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Bl. Cohosh

Herbs for Hot Flashes: New Attention, Mixed Results

erry Heaton will not find out for at least another year whether the pills she
tried for hot flashes were just blanks or really black cohosh, the much
ballyhooed Native American remedy for women's ailments.

As a participant in a federally financed study at Columbia University who
dutifully recorded the frequency and severity of her hot flashes over 12
months, Ms. Heaton, a 56-year-old retired airline employee, could see that her
menopausal symptoms were diminishing. She was definitely sleeping better.

Yet, toward the end of the year, Ms. Heaton, a Manhattan resident, was still
having mild anxiety attacks. So she wondered whether she had taken a placebo
after all.

"I believe it was the black cohosh because I felt it was helping me," Ms.
Heaton said. "But I don't know for sure."

Neither do experts, who are still identifying black cohosh's crucial
ingredient and sorting out how the flowering herb works, not to mention trying
to confirm whether it really does work significantly better than placebos.

Stunned by the string of negative studies about hormone replacement, including
research released last week that emphasized the risk of heart attacks and
breast cancer, millions of menopausal women are searching for safe
substitutes. Their quest for relief from hot flashes, night sweats and other
symptoms has coincided with the first wave of results from studies begun over
the last several years of popular herbs and other nonpharmaceutical

But to the dismay of enthusiasts of alternative medicines, the evidence of the
benefits has been limited and mixed. As a result, experts are urging caution
in using products that are just beginning to be understood, are of
inconsistent quality and are sold in nontraditional ways.

"The first thing we tell women about the alternatives is that it's really
important to realize that a product is not necessarily safe just because it's
`natural,' " said Amy Allina, policy and program director for the National
Women's Health Network in Washington. "The same questions we ask about drugs
should be asked of natural remedies too. Why are you taking it? What are the
risks associated with it? Are there studies proving it's effective for the
purpose you're taking it?"

Last year, Dr. Adriane J. Fugh-Berman, an expert in women's health at George
Washington University, and Dr. Fredi Kronenberg, a professor of physiology at
Columbia, surveyed scientific studies on complementary and alternative
treatments for menopausal symptoms. Most of the tests have focused on hot
flashes, the most common and concrete symptom that drives women to seek

Their review, published in The Annals of Internal Medicine, found that in 10
clinical trials of five herbs and one herbal mixture tested for hot flashes,
just black cohosh has shown a beneficial effect.

In most of the studies, the improvements for black cohosh were not drastically
different than for those taking hormone replacements or placebos, the review
noted. There is still no published information on the long-term safety of
black cohosh because none of the completed studies lasted more than six
months, their review said.

A more recent article, in the journal Menopause, cites the growing body of
evidence that black cohosh is safe. But the author, Dr. Tieraona Low Dog, said
she did not recommend using it for longer than six months.

"Take it for six months, then re-evaluate," said Dr. Low Dog, an assistant
professor at the University of New Mexico.

Despite the caveats, black cohosh had $59 million in sales last year, a more
than fivefold increase from 1998, according to The Nutrition Business Journal,
a trade publication in San Diego.

The Chinese herbs dong quai and ginseng showed no benefit for hot flashes, the
survey in The Annals of Internal Medicine found. Neither did oil of evening
primrose or red clover, another Indian folk remedy.

One of the most recent studies, published last month in The Journal of the
American Medical Association, found that the effects of two brands of red
clover on hot flashes were just slightly better than that of the placebo.

In urging a cautious approach, Dr. Fugh-Berman cited the roller coaster ride
of the hormone replacement therapies that the herbs could in theory replace.
Millions of women began taking replacements after studies found an association
between good health and their use. It was not until vast studies like the
Women's Health Initiative applied more rigorous methods that the picture began
to change.

"Herbs have not come out looking very good for the treatment of menopausal
symptoms so far," Dr. Fugh-Berman, an assistant clinical professor of
medicine, said. "One thing the Women's Health Initiative should have taught us
all is don't trust observational studies for ascertaining the benefits of

Even soy, now being sold in pill form, is not the miracle cure originally
believed, and it may affect the body differently as an extract than as a food,
several experts said.

A staple in Asian cuisine for thousands of years, soy foods are considered a
possible reason for the lower prevalence of menopausal symptoms reported by
women in China, Japan and Korea.

The bean has gained popularity on American tables, and its active ingredients,
a group of plant estrogens known as isoflavones, have been turned into an
extract that has become the biggest-selling dietary supplement in the
so-called menopause market. Sales of soy supplements have quadrupled for five
years, to $102 million last year, according to The Nutrition Business

But of eight studies of soy or isoflavone supplements that lasted more than
six weeks, three showed significant improvement in hot flashes, according to
The Annals survey. The longest study showed no benefit for hot flashes or
other menopausal symptoms at 24 weeks. Other published results showed only
modest benefits.

All beans contain plant estrogens, not just soy, and eating more of them is a
harmless way to try to manage menopause, several experts said. But the same
presumption of safety, they added, cannot be made for extracts sold over the
counter, many of which are packaged in high concentrations. "Soy foods are
safe," Dr. Kronenberg said. "Soy extracts remain to be seen."

Similarly, acupuncture and deep-breathing and relaxation exercises are
considered benign therapies that have shown benefits in the few studies
conducted so far. But wild yam cream has proved to be useless. And although
progesterone cream showed significant improvements in hot flashes in a study
whose primary focus was bone density, it also caused vaginal spotting in 8 of
30 women.

Another complication in the study of alternatives is that hot flashes have
been extremely responsive to placebos. They seem to improve, at least
temporarily, with just about any intervention. Most therapies have a placebo
response rate of 30 percent in clinical trials. The rate with hot flashes is
40 to 50 percent. Researchers have yet to figure out

why. "We don't know what causes a hot flash, to this day," said Dr.
Kronenberg, who has been studying the phenomenon for 15 years.

In a series of federally financed trials at Columbia, where she is director of
the Richard and Hinda Rosenthal Center for Complementary and Alternative
Medicine, Dr. Kronenberg is studying not only black cohosh, but also flax
seeds and macrobiotic diets.

Flax, a grain rich in essential fatty acids, vitamin E and plant estrogens, is
being added to the diets of some participants to see whether it helps hot
flashes, sleep problems and other menopausal symptoms. One participant, Maria
Paniagua, 57, a technician for a telephone company, said she felt no changes
but enjoyed losing some weight. More enthusiastic was Patt Haring, 59, a
retired teacher with glowing skin who said the night sweats that had been
driving her crazy improved within weeks after she started following the strict
macrobiotic diet. "It was really liberating," Ms. Haring said, "to be off all
those hormones and learn which foods you can eat to heal yourself."

At the University of Illinois, an expert on medicinal plants, Norman
Farnsworth, said his laboratory had confirmed that black cohosh acted on the
hypothalamus, the area of the brain that regulates hormones and body
temperature, a development that could support the herb's safety.

Native Americans did not historically use black cohosh for hot flashes, but
rather as an aid for labor and as an antidepressant, said Dr. Low Dog, who is
of Indian descent and has been practicing herbal medicine for 25 years.

"What I find interesting is that its historical use was for melancholy," Dr.
Low Dog said. "And now studies clearly show it is not estrogenic, but appears
to be working through the central nervous system. This would be consistent
with its historical use."

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