By Sheryl Gay Stolberg
For decades, women around the world have
treated the symptoms of menopause with a simple herb called
Now the N.I.H. is putting it to the test.
There isn't a 50-year-old woman in America
today who isn't obsessed with menopause. In my grandmother's
day, the loss of a woman's ability to have babies was chalked
up, quietly, to "the change of life" -- if, that
is, she lived that long.
Now aging baby boomers, never quiet about
anything, can spend as many years without functioning ovaries
as with them. Menopause, circa 2001, is no longer a life passage.
It is a medical event.
Of all the symptoms of menopause, the
hot flash is the most intriguing. A classic hot flash begins
with an aura, a vague sensation in the face and neck that
blossoms over a period of a minute or two, skin temperature
rising, pulse quickening, into a full-blown wave of heat and
blushing and drenching sweat, often followed by chills.
Japanese women, mysteriously, report fewer
hot flashes than Americans. Spicy foods and hot drinks trigger
hot flashes in some women but not others. Some women flash
only sporadically. Some flash like clockwork, night and day,
some only during sleep.
the standard therapy for hot flashes has been the hormone
The good news about estrogen is that it
prevents osteoporosis, and possibly heart disease; the bad
news is that, taken long-term,
it may increase the risk of breast cancer.
This has put the modern menopause generation
in a pickle.
Now comes a possible solution to the estrogen
dilemma: black cohosh, the leading herbal therapy for hot
flashes in Europe. A cousin of the buttercup, with tall spikes
of brilliant white flowers and a gnarled, resin-scented root,
black cohosh -- the name is believed to be Indian in origin
-- grows wild in the deciduous forests of the eastern United
States. American Indians have used it as a folk remedy for
The Cherokee relied on alcoholic spirits
of black cohosh root to treat rheumatism and ground the root
into teas to treat consumption and fatigue; the Algonquins
used it for kidney trouble. By 1849, the newly formed American
Medical Association was describing black cohosh as useful
for "the debility of females attendant upon uterine disorder."
Today, the extract of black cohosh's roots
and rhizome is sold in capsules or tablets of varying strength
and dispensed in European pharmacies as a drug. Though no
one is quite certain how the herb works, German
studies show it is better at treating hot flashes than dummy
pills, and Commission E, a German panel of scientific
experts, recommends black cohosh for menopause and menstrual
Word has spread across the Atlantic; according
to Nutrition Business Journal, a trade publication, sales
of black cohosh preparations in this country jumped to $34
million in 1999, from $11 million the year before
-- a trend that is occurring almost entirely outside the medical
mainstream, because many American doctors behave as though
herbal remedies don't exist.
Eighty percent of the world's population
relies on traditional forms of medicine, chiefly herbal medicine.
From a global perspective, the United States is a third-world
country when it comes to herbal products.
how future studies turn out, black cohosh will never replace
estrogen, because it is probably
not as powerful as the hormone and may not have the same positive
effect. But if it does ease hot flashes -- and both Kronenberg
and Farnsworth say that based on past research there is little
reason to think it will not -- American doctors may one day
find themselves doing the unthinkable: recommending a traditional
botanical folk remedy as an alternative to a modern prescription
A decade ago, there would have been little
place for this kind of research in academic medicine; many
serious scientists dismissed botanical remedies as quackery.
But in recent years, just about every big-name university
in the country -- Johns Hopkins, Duke, the University of California
at Los Angeles -- has become involved in some type of alternative-medicine
research. Their studies offer the promise of new treatments
for everything from Alzheimer's disease to heart disease to
The driving force behind this work is
Congress, which in 1992 gave the National Institutes of Health
$2 million to open an office of alternative medicine -- an
initiative that many at the N.I.H. scorned as a waste of money
Two years later, Congress passed the Dietary
Supplement Health and Education Act, which classifies
herbs as dietary supplements, as opposed to drugs, and allows
them to be sold without the approval of the Food and Drug
Administration or the stringent testing required of pharmaceuticals,
so long as their manufacturers do not claim to prevent or
has been an explosion in botanical sales;
Americans spent $4 billion last year on herbal remedies, Nutrition
Business Journal says, double what was spent in 1994.
In Washington, meanwhile, Congress has
kept pouring money into the N.I.H. alternative-medicine office;
it has since evolved into the National Center for Complementary
and Alternative Medicine, with a budget of $89 million and
a well-respected virologist, Dr. Stephen E. Straus, as its
Straus has no particular affinity for
herbs; asked if he takes any, he shakes his head in a vociferous
no, as if to say yes would admit some kind of weakness or
bias. His mission, he says, is simply to apply "exacting
science" to the alternative therapies Americans are already
spending money on.
To that end, his center is financing studies
on a laundry list of popular medicinal plants: gingko for
memory loss; saw palmetto for enlarged prostate; echinacea
for childhood ear infections.
The first large-scale study, a $4.3 million
four-year examination of St. John's Wort to treat mild depression,
led by a team at Duke, is due to report results this fall.
These herbs are in no way a panacea: another study, financed
by a different branch of the N.I.H. and Pfizer, which makes
a St. John's Wort extract, recently found it useless for serious
Still, Straus says: "The Western
scientific tradition has been enormously successful, but admittedly,
it doesn't solve everything. The thought is that herbal remedies
harbor all sorts of forgotten secrets.
question is, Are these claims correct?"
To listen to Straus talk, it might sound
as if nobody had ever studied herbal remedies before, but
that is hardly the case. The problem for American doctors
is that the research is not American research, conducted according
to the strict standards to which pharmaceutical companies
But that, says Varro E. Tyler, a professor
emeritus of pharmacognosy at Purdue University, has more to
do with pharmaceutical economics than whether botanicals are
useful for treating disease.
Throughout the 19th and early 20th centuries,
American medicine was steeped in herbals; black cohosh was
listed in the United States Pharmacopoeia, the nation's official
drug reference book, from 1820 to 1926. But around the time
of World War II, drug manufacturers began focusing almost
exclusively on synthetic molecules that, unlike herbs, could
be patented and held the promise of big profits. So research
stopped, and medicinal plants were dropped from use.
"It makes me very angry," Tyler
says. "Many of these things are native American plants,
like echinacea and saw palmetto, black cohosh. But
we dropped them largely because companies felt they couldn't
make any money on them."
They were not dropped in Europe; Germans,
especially, remained faithful to their long history with botanicals.
"During the Third Reich, the Nazis actually promoted
it," says Edzard Ernst, a Munich native and professor
of complementary medicine at the University of Exeter in England.
"They liked the idea of natural medicine. It fitted their
ideology. It was very German, homemade, very Teutonic, that
sort of thing. And potentially very cheap."
With so many German doctors prescribing
herbals, Ernst says, it was inevitable that manufacturers
would begin doing research, if only to give themselves a marketing
The leading black cohosh manufacturer
is Schaper & Brummer, which has been selling the herb
under the trade name RemiFemin since 1955. Over the past half-century,
about 15 clinical studies of black cohosh have been published
in the scientific literature. Every one of them, says Johannes
Freudenstein, head of research and production at Schaper &
Brummer, has been conducted either by his company or with
The best studies, Freudenstein says, show
that RemiFemin is nearly
as effective as estrogen and far more effective than dummy
pills at treating hot flashes and is also useful
in managing the mood swings and irritability that may go along
None of the clinical trials lasted longer
than six months, so the jury is still out on whether black
cohosh is safe over the long term. But the Schaper & Brummer
findings were compelling enough to lure GlaxoSmithKline, the
pharmaceutical giant, into a partnership with the German firm;
Glaxo recently acquired the rights to market RemiFemin as
a dietary supplement in the United States and is now waging
a promotional blitz, complete with a national television ad
Michele Klingensmith, the Glaxo official
managing RemiFemin's American introduction, explains her company's
interest this way: Glaxo wanted to get into the herbal business
and was looking for products that would fill unmet medical
needs. "When we saw the data, we said, 'This is perfect."'
is hardly the only black cohosh preparation on the market,
as a visit with Fredi Kronenberg confirms. On her desk she
has an array of two dozen products containing black cohosh:
teas and tinctures, creams and pills, with soothing pictures
of flowers on their boxes and names like Flash-Ease and MenoPoise.
Even Lydia Pinkham's Vegetable Compound,
patented in 1876 "for the female discomforts," is
advertising itself as Lydia Pinkham Herbal Compound, "now
with black cohosh."
The collection irritates Kronenberg; each
May, she leads a course in botanical medicine for doctors
who, she says, are often as confused as patients by the many
herbs on the market. "They are all different dosages,"
she complains of the black cohosh collection. "Some are
ground root. Some are extract, some have subtherapeutic doses,
and the public just doesn't know what to make of it."
Yet neither her study nor Farnsworth's
will help sort the mess out. That is because women in their
clinical trials will receive black cohosh extract prepared
according to each study's specifications. The studies will
answer only the narrow question of whether those two particular
preparations have benefits. This is a problem common to all
studies of herbs, and Farnsworth and Kronenberg approach it
If his study shows a positive effect,
Farnsworth says, the University of Illinois could patent his
group's "unique method" for standardizing black
cohosh extract and then license that method to a company that
would market a competitor to RemiFemin and the rest. Kronenberg,
for her part, is not interested in commercializing black cohosh.
"I'm just interested in understanding
how it works," she says.
black cohosh works, of course, will be essential to persuading
American doctors to recommend it.
Farnsworth explains: "If you know
the mechanism of action, you can predict ahead of time what
this extract might interact with. Then you can advise people
whether or not to take it, or how to take it without getting
But as for mechanism, unanswered questions
abound. A 1985 pharmacological study conducted in Germany
reported that black cohosh contained an isoflavone, a type
of phytoestrogen, or plant estrogen. (Isoflavones are also
found in soy, which has been studied as a treatment for hot
flashes, on the theory that a soy-rich diet is the reason
Japanese women have fewer of them.)
The isoflavone discovery offered a plausible
explanation for how black cohosh works. But scientists have
found contradictory results; in a recent analysis of 13 black
cohosh samples, Kronenberg and her colleagues failed to find
"We don't think it's in there,"
she says. And Farnsworth says his research suggests that black
cohosh acts not on estrogen receptors (as it would if it contained
isoflavones) but rather on the hypothalamus,
the gland involved in regulating hormones and body temperature.
Or perhaps black cohosh contains an estrogenlike
compound that hasn't been identified. If so, black cohosh,
like estrogen, might indeed turn out to be good for the bones
and the heart.
But obvious questions remain.
Is it safe
for women who are at risk of breast cancer?
The scientist in Kronenberg thinks it
is likely to be proved effective. But the naturalist in her
can't help worrying that there might be a downside to the
sudden explosion of botanical research.
While some companies have recently begun
cultivating black cohosh, a 1998 paper from the American Botanical
Council warned that a growing commercial demand for the herb
could threaten its long-term viability in its native environment.
What will happen to the world's plant
life if studies like Kronenberg's foster a big appetite among
Americans for certain herbs? How will cultures that depend
on botanicals as their only source of medicine be affected?
York Times Magazine May