Herbal Supplements Face New Scrutiny

From the WSJ:

Elderberry extract and acai to boost the immune system. Black cohosh to lessen the discomforts of menopause. Soy capsules to prevent bone loss and prostate cancer.

Many botanical supplements—made from the seeds, bark, leaves, flowers and stems of a wide range of plants—have been widely used as folk remedies for centuries. Americans
have been consuming growing quantities of the supplements in hopes of
warding off disease and easing symptoms of various conditions. But there
is scant scientific evidence to support their health benefits.

Now, the federal government is stepping up research into the safety and effectiveness of a wide range of over-the-counter supplements, including plant oils, garlic, soy, elderberry, licorice, black cohosh,
St. John's wort and the Asian herb dong quai. The aim is to better
understand how compounds in the plants affect health and to help
consumers make more informed choices about supplements, which can
interact with prescription drugs, cause side effects or lead to new
health risks. Sales of botanical supplements in the U.S. topped $5
billion last year, up 17% from five years earlier, according to the
non-profit American Botanical Council.

"Sometimes people assume because a product is natural, it is also safer. But these compounds can have both benefits and potential side effects and we need to understand
both of those," says Floyd Chilton III, director of the Center for
Botanical Lipids and Inflammatory Disease Prevention at Wake Forest
University Baptist Medical Center in Winston-Salem, N.C. Dr. Chilton's
center received a $7.5 million federal grant to study botanicals,
including whether plant oils such as echium and borage can help play a
role in preventing cardiovascular disease, asthma and diabetes.

"People are using supplements for purposes for which they were not intended," such as treating health conditions they have self-diagnosed, or using
multiple supplements in combination with prescription medications, says
Marguerite Klein, director of the Botanical Centers Research program at
the National Institutes of Health. One concern, she says is the heavy
use by women of black cohosh to treat menopause symptoms, such as hot
flashes. Limited research seems to support the black cohosh's benefit.
But it isn't known how the botanical works. Black cohosh has been linked
in some patients to liver damage, and breast-cancer patients are often
advised to avoid using it because its effects on breast tissue are
unknown.

Helping to spur the research initiative are the Office of Dietary Supplements and the National Center for Complementary and Alternative Medicine, both part of the National Institutes of Health.
The agencies last month awarded grants totaling about $37 million to
five dietary supplement research centers, expanding a program that has
already awarded more than $250 million in research grants for herbs and
botanicals since 2002. The NIH is also funding research into botanical
products through the National Cancer Institute, which is interested in
how components in botanicals might influence cancer risk and tumor
growth.

Studies funded by the federal grants have so far shown that chamomile capsules may help reduce anxiety compared to a placebo and that an extract from the milk thistle plant can interfere with the life cycle of
the hepatitis C virus. They also have refuted some purported benefits
of botanicals, showing, for instance, that ginkgo biloba does not
prevent heart attack, stroke, or cancer, or stem memory loss and that
St. John's wort was no better than a placebo in treating symptoms of
attention deficit hyperactivity disorder in children and teens.

Unlike drugs, which must be tested in clinical trials and approved by the Food and Drug Administration before they can be marketed, botanicals and
other supplements don't require regulatory approval. The FDA in June
began requiring all supplement makers to follow strict quality
manufacturing standards, but the agency only periodically inspects
plants.

An investigation published in May by the General Accounting Office found deceptive marketing practices at a number of online retailers, including claims that supplements could prevent or
cure conditions such as diabetes, cancer, or cardiovascular disease. The
investigation also found trace amounts of potentially hazardous
contaminants, such as lead or bacteria, in 37 of 40 herbal dietary
supplement products it tested.

Tod Cooperman, president of ConsumerLab.com, which tests supplement brands for quality, says the group finds problems with about 25% of all supplements, and
especially with herbal products, many with ingredients from overseas. A
recent review of supplements made from ginseng—commonly taken to boost
energy and vitality—found that 45% failed quality tests because they
didn't contain the advertised amount of ginseng or were contaminated
with lead. Test results and other information are available to members,
who pay $30 annually.

Consumers also can find information about potential uses, benefits and risks of dietary supplements at federal websites ods.gov and nccam.gov. Another government site,
Medlineplus.gov, grades scientific evidence on a variety of supplements.

William Cefalu, director of the Pennington Biomedical Research Center at Louisiana State University in Baton Rouge, says
researchers are only beginning to understand how thousands of different
compounds in a single plant may interact, and how the concentration of a
particular plant chemical affects its potency. For example, peppermint
tea is considered safe to drink, but peppermint oil, often taken for
irritable bowel syndrome or indigestion, is much more concentrated and
can be toxic if used in high doses.

Because the potency of wild plants can vary, some researchers are cultivating their own. At the Center for Botanical Interaction Studies
at the University of Missouri in Columbia, 600 types of soybean seeds
are being cultivated to study different concentrations of the same
compounds in the plants and how they might work to prevent prostate
cancer. The center is also growing 60 types of elderberries to study the
plant's possible role in boosting the immune system against infection
and fighting cancer and inflammation in the body. Center director Dennis
Lubahn says there may be variations in individual plants that will make
a difference in how well they fight disease. "We've come a long way
from the traditional medicine woman sampling leaves in the forest," he
says.