• Qian Liu, Dongdong Qi, Jiarui Kang, Yiduo Jin, Wenxiang Liu, Wenbin Gao, Peng Hou, and Jiangyang Lu.
• Departments of aPathology bGastroenterology, the First Affiliated Hospital of General Hospital of PLA, Beijing cDepartment of Oncology, Affiliated Zhongshan Hospital of Dalian University, Dalian, China.
• Eur J Gastroenterol Hepatol. 2015 Mar 1; 27 (3): 221-5.

BackgroundThe eradication rate of Helicobacter pylori is steadily decreasing because of increasing resistance to clarithromycin. According to the new version of Maastricht IV guidelines, molecular tests can be performed as a substitute for bacterial culture and the standard clarithromycin susceptibility test for the detection of H. pylori and clarithromycin resistance directly on gastric biopsy samples.ObjectiveTo evaluate the clinical efficacy of H. pylori detection using a molecular test and treatment outcomes of the clarithromycin-based genotypic resistance test.Materials And MethodsA total of 385 patients diagnosed with functional dyspepsia were recruited in this clinical trial. Total DNA was extracted from formalin-fixed paraffin-embedded samples and prepared for a molecular test and H. pylori detection was performed simultaneously by modified Giemsa staining. Genotypically sensitive patients with positive H. pylori were treated by quadruple therapy: bismuth potassium citrate, rabeprazole, amoxicillin, and clarithromycin (BRAC) and genotypically resistant individuals were treated by bismuth potassium citrate, rabeprazole, amoxicillin, and furazolidone (BRAF) twice daily for 7 consecutive days. The eradication rate of H. pylori was assessed using the C-urea breath test at 6 weeks after treatment.ResultsThe prevalence of H. pylori infection in functional dyspepsia patients was 35.3% (136/385), 29.1% for women (53/182) and 40.9% for men (83/203). The sensitivities of real-time PCR and histological examinations were 95.6% (130/136) and 69.9% (95/136). Forty-one samples were found to be positive by real-time PCR alone and six by histological examination alone, the majority of which (32/41, 5/6) were identified as grade 1 multiplicity of infection. The overall resistance rate to clarithromycin was 37.7% (49/130): 37.3% (19/51) for women and 38.0% for men (30/79). Eighty-nine patients with positive H. pylori detected by both real-time PCR and histological examinations received quadruple therapies. For the intention-to-treat analysis, the eradication rates of BRAC and BRAF were 98% (52/53) and 92% (33/36), or 100% (52/52) and 94% (33/35) for per-protocol analysis.ConclusionReal-time PCR is efficacious for H. pylori detection and genotypic resistance-guided quadruple therapy has a high efficacy in treating functional dyspepsia with H. pylori infection.

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