Weifuchun Tablet or Bismuth Combined with Standard Triple Therapy for Helicobacter pylori Eradication: A Clinical Trial / 胃肠病学

ABSTRACT

Background: Integrative traditional Chinese and western medicine may be a new approach to improve the eradication rate of Helicobacter pylori (Hp).Aims: To compare the efficacy and safety of Weifuchun tablet versus bismuth combined with standard triple regimen as the first-line therapy of Hp infection.Methods: A total of 141 patients with Hp infection and na(i)ve to treatment were randomly assigned into 3 groups receiving a 14-day eradication therapy.In standard triple therapy group, esomeprazole, amoxicillin and clarithromycin were given twice a day;while in Weifuchun group and bismuth group, Weifuchun tablet and bismuth potassium citrate were added, respectively, to the standard triple therapy.Hp eradication was assessed by 13C-urea breath test at least 6 weeks after the end of treatment.Hp isolates were tested for resistance to antibiotics.Results: One hundred and twenty-eight patients completed the study.Hp eradication rates in Weifuchun group, bismuth group and standard triple therapy group were 83.7%, 91.8% and 79.1%, respectively by ITT analysis and 88.4%, 97.8% and 84.6%, respectively by PP analysis.The eradication rate of Weifuchun group was lower than that of bismuth group and higher than that of standard triple therapy group, but the differences were not statistically significant (P>0.05).Only PP eradication rate of bismuth group was significantly higher than that of standard triple therapy group (P0.05).Conclusions: Weifuchun tablet combined with standard triple regimen is safe and effective for use as first-line treatment for Hp infection, however, the eradication rate is relatively low in cases infected with clarithromycin resistant strains.Bismuth combined with standard triple regimen is a good alternative in areas with high clarithromycin resistance and regions where tetracycline is unavailable.