We aimed to compare the efficacy of 14 day levofloxacin sequential therapy versus 10 day bismuth quadruple therapy in the second-line and third-line treatment of Helicobacter pylori (H. pylori) infection.Methods
H. pylori infected patients who failed after one treatment were eligible in this open labelled, multicenter, randomised trial, and were randomised to receive (1) levofloxacin sequential therapy (EAML): esomeprazole 40 mg and amoxicillin 1 g for the first 7 days, followed by esomeprazole 40 mg, metronidazole 500 mg, and levofloxacin 250 mg for another 7 days (all twice daily); or (2) bismuth quadruple therapy (BQ): esomeprazole 40 mg twice daily, bismuth tripotassium dicitrate 300 mg four times a day, tetracycline 500 mg four times a day, and metronidazole 500 mg three times a day, for 10 days. The primary end point was the eradication rate in the second-line treatment according to intention to treat (ITT) analysis. The minimum inhibitory concentrations were determined by agar dilution test.Results
The results were available for analysis in 398 patients up to Dec, 2017. The preliminary eradication rate in the EAML and BQ groups were 88.9% (169/190) and 91% (172/189), respectively (p=0.505) in the ITT analysis, and were 89.9% (169/188) and 96.1% (172/179) in the PP analyses, respectively (p=0.021) in the second line treatment. The efficacy of levofloxacin sequential therapy, but not bismuth quadruple therapy, appeared to be affected by levofloxacin resistance. In the third-line therapy, the eradication rate of EAML was 60% (3/5) for patients who failed after bismuth quadruple therapy. The eradication rate of BQ was 80% (12/15) for patients who failed after levofloxacin sequential therapy. The cumulative eradication rates were 95.3% (181/190) and 92.6% (175/1189) in the EAML (2nd)-BQ(3rd) and the BQ(2nd)- EAML (3rd) groups (p=0.276). The frequencies of adverse effects were 42.8% (62/145) and 81.9% (118/144) in patients treated with EAML and BQ, respectively (p<0.001).Conclusions
Levofloxacin sequential therapy and bismuth quadruple therapy are similarly effective in the second-line treatment for H. pylori infection. (Trial registration number: NCT NCT03148366).