Researchers test herbal pills on menopausal women

[Guest guest]

Posted on Wed, Feb. 20, 2002

Researchers test herbal pills on menopausal women

By Patty Shillington

THE MIAMI HERALD

One of the principal problems with dietary supplements, at least from the

American medical establishment's point of view, is the lack of scientific

evidence to back up the manufacturers' claims. So University of Miami

researchers are excited to be taking on a rigorous clinical trial testing

the safety and effectiveness of an herbal pill designed to treat the

symptoms of menopause.

The trial will be double-blind and randomized - in other words, some of the

250 women will receive a placebo and others will receive the supplement. But

neither the women nor the researchers will know who is getting what.

" It's the purest scientific study; it ferrets out bias, " said Dr. Wayne

Whitted, an assistant professor of gynecology who also has a private

practice devoted to treating women in menopause. Whitted is the co-principal

investigator for the four-month study, which is scheduled to begin in April.

Whitted and , a clinical physiologist and the study's principal

investigator, said studies like this one are past due.

" I think many, if not most, women have tried some sort of alternative

product, " Whitted said. " But they really have not been studied in a

scientific way that shows whether the product can assist women. "

Sales of herbal potions and supplements marketed to menopausal women are

rising exponentially. In 1999, grocery and drug store sales of soy

isoflavones, a phytoestrogen, rose to $21 million, more than triple the 1998

figures. And sales for general menopausal formulas were $36.2 million in

'99, up by nearly 200 percent, according to the market research firms Spins

and ACNielsen.

The supplement maker funding the study cannot be identified because it could

compromise the blind nature of the research, said. One of the two

products the study will address already is on the market, she said. The

unidentified pill's primary ingredients are black cohosh, kava kava and

isoflavones.

" Some of the ingredients have been investigated independently and have been

shown to be effective, " said. " However, the combination of ingredients

has not been looked at together and that's the beauty of it. "

said she had to persuade herself to take on the study when the

" nutriceutical " company came calling. " I'm a scientist, so I'm a skeptic

about these natural remedies, " she said. " I did a lot of digging to see if I

even wanted to do a study like this. I was pleasantly surprised with the

literature.

" We have good evidence to suggest it will be effective and that's why the

company is willing to put forward money to find out for sure. "

In addition, said " the ingredients are in the amounts that have been

shown to be safe, " a key concern about unregulated supplements.

Kava kava, for instance, has come under fire in Europe, where Germany is

investigating cases of liver damage relating to the supplement's use. But

said the cases involve an excessive use of kava kava - at least five

grams a day, or 100 times the recommended daily dose of 50 milligrams. In

addition, the people were combining the kava kava with other drugs or

supplements.

" It's relatively safe at low levels, and it's effective, " said about

kava kava. " I'm very leery of supplements that are many times the

recommended levels. Some people think a little is good and a whole bunch

more is better, and that is not necessarily true. "

Whitted said he believes herbal treatments for menopausal symptoms can be

effective and he sometimes suggests his patients give them a try.

" I have found some patients have used them with a positive result, " he said.

" One of the things I see from my practice is women want to have some control

and this gives them some control without having to seek medical assistance. "

Some conditions - including high blood pressure, diabetes, kidney or liver

disease, blood clots and some cancers - may preclude women from taking

synthetic hormones.

Participants will keep a daily diary of symptoms; when the study is over,

they will receive a free six-week supply of the supplement.

Terry Mulrooney, 53, was so impressed with the details of the study after

attending an information session that she signed up - and persuaded her two

older sisters to join as well.

" I have the usual symptoms - the hot flashes, the mood swings, fatigue, "

Mulrooney said.

She tried hormone replacement for three months and " felt horrible, worse. "

And she worried about the impact of the hormones, so she went off them.

She also has tried a phytoestrogen supplement. Now that she's off the

supplement in anticipation of the study, she is experiencing more hot

flashes, leading her to conclude that the phytoestrogen had been easing her

symptoms.

Still, she's " concerned " about unregulated supplements and especially the

doses. " You wonder, is this too much, is this too little? "

Trial participants will receive physical examinations and their blood will

be monitored to check liver function and cholesterol levels, among other

things.

Results will be compiled several months after the trial, said , who

hopes the study signals the start of a trend.

" I think this represents the new wave of research that supplement companies

will be heading toward, " said, " because people want facts, they don't

want anecdotal information. "

Posted on Wed, Feb. 20, 2002

Black cohosh among the ingredients in supplement

By Patty Shillington

THE MIAMI HERALD

Here's a look at the main ingredients in the herbal supplement that will be

tested in the University of Miami clinical trial:

Black cohosh, a plant once used by Native Americans to treat snake bites, is

a top herbal treatment for menopausal symptoms including hot flashes, sweats

and mood swings. One particular brand, RemiFemin, now available in the

United States, has been studied for decades in Europe and has been found to

be safe and effective. One double-blind trial in Germany found that women

taking the supplement for 12 weeks saw their hot flashes reduced from five

to fewer than one daily, compared with two groups of women - one taking a

placebo, the other taking hormone-replacement therapy - whose hot flashes

declined from five daily to about four.

Other scientific studies on RemiFemin reported similar results and side

effects were minor, such as upset stomach. But U.S. researchers note that

data are not available on other black cohosh brands, which sometimes use

different parts of the herb and can be marketed at 10 times the strength

recommended by the German studies, which is 40 to 80 milligrams of extract

daily. Because no studies have focused on the effects of long-term use of

RemiFemin, the manufacturer recommends the product be taken for six months

at a time, stopping for six months, and using it again if symptoms are

troublesome.

Columbia University recently started a year-long study on black cohosh,

which will look at the herb's effect on heart-disease prevention and bone

loss as well as menopausal symptoms.

Kava kava, also known as kava, is a member of the pepper family. It has

grown popular as an herbal treatment for anxiety and stress, and also has

been recommended for muscle spasms and pain management. In Samoa, it has

traditionally been used to relieve migraines, upset stomach, irritable

bladder and muscle tension.

Some studies have found the herb, with an active ingredient called

klavalactones, useful at low dosages over the short term. But Switzerland

and France have banned kava sales for now, and Germany is considering a ban,

while Britain has requested a voluntary withdrawal of the product. The

action comes after German scientists late last year reported that kava use

might be responsible for 30 cases of liver toxicity in Germany and

Switzerland.

The U.S. Food and Drug Administration is studying 60 cases of adverse

reactions to kava in the past four years but has issued no official warning.

The cases may relate to massive doses of the herb or interactions with other

products.

Isoflavones are phytochemicals found in soy protein and other plants that

are believed to act like a weak estrogen - providing some of the benefits of

the hormone, perhaps without the potential drawbacks. Small studies have

shown that taking 25 grams a day of soy protein significantly reduces " bad "

LDL cholesterol and may increase " good " HDL levels. It fights heart disease

in other ways, making the arteries less likely to get clogged with plaque.

Based on the studies, the FDA now allows foods with at least 6.25 grams of

soy protein per serving to be labeled with claims that they could help

reduce heart-disease risk.

In addition, genistein and daidzein, two chemicals found in isoflavones, may

protect against cancer by stemming the proliferation of cells. One study

found isoflavones reduced hot flashes.

But there is some concern. A recent study of more than 3,000

Japanese-American men in Hawaii suggested a link between a long-term diet

high in soy protein and a decline in mental abilities and brain size. Other

researchers note that supplements containing large amounts of isoflavones -

many times more than could be consumed through diet - might not be safe.

They suggest the best way to get the benefits of isoflavones is through food

and beverages, not supplements. Because of a lack of scientific data,

isoflavones are not recommended for women with hormone-related breast cancer

or at risk for the disease.

Switzerland and France have banned kava sales for now, and Germany is

considering a ban, while Britain has requested a voluntary withdrawal of the

product. The action comes after German scientists late last year reported

that kava use might be responsible for 30 cases of liver toxicity in Germany

and Switzerland.