Natural Health Care Articles by Center for Preventive Medicine of East Providence, Rhode Island (RI)

We’ve all heard about the latest controversy regarding the use of combined estrogen and progestin in healthy menopausal women.In their July 17, 2002 issue the Journal of the American Medical Association (JAMA) published a report on the estrogen plus progestin study findings of the Women’s Health Initiative (WHI). The study, which was scheduled to run until 2005, was stopped after an average follow-up time 0f 5.2 years.The estrogen/progestin trial of the WHI involved 16,608 healthy women fro ages 50 to 79 years with intact uteruses. The objective of the trial was to examine the effect of Prempro (estrogen/progestin) on the prevention of heart disease, hip fracture and associated risk for breast and colon cancer. Women enrolled in the estrogen plus progestin study were randomly given a daily dose of estrogen plus progestin (0.625 mg of conjugated equine estrogen plus 2.5mg of medroxy progesterone acetate.) About half of the group members were taking placebos. Participants were enrolled in the study between 1993 and 1998 at 40 clinical sites across the country.

What was the cause of premature termination?
At the tenth interim analyses of the trial, the data and safety monitoring board found that the risks for invasive breast cancer, coronary heart disease events, pulmonary emboli and strokes outweighed the evidence of benefit for hip fractures and colorectal cancer over the average 5.2-year follow-up period. The results of cardiovascular risk are consistent with previous trials examination of Prempro in women with and without previous cardiovascular disease.It is important to note that the Women’s Health Initiative involves over 161,000 women who participate in a series of clinical trials. The ongoing trials include the effects of Prempro on women who had hysterectomies, the effects of estrogen therapy alone, the effect of low-fat dietary pattern and the effects of calcium and Vitamin D supplementation. The results of those trials will be published in 2005 unless risk factors cut the trials short.

Menopausal Statistical Data
Perimenopause is defined as the time when hormones are winding down and often fluctuating. The results of this may include, but are not limited to hot flashes, mood swings, depression, vaginal dryness, sleep disturbances, facial hair and acne, heart palpitations, headaches, urinary tract infections and decreased libido. Menopause is defined as the cessation of periods for at least three consecutive months with a significant drop in the level of estriodol (less than 20pg/ml) and lack of ovulation. Long term concerns for menopausal women include an increased risk for osteoporosis, cardiovascular disease, Alzheimer’s-type dementia and cancer.There are an estimated 50 million post-menopausal women in the U.S.: about six million of these women take estrogen plus progestin. The onset of menopause affects 1.8 million women each year. In the year 2000, 46 million prescriptions were written for Premarin (conjugated mare estrogen) making it the second most frequently prescribed medication in the U.S., accounting for more than one billion dollars in sales. In that same year 22.3 million prescriptions were written for Prempro. It is estimated that only 10-20% of postmenopausal women use estrogen/hormone replacement therapy in the United States. Approximately 30% of women never fill their prescriptions: another 20 to 40% discontinue use within one year. That leaves about 40% of the women prescribed with estrogen / hormone replacement therapy taking them on a continuous basis (for over one year).

So what is estrogen anyway?
Estrogen is a steroid hormone derived from cholesterol. It is produced by the adrenal cortex, ovaries and by conversion of aromatase in fat and muscle from androstenedione. The three main forms of estrogen produced in the body are 17-beta-estradiol (E2), estrone (E1) and estriol (E3). The ovaries produce 17-beta-estradiol; during the menstrual years. It is the most potent form of estrogen in the body and its circulating levels fluctuate from 40 to 200-400 pg/ml throughout a menstrual cycle. Estrone is the main source of estrogen in menopausal years. It is about one-third less potent than 17-beta-estradiol and its levels are highly dependent on the conversion of aromatase in fat and muscle from androstenedione. Estriol is the weakest estrogen and is produced by the placenta during pregnancy and is also found in small amounts in non-pregnant women.In the bloodstream about 98% of estrogen is bound to a protein called sex hormone binding globulin (SHBG). These bound estrogens are biologically inactive. The remaining 2% of estrogens are unbound and biologically active, thus able to enter cells and stimulate physiological function.Estrogens act through binding with two types of receptors – ER-alpha and ER-beta. Tissues and organs containing both types of receptors are those in the cardiovascular system, brain, ovary, uterus, breast and bones. The liver contains only ER-alpha receptors and the gastrointestinal tract contains only ER-beta receptors.

The following are important estrogenic actions on particular organs and tissues.

In the genital tract they are involved in the development of female reproductive organs by stimulating the growth of smooth muscles. They also regulate the menstrual cycle through the development of the uterine lining.

In the breast they lead to the proliferation of glandular and ductal tissue.

In the skin and muscles they increase water and hyalukonic acid concentration, collagen metabolism and prevent wrinkles and vaginal atrophy.

They increase bone mineral density by decreasing bone reabsorption, thus reducing the risk of fractures.

In the liver they stimulate production of sex hormone binding globulin (SHBG). They also increase the synthesis of triglycerides, HDL cholesterol and clearance of LDL cholesterol.

They stimulate clotting factors that may increase the risk for thromboembolic events.As you can see, estrogen plays a very important role in many different bodily functions.

Methods of Estrogen/Hormone Replacement Therapy
There are a variety of treatments available for women during menopause, either for symptomatic relief or for long-term health. As previously stated, Premarin and Prempro are the most widely prescribed forms of therapy; however, there are a variety of oral, vaginal and transdermal preparations available (TABLE 2). In addition, dosage and duration of treatment may vary depending on the healthcare professional’s preferences and treatment goals (i.e. short term relief vs. long term health). Furthermore, there are several precautions and contraindications for therapy that also factor into use of ERT/HRT (TABLE 1)

Conclusion
Historically, hormone replacement therapy was predominantly used on artificially induced menopausal women who underwent total hysterectomies and/or oophorectomies (removal of ovaries). HRT started being used much more widely in the mid-70s when some studies showed the possible benefits of heart disease prevention and osteoporosis prevention. Let’s not forget the vanity aspect of the anti-wrinkle estrogen effect. It’s been a huge business ever since and physicians have put these drugs on their altar of menopausal women’s necessities. We all know that, for example, Asian women rarely use HRT and seem to go through menopause smoothly. The issue is, how should millions of American perimenopausal women respond or react to these findings? Scientifically and statistically speaking, the risks of HRT in individual women are still relatively small. Yet considering that millions of American women might take estrogen plus progestin therapy, that could translate into tens of thousands of cases of breast cancer or cardiovascular disease over several years. Additionally, the cardiovascular incidents were higher in the first twelve months of the use of HRT.It is the author’s observation that the strongest effect of combined estrogen and progestin therapy, both negative and positive, are in anatomical areas that included both alpha and beta estrogen receptors. We hypothesize that the use of synthetic hormones over stimulates receptors in those tissues and organs, resulting in unwanted pathophysiological effects. In contrast, the use of endogenous estrogens or much weaker phytoestrogens may influence receptor sites in a much more balanced manner.The clinical implications of the Women’s Health Initiative studies are complex: 1. women should be more careful in embarking on prolonged use of HRT. 2. Short term use (6-12 months) of HRT for symptomatic relief of hot flashes, insomnia, mood swings, and vaginal dryness is more appropriate. 3. Individual approach with different hormone doses depending on women’s age, weight, sensitivity and family history should be considered. 4. Preventive measures of non-pharmaceutical approaches such as dietary changes, exercise, meditation and use of supplements may gain more positive fro the baby boomer generation.Pert II of this article will address issues of prevention, lifestyle changes, and treatments that are at the heart of Oriental Medicine, which, for thousands of years, has dealt with women’s health problems.

Table 2

“It is the authors’ observation that the strongest effect of combined estrogen and progestin therapy, both negative and positive, are in anatomical areas that included both alpha and beta estrogen receptors. We hypothesize that the use of synthetic hormones overstimulates receptors in those tissues and organs, resulting in unwanted pathophysiological effects.”Tadeusz Sztykowski, D.Ac., MD ( Poland) has been studying and practicing medicine since 1975. He received his M.D. diploma in Gdansk, Poland in 1982. He became board certified in OB/GYN in 1987. Upon graduation from New England School of Acupuncture in 1990 he opened his private practice. His practice specializes in treatment of female disorders. He has been a frequent lecturer on women’s health issues, including the Ground Round lectures at Women’s and Infant’s Hospital in Rhode Island. He maintains privileges at Women’s and Infant’s. He is the cofounder of the Foundation for the Development of Integrative Medicine. He is the Vice President of AAOM.Robert E. Burke, MPS, L.Ac. has been studying and practicing Acupuncture and Oriental Medicine since 1997. He received his Master’s degree from Mercy College in 2000. In addition, Robert is a nationally certified diplomate in acupuncture and Chinese herbology. In March 2002 he completed a pot-graduate fellowship in collaboration with Mercy College and Sound Shore Medical Center. In the fellowship Robert was successful in integrating Acupuncture and Oriental Medicine within a hospital setting. Robert maintains his private practice in Briarcliff Manor, NY.

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NIH Findings: Controversy of Hormone Replacement Therapy