No beneficial effects of pine bark extract on cardiovascular disease risk factors.

BACKGROUND Although modifiable cardiovascular disease risk factors are common, some patients eschew conventional drug treatments in favor of natural alternatives. Pine bark extract, a dietary supplement source of antioxidant oligomeric proanthocyanidin complexes, has multiple putative cardiovascular benefits. Studies published to date about the supplement have notable methodological limitations. METHODS We randomized 130 individuals with increased cardiovascular disease risk to take 200 mg of a water-based extract of pine bark (n = 64; Toyo-FVG, Toyo Bio-Pharma, Torrance, California; Shinyaku Co, Ltd, Saga, Japan; also marketed as Flavagenol in Japan) or placebo (n = 66) once per day. Blood pressure, our primary outcome, and other cardiovascular disease risk factors were measured at baseline and at 6 and 12 weeks. Statistical analyses were conducted using regression models. RESULTS Baseline characteristics did not differ between the study groups. Over the 12-week intervention, the sum of systolic and diastolic blood pressures decreased by 1.0 mm Hg (95% confidence interval, -4.2 to 2.1 mm Hg) in the pine bark extract-treated group and by 1.9 mm Hg (-5.5 to 1.7 mm Hg) in the placebo group (P = .87). Other outcomes were likewise not significantly different, including body mass index, lipid panel measures, liver transaminase test results, lipoprotein cholesterol particle size, and levels of insulin, lipoprotein(a), fasting glucose, and high-sensitivity C-reactive protein. There were no subgroups for whom intake of pine bark extract affected cardiovascular disease risk factors. CONCLUSIONS This pine bark extract (at a dosage of 200 mg/d) was safe but was not associated with improvement in cardiovascular disease risk factors. Although variations among participants, dosages, and chemical preparations could contribute to different findings compared with past studies, our results are consistent with a general failure of antioxidants to demonstrate cardiovascular benefits. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00425945.