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

Abstract

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.

Standardized Brazilian green propolis extract (EPP-AF®) in COVID-19 outcomes: a randomized double-blind placebo-controlled trial

“…The safety analysis was performed throughout the entire study period. Previous randomized studies that used EPP-AF had already shown the safety profile of this medication, even in patients with chronic kidney disease undergoing hemodialysis 11 , 17 , 26 . Although shock and MV were on the list of severe adverse events, we cannot link the occurrence of such events to the drug tested due to the severity of the disease or even secondary infections in every patient who had them, especially because it has happened in both groups tested.…”

Exploring the Prospective Role of Propolis in Modifying Aging Hallmarks

“…Attention is drawn to the imperative of standardizing this bee-derived product while implementing rigorous quality control measures. Certain researchers have already taken steps in this direction, particularly in relation to Brazilian green propolis [ 315 ] and propolis of the poplar variety [ 316 , 317 , 318 ]. It is only when such standardization is achieved that this natural product can truly serve as a viable adjunctive therapy with internationally recognized quality control standards.…”

Inflammation in Coronary Atherosclerosis: Insights into Pathogenesis and Therapeutic Potential of Anti-Inflammatory Drugs

“…For instance, in a population with chronic kidney disease undergoing hemodialysis, the use of propolis for four weeks led to significant reductions in the levels of TNF-alpha, gamma interferon, IL-1, and other cytokines [ 45 ]. Additionally, a randomized study involving patients hospitalized with COVID-19 revealed that those who received daily doses of 400 to 800 mg of propolis for seven days had a shorter hospital stay compared to those who received placebo [ 46 ].…”