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11/28/06 News Release

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Barking up the right tree? Stanford study will evaluate effects of pine bark extracts

STANFORD, Calif. — High blood pressure puts millions of people at risk for heart attacks, stroke or kidney failure. While there are many prescription medications for the condition, some patients are also interested in natural supplements as an alternative treatment option.

A new study at the Stanford University School of Medicine will assess whether a supplement made from pine bark extract can help reduce the blood pressure of people who are at mild to moderate risk for heart disease. They will also assess whether the supplement has other positive effects on the cardiovascular system.

“Like most herbal supplements and natural remedies, pine bark extract is marketed with claims that it improves health,” said Randall Stafford, MD, PhD, associate professor of medicine at the Stanford Prevention Research Center and principal investigator for the study. “Most such claims lack the proof of sound clinical trials, yet millions of people spend billions of dollars out-of-pocket every year on dietary supplements and natural remedies.”

Humans have consumed pine bark for many centuries, and the first commercial pine bark extract was patented in 1948. Stafford noted that in 2002, supplements with oligomeric proanthocyanidin complexes, the main antioxidants in pine bark extracts, were the fourth-highest selling herbal supplement in the United States.

Pine bark extract contains numerous compounds that function as antioxidants — chemicals that help repair and protect cells from damage caused by the processes that breakdown food in the body and by exposure to environmental pollutants. The compounds in pine bark have also been shown to help strengthen blood vessel walls.

Previous studies have indicated that pine bark extract may reduce blood pressure and cholesterol levels, but Stafford said these studies weren’t large or rigorous enough to provide conclusive evidence of the effects of the extract. “It is important to learn what supplements are effective for particular conditions. This will allow consumers to make better choices and provide physicians with the information they need to advise their patients about supplement use,” he said.

For the Stanford study, researchers are recruiting 130 people who will be randomly assigned to take either a pine bark supplement or a placebo for 12 weeks. Participants will be assessed at the study’s outset and at the six- and 12-week marks to track their blood pressure, insulin and cholesterol levels, among other measurements. Blood samples will be collected from each participant five times over the course of the study.

To be eligible for the study, participants must be between the ages of 35 and 70, live within 30 miles of Stanford, have blood pressure levels of at least 125/80 and have an elevated body mass index (a measure of body fat based on height and weight) of between 24 and 36.

The pine bark extract being used in the study is manufactured by Toyo Shinyaku, a Japanese company that markets the supplement under the name Flavangenol. The company is funding the trial, but has no role in the study design. Additionally, the investigators are free to publish the study findings, regardless of the results. None of the Stanford researchers involved in the study has financial ties to the company.

More information about the Understanding Pine Bark Extract as an Alternative Treatment, or UPBEAT, study is available online at http://ppop.stanford.edu/PineBarkRecruitment.html or by calling (650) 724-9293.

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The Stanford University School of Medicine consistently ranks among the nation’s top 10 medical schools, integrating research, medical education, patient care and community service. For more news about the school, please visit http://mednews.stanford.edu. The medical school is part of Stanford Medicine, which includes Stanford Hospital & Clinics and Lucile Packard Children’s Hospital. For information about all three, please visit http://stanfordmedicine.org/about/news.html.

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