Abstract

Background: Eradication therapy for Helicobacter pylori-related chronic gastritis was approved for coverage by the Japanese national insurance in February 2013. Therefore, the use of eradication therapy has rapidly increased in Japan. The primary eradication rate of H. pylori using the 7-day triple therapy has gradually decreased in recent years. Drug resistance to clarithromycin (CAM), poor treatment compliance, and smoking are factors associated with eradication failure. A recent study showed that combination of eradication agents is useful for increasing eradication success, because combination treatments are prepared using daily dosages on one sheet. In our study, we prospectively compared the eradication rate in patients receiving conventional therapy with three drugs to that in patients receiving combination therapy. Patients and methods: Between July 2012 and September 2013, we included 276 patients (147 men and 129 women; mean age, 62.2 years) with H. pylori-positive peptic ulcers and gastritis. Combination therapy (Lansap®; lansoprazole 30 mg plus amoxicillin 750 mg plus CAM 200 mg) was administered to 54 patients twice a day for 7 days, and conventional therapy (omeprazole 20 mg or esomeprazole 20 mg or rabeprazole 20 mg plus amoxicillin 750 mg plus CAM 200 mg) was administered to 221 patients as individual drugs twice a day for 7 days. The 13C-urea breath test was used to confirm the eradication of H. pylori at least 6 weeks after the completion of eradication therapy. Patients who had undergone H. pylori eradication therapy in the past and patients who used proton pump inhibitors and antibiotics within 4 weeks were excluded. Results: No significant difference was observed in the background criteria of patients between the combination group and conventional group. The eradication rate (per protocol analysis) in the combination group was 90.3% (47/52), which was significantly different from that in the conventional group (74.9%; 161/215; p< 0.01). In addition, the eradication rate in intention-to-treat (ITT) analysis was significantly higher in the combination group (85.4%, 47/55) than in the conventional group (72.8%, 161/221; p< 0.01). No significant difference was observed in the incidence of adverse drug reactions (such as diarrhea, dysgeusia, and eruption) between the two groups (combination group 4.1%; conventional group 4.7%). Conclusions: Our study suggested that combination therapy with eradication agents is more useful for successful eradication of H. pylori than conventional therapy, although the primary eradication rate has decreased in Japan in the recent years. The underlying reason for the decrease in the primary eradication rate might be greater compliance to combination therapy.

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