'Wiley Protocol' for bio-identical hormone replacement

What is it?

   Recently there has been a lot of interest in a program of bio-identical hormone replacement therapy (BHRT) that has been referred to as 'The Wiley Protocol’. This name comes from the principal author, T.S. Wiley, of the book ‘Sex, Lies, and Menopause’.  This book is recommended reading for all women interested in menopausal and hormone replacement issues. If a woman is considering personally beginning the ‘Wiley Protocol’, the book is virtually mandatory reading. You can never have enough information about health issues which apply to one’s own personal situation and condition.

   Fundamentally, this is a program of bio-identical hormone replacement that follows the cyclical pattern of estrogen/progesterone that existed prior to the onset of menopause. It differs from conventional hormone replacement therapy in two basic respects.

   • First of all, the hormones that are utilized are ‘bio-identical’. This means that they have the identical chemical structure to the estradiol and progesterone made in the human body. In particular, this is in contrast to Premarin, which is a combination of estrogenic substances extracted from the urine of pregnant horses. The progestin component, akin to progesterone, is frequently a synthetic compound as well. The popular medication ‘Prempro’ is a combination of Premarin and medroxyprogestin, a synthetic progesterone analog. Over millions of generations, humans have evolved with the enzymes necessary to metabolize and eliminate natural substances (such as estradiol and progesterone) in a safe and effective manner. Synthetic hormones or other those derived from a non-human species cannot be removed as efficiently as natural substances. This can lead to higher and more protracted levels of these biologically active materials. The results of this cannot be definitely known or predicted. Bio-identical hormones are derived initially from plants (primarily soy and flax) and then altered in the laboratory to a structure identical to human estrogen and progesterone. These issues are fully discussed in the book ‘Sex, Lies, and Menopause.’

   • Secondly, the Wiley protocol consists of the cyclical administration of estradiol and progesterone in amounts that vary and that roughly approximate the cyclical production of hormones in the pre-menopausal woman. The estradiol and progesterone are prepared by a compounding pharmacy and are dispensed in syringes marked by multiple small lines. According to a standardized schedule, the hormones are applied in varying amounts (lines) through the month. Laboratory tests are obtained on a biweekly basis for the first three months of the program. By measuring levels of Estradiol and Progesterone, in correlation with presence or absence of symptoms, appropriate dosage adjustments can be made in administration amounts.

Who is it for?

   The decision as to whether to start on hormone replacement must rest with the individual involved. Symptoms of menopause can vary among different women. In some, they can be quite extreme. Hormone replacement can provide significant relief from many these symptoms. There have been recent highly publicized studies (particularly the 'Women's Health Initiative' and the 'HERS' study) that have indicated that hormone replacement therapy can be associated with a statistically increased incidence of health issues such as heart disease and certain types of cancer. These studies, while extensive, are based on evaluation of women who were taking Prempro, which, as discussed above, are not bio-identical to the hormones made in a womens body.  There have been no similar large studies on bio-identical hormone replacement. One of the considerations that each person has to make is whether the potential risks revealed in the studies on non-bio-identical hormone replacement are sufficient to avoid hormone replacement treatment of any form - specifically, a bio-identical replacement program such as the Wiley protocol. The general recommendation of the conventional medical community at this point is to eliminate or minimize any hormone replacement therapy (HRT).

 

    As mentioned, the final decision has to rest with the individual and be based on personal considerations such as severity of menopausal symptoms. Ideally, this decision is made in consultation with their physician and other reliable sources of information.   

In conjunction with the resumption of premenopausal hormone levels, women will generally experience the recurrence of cyclical menstrual bleeding. Breast tenderness in the first several months of hormone replacement is not uncommon.

   Prior to beginning the Wiley protocol a recent gynecologic evaluation and a mammogram should be obtained. Since hormonally sensitive tissues will be affected it is important to establish the absence of any pre-existing or underlying abnormalities.

Before Starting the Wiley protocol

1) Obtain and read through the book 'Sex, Lies, and Menopause'.  Gather as much information as you can on menopause and hormone replacement.

2) Consider whether hormone replacement therapy is something that you feel would be beneficial to you. Consider the studies on non-bioidentical hormone replacement and the adverse health consequences that were shown to be associated with those studies.

3) Discuss your decision with your physician, family members and others that you trust.

4) Make your decision.

If you decide to commence the program:

1) Obtain a baseline gynecologic examination and mammogram

2) Schedule an appointment with your physician

If your physician is Dr. Young

1) Discuss the protocol and ask any questions you may have

2) Gynecologic exam can be done by Dr. Young or another physician or qualified nurse practitioner. Obtain a mammogram. If these have been done within the past year that is sufficient.

3) Obtain prescription for Estradiol and Progesterone; this must be taken to a 'compounding' pharmacy (where the prescription is individually prepared from basic ingredients by the pharmacist).  There are pharmacies which are especially trained and registered with the Wiley program.  A list of these pharmacies can be obtained from caren@thewileyprotocol.com

4) Start protocol on full or new moon according to schedule provided by pharmacy

5) Schedule appointment with Dr. Young for one week following start of program.

6) Laboratory tests are to be obtained on day 12 (Estradiol) and day 21 (Progesterone). If these days fall on a weekend, obtain the tests as near as possible to day 12 or 21.

About the blood tests:

   Blood tests for Estradiol (day 12) and Progesterone (day 21) should be done 3 to 4 hours after application of the hormone cream(s) . Ideally, do not have anything to eat before the blood test is obtained. Although not critical, this will minimize any interference from foods which may contain estrogenic substances.

   If you have medical insurance which covers the tests it is best to obtain them at the laboratory. If not, discuss with our office staff alternative arrangements.

Support groups

   There are excellent ongoing support groups available for women participating in the Wiley program. If you would like to be on the email mailing list for the times and locations of these meetings, send an email to Caren at: caren@thewileyprotocol.com .

 

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