No beneficial effects of pine bark extract on cardiovascular disease risk factors.
What this study found
Pine bark extract did not improve blood pressure or other cardiovascular risk factors over 12 weeks. In the active arm, resting blood pressure changes were small and not different from placebo: systolic -0.1 (-2.2 to 2.0) mm Hg, diastolic -0.9 (-2.2 to 0.4) mm Hg, combined -1.0 (-4.2 to 2.1) mm Hg; the between-group P value for 12-week BP change was .87. BMI increased slightly in the pine bark extract group versus placebo, with a between-group difference of 0.20 (95% CI 0.03-0.39; P = .02). Adverse events were similar overall, with 43 events in the pine bark extract group and 42 in the…
- Study & population
- Randomized, placebo-controlled, 1:1 trial in 130 community-recruited overweight or obese adults with prehypertension or hypertension who were not taking antihypertensive medications.
- Intervention
- Participants took 200 mg/day of French maritime pine bark extract (Toyo-FVG, Pinus pinaster) as 4 oral 50 mg tablets each morning for 12 weeks, compared with placebo.
- Key limitation
- The trial was relatively small, single-center, and only 12 weeks long, which limits power to detect modest effects and longer-term outcomes.
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Open PDFOriginal abstract
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.