Tailored Triple Plus Bismuth Therapy Increases H pylori Eradication Rate

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.