Women’s Health Initiative Study — HRT and Chronic Health Risks

May 4, 2016 | By Larry Gurley, MD

THE WOMEN’S HEALTH INITIATIVE STUDY AND WHAT IT MEANS TO YOU

WHI followed 16,608 healthy women ages 50-70 who took either combined, continuous estrogen and progestin therapy (HRT), estrogen alone (if they have had a hysterectomy), or a placebo. Progestin is used along with estrogen in persons who have not had a hysterectomy to reduce the risk of cancer of the uterus. The goal of the study was to determine the relationship between HRT and it’s possible benefits for heart disease and hip fracture, as well as its possible risks for breast cancer, endometrial cancer, and blood clots. The trials were stopped when it was concluded that the medical risks for the study groups outweighed the benefits..

1) Specific risks and benefits uncovered by the WHI study are as follows (estrogen plus progestin):

Heart Disease: The risk for heart disease was 29% higher for the group taking combined HRT than for the group on placebo. There were, on the average, 7 more cases per 10,000 women per year in the HRT group. The risk appeared in the first year of HRT use.

Breast Cancer: The risk for invasive breast cancer was 26% higher in the group on HRT. There were, on the average, 8 additional cases of breast cancer per 10,000 women per year, in the HRT group. The increase was apparent after 4 years of HRT use, and the risk appears to be cumulative, increasing over time.

Stroke and Blood Clots: There was a 41% increased risk for stroke for the group on HRT. There were 8 more occurrences of stroke per 10,000 women in the HRT group than in the placebo group. There were 18 more cases per 10,000 women of blood clots in the HRT group than in the placebo group.

Dementia: There were 23 more cases of dementia in women over 65 years of age per 10,000 women in the study.

Specific benefits uncovered by the WHI study are as follows:

Colon Cancer: The risk of colon cancer was reduced by 37% in the HRT group. There were 6 fewer cases per 10,000 women of colon cancer in the HRT group than the placebo group.

Bone Fractures: There was a 24% reduction in total fractures and a 34% reduction in hip fractures in the HRT group. There were 5 fewer cases per 10,000 women of hip fractures in women on HRT when compared to the placebo group.

2) For women using Estrogen only, the findings showed a slight increase in stroke risk. No increase in breast cancer or heart attack was found for this group.

Although the above statistics and numbers are extremely important, the risks for the individual woman (YOU) is equally as significant and not quite as staggering. Since the percentage of women in the WHI study who actually had adverse effects from HRT use was small, the size of the risk for each individual woman on HRT was also small. For example, with breast cancer, while the increased risk for the group on HRT was 26%, an individual woman’s increased risk for breast cancer with HRT use was less that one tenth of one percent a year, according to study authors. This small increase in individual risk appeared to be cumulative over time. The longer a woman stayed on HRT, the more her risk for breast cancer increased, at a higher rate than would normally occur with advancing age.

What does this information mean for YOU as you try to make a decision about HRT? You will have to decide in consultation with your clinician whether the risks uncovered by the WHI are acceptable to you. This means reviewing with your clinician why you want to be on HRT; your personal benefits with HRT use; and your increased risks with HRT use, taking into account your individual and family history for conditions such as heart disease or breast cancer.

If you are taking HRT just to protect against heart disease, it is recommended that you stop. Lifestyle changes can help prevent heart disease—particularly regular exercise, smoking cessation, and weight control. And, for certain women at high risk for heart disease, other medications have been shown to be effective.

If you are taking HRT solely for the prevention of osteoporosis consider stopping it, because there are other medications that can help prevent osteoporosis and fractures that appear to carry lower risks for conditions such as breast cancer or heart disease, such as bisphosphonates or selective estrogen receptor modulators (SERMS). For all women, lifestyle recommendations for healthy bones include a diet high in calcium (postmenopausal women should be taking 1200 to 1500 mg of calcium per day), a multi-vitamin containing Vitamin D, and regular weight-bearing exercise such as walking or jogging.

If you are taking HRT only for the relief of hot flashes and sleep disturbances, genitourinary symptom, or vaginal dryness, your decision becomes more complicated considering the small but real increased risks uncovered by the WHI study. Some lifestyle modifications may help reduce symptoms such as hot flashes. These include; quitting smoking, avoiding or reducing foods or substances that may trigger flashes, such as spicy foods, caffeine and alcohol, lowering stress levels, exercising regularly and wearing loose clothing or dressing in layers to peel off top layers during a hot flash.

How to stop hormones: We recommend tapering by using ½ of your current estrogen patch or pill for 4 weeks and then stopping. If you are using a progestin (Prometrium, progesterone, or provera), continue this until you have stopped the estrogen.

Hormone Alternatives (Prescription Medications are CAPITALLIZED)

Hot Flashes: CLONIDINE 0.1 mg three times a day by prescription only—could rarely cause dizziness. SSRI’s (such as FLUOXITINE) and EFFEXOR are reported to help hot flashes. Black cohosh and traditional Chinese herbal preparations, soy food, or acupuncture are also options.

Vaginal Dryness or Irritation: Small doses of vaginal estrogen such as VAGIFEM will help these symptoms and won’t raise blood estrogen levels

Osteoporosis prevention/treatment: Prevention: EVISTA (an estrogen receptor agent, not a hormone), (bone re-building agents), Calcium 1200mg per day, Vitamin D 400 units per day, walking, may add FOSAMAX or ACTONEL (bone rebuilders) for treatment

Cholesterol or blood lipid elevation: Lipid lowering agents such as LIPITOR

Sleep Disturbance: SONATA or AMBIEN—use 3 times per week; if taken every night may stop working

PMS or Anxiety/Depression: Serotonin activity medications such as FLUOXITINE or EFFEXOR, acupuncture

Muscle Cramps: Quinine: drink ½ cup of tonic water (contains quinine) at bedtime

Traditional Chinese Herbs or Acupuncture are available for many symptoms: Our staff can dvise and offer specific treatments.

If you choose HRT for relief of menopausal symptoms, the American College of Obstetricians and Gynecologists recommends the following: (1) Take HRT for the shortest possible time that works for you, in the smallest effective dose; (2) Have regular consultations with your clinician at least once a year-to review your reasons for taking HRT and to see if you can successfully discontinue HRT use; and (3) Like all women, get regular breast cancer screenings, including annual clinician breast exams and periodic mammograms (which ACOG recommends every one to two years during your forties, and annually thereafter), and have a colon screening test at age 50.