FAQ on the Wiley Protocol

Q. What is the Wiley Protocol^TM?

A. The Wiley Protocol^TM, as described in the book Sex, Lies, and Menopause, by T. S. Wiley and Julie Taguchi, M.D., is a specific protocol of administering bio-identical hormones to women for those seeking hormone replacement therapy (HRT). This protocol differs from conventional HRT in many ways: it uses only bio-identical estrogen (estradiol, specifically) and progesterone, made by compounding pharmacies in cream form; the hormones are applied on the skin; the dosage for each day varies so as to attempt to duplicate the 28-day menstrual cycle of a youthful reproductive woman, including hitting peri-ovulation peak serum levels of estradiol and progesterone (in the luteal phase). The reasons for administering HRT in this specific manner are detailed in the book. The book offers a detailed look at why women not only need HRT, but that they need it at youthful levels, from an evolutionary biological perspective. Ms. Wiley and Dr. Taguchi discuss the benefits of this protocol in the book, which include, but are not limited to, the achievement of G1 growth arrest in appropriate estrogen-receptive cells with peaking of estrogen to peri-ovulation ranges, and apoptosis (pre-programmed cell death) when progesterone peaks to in the luteal phase (typically day 21 of a 28-day menstrual cycle). They argue that without regular G1 arrest and apoptosis, as intended to naturally occur with each menstrual cycle, diseases such as cancer are much more likely to occur.

The Wiley Protocol^TM largely differs from conventional HRT in its recommendation of using much larger doses of hormones in HRT, as well a reinstituting rhythm (not static dosing), since the aim is youthful levels of hormones. Traditional conventional methods have largely used very low doses without blood-monitoring, in flat-line, static doses. The Wiley Protocol^TM also utilizes large doses of progesterone transdermally (through the skin), whereas FDA-approved forms of natural progesterone are only available in oral or vaginal routes, based on absorption studies. Monitoring of hormone levels on this protocol are done with serum blood tests, which has not been concluded to be a valid way of measuring progesterone levels when it is applied through the skin. Many practitioners argue that saliva testing is more accurate specifically with regard to the application of progesterone topically through the skin, although this is currently controversial. It appears that levels of progesterone measured in the saliva vs. venipuncture appear to vary widely.

Based on the Women's Health Initiative (WHI) results published in 2002, conventional medical practitioners have recommended against routine HRT for preventing disease, and to only resort to HRT for the treatment of poorly-tolerated menopausal symptoms. In such cases, current conventional wisdom advises patients to use the lowest doses of HRT for the shortest amount of time necessary for control of symptoms. However, the results of the WHI do not apply to all women, and I advise all women to thoroughly review the results of the WHI with their physicians before making any final decisions. For a more detailed review of WHI results, please see my FAQ section, as well as log on to www.imsociety.org, the website for the International Menopause Society (IMS), for an excellent critique of the WHI in their position statement presented by the IMS expert panel, revised in 2004, and again in 2007, with recent meeting updates from 2008.

The effects of this protocol have not been evaluated in any recognized clinical trials, although the BHOT (Bio-identical Hormones On Trial) study, which will also evaluate this protocol, is in its initial stages of data-gathering. The Wiley Protocol^TM is currently the only compounded bio-identical hormone regimen that is standardized in its dosage and preparation, via multiple Wiley-registered pharmacies, who have entered into contract with Ms. Wiley. Beyond that, the only results we have which speak to the effects of this protocol are largely anecdotal, mainly from the probable 10,000 women nation-wide who have been on this protocol for various lengths of time over the past 10 years. T. S. Wiley herself, as well as her close friends and family members, have reportedly been on this protocol for over 10 years, with very positive results.

Opinions, both positive and negative, regarding this protocol abound, and have recently received great attention in the lay press coverage and across the internet. However, the only consensus about this protocol put forth by a recognized medical organization thus far is summarized in the May 2005 conference of the American College for the Advancement of Medicine (ACAM), which can be reviewed at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1193553.

Q. How is the Wiley Protocol^TM administered and what can I expect?

A. The protocol is administered either in the arms or the thighs, in a consistent manner. Side effects are usually transient, and depend largely on a woman's hormone status prior to applying the protocol. For instance, a woman who is several years postmenopausal without HRT may require a longer period of adjustment to such youthful levels of hormones as compared to someone who is just entering menopause, whose body has been used to much higher levels of hormones up until recently. Predictable monthly 5-day menstrual bleeds are the rule on this protocol in women with intact uterus, although establishing such regularity may take up to 1-3 months depending on the woman's individual situation. The protocol calls for administration of full complement of progesterone along with estrogen, even in women who have had hysterectomies, which is another point of difference from conventional HRT. Detailed instructions on how to apply the hormones, potential drug interactions, and potential interfering factors such as exercise, are included on a pharmacy package insert with each batch of the creams. Common symptoms during the adjustment period as the body adapts to the protocol include and are not limited to: headache, nausea, dizziness, fluid retention, and breast tenderness. Patients should thoroughly review the FAQ section of T. S. Wiley's official website at www.thewileyprotocol.com before actually initiating the protocol, as answers to commonly asked questions are reviewed.

Q. What if I want to try the Wiley Protocol^TM?

A. The decision to initiate HRT (which includes the Wiley Protocol^TM) or not is a very personal decision, and should be arrived at after thorough research of the literature and discussion with a knowledgeable physician regarding each individual's situation, including risk/benefit assessment based on genetics, risk factors, lifestyle, symptoms, and quality of life. Patients should also realize that the decision whether to initiate HRT need not be a permanent decision, and that repeat assessments at regular intervals regarding such a decision may actually be beneficial. As mentioned in the answer to the previous question, the Wiley Protocol^TM has garnered much attention in the lay press recently, both positive and negative. Those who are interested in initiating this protocol are advised to thoroughly peruse the May 2005 summary of the ACAM conference at http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1193553, which renders an opinion from a respectable medical organization. It is interesting to note that in the past few years, several prominent anti-aging experts are now acknowledging the importance of rhythm in HRT by adapting variations of the Wiley Protocol^TM, only at lower doses into their own practices, as per presentations at ACAM. Positive opinions can be found at T. S. Wiley's official website at www.thewileyprotocol.com, as well Suzanne Somers' personal testimonial in her new book, Ageless. Negative opinions can be found at http://www.nytimes.com/2006/10/15/fashion/15suzanne.html?_r=1&ref=health&oref=slogin, which discusses a letter sent by physicians Erika Schwarz, et al to the editors of Ageless, and can also be found on multiple websites using a Google search of "Wiley Protocol^TM".

Documentation regarding the effects of administering this protocol to women of all ages have been anecdotal thus far, and my own observations of a limited number of patients on this protocol should also be classified as such. I have seen a wide range of effects, varying from very positive, to neutral, to less positive, when administering this protocol to women who had previously only partially responded to conventional methods of relieving their symptoms of hormone imbalance. There appears to be wide variation in how women absorb the protocol transdermally, and multiple adjustments may need to be made over several months in order to arrive at blood levels of estradiol and progesterone as specified by Wiley in her book.

Once a woman has made the decision to initiate the Wiley Protocol^TM, the prescription will be filled at a Wiley-registered pharmacy, who has agreed to compound the bio-identical creams to Ms. Wiley's specifications. Wiley-registered pharmacies have also agreed to cap the monthly price of both hormones at a reasonable rate, as most insurances may opt to not provide coverage for this non-FDA-approved protocol. Wiley registration also allows standardization of the hormone creams (the lack of standardization was the basis for Wyeth's--maker of Premarin--petition filed with FDA a few years ago to urge the FDA to closely examine the lack of regulation and standardization of compounded products offered by compounding pharmacies in general), which, more importantly, allows this protocol to be studied scientifically, as in the BHOT trial that is ongoing.

Patients wishing to initiate the Wiley Protocol^TM must read the book before scheduling an in-person consultation with Dr. Chen to discuss the protocol in detail, including a detailed discussion of the controversy surrounding this protocol. By the third month of using the protocol, patients must have day 12 serum estradiol level checked, along with FSH and progesterone levels, and a day 21 serum estradiol and progesterone levels. These blood levels are helpful in assessing the peaking of both estradiol (day 12) and progesterone (day 21), and provide guidance in determining whether or not the protocol needs to be adjusted for each individual, although most adjustments are symptom-based. Patients should have repeat appointments with Dr. Chen shortly after the results of these levels are available to discuss any fine-tuning which may need to be made based on their lab results as well as tolerability of and response to the protocol. If adjustments in the protocol have been made, then follow-up lab testing should be obtained in another three months. Dr. Chen also requires patients to have regular follow-up pelvic ultrasounds in those who still possess their uterus, so as to monitor closely for any potential side-effects, such as development of fibroids, or endometrial (uterine lining) thickening. This is especially important given that monitoring progesterone effects via serum testing is not always reliable, as stated above. This is Dr. Chen's standard recommendation for any woman wishing to initiate any form of HRT and is not limited to those on the Wiley Protocol^TM.

Q. What is the difference between the Wiley protocol and bio-identical hormones?

A. Wiley Protocol^TM uses bio-identical hormones applied to the skin, in a rhythmic pattern, trying to duplicate the youthful woman's menstrual cycle. All other forms of traditional bio-identical hormones have used them in static (without rhythm), low doses, copying prempro (the combination drug premarin plus provera, which was the drug studied in the Women's Health Initiative) as a template. For a more thorough explanation of the comparisons, as well as how the use of bio-identical hormones have evolved over the past several decades, please refer to www.thewileyprotocol.com.