Background and aims: Efficacy with substitution of tetracycline with amoxicillin, an antibiotics having a very low resistance rate and a high tolerability, in bismuth quadruple therapy (BQT) have not been studied in Vietnam. Our study aimed to evaluate the efficacy and tolerability of modified BQT vs. standard BQT for first-line Helicobacter pylori eradication.
Patients and methods: This is a randomized, prospective study. 120 patients with H.pylori positive-chronic gastritis were randomly divided into two groups. The RBMA group containing rabeprazole 20 mg, bismuth subsalicylic 524mg, metronidazole 500mg, amoxicillin 1000mg, all 2 times a day, for 14 days. The RBMT group received rabeprazole, bismuth subsalicylic, metronidazole and tetracycline. Evaluation for compliance and drug-related side effects were evaluated at the end of two weeks. 4-6 weeks after the end of treatment, the H.pylori eradication rate was determined by the C13urease breath test.
Results: Eradication rate was not statistically significative different between the RBMA and the RBMT: 91.2%; 95% confidence interval, 78.2% - 96.7%) vs. 90%; 95% CI, 81.6% - 96.3%) by per-protocol analysis (p = 0.42) and 86.7% (95%CI, 75.84% - 93.09%) vs. 75% (95%CI, 62.1% - 85.3%) by intention-to-treat analysis (ITT, p = 0.06). Adverse effects were significant higher in the RBMT group than in the RBMA group (48.3% vs. 26.7%; p = 0.071) and rate of good compliance was significantly higher in RBMA group than in RBMT group (p < 0.05).
Conclusion: The modified BQT including rabeprazole, bismuth, metronidazole and amoxicillin achieved a fairly high rate of H.pylori infection eradication with a higher compliance and lower rate of adverse effects compared to the BQT in patients with chronic gastritis. Further studies need to conduct to confirm this new regimens as a first-line therapy in our country.
Key words: Modified bismuth quadruple therapy, BQT, Helicobacter pylori eradication
