What do you expect of menopausal hormone therapy?

Putting a name on an illness is the first step in the direction of finding a treatment for it. For instance, a treatment for high blood pressure is something that will lower blood pressure and a treatment for a fever will lower the fever.

This is how clinical trials evolve into effective treatments. Except when it comes to menopause.

Have you ever asked yourself why treatment for menopause is so hard to get, or why medications for hypogonadism, the illness that you are treating when you are treating menopause, are few and far between? Have you ever asked yourself why huge clinical trials that cost millions and millions of dollars have not come up with a way to reliably restore sexual function that is lost because of ovarian failure?

The answer is simple. If these clinical trials were meant to be helpful then they would be.

Here is a good example.

A clinical trial called KEEPS was started just as the Women's Health Initiative was ending. It was supposed to be the next generation in menopause trials.

On the KEEPS website the purpose of the study is stated as:

This study will help researchers determine if menopausal hormone therapy (HT) prevents or delays the onset of the number one killer of women, heart disease.

Makes sense. Menopausal hormone therapy for menopause. So what is in this HT that is being tested in the KEEPS trial? Will we find out the best levels of estrogen, testosterone, progesterone, dhea, or oxytocin to treat hypogonadism and prevent heart disease?

The answer is no. The level of estrogen, for either the pill or the patch used in this study, is not in the replacement range, nor is the progesterone, and there is no testosterone, dhea, or oxytocin. The oral estrogen given (Premarin) actually lowers the available testosterone and creates very high, unnatural levels that would never happen naturally in a woman's lifetime, unless, of course, she took this pill. If a woman walked into a doctor's office with levels given with the patch she would be diagnosed with hypogonadism and imminent menopause. If a woman walked in to a doctor's office with levels resulting from the pill, the doctor would likely think the woman has a tumor secreting very large amounts of estrogen and would arrange to have it taken out.

What is the point of recreating the months just prior to full ovarian failure? What is the point of creating a disease state on purpose? Would you want to take a medication that kept you in a state of imminent menopause or a disease state for decades? Clearly the answer to this question is no. Hypogonadism is clearly not being treated so why are these regimens called menopausal hormone therapy?

The KEEPS trial is very similar to the Women's Health Initiative trial which is very similar to the PEPI trial and every other trial that says that they are using HRT or HT or MHT. All of these trials do not attempt to treat the very illness that these women volunteered to have treated. That is misleading and violates the intent of the informed consent laws that are there to protect the public.

So what can be done?

Recognize that the terms HRT, HT, and MHT have become meaningless and manipulative when referring to hypogonadism in women. If you want treatment for hypogonadism, then you'll have to ask for it directly.

Women need to see that treated hypogonadism is healthier than leaving it untreated and for that to happen they need successful trials. The only way to see a successful trial is to have a trial that actually sets out to treat this terrible illness.

Until that day comes, every single woman who is taking hormones to relieve her symptoms and improve her quality of life is going to have to be her own scientist. Until that day comes and scientists take menopause seriously every woman is going to be in her own clinical trial every day until she comes up with the treatment that the scientists should have come up with.

Don't give up. This illness is treatable, the technology is there for those who want to see it, and hopefully with your doctor's help you can improve your health and your quality of life.
8/19/2008 11:13:44 PM
Beth Rosenshein
Written by Beth Rosenshein
Beth Rosenshein is an electrical/bio-medical engineer and is very familiar with medical research. She holds two United States patents, one for a unique design of a vaginal speculum, and one for a clever urinary collection device specifically designed for women. Beth discovered and documented an important drug interaction...
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