URGENT
Because of my experience in educating physicians and the public about menopause, I have been asked to interpret the information about taking hormones from the Women’s Health Initiative released July 9, 2002. Our office has received an unprecedented number of calls from physicians, patients and the media in the last 48 hours and our website, www.drkomer.com has also been extremely busy.
It seems that what people really want to know is how this new information will affect them and whether they should stop hormones right away. As usual, I want to take a practical, unbiased and scientific approach but present the information in a way that intelligent women (and their mates) can make informed choices as to what is best for their individual situation.
A Caution
There has been an overreaction to the study because of the media. For most women who are on Hormone Replacement Therapy (HRT), the wisest path would be to stay on their medications until they have had a chance to discuss their unique situation with a physician who is skilled and interested in management of menopause.The risk of staying on existing therapy until the woman has had an assessment is very low indeed. There can be problems if one stops HRT abruptly.
What the Study Said
- Women who are taking estrogen only (presumably all of whom have had a hysterectomy) have not been cautioned to discontinue therapy. There has not been data to show risks of therapy outweigh benefits in this group.
- There was no difference in the number of deaths between the therapy and the placebo groups. This is important. Even though there had been a slight increase in the number of adverse events, this did not translate into deaths.
- Only 2.5% of the women in this study had any of the events studied (either good or bad events). This means that 97.5 percent of the women were unaffected (and as I will discuss later, what was not studied was the commonest reason for women starting hormones: hot flashes and night sweats and changes in memory, mood, concentration and energy).
- The increase in problems was only on the combination of HRT using oral conjugated estrogen (eg. Premarin) and the synthetic hormone progestin. Progestins are not progesterone. Progesterone was not studied. I have used progesterone almost exclusively in my practice for the last 5 to 10 years. Progesterone has different effects than progestins and is better tolerated. There is no information to suggest that progesterone would be a problem.
- The study spoke only of oral estrogen and did not make any negative comments on estrogen patches and gels. Since we know that these transdermal (delivered through the skin) estrogens have some significantly different effects than oral estrogen, their benefits and risks may be different than the combination studied.
- The HRT in the study was said to cause an increased risk of heart attack. In fact, the rate of heart attack with women not on hormones was 3 per 1,000 and the risk for those on HRT was 3.7 per 1,000, a tiny increase.
- The rate of breast cancer in the women not on medication was 3 per 1,000 and the rate on HRT was 3.8 per 1,000, once again a small increase. However, there was no increased risk of breast cancer in the first four years on HRT. A large percentage of women go on HRT for symptoms (hot flashes, decreased memory, poor sleeping, mood changes) and symptoms often disappear in the first 3 or 4 years of menopause when HRT can be stopped. With this approach there would not be increased breast cancer risks. In addition, not exercising doubles the risk of breast cancer and drinking any alcohol also increases the risk. These risk factors may be even more important than HRT.
- The risk of stroke was2.1 per 1,000 women not on therapy and increased to 2.9 per thousand on HRT, a small increase.
- The risk of thromboembolism (blood clots) was 1.6 per 1,000 with no therapy and 3.4 per 1,000 on HRT. The majority of these clots were in the leg and were not serious. Also let’s put this increased risk into perspective. The risk of developing a clot with a broken leg is probably 8 to 10 per 1,000, a much higher rate. We know that riding in an airplane and not getting up and walking increases the risk of thromboembolism.
- The were two major benefits of HRT in the study: a reduction in colon cancer down from 1.6 per 1,000 with no therapy to 1.0 per thousand on HRT and a reduction in hip fractures from 1.5 per 1,000 to 1.0 per thousand.
- The increase in adverse events over beneficial events was 0.19 %. This is a negligible increase and makes me wonder why the WHI study was stopped.
What The Study Did Not Look At
This to me and to many of my patients is critical. Most patients start HRT for annoying and debilitating symptoms. They often cannot sleep, cannot think as clearly as before, have significant mood changes and cannot function and enjoy life normally. These symptoms often fade in the first 3 or 4 years of menopause and usually nothing helps moderate to severe symptoms as much as HRT. For many women, lifestyle changes such as wearing light clothing and avoiding hot or spicy food may help with the flashes, but for many, life becomes hell. This study did not look at these quality of life issues.
What Should Menopausal Women Do?
Each women and her health care provider need to sit down and assess the patient’s individual unique situation and together formulate a plan of action to thrive and enjoy life. This study has not changed this type of interaction, and if anything has emphasized it.
Often the personal plan can include hormones for a period of time and then, if appropriate, a tapering off of the medication to see if the woman continues to need them or not.
There are also other alternative for maintaining bone strength and warding off osteoporosis. Every individual plan should include looking at lifestyle changes such as decreasing or stopping alcohol and smoking, eating better and getting more exercise. There should be a consideration as to whether any natural products and vitamins may be helpful. There are good studies to show than taking soy isoflavones may decrease heart disease, breast cancer and heart disease as well as decrease hot flashes.
If a woman chooses a trial of HRT, it may be wise to use transdermal estrogen in the lowest dose that relieves symptoms. If the woman has a uterus, she should also take progesterone and not a progestin to prevent cancer of the uterus. After 2 to 4 years, the woman should be tapered off HRT to see if symptoms have stopped. If they have, then other therapies such as SERMs or bisphosphonates may be better choices to reduce osteoporosis. Recent research suggests that the SERM Evista may actually reduce significantly the risk of breast cancer. However, it will not treat hot flashes.
If there are vaginal symptoms, then the Estring or the recently introduced vaginal tablet Vagifem are excellent choices since they moisturize the vagina and help bladder function but do not enter the circulation and so would have no effect on breasts.
Measures such as reducing cholesterol, treating elevated blood pressure, treating diabetes and taking a children’s aspirin a day should be instituted to reduce the risk of heart disease.
Summary
Over the last three years there has been an evolution from using HRT for a lifetime to using it for relief of symptoms. As the woman changes, so does her needs. With more new choices of treatments and more information, the science of menopause will continue to evolve. Research such as the WHI study should be expected and data should be evaluated. However, it should be presented to women in an unbiased and non-sensational manner to allow them to make informed choices as their menopause evolves. In this way physicians, women and those who love them can Be Menopositive