Non-bismuth quadruple therapy for first-line Helicobacter pylori eradication: A randomized study in Japan

AIM: To find the way to improve the eradication rate of first-line therapy in Japanese patients. METHODS: We prospectively compared the effectiveness of 7-d quadruple therapy to standard 7 d triple therapy in Japanese patients infected with Helicobacter pylori (H. pylori). One hundred and nineteen patients were randomly assigned to receive 7-d non-bismuth quadruple therapy with lansoprazole, amoxicillin, clarithromycin and metronidazole (LACM7) or 7-d triple therapy with lansoprazole, amoxicillin and clarithromycin (LAC7). After three months, H. pylori status was analyzed by 13C-urea breath test. Incidence rates of adverse events were evaluated by use of questionnaires. RESULTS: By intention-to-treat (ITT) analysis, the eradication rate in the LACM7 group was 94.9%, which was significantly higher than the LAC7 group (68.3%, P < 0.001). Per protocol analysis also showed a significantly higher eradication rate in the LACM7 group (98.3%) than the LAC7 group (73.2%, P < 0.001). Nevertheless, the incidence of serious adverse events did not differ between the two groups (RR: 1.10, 95% CI: 0.70-1.73, P = 0.67). CONCLUSION: Seven day non-bismuth quadruple therapy (LACM7) was superior to standard 7-d triple therapy (LAC7) for first-line eradication.