A Randomized Clinical Trial Of Ten-day Concomitant,Sequential And Bismuth-based Quadruple Therapy For Helicobacter Pylori

Background and aims:Helicobacter pylori (H. pylori) infection is a disease distributing worldwide. It has been proved that H. pylori infection is closely relate to many gastric mucosal diseases including chronic gastritis, peptic ulcer, gastric mucosa associated lymphoid tissue (MALT) lymphoma, gastric cancer, and so on. It has been listed as a class I gastric carcinogen by WHO since1994. Due to increasing H. pylori resistance rate to antibiotics, the eradication rate of classical triple therapy has declined to no more than70%. Maastricht Ⅳ international guideline recommended quadruple therapy which contains concomitant therapy, sequential therapy and bismuth-based therapy as the first line regimens in eradicating H. pylori infection. However, there is lacking of randomized controlled trail in comparing H. pylori eradication rates among these quadruple regimens simultaneously. And till now, there is no direct evidence to determine the best regimen which is suitable for our country in H. pylori eradication. So, this trail aims to determine the best empiric regimen in daily clinical work by comparing H. pylori eradication rates among ten-day concomitant, sequential and bismuth-based quadruple therapy.Methods:A total of226consecutive patients scheduled to undergo endoscopy and proven positive for H. pylori by rapid urease tests (RUT) were enrolled in the study from February2013to October2013in Qilu Hospital of Shandong University. Patients enrolled in this study randomly received concomitant therapy (omeprazole20mg, amoxicillin1000mg, clarithromycin500mg and tinidazole500mg), sequential therapy (omeprazole20mg, amoxicillin1000mg for first5days, followed by omeprazole20mg, clarithromycin500mg and tinidazole500mg for another5days) and bismuth-based therapy (omeprazole20mg, amoxicillin1000mg, clarithromycin500mg and colloidal bismuth pectin200mg). All regimens above were taken twice a day for10days. H. pylori status was confirmed by13C-urea breath test6weeks after completion of treatment and negative result was considered as success in H. pylori eradication. Demographic characteristics of patients such as gender, age, height, gender, smoking and body mass index (BMI) were recorded and evaluated exactly. Adverse reactions and patients’ compliance in each group were also evaluated.Results:A total of226patients participated in this study. In intention-to-treat analysis, the eradication rates of concomitant therapy, sequential therapy and bismuth-based therapy were85.6%(95%CI:77.7%,93.5%),70.7%(95%CI:60.4%,81.0%),85.3%(95%CI:77.3%,93.3%), respectively. Either concomitant therapy or bismuth-based therapy was significantly superior to sequential therapy (p<0.05). In per-protocol analysis, the eradication rates of the3regimens were87.8%(95%CI:80.3%,95.3%),82.8(95%CI:73.6,92.0%)和88.9%(95%CI:81.7%,96.1%), respectively. And there was no statistic significant between any two of the three groups (p>0.05). Among the3experimental groups, patients’ age, sex, height, smoking, BMI, and other demographic characteristics are not statistically significant (p>0.05). Adverse reactions among the groups have no significant differences (p>0.05). The compliance of sequential therapy group is significantly lower than concomitant therapy group and bismuth-based therapy group (p<0.05).Conclusion:Ten-day bismuth-based therapy can be adopted as the best empiric regimen to cure H. pylori infection in daily clinical work.