Atorvastatin and standard treatment of Helicobacter pylori: Single Blinded Randomized Controlled Clinical Trial

BackgroundConsidering the increase in drug resistance over time to Helicobacter pylori treatment relying on the anti-inflammatory and antibacterial effects of atorvastatin to increase the success rate of H. pylori eradication, we examined the effect of adding atorvastatin to standard treatment of H. pylori eradication. Materials and MethodsA total of 186 symptomatic patients who had been diagnosed with Helicobacter pylori infection and tested for H. pylori eradication were examined by a pathological response or positive urea breath test. Patients who received atorvastatin in addition to standard treatment were also identified based on a table of random numbers. Standard treatment included a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, all taken BID for 14 days. After 4 weeks of treatment, all patients underwent stool testing for H. pylori fecal antigen. If the test was positive, the request was considered a failure of treatment, and if the test was negative, it was considered a successful eradication of H. pylori. The clinical trial registration code for this study is IRCT20190823044589N1. ResultsThe eradication rate of H. pylori was 80% in the control group and 80.9% in the intervention group, which did not show a statistically significant difference between the two groups (P-value=0.971). ConclusionAdding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective. Significance of this Study (Summary box)O_LIWhat is already known about this subject? O_LIInfection of H. pylori is common worldwide and the antibiotic resistance is increasing C_LIO_LIAtorvastatin, has anti-inflammatory and antibacterial effects. But also, have D grade interaction with clarithromycin in H. pylori eradication regimen and increases the toxic and lethal risk of atorvastatin toxicity. C_LI C_LIO_LIWhat are the new findings? O_LIEradication rate of H. pylori using the standard treatment of a 240mg bismuth subcitrate tablet, a 40mg pantoprazole tablet, a 500mg metronidazole tablet, and 2 capsules of 500mg amoxicillin, BID for 14 days, is at least 80%. C_LIO_LIAdding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective. C_LI C_LIO_LIHow might it impact on clinical practice in the foreseeable future? O_LIThere should be more analysis on cost-benefice of adding atorvastatin to standard regimen of treatment for H. pylori eradication, but adding the atorvastatin to metronidazole-based H. pylori treatment is ineffective and for clarithromycin-based treatment is dangerous. C_LI C_LI