The Wiley Protocol

What is the Wiley protocol? Why is so popular? Is it a valid therapy with strong basis? How does it work?

We will try to answer all these questions is this article. The Wiley protocol is a bioidentical and biomimetic hormone replacement therapy (BHRT) delivery system, based on estradiol and progesterone in a topical cream preparation. The reasoning behind this therapy is that the individual daily doses of hormones a woman should take varies throughout a period of 28 days, i.e. supposedly mimicking the natural hormone changes that occur on a menstrual cycle. It is based on the concept that young adults in fertile age (and therefore the hormone levels they would have then) would not develop health problems characteristic from later stages in life, because the incidence of heart disease, stroke, type II diabetes, cancer and Alzheimer’s disease are not usual matter of concerns amongst young and healthy individuals. Even though this itself can be a hot topic open for debate, it is indeed one of the pillars that sustains the Wiley protocol. This is how individual dosages are calculated. So this pretty straightforward ‘evidence’, which is ‘the younger the better’, can easily engage women seeking for proper care of their menopause symptoms, or when looking for an alternative outside standard HRT. However the question we should ask is: “Is having similar hormones levels in your fifties like you had in your twenties the answer to your menopause related symptoms?”

There must be reasons why we women are designed in the way we are, and having oestrogen declining in some stage later in life… but it is also a bit naive to place believe lack and change of hormones is the sole reason for heart disease, stroke, type II diabetes, cancer and osteoporosis.

Lack of hormones doesn’t help, I agree, but neither does aging nor unhealthy lifestyle choices. I personally think you can’t restore youth just by giving a hormonal cocktail, but again we may diverge on opinions here.

So, Wiley protocol uses bioidentical hormones, which means that these are not synthetically produced, but yet derived from plant oestrogen as similar as possible to our human counterpart. The “normal” HRT hormones are generally synthetically derived or animal derived. Therefore, by the concept of being more natural in its source, bioidentical hormones are thought to be better than classical HRT. But it is not always the case. Food and Drugs Agency in America has approved some of the individual components for bioidentical estradiol and progesterone, but it has not approved any compounded bioidentical hormones (an explanation on why we are taking those hormones and what they are will be subject of the next set of articles). There are also claims that bioidentical hormones seem to be safer and more effective than traditional HRT because they are identical in their structure to those produced in our bodies. But unfortunately, these claims have not been confirmed in large-scaled, reputable scientific studies.

The FDA at this point urges caution when using compounded products.

The most important aspect when taking hormones is the dosage: a dosage too high can really be detrimental, especially in menopausal women which need to be careful with hormones, because of all the side effects they can experience. One could argue that hot flushes, aching, loss of energy, loos of appetite are good enough reason to start hormone therapy, and they are, yet they need to be carefully prescribed. So Wiley protocol seems very appealing because it is very precise, you have your table with your hormones and the dosage already settled. But, it does not (1)  precisely take into account the natural hormone levels that may already be occurring in your body (since until you are post menopausal you still have natural fluctuations of oestrogen and progesterone even if its patterns have fallen out of the ones you should have when you have your regular menstrual cycles) and (2) tries to mimic something that you had when you were 20 years old. There have been research studies arguing about the safety of the Wiley protocol, since the hormones dosage is higher than traditional therapies, and also criticising the lack of full disclosure of risks, as well as misinformation about the study goals and safety. Breaches in professional ethics include conflicts of interest, patient accrual, and inadequate standards of awareness.

It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for being less strict in following medical regulations. So this is the Wiley protocol: it starts from an assumption which we would like to be true (restoring your hormone levels to the equivalent of a younger age) and uses unregulated formulations (many of them). It might work for some but not for others. I think we need to be careful with those kind of therapeutical routes, especially if there is not regulation about it, or they are not administered by a licensed medical professional.

By Ornella Cappellari 



Menopause. 2008 Sep-Oct;15(5):1014-22. doi: 10.1097/gme.0b013e318178862e. The Wiley Protocol: an analysis of ethical issues. Rosenthal MS