Abstract

Abstract Background and Aims End-stage chronic kidney disease is associated with the condition of chronic inflammation, impacting increased cardiovascular mortality in this specific population. Patients on hemodialysis are known to be predisposed to several factors that predispose to inflammation: dialysis membranes, central venous catheters, oxidative stress, fluid overload, sodium overload, uraemic toxins. Propolis, a natural resin produced by bees from plant materials, has anti-inflammatory, immunomodulatory, and anti-oxidant properties. The aim of this study was to evaluate the impact of Brazilian green propolis extract on inflammation in hemodialysis patients. Here we present preliminary results of the trial NCT04072341. Method We performed a prospective trial, open-label 9-week crossover study examining the effect of Brazilian green propolis (250mg/day, in capsules) on inflammation in hemodialysis patients. We included patients over 18 years, under intermittent hemodialysis (thrice per week), on hemodialysis for at least 1 month and until now 37 patients were included. We excluded pregnant women, cancer carried and patients who developed infection or underwent any surgical procedure during the study period. Each period was 4 weeks in duration with a 1-week washout period in between. The primary end point was change in serum level of high-sensitivity c-reactive protein (HsCRP). Secondary end point evaluated the safety of propolis use in hemodialysis patients. Results Their mean age was 58.6 ± 15.2 years (mean ± SD), and 22 (59.4%) were men. The proportion of patients with hypertension was 14 (37.8%) and diabetes was 9 (24.3%). The number of patients using arteriovenous fistula were 26 (70.2%). The HsCRP presented (mean ± SE) 5.31 ± 1.02 mg/L at baseline, 4.26 ± 0.76 mg/L after propolis period and 4.56 ± 1.32 mg/L in control period, p = 0.0042. Safety parameters were analyzed such as amylase, aspartate aminotransferase (AST) and creatine phosphokinase (CPK); there was no difference between them before and after the use of propolis. None of the participants reported any adverse effects or allergic reactions during the treatment. Conclusion Patients on hemodialysis have an increased inflammatory state. For the best of our knowledge it was the first clinical trial who demonstrated the safety of propolis in hemodialysis patients. Brazilian green propolis demonstrated a tendency to reduce inflammation in these patients.

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