Wiley Protocol

The Wiley Protocol is a controversial form of bioidentical hormone replacement therapy (BHRT) devised and advocated by T. S. Wiley. The protocol claims to relieve the symptoms of menopause but is also promoted as increasing overall health through the recreation of a pre-menopausal woman's monthly hormonal cycle using rhythmic doses of hormones standardized to a uniform purity. Wiley claims the protocol is a step beyond the symptomatic treatment of conventional hormone replacement therapy.

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, Wiley's lack of qualifications to design the protocol, and ethical problems with the clinical trial that is being run to test it. The protocol has not been empirically verified as safe or effective.

pecific dosing

The Wiley Protocol uses bioidentical hormones, specifically estradiol and progesterone. Hormones are applied transdermally, using an oil-based skin cream for topical administration.cite web | url = http://www.freshpatents.com/Hormone-replacement-composition-and-method-dt20070301ptan20070049567.php?type=description | title = Hormone replacement composition and method | publisher = FreshPatents.com | date = 2007-01-03 | accessdate = 2007-12-20 | author = T.S. Wiley ] 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. [ cite web | title = Testimony of T.S. Wiley before the Special Committee on Aging United States Senate | url = http://aging.senate.gov/events/hr171tw.pdf | format=PDF | date = 2007-04-19 | publisher = United States Senate Special Committee on Aging | accessdate = 2007-12-20 ] 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
* A dose that varies over a 28-day cycle rather than remaining static
* Topical rather than oral administrationThe protocol also includes a follow-up program to monitor the serum of the bioidentical hormones.

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. [cite web | url = http://personallifemedia.com/podcasts/226-beauty-now/episodes/2969-interview-ts | title = Interview with T.S. Wiley ]

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. [ cite journal | title = Summary of the American College for Advancement in Medicine May 2005 Conference: Menopause, Andropause: Power in Transition | author = Feig SA, Hynote E, Speight N, Magaziner A, Miranda RA, Schachter MA | journal = Evidence-Based Complementary and Alternative Medicine | volume = 2 | issue = 3 | date= September 2005 | pages = 416 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1193553 | doi = 10.1093/ecam/neh113 ] cite journal |author=Rosenthal MS |title=The Wiley Protocol: an analysis of ethical issues |journal=Menopause (New York, N.Y.) |volume=15 |issue=5 |pages=1014–22 |year=2008 |pmid=18551081 |doi=10.1097/gme.0b013e318178862e |url=]

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. [cite web | author = Schwartz E, Schwarzbein D. "et al". | title = Letter to Suzanne Somers |date=October 11, 2006 | url = http://drerika.typepad.com/notepad/2006/10/letter_to_suzan.html|publisher=Dr Erika's blog| accessdate=2007-12-01] [cite news|url=http://www.nytimes.com/2006/10/15/fashion/15suzanne.html?pagewanted=all|title=A Battle Over 'Juice of Youth' |publisher=The New York Times |author=Ellin, Abby|date=October 15, 2006|accessdate=2007-12-01] The Wiley Protocol has been criticized as unethical due to the start of a Phase II clinical trial with no Phase I, a lack of approval by an institutional review board, a lack of an experienced scientific investigator leading the trial, no inclusion or exclusion criteria and no evidence that the study population has been told that the research has not passed an ethical review,cite journal |author=Rosenthal MS |title=Ethical problems with bioidentical hormone therapy |journal=Int. J. Impot. Res.| url = http://origin.www.nature.com/ijir/journal/v20/n1/full/3901622a.html | accessdate = 2008-04-01 |volume=20 |issue=1 |pages=45–52 |year=2008 |pmid=18075509 |doi=10.1038/sj.ijir.3901622] as well as concerns over conflicts of interest regarding financial incentives.

References

External links

*
* [http://www.thewileyprotocol.com/ T. S. Wiley's official web site]
* [http://www.wileywatch.org/ Wiley Watch] , a website critical of the Wiley Protocol