FDA’s Ridiculous Stand on Bioidentical Hormones

Tuesday, April 14, 2009 by Kimberly Day

Ever since the Journal of the American Medical Association (JAMA) reported on the dangers of conventional hormone replacement therapy (HRT) in the July 17, 2002 issue of the journal, women have been scrambling to find a safer, yet still effective treatment for menopause symptoms.

In case you are not familiar with the study, JAMA reported on the findings from one part of the Women’s Health Initiative, an 8.5 year project funded by the National Institutes of Health. According to the findings, menopausal women taking estrogen/progestin for five years or more had an increased risk for blood clots, coronary heart disease, strokes, and breast cancer. In fact, researchers felt so strongly about the negative implications of long-term combined HRT, especially the unacceptably high risk for breast cancer, that they ended the study three years early! Participants were contacted and instructed to stop taking the drug—immediately.

As you can imagine, the pharmaceutical companies have been in a panic ever since, as hundreds of thousands of women have stopped taking their medication and look to natural medicine for answers…answers that many have found in bioidentical hormones.

Dr. Lark has written about and prescribed bioidentical hormones for more than 20 years. In fact, in our book Hormone Revolution, we have devoted several pages to the topic. And when it comes to using bioidentical hormones to treat menopause symptoms such as night sweats, hot flashes, and other signs of menopause, the most commonly prescribed hormone is estriol.

Given the sudden drought in conventional HRT usage (and therefore loss of money to pharmaceutical companies), as well as the increased interest and media attention surrounding the usage and efficacy of bioidentical hormones—namely estriol—it shouldn’t come as a surprise that the FDA is now cracking down on these natural options.

According to the FDA’s Web site, the “use of ‘bio-identical’ as a marketing term implying a benefit for the drug, for which there is no medical or scientific basis.” They even go so far as to state that estriol “is not a component of an FDA-approved drug and has not been proven safe and effective for any use.”

This is simply ridiculous and just plain outrageous. Estriol is the weakest, and therefore safest, of your three main types of estrogen. It has been studied in various animal and human studies and has been shown to be less likely to promote excessive tissue growth, and even helps prevent breast and endometrial cancers.

To me, that seems to contradict the “not been proven safe” part of the FDA’s statement. And, as for the “not been proven effective for any use,” I cannot help but wonder if the FDA is familiar with the JAMA study that found that estriol was particularly effective in treating vaginal atrophy, mood swings, and hot flashes. Or, how about study from Alternative Medicine Review, which found that estriol provided the protection of conventional hormone replacement therapy without the risks. Plus, estriol was found to ease menopause symptoms, including hot flashes, insomnia, vaginal dryness, and urinary tract infections.

Don’t be fooled by the FDA’s “concerns.” Sadly, in this arena, their main concern seems to be with the pharmaceutical company’s checkbooks, not your health. Keep yourself informed by reading blogs, newsletters, and informative emails from trusted sources and doing research for yourself. And fight for your right to natural alternatives to all your health concerns.

Study Shows Hormone Replacement Therapy May Cut Colorectal Cancer Risk…but at What Risk?

Thursday, January 15, 2009 by Susan Lark

According to a study published in the latest edition of the journal Cancer Epidemiology, Biomarkers and Prevention, long-term use of hormone replacement therapy may cut the risk of colorectal cancer. The greatest reduction in risk was seen in women who used a combination of estrogen plus progestin for two to five years. Current users had the greatest risk reduction, but past users who had stopped at least five years ago also benefited.

So, based on this study, would I recommend using conventional hormone replacement therapy now that it has been found to reduce your risk of colorectal cancer? My answer is unequivocally no! It has been well established that conventional hormone replacement therapy has been associated with a significant increase in the risk of invasive breast cancer, cardiovascular disease, strokes, heart attacks, blood clots, and Alzheimer’s disease. So, while HRT is helpful in reducing menopause symptoms like hot flashes and night sweats—and now colorectal cancer—it is at the expense of your breast, heart, and brain health!

There are much safer and more effective ways to reduce your risk of colorectal cancer—even if you are at high risk due to family history:

1. Eat a Mediterranean diet rich in fruits, vegetables, wild-caught fish, nuts, whole grains, free-range poultry, and unsaturated fats such as olive oil and almond butter; avoid red meat, dairy products, fried and processed foods, and refined sugar and flour. 


2. Add 4 to 6 Tbsp. ground flaxseed to your diet. It’s a great source of fiber, as well as mucilage and lubricants, which provide bulk and soften your stool, helping to promote its elimination through the intestines. 

3. Don’t smoke. Smokers are 30 to 40 percent more likely than nonsmokers to die of colorectal cancer.


4. Exercise.
Inactive people have a higher risk of developing not only colorectal cancer, but many other types of cancer, including breast cancer.

5. Drink alcohol in moderation, if at all.


6. Take these supplements:


Selenium is an antioxidant that has been found to inhibit cancer in animal studies. Additional research indicates that selenium shows promise in colorectal cancer prevention in humans. I recommend 50–200 mcg a day.

Calcium helps reduce the risk of colorectal cancer and precancerous polyps. I recommend at least 700 mg a day, along with 800 IU of vitamin D.

Resveratrol, a naturally-occurring compound found in grapes, may help protect against the growth and proliferation of colon cancer cells. In fact, a study published in Cancer Letters found that resveratrol reduced the growth rate of colon cancer cells by 70 percent! I recommend 200 mg, standardized to at least 8 percent total resveratrol, mixed with flavonoids for better bioavailability.

Fight Fibroids Naturally

Wednesday, January 7, 2009 by Susan Lark


Another common perimenopause symptom is uterine fibroids. Approximately 40 percent of women have fibroids by mid-life, and usually, they don’t cause problems. However, fibroid removal accounts for nearly one-third of all hysterectomies performed annually in the United States, many of which are completely unnecessary. The fact is, many fibroids will likely shrink and may even disappear with menopause.


As with estrogen dominance, another premenopause symptom, fibroids can be largely controlled through diet. You need a wide range of nutrients to help balance your hormones and reduce your estrogen levels, decrease cramping and inflammation, and generally improve your physical and mental well-being. Increasing your intake of the foods listed below will provide the necessary nutrients to produce these effects.


1. Whole grains are excellent sources of B vitamins, as well as vitamin E, magnesium, calcium, and potassium. Fiber in whole grains absorbs estrogen, helps remove it from the body, and normalizes bowel function.
 

2. Legumes contain fiber and are high in calcium, magnesium, and potassium. I am especially fond of soybeans, which help regulate estrogen levels.


3. Fruits and vegetables contain a wide range of nutrients that can relieve menstrual cramps, including vitamin C and bioflavonoids.


4. Seeds and nuts, especially flaxseed and pumpkin seeds, are wonderful sources of essential fatty acids (EFAs), the raw materials necessary for the production of prostaglandins.


5. Fish contains linolenic acid and is an excellent source of minerals, especially iodine and potassium. Salmon, tuna, mackerel, and trout are especially good for women with menstrual cramps.


6. Oils containing vitamin E help to balance mood, and ease fatigue and cramps that occur at the onset of menstruation for women with fibroids. Good oil sources include sesame seeds and wheat germ.


7. Avoid saturated fats; dairy products such as yogurt, milk, cheese, and cottage cheese; salt; refined sugar; caffeine; and alcohol.


 
 

A New HRT Drug? Thanks, But No Thanks!

Wednesday, January 7, 2009 by Susan Lark


Wyeth Pharmaceuticals is the largest maker of hormone replacement therapy (HRT) drugs, including Prempro—which was found to be associated with an increased risk of breast cancer in the Women’s Health Initiative studies. However, that didn’t stop Wyeth from developing a new HRT formulation named Aprela for the relief of menopause symptoms such as menopause hot flashes and sleep disturbances, reportedly without increasing a woman’s risk of estrogen-related cancers.

 

 According to Wyeth, Aprela combines estrogen (Premarin) with a SERM (selective estrogen receptor modulator) called bazedoxifene. SERMs block the action of estrogen in certain tissues, including the breast, by occupying estrogen receptors so that estrogen cannot attach to the receptor sites. At the same time, SERMs reportedly stimulate estrogen receptors in other tissues, such as the liver, bone, and uterus (which increases your risk of uterine cancer!). But Wyeth’s studies suggest that bazedoxifene doesn’t have that uterine-stimulating effect, thereby making it a better SERM for a safer HRT drug. In clinical trials, women have been taking Aprela daily for two years while being monitored for breast cancer. However, the study is less than three years old, and it can take 10 years for breast cancer to develop!

 

If you need to take hormone replacement therapy to relieve menopause symptoms, I much prefer that you consider taking bioidentical hormones, which can provide menopause relief without increasing your risk of life-threatening cancer. Talk to your doctor about bioidentical hormones, a much safer and more effective option.
 

Strong Nails and Smooth Skin

Thursday, September 4, 2008 by Susan Lark

One of my patients had a hysterectomy in her late 30s for endometriosis, and her doctor at the time put her on low-dose hormone replacement therapy. She was on hormone replacement therapy for seven years, but found that when she hit her early 50s, her body began to change. Her nails began to crack and split and her skin became incredibly dry. Lotions and other solutions didn’t work.

She came to me to see what we could do about this problem. I looked at her diet and made some changes that would support estrogen production in her body. First and foremost, she cut out caffeine and alcohol. I started her on wheat germ oil and flaxseed (a great omega-3–based food) to moisturize her skin from within. She also started eating wild salmon, butterfish, and other fish high in omega-3s. In addition, I recommended that she up her B-vitamin and silica intake.

Within months, her nails went from being really soft to strong and firm. Her skin also became much more moist and supple. We also noticed a slight increase in her estrogen levels, which helped to ease her other menopause symptoms, such as hot flashes and night sweats.

Are you a Fast Processor or Slow Processor?

Tuesday, September 2, 2008 by Susan Lark

During menopause, I’ve found that things aren’t as simple as just too much or too little of any given hormone. Instead, my patients tended to experience a total shift in their entire physical and chemical makeup that manifested as one of two patterns. Their body and brain chemistry tended toward becoming either too fast or too slow. For this reason, I call the first pattern estrogen deficiency–fast processor. The second is its mirror image: estrogen deficiency–slow processor.

An estrogen deficiency–fast processor woman is in menopause with too little estrogen. Characteristics include:
• Anxiety
• Thin, dry skin and tissues
• Menopause hot flashes
• Night sweats
• Insomnia
• Vaginal dryness
• Sore joints
• Increased risk for heart disease and osteoporosis

An estrogen deficiency–slow processor woman is also in menopause, but she has the opposite body type and temperament. Characteristics include:
• Plumper/difficult time losing weight
• Fluid retention
• Stronger bones and connective tissue
• Thicker skin and hair
• Placid temperament

In future entries, I’ll tell you how to balance your hormones, depending on which of these categories you fall into.

Boost Your Libido with Maca

Monday, August 25, 2008 by Susan Lark
If you have found that natural hormone replacement therapy isn’t strong enough to relieve your menopause symptoms, an herb called maca is a perfect option. By some estimates I’ve read about in research studies, approximately 80 percent of menopausal women find menopause relief with maca. 

Maca is most commonly used in traditional medicine to increase libido, promote fertility, and balance hormone levels. An added bonus is that it increases vaginal lubrication, which obviously can improve sexual activity and satisfaction. Because it increases energy, it helps create more vigor for sexual activity, which is why Peruvians have used it for centuries to increase sexual desire.

Dosages are unique to each woman, so you will need to determine the dosage that works for you. You can take it indefinitely—there have been no acute toxic effects, even at very high doses. If you are sensitive to herbs, start with the low end of the recommended dosage, as too much can cause increased menopause hot flashes, breast tenderness, or headaches. Also avoid maca if you have a hormone-related cancer, liver disease, or are pregnant or nursing.

I like the Whole World Botanicals’ Royal Maca brand, which is available at www.wholeworldbotanicals.com.

Estriol: Excellent for Menopause Relief

Monday, August 18, 2008 by Susan Lark
For my patients whose menopause symptoms do not respond to the various herbs and nutrients I recommend, I have frequently prescribed natural hormone replacement therapy using estriol and natural progesterone. 

Estriol (2–4 mg daily) is prescribed in capsule or cream form to reduce menopause hot flashes, vaginal dryness, and mood swings. Estriol is the weakest and safest type of estrogen and is less likely to promote tissue growth. Unlike conventional estrogen replacement therapy (replacement therapy using estrogen alone) that may cause fluid retention, headaches, nausea, and the buildup of uterine tissue, estriol has few, if any, side effects. You’ll need a prescription and then you or your doctor can contact the Women’s International Pharmacy (www.womensinternational.com) to fill the prescription. If used directly on vaginal tissues, not only will estriol cream rebuild vaginal cells, it can also help restore clitoral sensitivity and orgasmic intensity, and reduce bladder infections.

Easing Off Hormone Replacement Therapy

Friday, August 8, 2008 by Susan Lark

If you are already taking hormone replacement therapy but want to transition to some of the natural therapies I’ve discussed throughout my blog, discuss your decision and alternative therapies with your doctor before you make any changes. A good physician will work with you to come up with a plan specific to your needs.

One of the first things you should talk to your physician about is weaning yourself off your current hormone replacement therapy dose. You should do this slowly, because stopping abruptly can increase the severity of the symptoms for which you began taking hormone replacement therapy, such as night sweats and menopause hot flashes.

Begin by cutting the dose of estrogen by one-half each month for one or two months. Then cut back to every other day for a month, then to twice each week, and then once a week each month. Continue to take the progesterone regularly until you have stopped all estrogen, so that you stay in balance.

Flaxseed: A Perfect Menopause Food

Thursday, July 31, 2008 by Susan Lark
Flaxseed contains the entire range of essential amino acids in an easily assimilated form. It also contains calcium, potassium, magnesium, and zinc; is an excellent source of phytoestrogens; and is high in fiber, which promotes healthy bowel function. In addition, flaxseed is 100 times richer in lignans (part of the seed’s cellular structure) than any other plant. Lignans reduce production of estrogen before menopause and help balance your hormones during and after menopause. This, in turn, can provide menopause relief.

A study published in the Journal of the American Nutraceutical Association showed that taking 38 grams (about four tablespoons) of ground flaxseed daily significantly reduced the rate of bone loss in post-menopausal women not on hormone replacement therapy.

An added bonus is that the fatty acids in such products as flax and pumpkinseed oil make hair shiny. So with flaxseed, you’ll not only feel better, you’ll look better, too! Take 4 to 6 tablespoons of ground flaxseed daily. If you prefer flaxseed oil, take 1 to 3 tablespoons daily.

Using Progesterone to Balance Estrogen

Monday, July 28, 2008 by Susan Lark
With so much attention given to estrogen, many women don’t know what role progesteron plays in the body. In short, progesterone balances the effects of estrogen. Where estrogen is growth stimulating, progesterone is growth limiting. Estrogen is mood elevating; progesterone has a sedative effect on mood. One of progesterone's tasks is to prevent menstrual bleeding from becoming too profuse or long lasting and prevent the uterine lining from becoming too thick, which may lead to uterine cancer. This is the reason progesterone is often a part of hormone replacement therapy.

I suggest looking into progesterone supplementation if you have menopause symptoms or signs of menopause.  There are natural forms of progesterone, which has no known side effects at the usual dose of 20–40 mg daily. Be sure to consult a physician who is knowledgeable about natural progesterone before beginning treatment with it.

Although it's available in pill form, many women prefer natural progesterone in a skin cream base, which you can get without a prescription. Topically applied creams are absorbed into body tissues immediately. Oral progesterone is first metabolized by your liver and converted into three different compounds. You can also use a transdermal spray such as Progest-Ease, that can be applied to the skin and absorbed into the blood stream without going through the liver.

A typical dosage of natural progesterone cream is 20 mg a day or one-quarter to one-half teaspoon amounts applied to any clean area of the skin twice a day. Look for a product that contains 400–600 mg of progesterone per ounce like Pro-Gest or Fem-Gest.

Perimenopausal women can apply the cream from day 12 to day 26 of their menstrual cycle. Menopausal women not taking estrogen may use progesterone for two to three weeks each month. And don't buy products that list wild yam on the label. Unprocessed, wild yam can't be converted to progesterone in your body. This conversion from the plants can only be done in a laboratory. And don't buy progesterone products that are made with mineral oil, which blocks the progesterone from entering your body. You can find a good natural progesterone cream at the Women's International Pharmacy (www.womensinternational.com).

Solving Insomnia

Monday, June 30, 2008 by Susan Lark

Tired?

You’re not alone! I can’t even begin to tell you how common insomnia can be during menopause. And menopause symptoms such as hot flashes and night sweats are some of the major reasons for insomnia, as well as stress, anxiety, and thyroid disorder, just to name a few.

If you are menopausal, I urge you to use a natural form of hormone replacement therapy to treat your symptoms. Acupressure is also a great remedy. The two acupressure points traditionally used to relieve insomnia are the Spirit Gate and the Inner Gate. The Inner Gate is located in the middle of the inner side of the forearm, two and one-half finger widths from your wrist. The Spirit Gate is located on the inside of the wrist crease, in line with the little finger. To promote sleep, apply pressure to one point and then the other. You’ll soon learn whether you get the most benefit from pressing both points or one in particular.

When It Comes to Menopause Symptoms, Age Doesn’t Matter

Friday, June 20, 2008 by Susan Lark

In my 30-plus years of practice, I've found that most women eventually see an end to menopause hot flashes and night sweats—even if it takes a few years. But unfortunately, some women never become completely immune to these symptoms, regardless of their age.

About half of menopausal women suffering from hot flashes see them disappear within a year, even without hormone replacement therapy, while another 30 percent experience these symptoms for up to three years. The last 20 percent of women endure menopause hot flashes for five to ten years or longer. I've worked with women in their 60s, 70s, and even early 80s who continue to have menopause hot flashes if they're not on some form of hormone replacement therapy. Luckily, safe, natural therapies for menopause such as vitamin E, black cohosh, and soy isoflavones (which I’ve talked about in other posts) are useful in eliminating menopause hot flashes, no matter what your age.

This combination not only eliminates menopause hot flashes, but also provides additional support to the cardiovascular system and bones. As a rule, I recommend taking the following daily dosages for menopause relief: 400–1,000 IU vitamin E; 80–160 mg black cohosh; and 50 mg–150 mg soy isoflavones.

Go Green for Menopause Relief

Thursday, June 19, 2008 by Susan Lark

What are green foods? No, they’re not broccoli, spinach, and green beans(although these veggies are extremely nutritious). Instead, green foods encompass foods like spirulina, chlorella, barley green, and wild blue-green algae.

These “super foods” are exceptionally rich sources of vital nutrients, digestible protein, essential minerals, and vitamin A. Algae, like spirulina, also contain omega-3 and omega-6 fatty acids. “Green foods” may not sound appetizing, but trust me—they are! And on top of that, green foods can be especially helpful for menopause relief—including increased energy and improved mood.

So many of my patients have told me that when they add 1 to 2 Tbsp. of these green foods to their diet (either by mixing the powdered form with 8 to 12 ounces of water or using it in shakes and smoothies), they’ve experienced significant symptom relief.
 
If you are in menopause and suffer from fatigue or depression (which frequently occur as side effects of certain types of hormone replacement therapy), then I urge you to give greens a try.

Why You Should Choose Natural Hormone Replacement Therapy

Friday, June 6, 2008 by Susan Lark

Women always ask me if they should take hormone replacement therapy to alleviate their menopause symptoms. My answer is always the same, no matter what the situation: Choose bioidentical hormone replacement therapy over conventional.

Conventional hormone replacement therapy has been shown to have a wide range of risks, including increased risk of breast cancer and heart disease. Why take this risk? Instead, choose more natural forms of hormone replacement therapy, including estriol.

Estriol is produced in the lab from active steroid molecules found in soy. The resulting molecules are structurally the same as those produced in your body. Of the three types of estrogen produced within your body, estriol is the weakest and least potent. Several research studies have found that it is as effective as the stronger, more potent estrogens for treating menopause symptoms. And unlike conventional hormone replacement therapy that may cause fluid retention, headaches, nausea, and the buildup of uterine tissue, estriol has few, if any, side effects.

One study published in JAMA found that estriol was particularly effective in treating vaginal atrophy, mood swings, and hot flashes. Researchers selected 52 symptomatic, postmenopausal women and separated them into four groups, giving each group either 2 mg, 4 mg, 6 mg, or 8 mg of estriol per day for six months. On average, women in every group experienced a decrease in their menopausal symptoms after one month of treatment. Plus, in three of the four groups, women who had ranked their symptoms as severe now felt that their symptoms were very mild.

Talk to your doctor about this safe and effective option for menopause relief

Black Cohosh for Menopause Relief

Tuesday, June 3, 2008 by Susan Lark

So many women come to me looking for relief from such common menopause symptoms as night sweats, hot flashes, vaginal dryness, and insomnia. I tell all these women the same thing: One of my top solutions for menopause relief is an herb called black cohosh.

Right now in Germany, a special extract of black cohosh is the most thoroughly studied and widely used natural alternative to hormone replacement therapy. Clinical studies have shown that black cohosh extract not only relieves menopause hot flashes, but also depression and vaginal atrophy.

In one of the largest studies on black cohosh, women with menopause symptoms received 40 drops of liquid black cohosh extract twice a day for six to eight weeks. Within four weeks of treatment, a distinct improvement was seen in nearly 80 percent of the women. After six to eight weeks, all symptoms had completely disappeared in half of the women.

If you have signs of menopause or menopause symptoms, I suggest taking 80–160 mg of a standardized extract of black cohosh twice a day. This dose should contain 2 to 4 mg of the active components (triterpenes, calculated as 27-deoxyacteine). Black cohosh is available in most health food stores, nutrition centers, and even some pharmacies.