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Background: Helicobacter pylori infection is a major cause of chronic gastritis, peptic, mucosa associated lymphoid tissueMisdiagnosed as lymphoma and gastric cancer. The eradication rate of H. pylori with standard treatments are decreasing worldwide. The aim of this study was to determine the efficacy of adding simvastatin or probiotic as adjuvant to quadruple therapy on the eradication of H. pylori. Methods: This randomized clinical trial study was conducted on 160 patients with H. pylori. The patients were randomly divided in to 4 groups. The group 1: standard quadruple eradication regimen consisting of two antibiotics (clarithromycin 500 mg and amoxicillin 1 g, all twice per day), a proton pump inhibitor (pantoprazole 40 mg twice daily), Bismuth (120 mg twice daily) with placebo (daily), group 2: standard regimen plus probiotic (daily east 250 mg), group 3: standard regimen supplemented with simvastatin (10 mg daily) and group 4: standard regimen plus simvastatin (20 mg daily) for 14 days was given. The Eradication was determined by stool antigen test at least 1 month after treatment. Results: The risk ratio of eradication of the infection in the simvastatin group 10 mg and simvastatin 20 mg was 0.375 and 0.625 times in compare with the placebo group, indicating a negative effect of simvastatin 10 and 20 mg on the treatment of H. pylori infection, this relationship is not statistically significant (P > 0.05). Conclusion: Due to the high efficacy of simvastatin in H. pylori eradication, further studies are needed to evaluate the use of statins as adjunctive to improve the eradication rate.

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