Helicobacter pylori Eradication with Ecabet Sodium, Omeprazole, Amoxicillin, and Clarithromycin Versus Bismuth, Omeprazole, Amoxicillin, and Clarithromycin Quadruple Therapy: A Randomized, Open-Label, Phase IV Trial

Liang J et al. – Neither 10–day Ecabet sodium–containing quadruple therapy or 10–day bismuth–containing quadruple therapy can be recommended as empiric therapy in cities with high antibiotic resistance rate of China.

Methods

• The authors did a randomized, open–label, phase IV trial in four cities (eight sites) in China, comparing the efficacy and safety of 10–days ecabet sodium–containing versus bismuth–containing quadruple therapy in adults with H. pylori infection.
• Eligible patients were randomly assigned treatment and monitored H. pylori eradication by negative [13C]/[14C] urea breath test 28 days after the treatment as the primary outcome.
• Symptoms improvement and side effects were the secondary outcome.

Results

• A total of 311 H. pylori–positive subjects were enrolled: 155 were assigned ecabet sodium quadruple therapy and 156 bismuth quadruple therapy.
• The eradication rates with ecabet sodium–containing and bismuth–containing quadruple regimens were 68.4% (106/155) and 68.0% (106/156) p=.9339 intention–to–treat (ITT) and 75.4% (104/138) and 77.0% (104/135) p=.7453 per–protocol (PP), respectively.
• The eradication rates for the ecabet sodium quadruple regimen differed significantly between cities (e.g., 81.2% ITT and 89.6% PP in Shanghai and 50% ITT and 53.5% PP in Xi'an).
• The symptom improvements and safety profiles were also similar for both treatments.

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