Prospective, Randomized, Controlled Study for the Efficacy of Potassium Competitive Acid Blockers (P-CABs) versus Proton Pump Inhibitors (PPIs) in the First and the Second Line Eradication Regimens for H. pylori in Egyptian Patients

Abstract Background Helicobacter pylori (H.pylori) is a type of curved or spiral flagellated, Gram- negative micro-aerophilic bacterium that has been co-existing with human for over 5000 years. Since being discovered in 1984, H. pylori has been recognized as the main risk factor for gastritis, peptic ulcer, gastric carcinoma and gastric mucosa- associated lymphoma. Aim of the Work So the aim of the work was to compare the effectiveness of Vonaprazan based therapy vs PPI based therapy for the eradication of H.Pylori infection in treatment naive and experienced patients. Patients and Methods The current study was conducted on 232 patients selected from Tropical Medicine Department at Ain Shams University Hospitals and outpatient clinic of Tropical Medicine Department who were diagnosed to be H.pylori infection positive by the use of “H.pylori Antigen in stool test”, The recruited patients who fulfilled the study inclusion criteria were randomly assigned to one of the following using a computer based randomization program and were divided into 2 groups and 4 arms according to the used treatment regimens. Group 1 included H.pylori treatment naïve patients, which was then subdivided into Arms 1 and 2 according to the prescription of PPI vs P-CABs as a part of the classical triple H.pylori eradication regimen including “Clarithromycin and Penicillin”. Group 2 included H.pylori treatment experienced patients, which was then subdivided into Arms 3 and 4 according to the prescription of PPI vs P-CABs as a part of the LOAD H.pylori eradication regimen including “Levofloxacin, Doxycycline and Nanazoxide”. Results No statistical significant difference could be obtained between the P-CABs and the PPIs as a part of H.Pylori eradication regimens among the treatment naive and experienced patients. In Arm 1out of 58 patients, 3 patients “58.6%” achieved H.pylori eradication as per intention to treat analysis (ITT), while according to the per protocol analysis (PP), the percentage was “64.2%”, whereas those in Arm 2 out of 58 patients, 29 patients “50%”achieved H.pylori eradication according to ITT analysis, while according to PP analysis, the percentage was “56.9%”, while those in in Arm 3 out of 58 patients, “50%” achieved H.pylori eradication according to ITT analysis, while according to PP analysis, the percentage was “72.5%”, Whereas those in Arm 4 out of 58 patients, “43.1%”, achieved H.pylori eradication according to ITT analysis, while according to PP analysis, the percentage was “59.5%” Conclusion Results of eradication in P-CABs based group is comparable to that of the PPI based group. Treatment experienced groups showed lower eradication rates which indicates increased H.pylori resistance. It appears that the adherence was more in the triple therapy group than that of the quadruple therapy group which was reflected on the eradication rates. LOAD regimen adopted in the current study for H.pylori eradication in Egyptian patients resulted in a lower eradication rates compared to studies reported from other countries.