4-6 weeks after treatment.

Results: Among 200 patients, the intention-to-treat eradication rate was 82% for QTC and 87% for QTB (p = 0.29); per-protocol rates were 84.53% and 89.58%, respectively (p = 0.39). Compliance was high (97% in QTC vs 96% in QTB; p = 0.32). Adverse events were similar between groups (61.85% for QTB vs 69% for QTC; p = 0.29).

Conclusion: Bismuth and concomitant quadruple therapies were comparable in terms of efficacy and safety but didn't achieve the accepted minimum eradication rate (90%).

Keywords: Helicobacter pylori; bismuth; clarithromycin; cost-effectiveness; efficacy; metronidazole; safety.

Plain language summary

Helicobacter pylori is a common stomach infection that can cause ulcers and increase the risk of stomach cancer. Doctors usually use a combination of antibiotics to treat it, but some of these antibiotics, like clarithromycin and metronidazole, are becoming less effective due to resistance development.This study compared, in an area with high resistance for antibiotics, two treatments: one using a single-capsule bismuth quadruple therapy for 10 days and another using a standard combination of antibiotics for 14 days. Both treatments worked similarly well, and side effects were mild for most patients. Yet, the treatment without bismuth was cheaper.These results suggest that both options can be used. However, neither treatment achieved the expected efficacy that’s why it is important to develop new treatments to achieve a higher therapeutic outcomes.

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Figures

Figure 1.
Figure 1.
Flowchart of the study.
See this image and copyright information in PMC

References

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    2. *Tunisian consensus document outlining national resistance patterns and treatment strategies, highly relevant to the local context of our study.

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    2. **Recent meta-analysis comparing QTB and QTC as first-line treatments, supporting our study design and interpretation.

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