(Added online March 2010)
Menopause is typically described as a normal function of life. Women are told that there is nothing that can be done about it and to accept it and go on. Women are reassured that menopause is nature's way of protecting them from childbirth later in life. They are encouraged to embrace this change, make the most of it, and, more importantly, enjoy it. Yes, menopause is natural in that it happens to every woman; but that does not mean that it is healthy for a woman. Would preventing menopause be a healthy alternative for women? The National Institutes of Health (NIH) would say no. The NIH has not developed a healthy and effective treatment protocol to recommend after decades of clinical trials. Which raises the question, why prevent something that is normal and natural and that the NIH says should not be treated?
Whether menopause is normal or natural, it is still organ failure. Ovarian failure is the organ failure that creates menopause. As with any organ failure, the only result is ill health. Since the human body was designed to function optimally with all of its organs, the failure of one organ creates a deficit to all other organs. The entire body suffers from the loss of the ovarian hormones. This deficiency is called hypogonadism.
We are very familiar with the symptoms of hypogonadism. The symptoms include hot flashes, sleep disturbances, loss of mental acuity, profound loss of sexual function, flatulence, osteoporosis, and so on. Because we typically use the word menopause to describe the symptoms of hypogonadism, we think that it only happens to women. Not so! Hypogonadism strikes women and men with the same symptoms and ill health. We can easily see the negative physical, emotional, and career effects hypogonadism has on a man's life, yet somehow culturally we see it as something that a woman should embrace. In fact, we like to tell ourselves that women in different cultures adapt to it more easily. Again, not so! While different cultures may respond to women who are suffering in supportive ways, all women, no matter where they live, suffer the very same physical, emotional, and career effects.
The ill effects of hypogonadism, particularly over a long period of time, are well documented and not gender-specific. Hypogonadism is a condition in which a person, male or female, has lower than normal levels of sex hormones. The symptoms of hypogonadism are the same for women and men, because there is no such thing as a female or male hormone. The gonads, ovaries for women and testes for men, produce the same gonadal or sex hormones, estrogen, testosterone, and progesterone. The brain communicates with the ovaries and testes with the same hormones as well. Follicle stimulating hormone (FSH) and all other hormones produced by the pituitary help the gonads work. There is nothing gender-specific about sex hormones. The role of sex hormones is the same in women and men, and their loss, hypogonadism, is felt in the same way.
This is where the similarities end. The treatment of hypogonadism in men, also hormone replacement therapy (HRT), has evolved over the last century and now has a very effective protocol. The current protocol for men is based on well-designed studies of physiologic replacement (only putting back what is no longer being made) and strongly suggests the use of bioidentical hormones. Men benefit from appropriate replacement with an improved health status. Men who have hypogonadism and take HRT have their sexual function restored, improved cognitive function, improved sleep, less depression, reduced osteoporosis, and no hot flashes. If hypogonadism creates the very same symptoms in a man and an effective treatment is developed and bioidentical hormones recommended, why doesn't HRT work for hypogonadism in women?
The answer is simple, HRT for women isn't HRT. Since 1942, when it was dubbed HRT, Premarin has been the only regimen ever tested in clinical trials for hypogonadism in women. Premarin isn't HRT, because it isn't based on physiologic replacement. Premarin contains a very large amount of estrogen, many times higher than a normal menstrual cycle. The ovaries produce not only estrogen but testosterone and progesterone as well. The ovaries produce 10 times more testosterone than estrogen and 100 times more progesterone than estrogen. Of all the ovarian hormones, estrogen is produced in the smallest amount. The ratio of the ovarian hormones is very important for an effective treatment of hypogonadism. Taking Premarin creates a hormonal ratio sharply different from the ratio that arises with functional ovaries. We can see how important this ratio is when we consider sexual function.
Treatment for hypogonadism in a man restores sexual function. Sexual function is restored because the normal ratio of sex hormones is maintained. The fact that Premarin has never been associated with restoring sexual function clearly demonstrates that it does not act like physiologic replacement and should not be called HRT. After all, could a regimen for men that didn't restore sexual function be called HRT? Loss of sexual function isn't the only ill effect of hypogonadism. The dramatic increase in breast cancer is due to ovarian failure. That is because the ovaries produce sex hormones in a ratio that protects women from breast cancer. Any regimen called HRT should then reduce the occurrence of breast cancer, not increase it. Premarin increases the occurrence of breast cancer above and beyond the occurrence caused by the very ailment it is meant to treat. Clearly, Premarin is not HRT or hormone therapy (HT) or menopausal hormone therapy (MHT).
If Premarin isn't HRT, then what is? HRT in every other area of medicine is based on physiologic replacement. So HRT for hypogonadism in women, which is caused by ovarian failure, would be based on replacing all the hormones of the ovaries in the same ratio as the ovaries produced them. This can be done by recognizing the physiologic window of each of the hormones and replacing each one within this window. Since replacement would be based on physiologic replacement, it should be called ovarian replacement therapy (ORT).
ORT should have the same health benefits as functional ovaries. We should expect ORT to restore sexual function; prevent breast cancer; and improve cognitive function, overall mood, muscle tone, and sleep. As straightforward as this approach is, there are many obstacles to using physiologic-based HRT.
First and foremost, there is no protocol. Evidence-based medicine demands it, and it simple does not exist. In the 65 years since Premarin was introduced into the market, the NIH has used it for virtually every clinical trial that it has conducted on hypogonadism. The NIH continued to use Premarin even when, soon after it was introduced, it was discovered that it did not restore sexual function. The NIH has used the same dosages, made in the same way – from live horses – for the last 65 years. The NIH continued to use Premarin, even though there were no commercially available assays or test kits that a laboratory could use to monitor blood levels. Even though the Women's Health Initiative (WHI) cost more than half a billion dollars, there was no hormone testing of any kind done before, during, or after the trial. The NIH actually had an HRT trial and did not test the levels of the very hormones it was supposed to be replacing. Conducting a replacement trial and not measuring the levels of hormones being replaced raises the question, what is the point of this trial?
In sharp contrast to every other area of endocrine medicine, there has been absolutely no modernization of treatment. The same regimen used 65 years ago is the same regimen used today. There are still no lab tests to measure Premarin estrogen levels, and the product still comes from a live animal. Premarin is not based on physiologic replacement, and yet it is still called HRT. There is no evidence-based medicine on physiologic replacement, because the NIH has chosen not to modernize treatment. Without evidence-based trials showing health benefits, how is a physician supposed to effectively treat hypogonadism in women? How can ORT be used without supporting trials showing health benefits?
Evidence-based medicine is the best way to go. Unfortunately, the NIH has chosen not to modernize, still does not have one clinical trial based on physiologic replacement, and continues to recommend no treatment. This leaves women living with the ill effects of untreated hypogonadism. Any treatment will have to be based on good judgment until evidence-based medicine catches up.
ORT, by its very definition, is based as closely as possible on ovarian function. But even with a regimen of estradiol (the main estrogen of the ovaries), testosterone, and progesterone, there are more obstacles than a lack of an evidence-based protocol. Without an effective protocol, pharmaceutical companies are not developing products based on replacement. Without appropriate replacement products, doctors have turned to compounding pharmacists. They serve a very important purpose and have received very bad press lately. It is cheaper and easier to use FDA-approved products, and if they were available in the needed dosages, compounding pharmacists would not be so busy.
So what does it mean to prevent menopause? Preventing menopause means to prevent hypogonadism either through effective treatment or by extending the functional life of the ovaries. Can the ovaries really function past the age of 50? Is it healthy to have functional ovaries into old age? Would fertility be an issue?
Hypogonadism at any age is unhealthy, and if it can be avoided via effective treatment using ORT, that would be preventing menopause. Preventing menopause means maintaining sexual function, cognitive function, and normal blood pressure; preventing breast, uterine, and colon cancer; being able to sleep seven hours a night … the list goes on.
What about preventing menopause by preventing ovarian failure? Functional ovaries can maintain a healthy ratio of sex hormones in order to maintain a woman's health and quality of life. We have all been taught that ovarian failure is inevitable and that there is nothing that can be done about it. A recent study would suggest otherwise.1
The timing of ovarian failure can be influenced. Ovaries fail for one reason and one reason only: they run out of eggs. The ovaries contain a certain number of eggs at birth. After puberty, when the ovaries begin to recruit eggs every month, the store of eggs goes down. As long as things go well, the number of eggs recruited each month is approximately the same. Based on the number of eggs at puberty and the number of eggs recruited monthly, a woman's ovaries should last her until she is in her seventies.2 All goes well until a woman reaches her late thirties, when the ovaries begin to use more eggs than necessary every month. As a result, the store of eggs goes down faster than normal, and the ovaries run out of eggs about 20 to 30 years sooner than necessary. The reason ovaries begin to use more eggs is because the ovaries are not getting what they need to function well. Like any ailing organ, providing what is needed helps the ovaries work better.
Preventing menopause is more than a lofty idea. Medically, it means that a woman can avoid hypogonadism completely. Avoiding hypogonadism means avoiding a profound loss of sexual function and the devasting effect that it has on a marriage. Avoiding hypogonadism means that a woman will be able to compete in the job market because she will be able to avoid cognitive decline. Avoiding hypogonadism means that a woman can avoid a dramatic increased risk of breast cancer. Preventing menopause would very likely change the current window of fertility. Women would no longer feel the pressure to have a baby by age 40 and instead be able to change that to age 50. Preventing menopause means avoiding unnecessary ill health and maintaining a quality of life everyone deserves.
Beth Rosenshein is the author of Preventing Menopause: How to Stop Menopause Before it Starts. With her husband, she is also the cofounder of Diamond Research Foundation (DRF). DRF seeks to find ORT regimens that will seamlessly transition from ovarian function to ovarian failure, completely avoiding hypogonadism. DRF also seeks to find regimens to extend the functional life of the ovaries to avoid hypogonadism.
1. WebMD Medical News. Age of menopause getting later. WebMD. Available at: http://www.webmd.com/menopause/news/20031114/age-of-menopause-getting-later.
2. Gougeon A, Ecochard R, Thalabard JC. Age-related changes of the population of human ovarian follicles: increase in the disappearance rate of non-growing and early-growing follicles in aging women. Biol Reprod. 1994;50(3):653–663.