Does Green Brazilian Propolis Extract Improve Functional Capacity in
Symptomatic Chronic Coronary Disease? -- a Pilot Randomized Trial.
Abstract
Background: Inflammation plays a critical role in coronary heart disease
progression. Low-dose colchicine has shown promise in reducing
cardiovascular events, and Green Brazilian propolis extract (EPP-AF®),
with anti-inflammatory properties, may offer benefits in its treatment.
This pilot study evaluates whether six weeks of EPP-AF improves
functional capacity assessed by treadmill test. Methods: the PRAIA trial
was a randomized, double-blind, placebo-controlled pilot study conducted
at a coronary disease clinic in an outsourced center in Brazil. Patients
aged ≥18 years with stable coronary artery disease, receiving optimized
medical therapy, were randomized 2:1 to receive either 200 mg of EPP-AF®
or placebo twice daily for six weeks. The primary outcome was the
change, measured in seconds, in treadmill exercise duration. Secondary
outcomes included total exercise time, METs, hs-CRP levels, Seattle
Angina Questionnaire (SAQ), and CCS score. Statistical analysis was
performed on an intention-to-treat basis. Results: A total of 59
patients were randomized, with a median follow-up of 6.5 weeks. The
primary endpoint, median change in treadmill test time, showed no
difference between the propolis (39 seconds) and placebo (30 seconds)
groups (p = 0.83). There were no improvements in functional capacity,
hs-CRP levels, or angina symptoms assessed by SAQ in the propolis group.
No major adverse cardiovascular events occurred during the study.
Conclusion: EPP-AF® did not improve functional capacity, inflammation
markers, or angina symptoms assessed by SAQ in patients with stable
coronary artery disease compared to placebo.