The Wiley Protocol


Hormone Mega-Doses and Menopausal Menstruation

Q: My wife and I are grateful for you in your efforts to extend the work of Dr. John Lee. I am a biochemistry professor and teach medical students about the difference between hormones and xenohormones (the term bio-identical should never have been necessary). Recently, we have discovered the Wiley Protocol and the graded dosing of compounded creams throughout the month, and this makes biological sense to me. Would you address this in a newsletter to let a wider audience in on it and your evaluation of it?

By the way, very neat letter to Oprah!

A: Glad you liked the Letter to Oprah! Dr. Lee always used to say that if doctors would just go back to their biochemistry professors and textbooks they would find validation of everything he was saying. It’s so true that progestins and other synthetic hormones are simply xeno (foreign) hormones, not found in nature, and no further distinction needs to be made.

T.S. (Susie) Wiley is undoubtedly brilliant. She and Dr. Bent Formby have made significant contributions to our knowledge of how hormones work, and Wiley’s book about the importance of sleep, Lights Out, is a masterpiece. That being said, I believe that the mega-dose approach to hormone replacement and advocacy of menstrual bleeding in menopausal women is misguided, and may have the potential to do harm.

The Wiley Protocol uses extremely high doses of hormones and an expensive, complicated approach of varying doses designed to create menstrual cycles in menopausal women. I’m not aware of any good reason for a menopausal woman to have menstrual cycles, and many reasons why it seems unwise, not the least of which is the risk of endometrial cancer caused by monthly stimulation of the uterus in an older woman.

Normal Hormone Doses are Safe and Effective
There is no need for a complicated protocol if you’re not trying to recreate a menstrual cycle. Most menopausal women feel dramatically better simply using a normal dose of transdermal hormones (creams or patches). By normal I mean Dr. Lee's recommended dose of 15 to 30 mg of progesterone and 0.025 to 0.05 mg of estrogen. Of course this will vary some among individuals, and a good doctor will adjust doses up or down depending on symptoms and test results.

Research done by Dr. Kenna Stephenson and her team at University of Texas Health Science Center showed that women who used bioidentical hormones were able to significantly lower their C-reactive protein, fibrinogen, triglyceride and blood pressure levels, all important indicators of heart disease risk. This study was done with progesterone cream doses ranging from 20 to 60 mg daily and normal doses of estrogen. Dr. Helene Leonetti conducted a double-blind study of women using Premarin that showed the uterus is well protected with 20 mg daily of progesterone. In both of these studies, the women expressed a high rate of satisfaction with the treatment and significant relief from menopausal symptoms.

I’m not aware of any evidence whatsoever that mega-doses of hormones and menstruation in older women has anti-aging benefits beyond what a normal dose would give.

I have heard from many women and doctors over the years that mega-dosing of hormones causes symptoms to return within 3 to 6 months. This is likely because the hormone receptors on the cells are getting the “full!” message and are shutting down. The blood is overflowing with hormones unable to enter the cells. Often, doctors using this approach will keep increasing the dose of hormones trying to get a response!
Normal, physiologic (what the body would make) hormone doses very effectively relieve menopausal symptoms without creating bleeding, and without the complication of doses that vary through the month. When you keep the dose normal, there’s no need to vary the dose.

When using transdermal (delivered through the skin) hormones, the only accurate way to test is with a saliva test or blood spot test. Transdermal hormones will not show up in a serum test (taking blood from a vein and measuring hormones in the watery portion of the blood) because they aren't in that part of the blood.