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Dr. Charles Lively takes another look at hormone replacement data - Odessa American: Medically Speaking

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Dr. Charles Lively takes another look at hormone replacement data

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Posted: Monday, April 6, 2015 12:00 am

 I wrote this article for the readers of the OA 8 years ago.  When the study "Women's Health Initiative" was released there was a lot of "spin" off of the data that made the public and practitioners alike, question the value of hormone replacement.  Wide-spread fear had women stopping their hormones.  Hormone prescriptions dropped by 70%.  A Yale researcher estimates this contributed to the deaths of 50,000 women, a Mayo Clinic researcher estimates 90,000 and others have higher estimates.  Noting this, it clearly merits another review of benefits/risks and the medical literature.  I would like to make this article a Part I to discuss hormone replacement, and next time I will include some news for men.   

Menopause is a natural biological process that is part of every woman’s life cycle. It usually occurs as the woman approaches 51 years of age; it can also result from surgery, radiation or chemotherapy.   

When estrogen levels begin to decline, some women, though not all, experience uncomfortable symptoms. The most common are hot flashes, night sweats and vaginal dryness. The severity of these symptoms varies.   

If you’re not having bothersome symptoms, keep life simple. Do nothing.   

However, if you do experience uncomfortable or severe symptoms, prescription hormone therapies may relieve the problem.   

A woman should use the lowest effective dose for the time consistent with treatment goals and risks for her. Proven benefits include effective treatment of moderate to severe menopausal symptoms, relief for hot flashes, night sweats and vaginal dryness and prevention of postmenopausal osteoporosis.   

Estrogen plus progestin (or combined therapy) is prescribed for a woman who still has her uterus. Estrogen-alone therapy is prescribed for a woman who has had her uterus removed.   

Conditions under which a woman should not take hormones include a history of estrogen receptor positive cancers, such as breast or uterine cancers, heart disease, stroke or blood clots in the veins.   

About 30,000 scientific papers have been written on hormone therapy, most based on observation. Initially, studies showed benefits for women’s health issues including prevention of osteoporosis, possible reduction of heart disease, stroke, dementia and macular degeneration.   

However, the Women’s Health Initiative (WHI) study, released by the National Institute of Health (NIH) in 2002, changed opinions across the country and caused a great deal of confusion in the process. Most experts presently agree that hormone therapy should not be prescribed to prevent heart disease, heart attacks or dementia.   

When the WHI study was halted after 5.2 years due to increased risks to the study participants. In my opinion, the media sensationalized this study, and, as a result, masses of patients stopped their hormone therapy.   

Often, the press releases a story before we practicing physicians can sift through and analyze the data. I know in my practice, if controversy surrounds a drug — especially if the drug has been discussed on a talk show — I shy away from prescribing it. I would rather spend my time treating patients than fielding a slew of phone calls regarding a drug. It is certainly less stressful to stop prescribing the medicine, but, given the data, is that justified? I’ll let you be the judge.   

Consider this: Of the women in the WHI combined-therapy trial, 5.7% had prior coronary artery disease. Among the participants in the study: 1.8% of women had prior heart attack, 2.9% had prior angina and 1.3% either had stents or had undergone bypass surgery.   

Further, 87% of the coronary heart disease cases occurred at least 10 years after menopause. The average age of participants at the start of the WHI study was 63.3 years.   

Chart 1 shows the WHI results that had women tossing their hormones in the trash and going back to hot flashes. Risk is noted, but not as great as was perceived. Statistics are based on actual numbers per thousand women.   

The WHI estrogen-alone study results (Chart 2) were interesting. Once again, statistics are based on actual numbers per thousand women.    Look at the last columns according to the WHI trial and remember: that is the incidence of those events per 1000 patients. In many cases, the difference between those taking placebo and those taking estrogen plus progestin is fewer than one woman per 1000.   

In the media, the risks were cited as relative risk; however, they were not communicated as an actual number. Communicating the relative risk as a number per 1000 patients is easier to grasp. Good or bad, those are the risks per the WHI report.   

The conclusions drawn by the WHI report have come under fire. One investigator noted that after adjusting for a wide variety of confounding factors (smoking, high blood pressure, high cholesterol, diabetes, family history of heart disease, higher body mass index), a 30% lower risk of coronary heart disease was noted in both combined therapy and estrogen-alone groups.   

I want you to picture this study out of the New England Journal of Medicine. Right after the conclusions of the estrogen-alone arm of the WHI study, investigators wanted to know, “What is the state of these women’s coronary arteries on estrogen compared to placebo?”   

1064 women aged 50-59 underwent cat scan of their coronary arteries. You see, calcified plaque in coronary arteries is predictive of future cardiovascular events. A large number of CT scans were done through Harvard Medical School, UCLA, UC-Davis, UC-San Diego, NIH, Wake Forest Medical School, George Washington University, University of Minnesota and Stanford University.   

Women receiving estrogen had a 60% lower prevalence and quantity of coronary artery calcification than those receiving placebo. This data supports the possibility that timing of hormone therapy initiation in relation to menopause onset or to age might influence coronary disease risk.   

Remember, the purpose of hormone therapy is to treat symptoms, ideally at the lowest effective dose for the time consistent with treatment goals and risks.   

Talk with your doctor.   

Dr. Charles Lively is board-certified in women’s health care. For more information or to schedule an appointment, call (432) 580-9168.

Odessa, TX

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