Wiley Protocol

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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.

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[edit] 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.[1] 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.[2] The protocol is promoted as differing from conventional hormone replacement therapy in several ways:

  • 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[1]
  • A dose that varies over a 28-day cycle rather than remaining static[1]
  • Topical rather than oral administration[1]

The protocol also includes a follow-up program to monitor the serum of the bioidentical hormones.[1]

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.[3]

[edit] 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.[4]

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.[5][6] A 2007 publication criticized the Wiley Protocol as unethical due to a lack of Phase I clinical trials, no approval by an institutional review board, a lack of an experienced scientific investigator, no inclusion or exclusion criteria and no evidence that the study population has been told that the research has not passed an ethical review.[7]

[edit] References

  1. ^ a b c d e T.S. Wiley (2007-01-03). Hormone replacement composition and method. FreshPatents.com. Retrieved on 2007-12-20.
  2. ^ Testimony of T.S. Wiley before the Special Committee on Aging United States Senate (PDF). United States Senate Special Committee on Aging (2007-04-19). Retrieved on 2007-12-20.
  3. ^ Interview with T.S. Wiley.
  4. ^ Feig SA, Hynote E, Speight N, Magaziner A, Miranda RA, Schachter MA (September 2005). "Summary of the American College for Advancement in Medicine May 2005 Conference: Menopause, Andropause: Power in Transition". Evidence-Based Complementary and Alternative Medicine 2 (3): 416. doi:10.1093/ecam/neh113. 
  5. ^ Schwartz E, Schwarzbein D. et al. (October 11, 2006). Letter to Suzanne Somers. Dr Erika's blog. Retrieved on 2007-12-01.
  6. ^ Ellin, Abby. "A Battle Over ‘Juice of Youth’", New York Times, October 15, 2006. Retrieved on 2007-12-01. 
  7. ^ Rosenthal MS (2008). "Ethical problems with bioidentical hormone therapy". Int. J. Impot. Res. 20 (1): 45–52. doi:10.1038/sj.ijir.3901622. PMID 18075509. 

[edit] External links