The Efficacy, Safety, And Tolerability of Levofloxacin Quadruple Therapy For Helicobacter Pylori Eradication: A Randomized, Double-Blind Clinical Trial

The incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori. In a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention. According to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1 % (95 % CI: 39.3-57.8) and 47.6 % (95 % CI: 39.7-58.4), respectively compared to the BPAL- 10 regimen 62.7 % (95 % CI: 53.6-72.8) and 62.4 % (95 % CI: 55.1-72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6 %) and BPAL-10 (36.7 %) groups. Although the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19).

Prevalence, clinical course and treatment of chronic gastritis at the present stage

Background. The importance of the problem of chronic gastritis (CG) is determined by its high proportion in the structure of gastrointestinal pathology, reduced quality of life of patients, and possible complications. The study aimed at the investigation of the incidence and features of the clinical course of CG in servicemen at the present stage and pharmacoeconomic efficacy of bismuth and triple anti-helicobacter therapy (AHBT) in H. pylori (HP) — associated erosive gastritis with the use of domestic drugs. Materials and methods. At the first stage, the indicators of the admission rate of servicemen with CG and the peculiarities of the endoscopic picture of the gastric mucosa were analyzed. At the second stage, the features of the clinical course were studied and a pharmacoeconomic analysis of treatment regimens in servicemen with HP-associated erosive gastritis with proton pump inhibitors of different generations and domestic bismuth subcitrate, used in triple and bismuth-containing regimens, was performed. Results. An epidemiological, clinical, and pharmacoeconomic analysis of HP-associated CG in servicemen at the present stage has been conducted. It is reasonable to treat servicemen with HP-associated erosive gastritis with domestic drugs using bismuth-containing anti-helicobacter therapy, which will improve the efficiency and quality of treatment and avoid unjustified budget costs. Conclusions. Among the servicemen of the Armed Forces of Ukraine, starting from 2013, there is a tendency to increase the number of erosive gastroduodenal lesions with a predominant lesion of the antrum of the stomach. Pharmacoeconomic analysis of the treatment of HP-associated erosive gastritis showed the feasibility of switching to bismuth-containing AHBT with the use of domestic rabeprazole and bismuth subcitrate. This is justified by a higher anti-Helicobacter activity by 1.2 times (20 %), 1.6 times better (60 %) cost-effectiveness, and 1.4 times higher (40 %) cost-utility.

Atorvastatin in Helicobacter Pylori Treatment: A Randomized Controlled Trial and Review

Background: Considering 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.Results: A 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. The 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).Conclusion: Adding atorvastatin to 4-drug regimen of PPI, bismuth subcitrate, amoxicillin, and metronidazole as the first line of treatment for H. pylori eradication is ineffective.Trial registration: IRCT, IRCT20190823044589N1. Registered 28 December 2019 - Retrospectively registered, https://en.irct.ir/trial/41734

Comparing the Effect of Two Low-dose and High-dose Four-drug Regimens of Furazolidone in Eradicating Helicobacter Pylori

BACKGROUND Antibiotic resistance is a major cause of Helicobacter pylori (H. pylori) treatment failures. The increased resistance to clarithromycin and metronidazole has reduced the ability of this therapeutic regimen and prompted researchers to look for other drugs. One of the antibiotics of interest in this regard is furazolidone because of its low drug resistance. The aim of this study is compare two-drug regimens including low-dose and high-dose furazolidone in the treatment of H. pylori. METHODS This study is a clinical trial in which the studied subjects were categorized into two groups. The first group underwent treatment with amoxicillin 1000 mg-BD, furazolidone 100 mg-BD, omeprazole 20 mg-BD, and bismuth subcitrate 240 mg-BD for two weeks (low-dose OFAB). The second group received furazolidone 200 mg-BD (high-dose OFAB). Then eight weeks after completion of the treatment, they were examined in terms of eradication via the UBT test. RESULTS 85 participants completed the study in each group. The response to treatment was 76% and 83% in the low and high-dose groups, respectively, based on intention to treat analysis. Based on per protocol analysis the response to treatment was 78% and 84%, respectively, if excluded patients had completed their protocol and had response to treatment, and 72% and 79%, respectively, if excluded patients had completed their protocol and did not have response to treatment (p = 0.298). In the low-dose and high-dose groups, 16.5% and 24.7% of the participants suffered the complications of treatment with furazolidone (p = 0.18), respectively. Three patients in the high-dose group and one in the low-dose group did not complete the treatment because of the medication’s bad taste (p = 0.03). CONCLUSION Low doses of furazolidone had a comparable therapeutic effect compared with high doses, but patients experienced significantly lower levels of bad taste, which was a major cause of reluctance to continue treatment. Therefore, we think four-drug low-dose furazolidone treatment is a good choice in eradicating H. pylori.

Allosteric inhibition of SARS-CoV-2 3CL protease by colloidal bismuth subcitrate

Colloidal bismuth subcitrate (CBS) is an allosteric inhibitor of 3-chymotrypsin-like protease (3CLpro) in SARS-CoV-2. CBS binding causes dimeric 3CLpro dissociation and proteolytic dysfunction, leading to the suppression of SARS-CoV-2 replication.

The efficacy, safety, and tolerability of levofloxacin quadruple therapy for helicobacter pylori eradication: a randomized, double-blind clinical trial

BackgroundThe incidence of microbial resistance is increasing, and new rescue regimens are needed in order to treat Helicobacter pylori (H. pylori) infection. To evaluate the efficacy, safety, and tolerability of levofloxacin based quadruple therapies in the eradication of H. pylori.MethodsIn a randomized, double-blind clinical trial, 220 patients with dyspepsia and H. pylori infection were randomly assigned to receive either bismuth subcitrate 240 mg, pantoprazole 20 mg, amoxicillin 1000 mg twice a day, and levofloxacin 500 mg daily for seven days (BPAL-7), or ten days (BPAL-10). The eradication of H. pylori was evaluated two months after the end of treatment, and adverse drug reactions (ADRs) were assessed during the intervention.ResultsAccording to intention-to-treat and per-protocol, the eradication rate was significantly lower in the BPAL-7 regimen 49.1% (95% CI: 39.3–57.8) and 47.6% (95% CI: 39.7–58.4), respectively compared to the BPAL- 10 regimen 62.7% (95% CI: 53.6–72.8) and 62.4% (95% CI: 55.1–72.8), respectively. The incidence of ADRs was not statistically significant between BPAL-7 (33.6%) and BPAL-10 (36.7%) groups.ConclusionAlthough the ADRs were negligible in both groups, these regimens could not be an ideal alternative therapy for H. pylori because of low eradication rates compared to standard regimens.Trial registration: The study reviewed and approved by the Iranian Registry of Clinical Trials (IRCT201406141155N19). This trial was retrospectively registered on July 10, 2015.

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.