Progesterone-DP^TM
Natural Progesterone Cream

for PMS - Menopause - Osteoporosis - Libido - And More

By Gail Valentine, DO

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 estrogen 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.

It doesn't have to be this way. Women who have been replacing their missing estrogen 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 estrogen 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 (eg, Premarin�) or are slightly altered but patentable versions (eg, 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 (ie, 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

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 estrogen 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 estrogen 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, estrogen 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 remodeling 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.

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.^1,5 He 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 estrogen 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
Estrogen 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 estrogen levels. Replacement of estrogen 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 estrogen replacement by itself, she may increase her risk of endometrial uterine cancer . Estrogen 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 estrogen's carcinogenic potential by "opposing" it with progesterone. Premenopausal women with normal levels of estrogen and progesterone almost never get endometrial uterine cancer. But women who take "unopposed" estrogen (estrogen without concomitantly taking progesterone) may have a risk of endometrial cancer that may be as much as 14% higher.⁷

The participants in the PEPI trial, 875 postmenopausal women, were randomly assigned to receive either 1) placebo, 2) estrogen (Premarin), 3) estrogen + progestin (Provera), or 4) estrogen + 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 pretreatment baseline. By contrast, in those women who received "unopposed" estrogen replacement, HDL levels increased substantially over baseline to 0.14 mg/dL. By contrast, in the group that received estrogen + Provera, the increase in HDL was nearly completely nullified. However, when natural progesterone was substituted for the synthetic progestin, virtually all of estrogen's HDL protection was restored. Both Provera and natural progesterone produced significant improvements in LDL, triglyceride, 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."

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.

Creams or Caps?
Natural progesterone is derived from the wild yam (Dioscorea villosa) which 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 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, less hormone is 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 (eg, 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. Transdermal natural progesterone creme is not intercepted by the liver.

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 osteoarthristis, 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?