Wiley protocol
{{Short description|Controversial hormone replacement therapy}}
The Wiley Protocol is a form of bioidentical hormone replacement therapy (BHRT) devised and advocated by author 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 the dosages of the hormones used, side effects of the treatment, potential physiologic effects, Wiley's lack of medical or clinical qualifications to design the protocol, lack of empirical evidence demonstrating it as safe or effective, ethical problems with the clinical trial that is being run to test it and potential financial conflicts of interest regarding financial incentives.
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.{{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 | access-date = 2007-12-20 | author = T.S. Wiley | author-link = T.S. Wiley }}{{self-published inline|date=November 2017}} 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 | date = 2007-04-19 | publisher = United States Senate Special Committee on Aging | access-date = 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{{self-published inline|date=November 2017}}
- A dose that varies over a 28-day cycle rather than remaining static{{self-published inline|date=November 2017}}
- Topical rather than oral administration{{self-published inline|date=November 2017}}
The protocol also includes a follow-up program to monitor the serum of the bioidentical hormones.{{self-published inline|date=November 2017}}
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 |publisher=Personal Life Media}}
A patent was granted for the protocol in 2011 for the specific blend of hormones and dosing method.{{ cite patent | country = US | number = 7879830 | status = patent | title = Hormone replacement composition and method | gdate = 2011-02-01 | fdate = 2005-08-25 | inventor = 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 |vauthors=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 = 413–419 | doi = 10.1093/ecam/neh113 | pmc=1193553}}{{cite journal |author=Rosenthal MS |title=The Wiley Protocol: an analysis of ethical issues |journal=Menopause |volume=15 |issue=5 |pages=1014–1022 |year=2008 |pmid=18551081 |doi=10.1097/gme.0b013e318178862e |s2cid=196421747 }}
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. | 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| access-date=2007-12-01|display-authors=etal}}{{cite news|url=https://www.nytimes.com/2006/10/15/fashion/15suzanne.html?pagewanted=all|title=A Battle Over 'Juice of Youth' |work=The New York Times |author=Ellin, Abby|date=October 15, 2006|access-date=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.|volume=20 |issue=1 |pages=45–52 |year=2008 |pmid=18075509 |doi=10.1038/sj.ijir.3901622|s2cid=2313626 |doi-access= }} as well as concerns over conflicts of interest regarding financial incentives.
References
{{reflist}}
External links
- [http://www.wileyprotocol.com/ T. S. Wiley's official web site]