Objective: To compare the efficacies of non-bismuth quadruple therapy for 7 days versus standard triple therapy for 7 or 10 days in initial treatment of Helicobacter pylori (H.pylori) .
Methods: A randomized, open-labeled, controlled trial comparing non-bismuth quadruple therapy with standard triple therapy was performed at Peking University First Hospital from August 2010 to July 2012. A total of 246 patients with a diagnosis of H.pylori infection by (13)C-urea breath test and receiving no eradication therapy were randomly divided into non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days. There were 110 males and 136 females with an age range of 18-75 years. Among them, 81 patients received non-bismuth quadruple therapy (esomeprazole 20 mg, amoxicillin 1 000 mg, clarithromycin 500 mg and tinidazole 500 mg given twice daily for 7 days); 82 standard triple therapy (esomeprazole 20 mg, amoxicillin 1 000 mg and clarithromycin 500 mg given twice daily) for 7 days and 83 standard triple therapy for 10 days. The efficacies were examined at Week 4 post-therapy by (13)C-urea breath test. The incidence of adverse drug reactions was recorded.
Results: Among them, 242 patients completed the follow-up. The eradication rates for non-bismuth quadruple therapy and standard triple therapy for 7 or 10 days were 91.4% (74/81), 79.3% (65/82) and 79.5% (66/83) as determined by intention-to-treat analysis (ITT). The eradication rates were 92.5% (74/80), 81.3% (65/80) and 80.5% (66/82) respectively as determined by per-protocol analysis (PP).Non-bismuth quadruple therapy was superior to standard triple therapy for 7 days (ITT analysis P = 0.029, PP analysis P = 0.035) and 10 days (ITT analysis P = 0.032, PP analysis P = 0.026). The differences for the eradication rates between standard triple therapy for 7 days and for 10 days were insignificant (ITT analysis P = 0.968, PP analysis P = 0.902): Adverse reaction rates for non-bismuth quadruple therapy (8.8%, 7/80) and standard triple therapy for 7 days (7.5%, 6/80) and 10 days (9.8%, 8/82) were not significantly different (P = 0.872).
Conclusion: Non-bismuth quadruple therapy for 7 days is both effective and safe for the first-line eradication of H.pylori.