Wiley Protocol

The Wiley Protocol is a controversial form of bioidentical hormone replacement therapy (BHRT) devised and advocated by T. S. Wiley. Wiley promotes the Wiley Protocol as a means of restoring or preserving health, which is a step beyond the symptomatic treatment of conventional hormone replacement therapy. The protocol is an attempt to relieve the symptoms of menopause and increase health through the recreation of a pre-menopausal woman's monthly hormonal cycle using rhythmic doses of hormones standardized to a uniform purity.

The protocol has been criticized by members of the medical community for lacking proof. In addition there are criticisms about the dosages of the hormones used, and about Wiley's lack of qualifications to design the protocol. The protocol has not been empirically verified as safe or effective.

Specific dosing
The Wiley Protocol uses bioidentical hormones, specifically estradiol and progesterone. Hormones are applied transdermally, using an oil-based skin cream for topical administration. Doses of the hormones vary throughout a 28-day cycle that is designed to mimic the hormone levels and changes of a young woman who experiences regular menstruation, with each hormone cycling and peaking at separate times throughout the period. The protocol is promoted as differing from conventional hormone replacement therapy in several ways: The protocol also includes a follow-up program to monitor the serum of the bioidentical hormones.
 * The use of plant-derived hormones that are identical to endogenous hormones found in the body, rather than the synthetic derivatives of conventional hormone replacement therapy such as premarin
 * A dose that varies over a 28-day cycle rather than remaining static
 * Topical rather than oral administration

Wiley has stated that in her opinion, the most important aspect of the protocol is the specific schedule and levels of the hormone doses rather than their bioidentical nature.

Criticism
Concerns have been raised that serum levels may not be an acceptable marker for transdermally administered hormones, that some women have experienced significant side effects while following the protocol and have stopped using it, and that the dosages used are too high and not physiologic.

T. S. Wiley and Suzanne Somers have been criticized by some physicians for their advocacy of the Wiley Protocol. A group of seven doctors issued a public letter to Somers and her publisher, Crown, in which they state that the protocol is "scientifically unproven and dangerous" and cite Wiley's lack of medical and clinical qualifications. Somers is acting as a spokesperson for the protocol and was not involved in the development of the Wiley Protocol or its ongoing development.