NATRAGEST
BIO-IDENTICAL PROGESTERONE CREAM
 
 

 

Benefits:
SUPPLEMENT FACTS:
Serving Size: 1/8-1/2 teaspoon depending on application end use
1/4 teaspoon = 1.25 grams
No.Servings per Container: 56 grams
USP Progesterone 1.6% by weight
506 mg. per oz./ 1012 mg. per 2 oz. jar
1/4 tsp. = 20 mg. per dose
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In a Proprietary Blend of: Aloe Vera Extract in Distilled Water with Catalyst Altered Normalizer, Octyl Palmitate (palm vitamin A)
Tocopheryl Acetate (vitamin E), Glycerin
Stearic Acid, Glyceryl Stearate
Natural Wild Yam Extract, Cetyl Alcohol, Oleic Acid
Hazel Nut Oil, Grape Seed Oil
Panthenol (B5), Grape Seed Extract
Triethanolamine, Sodium Hyaluronate (Hyaluronic Acid--HA)
Carbomer, Potassium Sorbate
Methylparaben (fruit wax preservative)
Phenoxyethanol (alcohol preservative)
Fragrance
HYPOALLERGENIC. NO SOY, GLUTEN, EGG, DAIRY PRODUCTS.
Date of Manufacture rather than Date of Packaging given as Exp.Date to insure hormone activity
 
Use Instrucions: 1/8 to1/4 teaspoon per dose in a.m. or as directed by professional, 5 days on, 2 off. Discontinue during Mensus.
CAUTION: DISCONTINUE IF ADVERSE EFFECTS OCCUR.
Excerpts from Dr.Lee's Progesterone book & Discussions with John Lee, M.D., Ph.D. (deceased).
 
From the experiences of women before and after menopause, we know that menopause is accompanied with a long list of discomforts, from hot flashes to vaginal dryness to loss of libido to insomnia to mood swings to depression and more. We also know that postmenopausal women have a sharply increased risk for at least two serious disease states, osteoporosis and heart disease. Since these diseases, along with the discomforts of menopause, can be closely linked to chronically low levels of the hormones oestrogen and/or progesterone, replacement of those hormones has long been a major focus of medical treatment in women whose ovaries have gone into retirement, usually around age 50.
 
Likewise, research has suggested that premenstrual syndrome (PMS) is due to a hormone imbalance: women with PMS tend to have lower premenstrual levels of progesterone rather than higher levels, as was previously believed. The use of natural progesterone can usually alleviate the symptoms of PMS, such as bloating, weight gain, depression, breast tenderness, and swelling.
 
1. Conventional hormone replacement therapy (HRT) has typically employed estrogens made by horses and synthetic progesterone-like drugs made in the laboratory, both of which are unnatural in the human body. Nevertheless, many women have found conventional HRT to be quite helpful for alleviating menopausal discomforts, and many studies have correlated HRT's role in reducing the life-threatening risks of menopause-related heart disease and osteoporosis.

"Women who replace their missing oestrogen and progesterone using natural versions of these hormones (natural HRT) can reap all the benefits of conventional HRT with few or none of its unwanted effects or risks."

Effective as it is, though, HRT has been plagued from the start with severe adverse effects that have sharply limited the number of women who could use it. Conventional HRT promises to minimize a rather large risk of heart disease, and osteoporosis, but only in exchange for accepting the undesirable side effects ranging from hot flashes to insomnia to depression.
 
It doesn't have to be this way. Women who have been replacing their missing oestrogen and progesterone using natural versions of these hormones (natural HRT) have been able to reap all the benefits conventional HRT has to offer with few or none of its unwanted side-effects or risks.
 
2. Natural vs Unnatural Hormones
 
What's the difference between natural and unnatural hormones? It's quite simple, really. The natural oestrogen and progesterone used in natural HRT are identical to those the human body produces. When they enter the human body, natural hormones are right at home and are treated exactly the same as the hormones the body produces itself.
 
The hormones used in conventional HRT, by contrast, are either derived from horse estrogens (e.g., Premarin®) or are slightly altered but patentable versions (e.g., Provera®) of natural hormones manufactured in pharmaceutical company laboratories. Either way these unnatural substances (it's debatable whether some of them should even be called hormones) are often unwelcome guests in the human body. They may produce some of the same hormonal effects as their natural counterparts, but the human body does not always have the correct enzymes and cofactors to process them properly or completely. As a result, they may be too potent or, because they can't be easily inactivated, may overstay their welcome in the body.
 
Women who take natural progesterone (and/or natural estrogens) in physiologic doses (i.e., doses that reproduce normal levels in the body), report virtually no unwanted effects according to California physician John R. Lee, MD, who has studied the effects of natural progesterone in menopausal women for more than two decades. He believes that natural progesterone does have one "side effect": "That guy across the room will get better looking." Dr. Lee points out that progesterone is at least partly responsible for the sex drive in women. "Presumably, this is nature's way of assuring a meeting of the egg with a sperm after ovulation.
 
3. This is far from the case with synthetic progesterone's (known as progestins). A quick look at the Package Insert for the progestin, Provera (medroxyprogesterone), reveals that more than 60% of the text is devoted to Contraindications, Warnings, Precautions, and Adverse Reactions. Provera is a serious drug with many serious consequences, including the possibility of:

* Birth defects, if taken when pregnant
* Breast cancer (contraindicated in)
* The formation of blood clots, especially in the lungs or the brain
* Fluid retention, swelling
* Breakthrough bleeding, or other menstrual irregularities
* Depression
* Impaired glucose tolerance
* Breast tenderness and milk production
* Skin rash
* Acne
* Hair loss, or hair growth
* Weight gain

The Physicians' Desk Reference (PDR), which contains the labelling for most prescription drugs sold in the United States, lists 10 different Provera-like drugs with progesterone-like actions (progestins). A large proportion of women who start taking these unnatural synthetic "hormones" find the unwanted effects to be so unpleasant that they stop HRT altogether, thus giving up all its potential life-enhancing and life-extending benefits.
 
"Women who take natural progesterone in physiologic doses report virtually no unwanted effects."
All these progesterone wannabes generally have the same unwanted effects, because not one of them is really progesterone. The chemical structures of progesterone and Provera are quite similar. It is that similarity that enables Provera to perform many of the functions that progesterone normally does. But the two molecules also have some important differences, and it is those differences that account for the many unwanted effects that Provera and similar drugs cause."
 
What Does Progesterone Do?
 
The ovaries begin producing progesterone in earnest around puberty, and the monthly ebb and flow of this hormone, in harmony with oestrogen and other hormones, continues until menopause. Progesterone's primary role during this period is to help make the uterus ready for implantation of a new embryo. If implantation does not occur, progesterone production temporarily ceases, and the uterus sheds its endometrial lining.
 
At the same time it's helping drive the menstrual cycle, progesterone is also performing several other vital, but unfortunately less-appreciated functions (see box). Among the most important of these are building new bone tissue, thereby inhibiting osteoporosis, and countering the tendency of oestrogen to induce hyperplasia (excess growth) in the endometrial lining of the uterus. In some cases, this growth can turn cancerous. Progesterone is also a major precursor for the estrogens, testosterone, and other hormones. If the progesterone spigot is turned off, as occurs at menopause, oestrogen and testosterone levels may also fall.
 
Progesterone Builds Strong Bones
 
One of the great fears of women and of men too as they approach advanced age is osteoporosis, the disease in which bones become thinner, weaker, and prone to fracture. The incidence of fractures secondary to osteoporosis is one million per year. By very old age, one in three women and one in six men will have a hip fracture. It is estimated that 12 to 20 percent of hip fractures lead to death, and 50 percent lead to significant disability. Other vulnerable bones include the wrist, shoulder, ribs, and spine. As well, many years of osteoporosis are responsible for the "hunch back" seen in some elderly women, due to compression fractures of their vertebrae.
 
Bone tissue is constantly being "remodeled" throughout life in two phases. First, cells called osteoclasts travel throughout bone tissue. When they come upon older bone, they dissolve or reabsorb it, leaving tiny unfilled spaces or pores in their place. Following in the wake of the osteoclasts are cells called osteoblasts, which enter these spaces and begin construction of new bone tissue. Throughout youth and into middle age, bone remodelling reflects a balance between these two processes.
 
Osteoporosis means basically that the osteoclasts are outrunning the osteoblasts, resulting in a relative loss of bone tissue. In women, bone mass reaches its peak during their early to mid-30s, after which it begins a slow decline until menopause. Thus, as per Dr. John Lee, because osteoporosis begins several years before menopause it makes sense to begin natural progesterone early rather than waiting. After menopause, there is a rapid acceleration of bone loss for about five years of 3% to 5%, after which it tapers off to a still considerable rate of about 1% to 1.5% per year.

"In Dr. Lee's study, the bone density of women using natural progesterone cream increased by an average of 15.4%. Increases of 10% to 15% within 6 months and 20% to 25% in 3 years were common."

One of the prevailing myths in US medicine today is that osteoporosis can be treated by replacing oestrogen. In fact, although oestrogen replacement therapy may temporarily slow the progression of bone loss, it does not prevent it, and it does nothing to restore bone that has already been lost.
 
4. Moreover, as Dr. Lee contends, the idea that oestrogen retards bone loss (let alone prevents it) may be questionable, because in nearly every study that has examined the role of oestrogen in preventing or slowing postmenopausal bone loss, the women also received a synthetic progestin1. So how could one conclude which hormone (oestrogen, progestin, or a combination of the two) had the most significant influence on bone loss?
 
Evidence from many in vitro, epidemiological, and clinical studies support the view that progesterone is the hormone primarily responsible for building new bone.3 The primary study linking natural progesterone and reversal of osteoporosis was conducted by Lee.
 
5. Dr.Lee treated 100 postmenopausal women (mean age, 65.2 years) for a minimum of 3 years with a program that included natural progesterone skin cream. Of these women, Lee was able to carry out serial bone density testing on 63 of the women. Over 3 years, the women would have been expected to lose about 4.5% of their bone density with no treatment. But in fact, the women's bone density increased by 15.4% on average. "It was not uncommon," reported Lee, "to observe increases of 10% to 15% within 6 months and 20% to 25% in 3 years."
 
Lee found that advanced age was no hindrance to improved bone density, since those women who were older than age 70 had the same gains as those who were younger! The only factor that did seem to make a difference was the women's bone density at the start of therapy. Those with the lowest density at the start of treatment had the largest increases percentage-wise after 3 years. Whether or not the women were also taking oestrogen supplements made no difference.
 
Progesterone treatment had no side effects, which probably contributed to a high rate of compliance, Dr. Lee noted. The cost of the progesterone cream, which is about 10% of the cost of an equivalent dose of Provera, was also an important advantage.
 
Preventing Heart Disease and Cancer
 
Oestrogen seems to help control lipid levels, blood pressure, carbohydrate metabolism, coagulation factors, and endothelial function. Thus, the increase in heart disease risk following menopause is thought to be due, at least in part, to a reduction in oestrogen levels. Replacement of oestrogen in postmenopausal women increases the levels of HDL (the "good") cholesterol and decreases levels of LDL (the "bad")-cholesterol.
 
6. That's the good news. The bad news is that when a woman takes oestrogen replacement by itself, she may increase her risk of endometrial uterine cancer . Oestrogen is an excellent and important stimulator of cell proliferation in uterine and breast tissue. Unfortunately, if this proliferation is not checked, it can get out of hand, possibly leading to cancer.
 
Nature harnesses oestrogen's carcinogenic potential by "opposing" it with progesterone. Premenopausal women with normal levels of oestrogen and progesterone almost never get endometrial uterine cancer. But women who take "unopposed" oestrogen (oestrogen without concomitantly taking progesterone) may have a risk of endometrial cancer that may be as much as 14% higher.
 
7. "A quick look at the Package Insert for Provera (medroxyprogesterone) reveals that more than 60% of the text is devoted to Contraindications, Warnings, Precautions, and Adverse Reactions."

The addition of synthetic progesterone to an oestrogen replacement therapy regimen significantly reduces the risk of endometrial cancer. But again, there's a price to be paid. Replacing natural human progesterone with a drug like Provera significantly cuts into the heart disease protection you gain back by restoring oestrogen. Taking natural progesterone, though, does not blunt this cardiovascular benefit of oestrogen.
 
The PEPI Trial
 
This was demonstrated most clearly in a large well-controlled National Institutes of Health (NIH)-sponsored trial carried out over 3 years. Known as the "Postmenopausal Estrogen/Progestin Interventions (PEPI) Trial," its results were published in the Journal of the American Medical Association in early 1995.6
 
The participants in the PEPI trial, 875 postmenopausal women, were randomly assigned to receive either 1) placebo, 2) oestrogen (Premarin), 3) oestrogen + progestin (Provera), or 4) oestrogen + natural (micronized) progesterone (an oral formulation). Levels of HDL (the good cholesterol) in the placebo group decreased by 0.03 mg/dL, compared with their pre-treatment baseline. By contrast, in those women who received "unopposed" oestrogen replacement, HDL levels increased substantially over baseline to 0.14 mg/dL. By contrast, in the group that received oestrogen + Provera, the increase in HDL was nearly completely nullified. However, when natural progesterone was substituted for the synthetic progestin, virtually all of oestrogen's HDL protection was restored. Both Provera and natural progesterone produced significant improvements in LDL, triglycerides, and total cholesterol levels, compared with placebo.
 
The PEPI investigators were surprised by the superiority of natural progesterone over synthetic progesterone. The prominent cardiology researcher, Elizabeth Barrett-Connor, MD, of the University of California, San Diego, noted, "If I were treating a woman primarily because she was worried about heart disease or because she had dyslipidemia and low HDL cholesterol, I would probably see if she wanted to take micronized [natural] progesterone. I was quite impressed with the better effect." Another PEPI investigator, the former NIH head Bernadine P. Healy, MD, who is currently at the Cleveland Clinic Foundation, agreed, stating, "I think the biggest surprise certainly was the HDL effect of micronized [natural] progesterone.
 
8. Progestin vs. Progesterone: What's in a Name?
 
Why should the superiority of natural progesterone come as such a surprise to these prestigious researchers? One reason may be that, for the most part, the US medical community makes no distinction between progestins and progesterone. This is largely the result of a long-term pharmaceutical industry strategy to protect its investment in patentable synthetic progestins. By sponsoring thousands of studies on progestins, but none on progesterone, nearly all the large, well-controlled trials in hormone replacement have involved synthetic "hormones."

"Evidence from many in vitro, epidemiological, and clinical studies supports the view that progesterone is the hormone primarily responsible for building new bone."

"Somewhere early in the development of the HRT industry, progesterone was not only forgotten, it was mislabelled and mistaken as its [progestins] distant cousin," writes Dr. Lee.4 He points out that even well-researched books on menopause tend to make this error.
 
Progestins do not provide "the full spectrum of natural progesterone's biological activity, nor are they as safe," adds Dr. Lee. "It is a sad commentary on the pursuit of profit over women's well-being that the pharmaceutical companies take perfectly good natural hormones that our bodies know and can use and alter them, creating synthetic compounds with similar hormonal effects but toxic side effects. Research on natural progesterone has in the past two decades been essentially nonexistent. Thus does industrial profit influence the path of science," Lee writes.
 
As a result of this strategy, synthetic "hormones" have become the standard against which all other treatments have been measured. Never mind that they are demonstrably inferior to their natural counterparts. The fact that there have been no large, well-controlled, head-to-head comparisons between synthetic and natural hormones has been enough to convince most medical doctors to opt for progestins. Perhaps the results of the PEPI trial and any future studies which it may stimulate will begin to change that misperception.
 
Manufacturing Sources
 
Natural progesterone is derived from the wild yam (Dioscorea villosa) that contains the steroid precursor, diosgenin. How, you might well ask, can a wild yam yield a "natural" human hormone? While it's true that you can eat wild yams all day without raising your progesterone level (the human body does not possess the biochemical tools for converting diosgenin to progesterone or other steroid hormones), laboratory processing of diosgenin (cultured by bacteria) yields a molecule of progesterone that is chemically identical to natural human progesterone.

This progesterone can be taken by oral capsules or via a skin cream (transdermal). The transdermal route is often preferred, however, because progesterone is a small, fat-soluble molecule, which is absorbed very efficiently throughout the skin. Also, fewer hormones are required, and because it is stored in the fat tissues for use as needed, dosing is more consistent. When progesterone cream is rubbed on the skin, it is quickly absorbed into the underlying fatty layer and then diffuses into capillaries from where it enters the blood stream. Like other fat-soluble substances (e.g., vitamin E, vitamin A), it is carried along by red blood cells and is 100% bioavailable. Progesterone restoration occurs rapidly except for those who are especially deficient in progesterone, for whom, it may take two or three months to restore optimal levels.

Equivalent dosages of transdermal natural progesterone are 7 to 8 times more effective than ingested progesterone. The difference is that approximately 80% to 90% of oral progesterone is intercepted by the liver and conjugated for excretion in the bile. The liver does not intercept transdermal natural progesterone crème.
 
Natural Progesterone Creates Natural Balance
Natural progesterone is first absorbed into body fat and then passed into the body via the blood stream. Initially, much of the progesterone is absorbed in body fat. With continued use, fat levels of progesterone become stabilized and balanced because of the body's natural hospitality to this natural hormone. Further doses of progesterone increase the blood levels, and stronger physiological effects are felt.

Reclaim Youthful Biochemistry
Natural progesterone cream can correct the hormonal imbalances of PMS and menopause where they start: with low progesterone levels. And natural progesterone not only helps with the unpleasant symptoms of PMS and menopause but can also help to prevent osteoarthritis, heart disease and cancer. Furthermore, progesterone is known to enhance sex drive, maintain the lining of the uterus, protect against fibrocystic breasts, promote fat burning for energy, act as an antidepressant, improve thyroid hormone functions, help normalize blood sugar levels, and more. Doesn't it make sense to replace this vitally important hormone and reclaim the biochemical state of your 20s?

Progesterone's Many Roles:
* Precursor of other sex hormones (oestrogen and testosterone) and cortisone
* Maintains lining of the uterus
* Promotes the survival of the embryo and foetus throughout gestation
* Protects against fibrocystic breasts
* Natural diuretic thus helping to control fluid balance
* Promotes fat burning for energy (thermogenesis)
* Acts as a natural anti-depressant
* Aids thyroid hormone action
* Normalizes blood clotting
* Maintains sex drive
* Keeps blood sugar levels normal
* Normalizes zinc and copper levels
* Promotes proper cell oxygen levels for enhanced energy
* Protects against endometrial cancer
* Helps protect against breast cancer
* Promotes bone building and protects against osteoporosis
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References
1 Hargrove JT, Maxson WS, Wentz AC, Burnett LS. Menopausal hormone replacement therapy with continuous daily oral micronized estradiol and progesterone. Obstet Gynecol. 1989;73:606 612.
2 Barnard ND. Natural progesterone: Is oestrogen the wrong hormone? An interview with John R. Lee, MD. Good Health. 1994;Spring.
3 Prior JC. Progesterone as a bone-trophic hormone. Endocrine Reviews. 1990;11:386-398.
4 Lee JR. What Your Doctor May Not Tell You About Menopause. New York: Warner Books; 1996.
5 Lee JR. Is natural progesterone the missing link in osteoporosis prevention and treatment? Medical Hypotheses. 1991;35:316-318.
6 The Writing Group for the PEPI Trial. Effects of oestrogen or oestrogen/progestin regimens on heart disease risk factors in postmenopausal women. JAMA. 1995;273:199-208.
7 Estratab (esterified oestrogen tablets). Product Information. Physicians' Desk Reference: Medical Economics; 1996
8 Archives Journal Club/Women's Health. Oestrogen replacement therapy and heart disease: A discussion of the PEPI trial. 1995;
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