In 2005, a clinical study called The Women’s Health Initiative changed the lives of millions of women worldwide, but not for the better. This well-intentioned study was designed to focus on means to prevent heart disease, breast and colorectal cancer, and osteoporosis. These chronic diseases are major causes of death and frailty in older women, regardless of race or economic status.
The study started in 1993 and enrolled 161,808 women between the ages of 50 and 79, the age at which most women experience menopause. The trial was divided into 4 distinct groups:
Group One (the hormone replacement group)—68,132 women were given placebo,
estrogen alone, or estrogen plus progesterone if the woman still had a uterus.
Group One A (the dietary group)—some women were also given low fat, high fiber diets
for prevention of breast, colon cancer, and heart disease.
Group One B (the calcium and vitamin D group)—some women were also given calcium
and Vit D or placebo to evaluate preventive effects for osteoporosis, and colorectal
cancer
Group Two (clinical observation group)—93,676 women received nothing, but were
observed for the development of heart disease, breast and colorectal cancer.
The conclusions of the Women’s Health Initiative drastically changed the approach to the treatment of menopause and forced women to deal with symptoms which heretofore were well suppressed.
Before we go any farther, an explanation of menopause is warranted. Menopause is referred to as if it were a milestone in a woman’s life. However, it is more than that. It is a Syndrome; a complex of symptoms and circumstances that occur in women sometime after age forty but more frequently after age 50. In middle age years, a woman’s ovaries begin producing insufficient estrogen to stimulate the uterus to have menstrual periods. Eventually, the ovaries fail completely, and periods cease altogether. The absence of estrogen leads women to experience all the symptoms of menopause listed below.
The pituitary gland below the brain produces Follicle Stimulating Hormone (FSH) which stimulates the ovaries to produce estrogen. When there are decreasing, or absent, levels of estrogen in the blood stream, the pituitary gland automatically increases the amount of FSH produced to force the ovary to produce estrogen.
Using this information, we are now able to determine if a woman is in menopause.
The criteria necessary to diagnose menopause are:
1. Absence of menstrual periods for one year.
2. More than one elevated blood level of Follicle Stimulating Hormone
3. Lower than normal blood level of estrogen.
4. The onset of hot flashes.
These factors favor menopause as a diagnosis unless the patient is taking hormones (BCP’s) or has had a medical treatment that affects menstruation.
Additional criteria that point to menopause are:
1. The onset of vaginal dryness, thinning, painful intercourse
2. Mood swings, depression, anxiety
3. Disturbed sleep, insomnia
4. Memory lapses
5. Loss of libido (sexual desire)
6. Weight gain
7. Urinary Tract Symptoms
Menopause is not something that just suddenly happens one day. It sometimes takes months of observation and multiple blood tests to be certain of the diagnosis, but most women don’t go to that trouble and merely base menopause on the prolonged absence of menstrual blood flow and hot flashes. Menopause is a complex of symptoms and circumstances that aren’t always absolute. A lot of uncertainty can exist.
For decades, it was standard practice for menopausal women to take estrogen as hormone replacement therapy (HRT). Estrogen was prescribed to prevent the multiple symptoms of menopause, and it was effective. Taking estrogen pills, shots, skin patches, or using estrogen vaginally stops hot flashes, helps vaginal dryness and thinning, prevents painful intercourse, and helps prevent bone loss and osteoporosis. These were accepted axioms.
Then the Women’s Health Initiative upset the status quo. Suddenly women were scared to death of using HRT. In July 2002, the WHI was prematurely stopped when the group of women taking both estrogen and progesterone were found to have an infinitesimally small increase in the risk of breast cancer and cardiovascular disease. This was announced by the press and caused near panic among middle aged women and most discontinued HRT. Doctor’s phones rang off the hook and women began to have symptoms they hadn’t had since starting HRT. This report and its claims, as well as the decision to stop the study early, became a turning point in the treatment of menopause.
Surprisingly, the group of women who took estrogen alone did not have the same outcome. Instead, they were found to have an increased risk of stroke and no benefit for preventing coronary artery disease. Breast cancer risk for them was unchanged. Still the damage was done and women were confused, angry, disillusioned, and anxious. Unfortunately, most doctors, myself included, were not informed of the WHI’s decision to terminate the study, and were left unprepared to answer the millions of patient concerns. It was a confusing mess. Suddenly prescribing conjugated estrogen was almost malpractice. Suddenly millions of women were miserable!
Over the ensuing years, calmer heads prevailed, panic subsided, and a solution was found. Experts on HRT now agree that for most women with moderate to severe menopausal symptoms, under age 59 and within 10 years of the onset of menopause, it is ok to prescribe the lowest dose of estrogen that relieves symptoms, taken for only as long as necessary. Women who still have a uterus must take both estrogen and progesterone to prevent estrogen from causing uterine cancer. Estrogen stimulation thickens the inner lining of the uterus, and after long periods of such stimulation, the lining can become cancerous. Adding progesterone decreases that likelihood.
If a woman has a family or personal history of breast cancer, history of blood clots, or is at high risk for stroke, she should not take HRT. The WHI has learned, however, that women can take estrogen replacement therapy for seven (7) years before the risk of breast cancer increases. I think menopausal women have been made to suffer unnecessarily because of this study. My approach was always to listen to the patient’s concerns and symptoms, give full consideration to their personal and family medical history, and do what’s right for the betterment of the woman. I was never “burned” by a patient for whom I prescribed HRT. I watched closely for any adverse developments, insisted on regular mammograms, and didn’t use HRT in high risk patients. But those women who took HRT and had improved quality of life were very grateful.
References: https://www.nhlbi.nih.gov/science/Women’s-health-Initiative -whi
https://www.menopause.org/for-women/menopauseflashes/menopause-symptoms-and-treatments.
