How To Find Your Way Out of the Hormone Trap Part 2

[Guest guest]

http://askbillsardi.com/reports/hr.pdf

 

 

The Warning Box For Tamoxifen

 

(Astra-zeneca Pharmaceuticals)

 

 

WARNING - For Women with Ductal Carcinoma

 

in Situ (DCIS) and Women at High Risk for

 

Breast Cancer: Serious and life-threatening events

 

associated with NOLVADEX (tamoxifen citrate)

 

in the risk reduction setting (women at high risk

 

for cancer and women with DCIS) include uterine

 

malignancies, stroke, and pulmonary embolism.

 

Incidence rates for these events were estimated

 

from the NSABP P-1 trial. Uterine malignancies

 

consist of both endometrial adenocarcinoma

 

(incidence rate per 1,000 women-years of 2.20

 

for NOLVADEX vs. 0.71 for placebo) and uterine

 

sarcoma (incidence rate per 1,000 women-years

 

of 0.17 for NOLVADEX vs. 0.0 for placebo). For

 

stroke, the incidence rate per 1,000 women-years

 

was 1.43 for NOLVADEX vs. 1.00 for placebo.

 

For pulmonary embolism, the incidence rate per

 

1,000 women-years was 0.75 for NOLVADEX vs.

 

0.25 for placebo. Some of the strokes, pulmonary

 

emboli, and uterine malignancies were fatal.

 

Health care providers should discuss the potential

 

benefits versus the potential risks of these serious

 

events with women at high risk of breast cancer

 

and women with DCIS considering NOLVADEX

 

to reduce their risk of developing breast cancer.The

 

benefits of NOLVADEX outweigh its risks in women

 

already diagnosed with breast cancer.

 

The Warning Box For Tamoxifen

 

(Astra-zeneca Pharmaceuticals)

 

PART II: Tamoxifen and

 

Aromatase Inhibitors

 

Tamoxifen

 

The one heralded drug that did become widely used

 

for breast cancer is tamoxifen. Its use is limited to

 

treatment among advanced cases of breast cancer.

 

In 1896 Dr. George Beatson discovered that surgical

 

removal of a woman’s ovaries shrinks breast tumors.

 

[Lancet 2: 104-07, 1896] Thereafter efforts have

 

continued to control estrogen to limit the growth of

 

breast cancer. Tamoxifen doesn’t inhibit the production

 

of estrogen, it only blocks its entry into cells.

 

In this modern era, tamoxifen is the " gold standard "

 

of breast cancer treatment, heralded as the

 

" most important drug in the history of the management

 

of breast cancer. "

 

It is attributed to a decrease of 20 to 30 percent mortality

 

age-adjusted cause-specific breast cancer. It is said that

 

tamoxifen has spared more than 400,000 women who

 

are alive today due to tamoxifen therapy.

 

The data used to back the claims that tamoxifen is a

 

wonder drug is specious. Based upon a study that was

 

stopped short (less than four years) before adequate

 

long-term data could be analyzed, the US Food & Drug

 

Administration recently widened the use of tamoxifen

 

to high-risk but otherwise healthy American women.

 

But longer-term studies in Italy and Britain (four and

 

eight years) did not confirm the earlier study which was

 

abruptly halted. [Orv Hetil 144: 597-603, 2003] Was

 

the American study intentionally halted to produce a

 

positive result? If tamoxifen is such a godsend, why

 

has only the US approved tamoxifen for use among

 

healthy women? [Gynecology Obstet Fertil 31: 327-

 

36, 2003]

 

" If tamoxifen is such a godsend,

 

why has only the US approved

 

tamoxifen for use among

 

healthy women? "

 

Here is how the National Cancer Institute (NCI)

 

helps to promote drugs like tamoxifen to the public,

 

essentially acting as public relations shills for the drug

 

companies.

 

The NCI reports that 10 million American women

 

are at high risk for breast cancer and maybe ought to

 

see their doctors about taking tamoxifen. The NCI

 

concedes only 2.4 million of these women are likely

 

to benefit from taking the drug, and out of this group

 

of 2.4 million the number of cases of breast cancer

 

is likely to be reduced from 58,148 to 28,492. The

 

number of cases of breast cancer appears to be cut in

 

half (49 percent) when viewed as a relative percentage.

 

But in reality, only 2.4 percent of the 2.4 million

 

women would be expected to develop breast cancer if

 

they didn’t take tamoxifen and 1.2 percent if they did.

 

So the difference in hard numbers is only 1.2 percent,

 

hardly a way to sell tamoxifen to American women.

 

[J Natl Cancer Institute 95: 526-32, 2003; University

 

of Iowa Press Release, April 4, 2003] So the relative

 

numbers are used instead.

 

It’s very misleading. Yes, admittedly when looking at

 

hard numbers about 20,000 additional women would

 

be spared from breast cancer. The problem is you have

 

to get over 2 million women to take the drug to realize

 

this benefit.

 

Another one of the hidden facts about tamoxifen is that

 

half of the women with advanced estrogen-positive

 

tumors immediately fail to respond to this drug and

 

are removed from drug therapy. So the studies don’t

 

always include these failures. [Drugs 61: 1721-33,

 

2001]

 

Even generic tamoxifen at $25.00 per month for a 20

 

mg pill for 2 million American women would cost $600

 

million a year to save 20,000 lives over an unspecified

 

period of time, probably a five-year span. So $3 billion

 

is spent and the cost of saving one woman from breast

 

cancer is $150,000! This is not counting the cost of

 

exams, tests, etc. Kinda pricy and the government

 

ought to be looking for less costly alternatives, but not

 

when pharmaceutical companies have politicians in

 

their control.

 

Current efforts to expand tamoxifen therapy as a

 

preventive agent for breast cancer have begun. Highrisk

 

but otherwise healthy women derive some risk

 

reduction if given tamoxifen. Of the 6600 women who

 

took tamoxifen, there were 69 fewer tumors compared

 

to 6000 other women who took a dummy pill. In other

 

words, tamoxifen benefited only about 1 in 100 highrisk

 

women as a preventive measure. Yet it was widely

 

hailed as a breakthrough! [Associated Press Oct. 30,

 

1998] There has been resistance to the idea of giving

 

healthy women a drug that runs the risk of serious

 

side effects. The National Women’s Health Network

 

asked: " Does this trial represent disease prevention, or

 

disease substitution? " [breast Cancer Action, Feb. 26,

 

1996]

 

Concerning potential side effects

 

caused by tamoxifen, the National

 

Women’s Health Network

 

asked: " Does this represent

 

disease prevention, or disease

 

substitution? "

 

Side Effects of Tamoxifen

 

How did tamoxifen ever get approved as a cancer

 

treatment drug? For one thing, it was initially confined

 

to use among advanced cases of cancer as therapy

 

following surgery, chemotherapy and radiation (if that

 

isn’t an admission those other conventional treatments

 

don’t work, I don’t know what is?) The Food & Drug

 

Administration could be coaxed into approving the

 

drug for this group of patients because of the risks of

 

mortality facing post-treatment breast cancer patients.

 

In other words, the side effects could be overlooked

 

given potential mortal consequences from an otherwise

 

unimpeded tumor.

 

Because tamoxifen permits estrogen to continue being

 

produced from androgens (adrenal hormones, mostly

 

testosterone), women may experience some relief

 

from symptoms of menopause. Women’s estrogen

 

production is not blocked, only its entry into cells.

 

The existing estrogen helps to minimize age-related

 

bone loss. Since about two thirds of breast tumors

 

are estrogen-sensitive, tamoxifen may be helpful in

 

prolonging regression and delaying a relapse, as well as

 

preventing or delaying onset in the opposing breast.

 

But the list of potential benefits of tamoxifen stops there

 

and the realization this drug can turn into a carcinogen

 

on any woman who takes it ought to cause one to get

 

shivers. Here are the major drawbacks of tamoxifen.

 

Tamoxifen is listed as a carcinogen

 

(cancer-causing substance) in

 

the 9th edition of the RoC list

 

(reasonably anticipated to cause

 

cancer) prepared by the National

 

Toxicology Program of the

 

Department of Health and

 

Human Services.

 

1. Tamoxifen is listed as a carcinogen (cancercausing

 

substance) in the 9th edition of the RoC list

 

(reasonably anticipated to cause cancer) prepared by

 

the National Toxicology Program of the Department

 

of Health and Human Services. [National Toxicology

 

Program, Factsheet, May 2000] Canadian health

 

authorities issued a health warning in 2002 regarding

 

tamoxifen and its side effects. [Health Canada, Nov.

 

26, 2002] That is because tamoxifen is only an organspecific

 

anti-cancer agent. It blocks breast tumors but

 

encourages endometrial cancer. It has been known

 

since 1975 that the use of hormone replacement therapy

 

increases the risk of endometrial cancer by 450 percent.

 

[New England Journal Med 293: 1164-67, 1975; Int

 

J Gynecology 12: 496-500, 2002] Some physicians

 

suggest women undergo a complete hysterectomy

 

before they start on the drug to eliminate the risk of

 

endometrial cancer.

 

2. Estrogen blockers like tamoxifen eventually lead to

 

a dead-end street. Due to what is called " tamoxifen

 

resistance, " the drug inevitably turns on every woman

 

within five years. Tamoxifen must be stopped after five

 

years when cellular resistance materializes and turns

 

this drug into a cancer-promoter. [J Steroid Biochem

 

Mol Biol 79: 143-49, 2001; Drugs 61: 1721-33, 2001]

 

3. While the risk of second breast cancer is reduced

 

with tamoxifen, there is a five-times increased risk of

 

estrogen-negative breast tumors in the breast opposite

 

the first diagnosed tumor. [Fred Hutchinson Cancer

 

Research Center, July 3, 2001]

 

4. Despite its acclaim, tamoxifen has not been found to

 

increase life expectancy after five years of use. [british

 

Journal Cancer 85: 1280-88, 2001]

 

Other Side Effects of Tamoxifen

 

• Tamoxifen may induce irreversible blindness. It is

 

possible for Tamoxifen to cause retinal blindness.

 

[Am J Ophthalmology 131: 386-87, 2001; Cancer

 

Treatment Reports 62: 315-20, 1978; Bulletin Society

 

Belge Ophtalmol 238: 161-68, 1990] Tamoxifen also

 

increases the risk of blinding cataracts, as much as 400

 

percent. [breast Cancer Research Treatment 60: 167-

 

72, 2000]

 

• Tamoxifen may cause premature menopauase, weight

 

gain and mental depression. It may also induce hot

 

flashes, night sweats and vaginal discharge in addition

 

to blood clots, and stroke. [J Natl Cancer Institute

 

Monograph 30: 130-34, 2001]

 

• Scientists are currently mulling over data to determine

 

if tamoxifen is actually toxic to DNA. [Mutagenesis

 

18: 395-99, 2003]

 

Because of the long list of potential side effects,

 

" Women should be given all of the information about

 

the benefits and risks of tamoxifen use so that they

 

can make an informed decision based on the best data

 

available. " [Annals Pharmacotherapy 37: 268-73,

 

2003] But are they?

 

After all the side effects generated by more than 20

 

years of prescribing tamoxifen, threatened with a new

 

competitor (the aromatase inhibitors), researchers

 

finally decided that just 5 milligrams of tamoxifen may

 

be good enough to prevent relapse of breast cancer

 

after conventional treatment (surgery, chemotherapy,

 

radiation), not 20 milligrams. [American Assoc Cancer

 

Research, April 8, 2003; J Natl Cancer Institute 95:

 

779-90, 2003]

 

Despite its acclaimed achievements, health authorities

 

are now asking: " Has tamoxifen had its day? " [breast

 

Cancer Research 4: 213-17, 2002; Nat Review Drug

 

Discovery 2: 205-13, 2003] That’s because of a new

 

class of drugs called aromatase inhibitors.

 

Aromatase Inhibitors

 

Breast and prostate cells can produce enough sex

 

hormones via activation by the aromatase enzyme to

 

stimulate growth of tumors. [Clin Cancer Research 9:

 

455-59S, 2003]

 

Oral aromatase inhibitors are now being employed with

 

superior results to tamoxifen. [breast Cancer Research

 

4: 213-17, 2002; Nat Review Drug Discovery 2: 205-

 

13, 2003] The superiority of aromatase inhibitors over

 

tamoxifen is demonstration in a recent study. After 4

 

months of treatment, about 6 out of 10 women taking

 

Femara (letrozole) showed tumor shrinkage versus

 

only 4 in 10 for tamoxifen. [24th Annual San Antonio

 

Breast Cancer Symposium]

 

Whereas tamoxifen permits production of estrogen and

 

then blocks its entry into cells, the aromatase inhibitors

 

dampen the production of an enzyme responsible for

 

production of estrogen itself.

 

Now that aromatase inhibitors are under widespread

 

study and about to be prescribed to millions more

 

American women, The New England Journal of

 

Medicine has just published an extensive report on

 

aromatase inhibitors. [New Eng J Med 348: 2431-42,

 

2003] The report says " these drugs are effectively

 

challenging tamoxifen for use in postmenopausal

 

patients with estrogen-receptor-positive cancer, " the

 

majority of breast cancer cases. Aromatase inhibitors

 

don’t induce tumor resistance as does tamoxifen.

 

[Endrocrin Relat Cancer 6: 75-92, 1999]

 

Aromatase inhibitors are also being considered as

 

primary prevention. What this means is that the

 

pharmaceutical companies want to put every woman

 

on these drugs throughout life. Whereas tamoxifen

 

increases the risk of endometrial cancer and blood

 

clots and becomes a cancer promoter over time, the

 

aromatase inhibitors have no such side effects. But

 

they have their own set of problems.

 

The aromatase enzyme is found in high concentrations in

 

the ovaries, and in low levels in fat, liver, muscle, brain,

 

normal and abnormal breast tissue. The production

 

of residual estrogen production after menopause is

 

solely from these non-glandular sources, particularly

 

from subcutaneous fat. (This is the probable reason

 

why obesity increases the risk for breast cancer in

 

postmenopausal women.) Whereas menopause causes

 

a 16-fold drop in the blood plasma levels of estrogen,

 

menopausal breast tissue will exhibit concentrations

 

of estrogen 10 times that found in blood plasma. This

 

makes the breast the most likely tissue for estrogenrelated

 

tumors to emanate.

 

These aromatase inhibitors need to be mild since the first

 

generation drug, aminoglutethimide, previously used

 

as an anticonvulsant, induced adrenal insufficiency,

 

drowsiness and skin rashes. But the third-generation

 

aromatase inhibitors are three times more potent than

 

aminoglutethimide! [Clin Breast Cancer 1: 9-14S, 2000]

 

Pharmaceutical aromatase inhibitors are " remarkably

 

potent " at inhibiting aromatase activity. [Expert Opin

 

Investig Drugs 12: 337-51, 2003] Letrozole is such a

 

strong estrogen inhibitor only 1 milligram is needed to

 

produce an effect. [Annals Oncology 14: 62-70, 2003]

 

Strong inhibition of estrogen is likely to result in

 

depressed mood. [Cell Mol Neurobiol. 16:325-44,

 

1996; J Clin Psychopharmacology 11: 121-26, 1991]

 

The long-term effect of aromatase inhibitors on mood is

 

unknown. Doctors are likely to dismiss this biological

 

origin of depression and attribute it to psychogenic

 

factors surrounding diagnosis and treatment. Therefore,

 

many women undergoing cancer treatment with these

 

drugs may be inappropriately placed on antidepressant

 

drugs.

 

There is no question that aromatase inhibitors are going

 

to replace tamoxifen since they result in prolonged

 

tumor regression. But the use of aromatase inhibiting

 

drugs is not indicated for premenopausal women with

 

breast cancer who have normal ovarian function. Ditto

 

for women with estrogen or progesterone-receptornegative

 

tumors. [J Clin Oncol 19: 2596-2606, 2001]

 

Many studies are now underway with aromatase

 

inhibitor drugs. One study has been ongoing for the

 

past seven years. Even though tumor regression is

 

prolonged, absolute freedom from relapse " appears

 

to be very small so far, and no survival benefit has

 

emerged. " [New Eng J Med 348: 2431-42, 2003]

 

Side effects, reported as mild in most studies,

 

include headache, vaginal dryness, hot flashes and

 

musculoskeletal pain, similar to those experienced

 

with tamoxifen. [New Eng J Med 348: 2431-42, 2003]

 

There is a clear reduced risk of blood clots and uterine

 

cancer with the aromatase inhibitors. However, one

 

aromatase inhibitor, anastrozole (Arimidex), produces

 

a higher incidence of musculoskeletal symptoms and

 

fractures than reported with tamoxifen. [Lancet 359:

 

2131-39, 2002]

 

Obviously, tamoxifen preserves the production of

 

estrogen but just blocks its entry into cells, so estrogen

 

still exhibits beneficial effects upon bone mineralization.

 

But the aromatase inhibitors block the production of

 

estrogen altogether, and bone health is compromised.

 

It’s a major drawback of these drugs. The importance

 

of maintaining some estrogen production in the body

 

is underscored by the report of a man who could

 

not produce aromatase, had no detectable levels of

 

estrogen and experienced rapid bone loss. Succinctly,

 

widespread use of aromatase inhibitors could make

 

osteoporosis a bigger epidemic among postmenopausal

 

women than it is today. [Calcified Tissue International

 

59: 179-83, 1996]

 

Aromatase inhibitors in postmenopausal women

 

increase total serum cholesterol. [Eur J Cancer 37:

 

1510-13, 2001] Since sex hormones are made from

 

cholesterol, the reduced estrogen synthesis facilitated

 

by the aromatase inhibitors probably sends a signal

 

to the liver to produce more cholesterol in an attempt

 

to maintain youthful levels of hormones. [Med

 

Hypotheses 59:751-6, 2002]

 

Aromatase inhibitors are being promoted not only as

 

breast cancer treatment, but may also be useful for

 

uterine fibroids and endometriosis as well as male

 

prostate cancer. [Cancer Investigations 19: 649-59,

 

2001]

 

Sex hormones are implicated in colon cancer as well

 

as breast cancer. Cells in the colon can produce

 

aromatase, the enzyme that stimulates estrogen which

 

in turn excites growth of tumor cells. Drugs like

 

raloxifene, used for treatment of age-related bone loss,

 

and tamoxifen, an anti-cancer drug, inhibit production

 

of aromatase in colon cancer cells and thus inhibit their

 

growth. [J Steroidal Biochem Mol Biol 71: 223-30,

 

1999]

 

Combinations of tamoxifen and aromatase inhibitors

 

have not been shown to be advantageous. [Forum 12:

 

45-59, 2002]

 

Since aromatase inhibitors strongly reduce production

 

of estrogen, they may induce calcifications throughout

 

the body. Low levels of estrogen apparently induce loss

 

of calcium from bones which results in calcifications

 

throughout the body, including the arteries and breast.

 

[J Med Screen 9: 38-39, 2002; Acta Pathol Mcirobiol

 

Immunol Scandinavia 93: 13-16, 1985; Arteriosclerosis

 

Thromb Vasc Biol 20: 1926-31, 2000; Atherosclerosis

 

34: 469-74, 1979] Of interest is a study where

 

researchers noted that the rapid disappearance of

 

calcifications in breast mammograms was indicative

 

of the onset of breast malignancies. [british J

 

Radiology 72: 3-8, 1999] This spontaneous resolution

 

of calcifications in breast tissue could indicate a rise

 

or resumption in estrogen production and thus a signal

 

for tumors to grow. Hormone replacement therapy is

 

associated with a lower incidence of calcifications in

 

postmenopausal women. [british J Radiology 60: 457-

 

58, 1987]

 

Of interest to many, grapes and mushrooms contain

 

chemicals that mildly inhibit aromatase, the enzyme

 

that generates estrogen. [Ann NY Academy Sci 963:

 

229-38, 2002]

 

Health Effects of

 

Low Estrogen

 

Health Effects of

 

High Estrogen

 

Bone thinning

 

(osteoporosis)

 

Maintains bone

 

mineralization

 

Depressed mood Maintains elevated mood

 

Loss of moistureholding

 

hyaluronic acid

 

(skin, eyes, joints)

 

Sends " grow " signal

 

to cells

 

Calcifications (breast,

 

arteries, heart valves,

 

kidney stones,

 

bone spurs)

 

Releases iron from

 

carrier molecule;

 

increases ability for iron

 

to enter cells

 

Increases need for

 

magnesium and

 

vitamin C

 

Comparison: Tamoxifen vs. Aromatase Inhibitors

 

Tamoxifen (Nolvadex)

 

Currently about 1 million American women

 

receiving tamoxifen

 

Primary use: " gold standard " for treatment and

 

recurrence of advanced breast cancer following

 

surgery, chemo or radiation therapy.

 

Action: blocks entry of estrogen into cells; does

 

not impair estrogen production

 

Increases fertility; evidence this drug acts as a

 

pro-estrogen over time.

 

Proposed benefits: heralded 49% reduction in

 

invasive breast cancer is a relative number; in

 

hard numbers, improvement in survival compared

 

to no treatment, in hard numbers: 3.5% (The

 

Lancet 339: 71-85, 1992) About 1 in 10 women

 

will benefit from taking tamoxifen; only 1%

 

benefit among high-risk women when taken for

 

prevention

 

Active against estrogen-positive and negative

 

breast tumors (different mechanisms)

 

Bone: Retains bone integrity because it does not

 

impair estrogen synthesis

 

Side effects:

 

• Claim is that " benefits far outweigh the risks "

 

• Can only be taken for 5 years; then tamoxifen

 

resistance begins

 

• Selective anti-cancer agent: reduces risk of

 

recurrence after treatment for breast cancer,

 

but increases risk of uterine cancer; 400%

 

increased-risk women over 50; increase of 2

 

cases of uterine cancer per 1000 women; uterine

 

sarcoma increases 2 per 10,000 users; doctors

 

often recommend surgical removal of uterus to

 

eliminate this risk

 

• Cataracts, retinal blindness

 

• Migraines

 

• Blood clotting, strokes

 

• Hot flushes

 

Aromatase Inhibitors

 

Under clinical investigation

 

Femara (letrozole, Novartis)

 

Aromasin (exemestane, Pharmacia)

 

Arimidex (anastrozole, AstraZeneca)

 

Primary use: after 5-year tamoxifen therapy or in

 

place of tamoxifen; combined or alternate use with

 

tamoxifen of no extra benefit; potential use as 1st

 

preventive breast cancer drug; possible use for

 

uterine fibroids, endometriosis, prostate cancer;

 

not indicated for premenopausal women with

 

breast cancer who have normal ovarian function.

 

Ditto for women with estrogen or progesteronereceptor-

 

negative tumors.

 

Action: inhibits aromatase enzyme required to

 

produce estrogen; 3rd generation drugs more

 

potent

 

Proposed benefits: prevents estrogen from

 

being formed in the first place; prolongs remission

 

after conventional breast cancer treatment, but no

 

significant decrease in mortality rates

 

Active against estrogen-positive tumors

 

Bone: weakens bone due to loss of estrogen

 

production

 

Side effects:

 

• Decreased mood

 

• Headache, nausea, peripheral edema, fatigue,

 

vomiting, indigestion, hot flushes and vaginal

 

dryness [Endocrin Relat Cancer 6: 325-32, 1999]

 

• Possible calcifications throughout the body

 

including breast tissue

 

PART III: The Phytoestrogens

 

Hormone replacement therapy during menopause is

 

only utilized by 8 to 10 percent of eligible women,

 

mostly due to concern over health risks. Furthermore,

 

there is no proven drug that women in their fertile years

 

can take to ward off future breast cancer. So the door

 

is wide open for plant estrogens, called phytoestrogens,

 

to be self employed by American women. No

 

question, many American women are increasing their

 

consumption of soy, flax and other plant foods, primarily

 

for health reasons. In addition to the widely advertised

 

herbal phytoestrogens, the diet has some natural ones.

 

Green beans, alfalfa sprout, mung bean sprout and

 

kudzu root also exhibit estrogenic properties. [J Agric

 

Food Chem 51: 2193-99, 2003]

 

Women are trying extracts of black cohosh, red clover,

 

vitex, dong quai or a host of other plant estrogens in

 

an attempt to beat the sometimes difficult symptoms of

 

menopause.

 

Generally speaking, phytoestrogen extracts in pill

 

form all deliver about 50-100 milligrams of active

 

ingredient. Doses below 2 milligrams per kilogram of

 

body weight are considered safe. Thus, a 100-pound

 

female could safely consume up to 90 mg, a 160-pound

 

female up to 145 mg and a 200-pound female up to 180

 

mg of plant estrogen extract. [british Journal Nutrition

 

89: 898-906, 2003]

 

Plant estrogens reduce the number and intensity of hot

 

flashes by a modest 10 to 20 percent. [J Nutrition 133:

 

1983-86S, 2003] That’s not enough to be considered

 

reliable. However, one recent study found that flaxseed

 

40 grams a day) reduced symptoms of menopause

 

equivalent to hormone replacement therapy. [Obstet

 

Gynecol 100:495-504, 2002] Though one study with

 

flaxseeds reduced menopausal symptoms by 60 to 70

 

percent.

 

Researchers say there aren’t enough published studies

 

which identify the active ingredients in phytoestrogen

 

products or that indicate the proper dosage to be used.

 

International Journal Fertility Womens Medicine 48:

 

64-68, 2003]

 

In a landmark study published in 1997, researchers

 

obtained urine and blood samples from women

 

who were newly diagnosed with breast cancer and

 

compared them with healthy women. Among the

 

soy plant estrogens (genistein, daidzen and equol)

 

and the lignans from fiber-rich foods like rye and flax

 

enterodiol, enterolactone and matairesinol), only equol

 

from soy and enterolactone from flax were associated

 

with substantial risk reduction for breast cancer.

 

Lancet 350: 990-94, 1997]

 

Black Cohosh

 

Black Cohosh Flower

 

Black cohosh is an herb widely used in Europe

 

and marketed in the USA under the brand name

 

Remifemin.

 

Standardized extracts of black cohosh (Remifemin)

 

have demonstrated an ability to reduce postmenopausal

 

complaints and are also useful for women who have

 

undergone hysterectomy. [Alternative Therapy Health

 

Med 7: 93-100, 2001] Black cohosh appears to improve

 

complaints surrounding the monthly cycle. [J Steroid

 

Biochem Mol Biol 83: 133-47, 2002]

 

However, a study published in 2001 did not find that

 

women who had completed breast cancer treatment

 

experienced a reduction of hot flashes when taking

 

black cohosh. [J Clin Oncol 19: 2739-45, 2001]

 

Approximately 30 percent of women experience

 

menstrually-related migraine attacks. The provision of

 

soy, black cohosh or dong quai extracts has been shown

 

to relieve symptoms and reduce frequency of these

 

attacks. [biomed Pharmacotherapy 56: 283-88, 2002]

 

The current recommended dose of black cohosh is

 

40-80 mg per day. A popular commercial extract of

 

black cohosh, Remifemin, provides 20 milligrams per

 

pill. Weight gain, nausea, vomiting, headaches and

 

dizziness have been reported as side effects. [Nutrition

 

Clinical Care 5: 283-89, 2002] Gastrointestinal upset

 

and rashes are the most common among the few

 

reported side effects from black cohosh. [Menopause

 

10: 58-64, 2003]

 

Surprisingly, even though this herb is classified among

 

the phytoestrogens, recent studies have not confirmed

 

it has estrogen-like properties. Since 1985 it has been

 

believed that an isoflavonone called formononetin

 

in black cohosh is responsible for its mechanism of

 

action. But a recent laboratory analysis has been

 

unable to detect formononetin in samples of this herb.

 

[Phytomedicine 9: 461-67, 2002] A study conducted in

 

Austria confirmed the estrogen-like activity of soy and

 

red clover, but not black cohosh. [J Steroid Biochemistry

 

Mol Biol 84: 259-68, 2003] One report says that while

 

biological action of black cohosh may involve estrogen

 

effects, " new data dispute the estrogen theory and

 

indicate that extracts of black cohosh do not bind to

 

the estrogen receptor, up-regulate estrogen-dependent

 

genes, or stimulate the growth of estrogen-dependent

 

tumors in animal models. " [Nutrition Reviews 61:

 

183,86, 2003] Non-estrogenic components of black

 

cohosh are believed to relieve symptoms of menopause

 

and lower doses (~40 mg) appear to work as well as

 

higher doses (~125 mg). [J Womens Health Gender

 

Based Medicine 11: 163-74, 2002]

 

When black cohosh is combined with tamoxifen, it

 

appears to enhance the anti-estrogen effects of the drug.

 

[breast Cancer Research Treatment 76: 1-10, 2002]

 

A recent review declared black cohosh to be relatively

 

safe. [Menopause 10: 58-64, 2003] Black cohosh also

 

appears to be safe for women to use during menopause.

 

[breast Cancer Research Treatment 76: 1-10, 2002]

 

Despite its widespread use in Europe, a review of four

 

studies involving black cohosh extract did not yield

 

" compelling evidence " for this herb as a hormonereplacement

 

agent in menopause. [Euro J Clin

 

Pharmacology 58: 235-41, 2002]

 

While available evidence on the effects of plant

 

estrogens in regards to breast cancer is contradictory,

 

extracts from black cohosh have been shown to inhibit

 

the growth of breast cancer cells. [J Steroid Biochem

 

Mol Biol 80: 125-30, 2002] Components of black

 

cohosh also serve as antioxidants and may help protect

 

DNA from damage. [J Agriculture Food Chem 50:

 

7022-28, 2002] However, one researcher recently

 

gave mice bred to develop breast cancer the human

 

equivalent dose of black cohosh. These mice were

 

more than twice as likely to develop breast tumors

 

and for the tumors to spread to the lung. [American

 

Association Cancer Research, Vicki Davis, Mylan

 

School of Pharmacy, Duquesne University, Reuters

 

July 12, 2003] But this is an unpublished study and

 

various methods (MTT tetrazolium assay) of testing

 

for growth in breast cancer cells may produce false

 

positive results and thus, until the method of testing can

 

be scrutinized, this recent report must be withheld from

 

evidence used to judge black cohosh. [Planta Medica

 

68: 445-48, 2002]

 

Bottom line: black cohosh is probably safe to use for

 

symptoms of PMS and menopause. The reported skin

 

rashes appear to be similar to side effects reported with

 

the first-generation aromatase inhibitors. The contrary

 

results surrounding black cohosh in regards to growth

 

of breast cancer cells raises questions on the validity of

 

the testing.

 

Chasteberry (Vitex)

 

This fruit extract from a shrub native to west Asia

 

and southwestern Europe has been traditionally used

 

for thousands of years to quell symptoms involving

 

menstrual difficulties. In a study of 1634 patients,

 

a remarkable 93 percent reported a decrease in the

 

number of premenstrual symptoms, with no serious

 

side effects. [J Womens Health Gender Based Med 9:

 

315-20, 2000]

 

Dong Quai

 

Dong quai is an herbal phytoestrogen from China. It

 

is not as popularly used as red clover, soy or black

 

cohosh.

 

Dong quai may thin the blood, may induce skin

 

light sensitivity, and may induce abnormal heart

 

rhythm. It should not be used with blood thinners.

 

Pharmacotherapy 19: 870-76, 1999] Like red clover,

 

Contunued In Part 3

 

 

 

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