Background
Concomitant quadruple (CQT) or bismuth‐containing quadruple therapy (BQT) is recommended as first‐line treatment for Helicobacter pylori infection depending on antibiotic resistance.
Aim
To compare the efficacy, safety, and compliance of CQT and BQT as first‐line therapy for H. pylori eradication in real clinical practice in an area of high resistance to clarithromycin.
Methods
A prospective, open, comparative cross‐sectional study including dyspeptic patients >18 years with H. pylori infection and with no previous eradication treatment was performed. CQT (omeprazole 20 mg + clarithromycin 500 mg + amoxicillin 1 g + metronidazole 500 mg, all given twice daily, for 14 days) or BQT (omeprazole 20 mg twice daily + 3 capsules of Pylera® 4 times a day, for 10 days) was prescribed at the discretion of the prescribing physician. Eradication was tested by 13C‐urea breath test. Efficacy was assessed by intention‐to‐treat (ITT) and per‐protocol (PP) analyses.
Results
One hundred and four consecutive patients were included (64.4% female, age 52.9 years). Fifty patients received CQT and 54 BQT. Eradication rate was similar with both therapies at the PP (CQT 97.9%, 95% CI: 93.9‐100 vs BQT 96.2%, 95% CI: 90.9‐100, P = 0.605) and ITT analyses (CQT 98.0%, 95% CI: 94‐100 vs BQT 94.4%, 95% CI: 88.1‐100, P = 0.346). The rate of adverse events was also similar with CQT (56%) and BQT (46.3%). One patient in each group discontinued the treatment due to significant adverse events.
Conclusion
The use of CQT and BQT as first‐line treatment against H. pylori is similarly effective and safe strategy in an area of high clarithromycin resistance.