Introduction
A 10-14 day non-bismuth quadruple "concomitant" therapy is currently the preferred first-line regimen for Helicobacter pylori (HP) eradication in Greece 1,2. In this country, bismuth salts have recently become commercially available; however, lack of tetracycline still precludes use of bismuth quadruple therapy. Adding bismuth to the current concomitant therapy (ie; a quintuple regimen) could be an alternative; however, it has never been explored previously.
Aims & Methods
The present study aimed to assess a quintuple 10-day bismuth-enhanced concomitant regimen as first-line treatment for HP eradication in Greece. Prospective, open-label, multicenter pilot study including treatment-naïve patients diagnosed with HP infection via histology and/or rapid urease test. Exclusion criteria included recent use of PPIs, antibiotics, NSAIDs, bismuth, serious comorbidities, prior gastrectomy, pregnancy or lactation, allergy to any study drug, and refusal to participate. All patients received a 10-day regimen consisting of esomeprazole 40 mg BID, amoxicillin 1000 mg BID, clarithromycin 500 mg BID, metronidazole 500 mg BID, and bismuth subcitrate 240 mg BID. A specific probiotic supplement containing Lactobacillus acidophilus, Lactiplantibacillus plantarum, Bifidobacterium lactis, and Saccharomyces boulardii was also administered in all patients. Efficacy was evaluated by intention-to-treat (ITT), per-protocol (PP), and modified ITT (mITT) analyses. Successful eradication was defined as a negative histology or urea breath test at least 8 weeks post-treatment.
Results
A total of 52 patients were analyzed (mean age 48.6 ± 18.7 years, 50% male, peptic ulcer disease: 7/52, non-ulcer dyspepsia: 29/52). Eradication rates were: i) ITT: 47/52 (90.4%, 95% CI: 79.4–95.8), ii) PP: 46/49 (93.9%, 95% CI: 83.5–97.9), iii) mITT: 47/51 (92.2%, 95% CI: 81.5–96.9). Adverse events were reported by 29.4% (15/51) of patients, with taste disturbances being the most frequent (39.1%); no serious adverse events occurred. Compliance was excellent with 49/51 (96.1%) patients taking >90% of the prescribed therapy.
Conclusion
A quintuple 10-day bismuth-enhanced concomitant regimen appears to be an effective (93.9% PP), safe and well tolerated treatment option for first-line HP eradication in a country with high clarithromycin and metronidazole resistance, without negatively affecting patient compliance.
References
1. Rokkas T, et al. Assessment of first-line eradication treatment in Greece: data from the European Registry on Helicobacter pylori management (Hp-EuReg). Ann Gastroenterol 2022;35:42-7.
2. Georgopoulos SD, et al. Equivalence Trial of the Non-Bismuth 10-Day Concomitant and 14-Day Hybrid Therapies for Helicobacter pylori Eradication in High Clarithromycin Resistance Areas. Antibiotics 2024;13:280.
