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Controversies of Hormone Replacement Therapy

The controversies surrounding hormone replacement therapy (HRT) is confusing for menopausal women and to the medical community. In 2001, the Women’s Health Initiative (WHI) suggested that the risks associated with HRT use outweighed any benefits. The new evidence showed an increased risk for heart disease, breast cancer and strokes. When the trial was ended early many physicians were taking their patients off of HRT and giving them an antidepressant and or were told to use the herbal remedies for menopause.

As a health care provider the duty is to understand what each study is telling the medical community. The guidelines regarding hormone replacement therapy were driven by findings from a number of research studies such as the Nurses Health Study, a 20-year prospective cohort study of 120,000 women. It found that HRT use was associated with significant reductions in cardiac events as well as cardiovascular and total mortality. The more recent Women’s Health Initiative, a 5-year randomized trial with 16,000 women, found an increased incidence in cardiac events associated with HRT, although with no increase in either cardiovascular or total mortality. Why are the conclusions at variance? The truth is that the outcomes from both studies were largely correct. They were both right but differed principally in the timing when hormone replacement therapy was initiated. Women in the Nurses’ Health Study generally started HRT within 2 years of menopause, while those in the WHI did not start HRT until 10 years after menopause.

Estrogen has protective properties against cardiovascular disease in premenopausal women, and that the risk for atherosclerosis begins to rise as estrogen levels decline after menopause. Substantial evidence supports the use of hormone replacement therapy for primary prevention of atherosclerosis in women, but only if started during the early postmenopausal period and before the onset of atherosclerosis. Once atherosclerosis has already developed, however, HRT has no effect at reversing the process and may actually promote plaque destabilization and thrombosis. This largely explains the different outcomes from the Women’s Health Initiative compared to earlier studies.

What about an increase in cancer risk with hormone replacement therapy? The WHI consisted of two clinical arms. The first arm was the Hormone Replacement Therapy (HRT) trial, using premarin (an oral form of estrogen) and progestin (an oral form of synthetic progestin, known as medroxyprogesterone acetate). The Estrogen Replacement Therapy (ERT) trial made up the second arm, using only premarin. The HRT trial found 8 more cases of breast cancer but 6 fewer cases of colon cancer for every 10,000 women, compared to the control group. The women receiving only premarin in the ERT trial actually demonstrated a small, though not statistically significant, reduction in breast cancer cases, in addition to fewer cases of colon cancer. Several observational studies also found HRT to be associated with reduced mortality for colon cancer. The conclusion from this and previous studies is that the synthetic progestin used in the HRT trial of the WHI increases a woman’s risk for breast cancer. Synthetic progestin appears to be the culprit regarding breast cancer risk, not estrogen. It should be noted that the WHI found no increase in breast cancer deaths or total cancer deaths in either trial. Other recent trials, the NHANES and USC study, did not find any evidence of an increased risk for breast cancer.

Osteoporosis a progressive bone disease is a greater risk for menopausal women than breast cancer. One in six Caucasian women in the U.S. will fracture her hip, and this is greater than the risk of developing breast cancer or gynecological cancer. In Caucasian women 50 years and older, the lifetime risk of osteoporotic fractures approaches 40 percent and 33% of hip fracture patients die within one year of injury. Osteoporosis is responsible for almost 1 million vertebral and hip fractures annually. The Women’s Health Initiative demonstrated that hormone replacement therapy is associated with a 35% reduction of hip fractures.

Hormone replacement therapy has beneficial effects in conditions other than cardiovascular disease, cancer, and osteoporosis. Some studies have shown that HRT is associated with a reduction of cases of new-onset diabetes mellitus by as much as 35%, and a 60% reduction in recurrent urinary tract infections. Moreover, it reduces the risk for Alzheimer's disease. In cell cultures, gender-specific bioidentical estrogen or testosterone supplementation appears to slow the accumulation of tau protein, neurofibrillary tangle, and amyloid in human neurons, reducing the potential for Alzheimer’s disease.

The Journal of Internal Medicine, 2004 published findings from a meta-analysis of 30 randomized controlled trials involving hormone replacement therapy. The report analyzed several notable trials, including the Women’s Health Initiative. The authors concluded that while the risks of initiating HRT in older women or in the presence of coronary heart disease may outweigh the benefits, HRT use was not associated with any change in mortality. Furthermore, the authors concluded that the benefits of HRT outweigh the risks if treatment is begun in younger women who do not have coronary heart disease or breast cancer. The report found that initiating HRT in younger postmenopausal women actually resulted in a 39% reduction in mortality.

American College of Gynecology guidelines for hormone replacement therapy have unfortunately confined its use to short-term symptom treatment only, using the lowest dose possible. A better understanding of the conflicting evidence suggests that hormone replacement therapy provides significant health benefits and disease protection for many women if begun early. The PEPI trial in 1990 with 875 postmenopausal women proved the safety and efficacy of natural micronized progesterone combined with estrogen for the best cardiovascular protection. Other health benefits from this trial were less weight gain with women taking hormones after menopause, an increase in the HDL (good cholesterol) and protection against endometrial cancer. Later studies with natural estradiol and natural micronized progresterone have shown protection against cardiovascular disease, osteoporosis, alzheimers disease, urogenital atrophy, colon cancer, endometrial cancer and hypercholoesterolemia. Also, it helps to prevent depression, fatigue, incontinence, weight gain and the loss of feminity.

We as health care providers are compelled to look at the evidence in the older studies with the evidence in newer studies that supports natural hormone replacement. We are the front line to educate women in hormone replacement so that they become a partner in their health decisions for long term disease prevention.