International Journal of Nephrology (Jan 2022)

Effects of Standardized Brazilian Green Propolis Extract (EPP-AF®) on Inflammation in Haemodialysis Patients: A Clinical Trial

  • Marcelo Augusto Duarte Silveira,
  • Hayna Malta-Santos,
  • Jéssica Rebouças-Silva,
  • Flávio Teles,
  • Erica Batista dos Santos Galvão,
  • Sergio Pinto de Souza,
  • Fábio Ricardo Dantas Dutra,
  • Marcel Miranda Dantas Gomes,
  • Maurício Brito Teixeira,
  • Luis Filipe Miranda Rebelo da Conceição,
  • Carolina Sa Nascimento,
  • Carolina Kymie Vasques Nonaka,
  • Rodrigo Silva Cezar,
  • Paulo Benigno Pena Batista,
  • Andresa Aparecida Berretta,
  • Valeria M. Borges,
  • Rogerio da Hora Passos

DOI
https://doi.org/10.1155/2022/1035475
Journal volume & issue
Vol. 2022

Abstract

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Background. Patients on haemodialysis (HD) present a significant inflammatory status, which has a pronounced negative impact on their outcomes. Propolis is a natural resin with anti-inflammatory and immunomodulatory properties. We assessed the safety and impact of a standardized Brazilian green propolis extract (EPP-AF®) on the inflammatory status in patients under conventional HD. Methods. Patients were assigned to receive 200 mg/day of EPP-AF® for 4 weeks followed by 4 weeks without the drug, and changes in plasma levels of interleukins (ILs), interferon gamma (IFN-γ), tumour necrosis factor-alpha (TNF-α), and high-sensitivityc-reactive protein (HsCRP) were measured. A heatmap was used to illustrate trends in data variation. Results. In total, 37 patients were included in the final analysis. Patients presented an exacerbated inflammatory state at baseline. During EPP-AF® use, there was a significant reduction in IFN-γ (p=0.005), IL-13 (p=0.04 2), IL-17 (p=0.039), IL-1ra (p=0.008), IL-8 (p=0.009), and TNF-α (p < 0.001) levels compared to baseline, and significant changes were found in Hs-CRP levels. The heatmap demonstrated a pattern of pronounced proinflammatory status at baseline, especially in patients with primary glomerulopathies, and a clear reduction in this pattern during the use of EPP-AF®. There was a tendency to maintain this reduction after suspension of EPP-AF®. No significant side effects were observed. Conclusion. Patients under haemodialysis presented a pronounced inflammatory status, and EPP-AF® was demonstrated to be safe and associated with a significant and maintained reduction in proinflammatory cytokines in this population. This trial is registered with Clinicaltrials.gov NCT04072341.