Menopause is a natural process that occurs in every woman. A woman is considered menopausal when there is cessation of menstrual flow for 12 months. The average age of menopause occurs at 51 years of age. The menopause is due to decline of estrogen, which then can be associated with health problems and disorders such as hot flushes, memory loss, night sweats, vaginal dryness, sleep disturbance, osteoporosis and colon cancer.

Initially in the 1960’s when hormones were first used they were touted as the fountain of youth. They were prescribed widely to all menopausal patients. From observational studies we know the many benefits of Hormone Replacement Therapy (HRT). Observational studies involve, participants who choose to take medications for a particular problem.

There were many observational trials in the past and for the first time there was to be a randomized trial of one of the hormone regiment versus placebo. A randomized trial is one where the participants and physicians were not aware of which participant was given medication versus placebo pills. The trial is called the Women’s Health Initiative (WHI) that was designed to assess the major health benefits and risks of the most commonly used HRT in the United States. The study consisted of 16,608 women between the ages of 50-79 who were to be followed for 8.5 years. Half of the women were taking Prempro (0.625mg Premarin /2.5mg Medroxy-progesterone) and the other half placebo pills.

Since the publication of the results of the WHI in July of this year HRT has been scrutinized even more than in the past. The WHI discontinued the study after only 5.2 years. The trial was terminated because it seemed the overall risk exceeded the benefits of using HRT due to the increased risk of breast cancer, cardiovascular disease and strokes as assessed by the drug monitoring safety board.

The results stated that there was a 29% increase in cardiovascular disease, 41% increase in strokes, and 26 % increase in breast cancer over those in the placebo group. What does this really mean? It means if there were 10,000 women using HRT for one year there would be 8 more cases of strokes, 8 more cases of breast cancer, 7 more cases cardiovascular disease of and 18 more case of pulmonary emboli than in the placebo group. Leading experts in the field found that 97.5% of the women had no adverse effects after reviewing the results of the WHI. Therefore, overall risk appears small and was not as large as first indicated by the media and the WHI investigators.

There were also benefits reported: 5 fewer hip fractures and 6 fewer colorectal cancers. Also what is not addressed by the study are the quality of life benefits that one can receive as mentioned before such as improvement hot flush, memory loss, night sweats and vaginal dryness.

Let’s review a few of the individual outcomes:
CARDIOVASCULAR DISEASE
It is estimated that 250,000 women die from a heart attack each year. As we age the blood vessels become narrower and less flexible, leading to a greater risk of heart attacks. In the WHI study the average age of the participants was 60 years. The participants were not prescreened prior to starting the study, which may explain the increased risk of the disease in the population studied. Observational studies in the past have shown that HRT should not be used to prevent CVD in patients with preexisting disease, because there is an increased the risk during the first year of using HRT. The statins such as Lipitor, work much better in controlling disease in this patient population.

BREAST CANCER
The leading risk factors for breast cancer are simply being female and aging. About 75% of women diagnosed with breast cancer have no identifiable risk factors. The risk of breast cancer in the WHI study is small. It takes the stimulating effect of HRT 10 years to get a preexisting tumor to 1.0 cm. Tumors during the WHI study developed in five years, which would lead one to suspect these women probably had preexisting tumors prior to starting HRT. It has been observed time and time again that the tumors in women taking HRT are of lower grades and stage of disease. Also bear in mind the Estrogen Replacement Therapy (ERT) arm of the study continues.

OSTEOPEROSIS
Every year in the United States women suffer at least 600,000 bone fractures directly caused by osteoporosis. Approximately 250,000 are hospitalized each year as a result of hip fracture. 85% are over age 65. 5% die in the hospital. About 50% are discharged to nursing homes; half remain there. In the WHI and other observational study HRT/ERT to date is still one of the best treatment options for osteoporosis.

So where does this leave us? One has to remember the WHI trial evaluated just one formulation of hormonal therapy. Is it possible that other formulations could have better outcomes? Can the findings be attributable to Medroxy-Progesterone found in Prempro? One thing is for sure: Treatment of all patients should be individualized, taking into account family history, lifestyle and disease processes that occur as we age. Using the lowest dose of HRT to obtain all the benefits and limit the possible risks should the corner stone of treatment.

As we age we need to take better care of ourselves. That means a healthy diet, an exercise program which should include weight training in addition to aerobics, calcium supplementation, smoking cessation, control of all medical problems and if warranted hormonal supplementation.

If you are on hormonal therapy or have discontinued treatment on your own or are considering discontinuing therapy, please get the advice of a physician. Any decision should be made after a thorough discussion and not fear.

Sincerely,

Dr. Narisse Kendrick