For decades, women around the world have treated the symptoms of menopause with a simple herb called black cohosh. 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.
For decades, the standard therapy for hot flashes has been the hormone estrogen.
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 centuries.
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 cramps.
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.
No matter 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 drug.
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 AIDS.
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 and time.
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 treat disease.
The result 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 director.
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 depression.
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.
The fundamental 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 adhere.
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 edge.
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 its product.
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 with menopause.
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 campaign.
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."'
But RemiFemin 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 differently.
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.
Knowing how 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 side effects."
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 the compound.
"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?
New York Times Magazine May 6, 2001
This is nothing new, as I have been reporting on this for over two years (see links below). However, it is interesting to note that the pharmaceutical companies have started to catch on and are actually marketing their own versions of black cohosh.
Let's not forget though that black cohosh is only a band-aid. Admittedly, it is a safer band-aid than many hormonal approaches. I would not advise it as a first line measure. One would want to concentrate on food choices initially and perhaps using vitamin E and evening primrose oil (about 1-2 1300 mg capsules with each meal).
One could also use natural progesterone, but I am not a fan of the creams, as I used them for nearly five years and found them to work initially, but actually cause problems over time (see below).
If a woman has had her ovaries surgically removed, there may be an indication to actually use a natural estrogen replacement (Triest or Biest) to support the physiology. Once the ovaries are removed the body tends to lose this normalization capacity.
Additionally, balancing the adrenals and female hormones with the aid of salivary hormone testing can be useful. I have been using Bio Health Diagnostics for some time and have been pleased with their services.