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. 2022 Dec 6;12(12):2038. doi: 10.3390/life12122038

Table 2.

Clinical Efficacy and Safety.

Clinical Efficacy and Safety
Author and Study Groups Studied and Intervention Results and Findings Conclusions
Study 1: Single Capsule Bismuth Quadruple Therapy for Eradication of H. pylori Infection: A Real-Life Study
https://pubmed.ncbi.nlm.nih.gov/33995097/ (accessed on 11 August 2022)
A total of 250 treatment-naïve patients were given esomeprazole 40 mg bid and Pylera 3 tablets QID for 10 days.
  • 13 patients discontinued therapy due to side effects

  • Compliance was greater than 90%

  • Eradication rates were 90.8%

  • 26.8% experienced adverse effects

Using a combination capsule is an effective strategy that improves compliance and yields high eradication rates with low incidence of side effects.
Study 2: Long-term changes in the gut microbiota after triple therapy, sequential therapy, bismuth quadruple therapy, and concomitant therapy for Helicobacter pylori eradication in Chinese children
https://pubmed.ncbi.nlm.nih.gov/33899288/ (accessed on 11 August 2022)
  • 16 patients in triple therapy group

  • 15 patients in sequential therapy group

  • 16 patients in bismuth quadruple therapy

  • 16 patients in quadruple therapy

  • Fecal samples were sampled at weeks 0, 2, 6, and 52, and 16S RNA gene sequenced to assess alterations in gut microbiota

  • All groups showed alterations at week 2 but were restored by week 52

  • Immediately following treatment in the ST group, Proteobacteria significantly increased

Transient microbiota changes may occur following H. pylori treatment but return to normal within a year to indicate long-term safety.
Study 3: Half-dose clarithromycin-containing bismuth therapy is effective and economical in treating Helicobacter pylori infection: A single-center, open-label, randomized trial quadruple
https://pubmed.ncbi.nlm.nih.gov/30780194/ (accessed on 11 August 2022)
  • 210 patients assigned to either half dose clarithromycin (250 mg BID) or standard dose clarithromycin (500 mg BID) containing bismuth quadruple therapy for 14 days

  • UBT performed at 4 weeks post-treatment to assess eradication

  • Eradication rates were equivalent at 86.67% for both groups

  • The standard-dose group had a higher incidence of side effects at 54.21% vs. 34.29%

  • Lower dose also has an improved cost-effectiveness ratio

A half-dose clarithromycin regimen is as effective as the full dose regimen with improved tolerability and affordability.
Study 4: Efficacy of Lactoferrin with Standard Triple Therapy or Sequential Therapy for Helicobacter pylori Eradication: A Randomized Controlled Trial
https://pubmed.ncbi.nlm.nih.gov/34609303/ (accessed on 11 August 2022)
A total of 400 H. pylori-infected patients were either assigned to a triple therapy or sequential therapy group, and each regimen also had a separate group that added bovine lactoferrin for 2 weeks. Bovine lactoferrin showed improved effectiveness in the sequential therapy and triple therapy (94.5% vs. 82.8% and 85.6% vs. 70.3%). Bovine lactoferrin could help improve eradication rates as an addition to current regimens.
Study 5: Efficacy and safety of twice a day, bismuth-containing quadruple therapy using high-dose tetracycline and metronidazole for second-line Helicobacter pylori eradication
https://pubmed.ncbi.nlm.nih.gov/32074663/ (accessed on 11 August 2022)
A total of 100 patients in each group received either bismuth subcitrate 300 mg QID or BID, tetracycline 1 g, metronidazole 750 mg, and pantoprazole 20 mg BID for 1 week. The eradication rates between the twice daily and four times daily did not differ (93.9% vs. 92.9%), while adverse effects were more common in the four times daily than twice daily (50 vs. 36). The twice daily regimen is as effective and safe as the four-times-daily regimen.