FAQ on the Wiley Protocol
Q. What is the Wiley ProtocolTM?
A. The Wiley
ProtocolTM, 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-mimmetic 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
Wiley-registered 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 goal of attaining a youthful woman's hormone levels
are based on widely known statistics that youthful women who have
appropriate levels of hormones are the most protected from breast
cancer, heart disease, as well as most diseases which eventually
afflict women as they age and therefore lose their sex hormones.
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 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. Ms. Wiley's method of HRT
is the only one based on the priciniples of bio-physics and rhythm;
hence she coined the Protocol “bio-mimmetic”.
The Wiley
ProtocolTM largely differs from conventional HRT in its
recommendation of using much larger doses of hormones in HRT, as
well a re-instituting 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 ProtocolTM 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. In addition, it has now become widespread practice for
conventional practitioners to routinely prescribe anti-depressants
and anti-seizure medications for the symptomatic relief of
menopausal symptoms, despite the lack of symptoms of depression of
seizure disorder! 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 ProtocolTM 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 ProtocolTM administered and what
can I expect?
A. The protocol is administered either in the
arms or the thighs, in a consistent manner so as to duplicate normal
hormonal rhythm of a youthful woman, as verified by serial blood
testing on specific days of the Protocol. 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. Therefore,
this is NOT the protocol for a patient with an intact uterus who no
longer wishes to experience monthly bleeds! 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 ProtocolTM?
A.
The decision to initiate HRT (which includes the Wiley ProtocolTM)
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 ProtocolTM
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 ProtocolTM,
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, as well as
subsequent books over the past 3 years. 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
ProtocolTM".
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 ProtocolTM, 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. Insurance
coverage for this Protocol will vary according to individual
insurance plans. 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
ProtocolTM 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 ProtocolTM.
Q. What is the difference between the Wiley Protocol and
bio-identical hormones?
A. Wiley ProtocolTM 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.
Q. Is there a Wiley Protocol for men?
A. Yes, T. S. Wiley has created the Wiley Protocol for men, which has been in use by patients over the past 2-3 years. Here, the goal proposed is to duplicate the levels of testosterone as well as DHEA of a healthy, young man, using transdermal creams, dosed so as to provide normal rhythm. There has been less experience with this protocol compared to the Wiley Protocol for women, as it is fairly new. Specific levels of testosterone and DHEA are targeted for certain days of the man's cycle which are monitored with serial lab testing. As with the Wiley Protocol for women, patients who initiate the men's Protocol will be required to have baseline testing and evaluation before being prescribed the Protocol, followed by proper follow-up testing and appointments similar to women.