Teresa S. Wiley is the author of Lights Out: Sleep, Sugar and Survival, [1] and Sex, Lies and Menopause. [2] She writes about women's health, particularly sleep and hormonal issues, hormone replacement therapy and bioidentical hormone replacement therapy. Wiley has developed her own version of BHRT known as the Wiley Protocol, though she has been strongly criticized for lacking the relevant credentials and potentially putting women at risk with an unproven, untested intervention that uses possibly dangerously high doses of hormones.
Wiley's main thesis in Lights Out is that light is a physiological trigger that controls dopamine and hormones like cortisol. Wiley posits that with the extension of the natural day through artificial lighting, rest at the hormonal level is rarely adequate for optimum biological needs of the body. In her view, this results in both fatigue and unnatural appetite, which leads to weight gain, exhaustion and disease. Wiley theorizes that the body's responses are cyclical, reflecting the seasons of the year, and that the body's needs vary seasonally. According to Wiley, during the winter months the body needs more sleep, and carbohydrates should be restricted as they would have been naturally during hunter-gatherer times.
Wiley is listed as co-author of three scientific journal articles along with biochemist Bent Formby between 1998 and 2001. [3] [4] [5]
Wiley wrote a second book, Sex, Lies and Menopause, in which she claims that hormone imbalances cause many age-related diseases, and these imbalances are caused by humans straying from "natural" rhythms of light, seasonal eating and child birth. Wiley claims that mimicking the levels and cycles of estrogen and progesterone found in a 20-year-old woman will prevent or treat age-related diseases. [2] Subsequent to the book's publication, this hormone regimen became known as the "Wiley protocol" and Wiley created a pharmaceutical compounding program that pharmacists could contract into, stipulating compounding methods, materials, testing, packaging and recommended pricing in exchange for Wiley's company providing the packaging materials bearing the Wiley protocol's trademark.
Former actress Suzanne Somers advocates the Wiley Protocol in her book Ageless: The Naked Truth About Bioidentical Hormones. [6]
Wiley has been criticized for promoting her version of BHRT without proper qualifications or scientific evidence. On October 11, 2006, Erika Schwartz, Diana Schwarzbein, and five other MDs who have worked with BHRT during their careers issued a public letter to Suzanne Somers and her publisher, Crown, criticizing Somers' endorsement of Wiley's protocol. In the letter they alleged that the Wiley Protocol is "scientifically unproven and dangerous" and that Wiley has no medical or clinical qualifications; [7] other criticisms of the protocol itself have stated that the levels of hormone are dangerously high. [8] [9] Wiley has claimed on her website and in speaking engagements that she earned a B.A. in anthropology from Webster University in 1975. On November 27, 2006, Newsweek reported that Webster has no record of this degree. [10] Wiley's bio page was then changed to "Pending B.A. in Anthropology, Webster University, 1975" and then again to "Attended the B.A. Program in Anthropology, Webster University, 1970-1975". ABC News reported on February 16, 2007, that, according to Webster, she received only a blank diploma. [10] [11] [12]
On April 19, 2007, Wiley appeared as a witness before the Senate Special Committee on Aging to give testimony at a hearing in which the safety and oversight of BHRT and compounding pharmacy were discussed. [13]
Progesterone (P4) is an endogenous steroid and progestogen sex hormone involved in the menstrual cycle, pregnancy, and embryogenesis of humans and other species. It belongs to a group of steroid hormones called the progestogens and is the major progestogen in the body. Progesterone has a variety of important functions in the body. It is also a crucial metabolic intermediate in the production of other endogenous steroids, including the sex hormones and the corticosteroids, and plays an important role in brain function as a neurosteroid.
The menstrual cycle is a series of natural changes in hormone production and the structures of the uterus and ovaries of the female reproductive system that makes pregnancy possible. The ovarian cycle controls the production and release of eggs and the cyclic release of estrogen and progesterone. The uterine cycle governs the preparation and maintenance of the lining of the uterus (womb) to receive an embryo. These cycles are concurrent and coordinated, normally last between 21 and 35 days, with a median length of 28 days, and continue for about 30–45 years.
Estradiol (E2), also spelled oestradiol, is an estrogen steroid hormone and the major female sex hormone. It is involved in the regulation of the estrous and menstrual female reproductive cycles. Estradiol is responsible for the development of female secondary sexual characteristics such as the breasts, widening of the hips and a female-associated pattern of fat distribution. It is also important in the development and maintenance of female reproductive tissues such as the mammary glands, uterus and vagina during puberty, adulthood and pregnancy. It also has important effects in many other tissues including bone, fat, skin, liver, and the brain.
Progestogens, also sometimes written progestagens or gestagens, are a class of natural or synthetic steroid hormones that bind to and activate the progesterone receptors (PR). Progesterone is the major and most important progestogen in the body. The progestogens are named for their function in maintaining pregnancy, although they are also present at other phases of the estrous and menstrual cycles.
A progestogen, also referred to as a progestagen, gestagen, or gestogen, is a type of medication which produces effects similar to those of the natural female sex hormone progesterone in the body. A progestin is a synthetic progestogen. Progestogens are used most commonly in hormonal birth control and menopausal hormone therapy. They can also be used in the treatment of gynecological conditions, to support fertility and pregnancy, to lower sex hormone levels for various purposes, and for other indications. Progestogens are used alone or in combination with estrogens. They are available in a wide variety of formulations and for use by many different routes of administration. Examples of progestogens include natural or bioidentical progesterone as well as progestins such as medroxyprogesterone acetate and norethisterone.
Hot flashes are a form of flushing, often caused by the changing hormone levels that are characteristic of menopause. They are typically experienced as a feeling of intense heat with sweating and rapid heartbeat, and may typically last from two to 30 minutes for each occurrence.
Bioidentical hormone replacement therapy (BHRT), also known as bioidentical hormone therapy(BHT) or natural hormone therapy, is the use of hormones that are identical on a molecular level with endogenous hormones in hormone replacement therapy. It may also be combined with blood and saliva testing of hormone levels, and the use of pharmacy compounding to obtain hormones in an effort to reach a targeted level of hormones in the body. A number of claims by some proponents of BHT have not been confirmed through scientific testing. Specific hormones used in BHT include estrone, estradiol, progesterone, testosterone, dehydroepiandrosterone (DHEA), and estriol.
Julie Carmen is an American actress, dancer and a licensed psychotherapist. She came to prominence onscreen in the 1980s, for her role in John Cassavetes' film, Gloria (1980), opposite Gena Rowlands.
The Wiley Protocol is a controversial 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.
Bent Formby is a biochemist and researcher. He was born in Copenhagen, and came to the U.S. as a visiting professor in 1979. He co-authored two books and several articles on endocrinology with T. S. Wiley.
Hormone replacement therapy (HRT), also known as menopausal hormone therapy or postmenopausal hormone therapy, is a form of hormone therapy used to treat symptoms associated with female menopause. These symptoms can include hot flashes, vaginal atrophy, accelerated skin aging, vaginal dryness, decreased muscle mass, sexual dysfunction, and bone loss or osteoporosis. They are in large part related to the diminished levels of sex hormones that occur during menopause.
Catamenial epilepsy is a form of epilepsy in women where seizures are exacerbated during certain phases of the menstrual cycle. In rare cases, seizures occur only during certain parts of the cycle; in most cases, seizures occur more frequently during certain parts of the cycle. Catamenial epilepsy is underlain by hormonal fluctuations of the menstrual cycle where estrogens promote seizures and progesterone counteracts seizure activity.
Nomegestrol acetate (NOMAC), sold under the brand names Lutenyl and Zoely among others, is a progestin medication which is used in birth control pills, menopausal hormone therapy, and for the treatment of gynecological disorders. It is available both alone and in combination with an estrogen. NOMAC is taken by mouth. A birth control implant for placement under the skin was also developed but ultimately was not marketed.
Suzanne Marie Somers is an American actress, author, singer, businesswoman, and health spokesperson. She appeared in the television role of Chrissy Snow on Three's Company and as Carol Foster Lambert on Step by Step.
Kent Holtorf is an American physician and entrepreneur practicing in Los Angeles, California. He is a board examiner of the American Board of Anti-Aging Medicine (ABAAM), which is not recognized by established medical organizations. He is the founder and medical director of Holtorf Medical Group, a practice with five centers that offer treatment for conditions including fibromyalgia, adrenal fatigue, complex endocrine dysfunction, hypothyroidism, age management, chronic fatigue syndrome, low libido, chronic Lyme disease, migraines, PMS, perimenopause and menopause. His practice focuses on alternative therapies that are not recognised as effective. He has been criticized in the media for his controversial views on topics like bioidentical hormone replacement therapy and vaccines.
Graham Simpson is a medical doctor and advocate of “natural” and proactive medicine and health. He graduated from the University of the Witwatersrand Medical School in Johannesburg, South Africa, and is board certified in internal medicine and emergency medicine. He was also a founding member of the American Holistic Medical Association (AHMA).
Conjugated estrogens (CEs), or conjugated equine estrogens (CEEs), sold under the brand name Premarin among others, is an estrogen medication which is used in menopausal hormone therapy and for various other indications. It is a mixture of the sodium salts of estrogen conjugates found in horses, such as estrone sulfate and equilin sulfate. CEEs are available in the form of both natural preparations manufactured from the urine of pregnant mares and fully synthetic replications of the natural preparations. They are formulated both alone and in combination with progestins such as medroxyprogesterone acetate. CEEs are usually taken by mouth, but can also be given by application to the skin or vagina as a cream or by injection into a blood vessel or muscle.
Estradiol (E2) is a medication and naturally occurring steroid hormone. It is an estrogen and is used mainly in menopausal hormone therapy and to treat low sex hormone levels in women. It is also used in hormonal birth control for women, in hormone therapy for transgender women, and in the treatment of hormone-sensitive cancers like prostate cancer in men and breast cancer in women, among other uses. Estradiol can be taken by mouth, held and dissolved under the tongue, as a gel or patch that is applied to the skin, in through the vagina, by injection into muscle or fat, or through the use of an implant that is placed into fat, among other routes.
Progesterone (P4) is a medication and naturally occurring steroid hormone. It is a progestogen and is used in combination with estrogens mainly in hormone therapy for menopausal symptoms and low sex hormone levels in women. It is also used in women to support pregnancy and fertility and to treat gynecological disorders. Progesterone can be taken by mouth, vaginally, and by injection into muscle or fat, among other routes. A progesterone vaginal ring and progesterone intrauterine device used for birth control also exist in some areas of the world.
The pharmacokinetics of progesterone, concerns the pharmacodynamics, pharmacokinetics, and various routes of administration of progesterone.