A 10-day therapy of bismuth-containing quadruple therapy (BQT) was more effective at eradicating Helicobacter pylori (H pylori) infection than 7-day proton-pump inhibitor-clarithromycin-containing standard triple therapy (STT). These findings, from an open-label, single-center, randomized trial, were published in BMC Gastroenterology.
Researchers from the National Cancer Center in South Korea recruited patients (N=352) with confirmed H pylori infection and high risk for gastric cancers between 2015 and 2017. Patients were randomized in a 1:1 ratio to receive 10 days of BQT (30 mg lansoprazole twice daily, 500 mg metronidazole three times daily, 300 mg tripotassium bismuth dicitrate four times daily, and 500 mg tetracycline four times daily) or 7 days of STT (30 mg lansoprazole, 500 mg clarithromycin, and 1000 mg amoxicillin all twice daily).
BQT and STT recipients were of mean age 53.9±10.7 and 55.6±11.3 years, 52.6% and 53.1% were women, 34.9% and 36.7% had a family history of gastric cancers, and 55.4% and 56.5% had chronic gastritis with non-ulcer dyspepsia, respectively.
BQT had higher eradication rates in the intention-to-treat analysis (74.3%) compared with STT (57.1%; P <.001) and in the per-protocol analysis (92.9% vs 70.1%; P <.001).
Adverse events were observed among 67.5% of the BQT and 57.3% of the STT (P =.059) groups. BQT recipients reported more instances of dyspepsia, weakness, anorexia, nausea, vomiting, and headache (all P £.011) and STT recipients had more alteration of taste (P <.001). Poor compliance due to adverse effects was greater among the BQT (23.1%) participants compared with the STT (9.1%; P =.001) group.
Among the BQT and STT cohorts, patients who completed ³80% of the treatment had eradication rates of 92.9% and 70.1%, among those who were 50% to <80% compliant, eradication was 83.3% (P =.177) and 71.4% (P >.999), and among those who had poor compliance (<50%), eradication was 55.6% (P =.070) and 33.3% (P =.286), respectively. In the BQT treatment group, a significant difference in eradication rate was observed between the best and poorest compliers (P <.001), but not among the STT group (P =.078).
This study may have been limited by not assessing for antibiotic resistance among the H pylori strains. It remains unclear whether these results may be generalizable or were unique with regards to region-specific strains.
These data indicated a 10-day BQT therapy outperformed 7-day STT for eradication of H pylori, despite increased adverse effects and poor compliance.
Kim YI, Lee JY, Kim CG, et al. Ten‑day bismuth‑containing quadruple therapy versus 7‑day proton pump inhibitor‑clarithromycin containing triple therapy as first‑line empirical therapy for the Helicobacter pylori infection in Korea: a randomized open‑label trial. BMC Gastroenterol. 2021;21(1):95. doi:10.1186/s12876-021-01680-1