Tailoring triple plus bismuth therapy (TBT) based on a patient’s medical history can significantly increase Helicobacter pylori eradication rates compared with empiric TBT, according to study findings published in Digestive and Liver Disease.
Researchers conducted an open-label, single-center, randomized control trial to assess the efficacy of tailored TBT therapy compared with clarithromycin-, levofloxacin- and metronidazole-containing empiric TBT in treatment-naive adult patients with H pylori infection.
Participants (N=800) were randomly assigned to 1 of 4 groups receiving clarithromycin-, levofloxacin-, or metronidazole-containing empiric TBT or tailored TBT (clarithromycin or levofloxacin chosen based on previous medication history). The study population (N=800) included patients aged 18 to 70 years old with documented H pylori infection. A total of 373 men and 427 women with an average age of 41.4±13.0 years were included in the study. There were 103 participants with peptic ulcer disease.
The primary outcome was the eradication rate using intention-to-treat (ITT), modified ITT (mITT), and per-protocol (PP) analyses. Secondary outcomes were incidences of adverse effects and compliance.
All participants underwent a C-urea breath test 4 to 8 weeks after eradication to assess treatment efficacy.
There were 298 (37.3%) participants who previously received macrolide, 377 (47.1%) who previously received quinolone, and 206 (25.8%) who previously received nitroimidazole. A total of 692 (86.5%) patients had a successful H pylori culture.
Drug resistance rates for amoxicillin, clarithromycin, levofloxacin, metronidazole and tetracycline were 3.6%, 35.7%, 36.7%, 63.3% and 5.1%, respectively.
The eradication rates in the tailored TBT groups were significantly higher than those of the 3 empiric TBT groups according to the ITT (179/200 [89.5%]; 95% CI, 85.5%-93.5%; P =.047), mITT, (179/192 [93.2%]; 95% CI, 89.6%-96.4%; P =.033), and PP analyses (175/184 [95.1%]; 95% CI, 91.8%-98.4%; P =.025).
According to ITT analysis, the eradication rates for the clarithromycin-, levofloxacin- and metronidazole-containing empiric TBT groups were 80.0%, 81.5%, and 81.5%, respectively. According to PP analysis the eradication rates for these groups were 86.7%, 86.5%, and 87.8%, respectively (P <.05).
The incidence of adverse reactions was the lowest in the treatment group receiving levofloxacin-TBT therapy (16.2%) and the highest for patients receiving metronidazole-TBT therapy (28.3%). Nausea was most common among participants receiving metronidazole-TBT therapy.
Study limitations include potential inaccuracies in past medication histories and conducting the study at a single center.
“This study confirmed that drug selection and regimen adjustment based on past medication history could effectively improve eradication efficacy of empiric TBT,” the researchers conclude.
Song Z, Suo B, Tian X, et al. Tailored triple plus bismuth therapy based on previous antibiotic medication history for first-line Helicobacter pylori eradication: a randomized trial. Dig Liver Dis. Published online January 14, 2023. doi.org/10.1016/j.dld.2022.12.019