Clara Figueiredo

and 6 more

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.