Hormone Replacement Therapy

Is it Worth the Risks?

 

Rachael Harris

11/12/2007

 

       I.            INTRODUCTION

    II.            HORMONE REPLACEMENT THERAPIES

 III.            TYPES OF THERAPIES

a.       Pill

b.      Patch

c.       Vaginal Cream

  IV.            HRT SIDE-EFFECTS

a.       Cardiovascular Disease

b.      Thromboembolic Disease

c.       Types of Cancer

d.      Other HRT Linked Diseases

e.       Osteoporosis

     V.            ALTERNATIVES TO HRT

  VI.            NON-HORMONE THERAPIES

VII.            CONCLUSION

VIII.            BIBLIOGRAPHY


I.          INTRODUCTION

In today’s society, healthcare is a primary concern for many women.  They are questioning the physicians that they are seeing, the facilities that they are seen in, and even the types of medications they should take.  How can female patients be sure that there are no long term or adverse side effects to any of the medications that they are given?  Trusting the physician is a foremost concern.  So, what happens when their emotions are uncontrollable due to changing hormones, or their body is not responding the same way as in the past? Hormone replacement therapy is a method that has been used in the past to control hot flashes during menopause, osteoporosis, and sexual desire in both men and women.  But what do we really know about these forms of therapy?  In the past few years, new research has come out regarding adverse side effects of hormone therapy and how dangerous it can become.  With the development of breast cancer and heart disease in many women taking hormone replacement, the question of safety has become even more important.  What are the reasons for using hormone replacement therapy and do the benefits outweigh the costs in every situation?

It is inevitable that women will eventually go through menopause.  They will experience numerous symptoms including hot flashes, night sweats, vaginal dryness, reduced sex drive, hair loss, vaginal and bladder infections, and many more.  While not all women will experience these symptoms, there are many that will.  All these symptoms are due to that fact that women, at a certain age, stop ovulating.  Although the ovaries usually still have many eggs which are viable, the ovaries are no longer producing estrogen which is the female sex hormone that drives the menstruation cycle.  What this means for women is that they are no longer able to produce children.  When a woman begins experiencing these symptoms she wants relief, but what are her options?  Women will more than likely experience side effects due to their changing hormone levels, but the consequences of the estrogen and progesterone cocktails in the various medications on the market far outweigh the benefits that they provide.

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II.         HORMONE REPLACEMENT THERAPY

Hormone replacement therapy, also known as HRT, is an approach to treating women with one or more female hormones produced in insufficient amounts in their body.  Most commonly the hormones are estrogen and progestin, a synthetic form of progesterone.  HRT is most often used to treat the most severe symptoms that women experience which, again, include mood swings, sleep disorders, vaginal dryness, decreased sexual desire, and hot flashes (Menopause- Hormone Replacement Therapy, 2007).

Hormone replacement therapy has greatly impacted the medical field and bridged gaps in our healthcare, but the positive and negative consequences of these advances are not fully known.    Early on in the discovery of HRT, studies showed that it was a significant leap in treating the symptoms of menopause, but it also could prove beneficial for reducing the risk of heart disease and osteoporosis induced bone fractures.  The function of estrogen in the body is to increase the “good” cholesterol in the bloodstream while decreasing the levels or “bad” cholesterol.  The good cholesterol is the high-density lipoprotein (HDL) and the bad cholesterol is officially known as low-density lipoprotein (LDL).  Therefore estrogen, one of the main components of HRT, would seem to be a beneficial component in the makeup of beneficial drugs for menopausal symptoms.  However, there are far too many consequences that outweigh the positive benefits associated with conventional allopathic medicines to provide suitable relief from the grips of menopausal symptoms.

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III.               TYPES OF THERAPIES

a. Pill

  There are four main types of hormone replacement therapies which are delivered using three different methods, including pills, patches, and vaginal creams.  The first is cyclic hormone therapy.  This is the most commonly recommended form of HRT.  This is the pill form in which the individual takes estrogen for 25 days and then progestin is added into the regimen around day 10-14.  There are then no pills taken days 3-5 to allow for monthly bleeding.  This is usually not a period since most women on HRT have ended their natural cycles with the onset of menopause (UCLA Health System, 2007).   

The second form of therapy is also in pill form.  It is continuous therapy with estrogen and progestin taken together on a daily basis.  This is indicated for irregular bleeding for up to one year of use and does not have a built in three day period for monthly bleeding (UCLA Health System, 2007). 

b. Patch

The third is a patch which is applied to the abdomen or thigh.  This form of delivery absorbs the estrogen through the skin and into the bloodstream, which for some women is far more convenient, but it does lack the benefits of the progestin supplement (UCLA Health System, 2007). 

c. Vaginal Cream

The final method is vaginal cream which also contains estrogen only and has been known to have vaginal dryness as a major side effect.  This form of hormone replacement therapy is not usually used alone.  It is used in conjunction with the other forms of HRT because it has not been linked to the beneficial effects of HRT such as prevention of bone disease like the other forms of HRT. (UCLA Health System, 2007)This is important to note because higher levels of HDL and lower levels of LDL are crucial factors when assessing an individual’s risk factor for developing cardiovascular disease. 

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IV.              HRT SIDE-EFFECTS

a. Cardiovascular Disease

By having higher levels of HDL and lower levels of LDL, many researchers believed that it would thus lower the levels of cardiovascular disease in menopausal women.   However, when the Women’s Health Initiative (WHI) conducted the research on this hopeful method of treatment, they obtained very different results.  With the introduction of estrogen and progestin into the bloodstream, they found that the number of heart attacks increased by 29%.  Also, the risk of developing cardiovascular disease is increased when a woman reaches the age of 60, but that is not the only reason a women at 60 taking HRT could develop cardiovascular disease.   Another study published in 2002 by The Heart Estrogen/progestin Replacement Study (HERS) showed that there were essentially no benefits to taking HRT after following women for nearly 7 years (UCLA Health System, 2007).  There is also a study currently underway called Kronos Early Estrogen Prevention Study (KEEPS). This study is trying to better understand younger women and postmenopausal drug therapy.  Specifically, researchers in this study are trying to find the link, if any, between estrogen and heart disease in younger menopausal women. (KEEPS, 2006) 

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b. Thromboembolic Disease

Studies have showed for many years that women that take certain types of contraceptives with increased dosages of estrogen have increased risk of developing blood clots or thromboembolic disease.  Thrombosis occurs when blood clots form inside the veins in your body.  The risk for many women is at its highest in the first one to two years of therapy and generally affects women who have a high risk of blood clots regardless of the medication.  Another way that women have shown to increase their chances of developing this type of health problem has been through cigarette use.  A study by the Women’s Health Initiative (WHI) stated that there is a significant increase in the risk of strokes when taking estrogen-only therapy.  Further, their study also stated that the incidence of strokes among women taking both estrogen and progestin increased almost 41% compared to women not taking any form of hormones. (UCLA Health System, 2007)

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c. Types of Cancer

Cancer has also been a primary concern in relation to hormone replacement therapy.  Breast cancer is already one of the most common and most talked about forms of cancer in the United States today.  With the Susan G. Koman Foundation quickly raising awareness of the disease, many drugs are being heavily researched to fight this deadly form of cancer.  It has been found that women over the age of 50, using estrogen and progestin for less than five years have little to no increased risk of developing breast cancer.  Yet, women who are over 50 and have taken HRT with progestin for over five years have a slightly increased risk.  It has been shown that women that are only taking a estrogen supplement only have no increased risk of developing breast cancer with up to fifteen years of usage.  The concern is essentially with the progesterone replacement therapy, because women without it have no increased risk while those that have been taking it will have an increased risk of developing breast cancer.  It can be noted that the Women’s Health Initiative began an estrogen/progestin trial, but it was stopped due to the fact that there they found a 26% increased risk of breast cancer found in women taking HRT.  There was a second element to the WHI study which showed that in women who have had their uterus removed and were treated with estrogen only therapy, there was no increased risk found for breast cancer.(UCLA Health System, 2007) 

Uterine and endometrial cancer is also a concern of those that are taking HRT drugs.  It has been shown that women taking estrogen alone have an increased tendency for abnormal growth of the uterine lining.  The risk for endometrial cancer is 6-8 times greater for those women who are taking HRT medications (Menopause- Hormone Replacement Therapy, 2007).  Likewise, women who are taking only progestin find that they have a decrease in uterine lining.  In order to keep these effects under control, many physicians prescribe progestin to reduce the adverse effects of the estrogen.  The Women’s Health Initiative has found in various studies that there was little difference between women who are taking HRT drugs and those that are not except that some taking progestin experienced minor uterine lining bleeding (UCLA Health System, 2007).

Another form of cancer that has critics of HRT voicing concern is ovarian cancer.  In 2002 the National Cancer Institute published a study that said women using estrogen therapy have an increased risk of developing ovarian and breast cancer, which gets variably larger over time.  It was found that it is three times more likely for women using estrogen for 20 years or more.  Future research to be done is assessing the risk of ovarian cancer in women taking an HRT combination of progestin/estrogen to see if the risk is still heightened. (Use of proteomic patterns in serum to identify ovarian cancer. , 2002)

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d. Other HRT Linked Diseases

There are currently studies that are being done to better understand the benefits and risks of hormone replacement therapy for several different disease processes; however, many of them need further research to confirm their findings.  One such study is looking at gallbladder disease.  Numerous studies have indicated that women who are using the combination of estrogen and progestin for therapy have an increased risk of developing gallstones.  There are also studies currently being done to link the likelihood of women developing urinary incontinence after menopause when linked to HRT.  In addition, it has been shown that women who suffer from depression, mood swings, and sleep problems both during and after menopause have benefitted from hormone replacement therapy and many claim it has improved their quality of life.  However, no study has been linked scientifically to show that this actually is a beneficial treatment for certain types of depression.  Other such studies include those involving Alzheimer’s disease which has shown no significant conclusions; however, there are current studies being done on other forms of memory loss.  Other studies that being conducted are to better understand the pathways, and see if there is actually any benefit to memory loss with the help of hormone replacement therapy.

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e. Osteoporosis

Given that many women have a decreasing production of estrogen in their body because of menopause, their bone strength is many times compromised.  This is called osteoporosis, when women have a significant decrease in bone density.  This is because the osteoblast cells are not producing bone at a rate fast enough to keep up with the destructive rate of the osteoclast cells.  A Women’s Health Initiative study found that women taking hormone replacement therapy drugs were 24% less likely than women not taking them to have hip fractures (UCLA Health System, 2007).  This is found in women that have been taking HRT drugs for a significant number of years.  Women that take them only for the short term relief of menopause seem to have little protection from osteoporosis in aging bones, while it also does not help those that have reached the age of 75 or older.  Another problem with the estrogen supplement is that women who stop the therapy will lose the protective nature of the therapy and must continue the therapy in order to maintain that level of protection (UCLA Health System, 2007). 

Obviously, there are many concerns about taking HRT.  There is, however, significant symptom relief, and clear benefit in some diseases for women taking hormone replacement therapy drugs.  One is that women taking estrogen/progestin have been found to have a 37% decreased risk of developing colon cancer, according to a study done by the Women’s Health Initiative (UCLA Health System, 2007).    Regardless, women and physicians alike find it difficult to balance out the protective nature of estrogen for the prevention of osteoporosis with the harmful nature of the drugs on the cardiovascular system, liver, and the possible contraction of multiple forms of cancer.

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V.        ALTERNATIVES TO HRT

So, who can actually benefit from hormone replacement therapy?  We all should be aware that there are major health concerns that one would take on by taking hormone replacement drugs, but there are ways to take them to benefit your life.  Some women during menopause develop moderate to severe hot flashes that inhibit their ability to function in everyday life.  This would not be something that would be comfortable or “livable” for many women.  In this situation, short-term therapy significantly outweighs the potential risks that accompany HRT drugs.  Each woman has to weigh their own potential risks.  According to Sharonne Hayes, M.D., cardiologist and director of the Women’s heart Clinic at May Clinic in Rochester, MN, “The absolute risk to an individual woman taking hormone therapy is quite low and may be acceptable to you depending on your symptoms” (Mayo Clinic. Sept. 2007). 

What many women question now is, when is it appropriate to take hormone replacement therapy drugs for my symptoms and what symptoms benefit most?  There are three in particular that show greater response to this therapy.  There are generally a variety of treatments available today for any given symptom or condition because of the competing pharmaceutical market.  However, according to Mayo Clinic, one of the leading sectors of the medical field, “hormone replacement therapy is still the most effective treatment for troublesome menopausal hot flashes and night sweats” (Mayo Clinic. Sept. 2007).  Another symptom of menopause is vaginal discomfort with which hormone therapy can only “ease vaginal symptoms of menopause, such as dryness, itching, burning, and discomfort with intercourse” (Mayo Clinic. Sept. 2007).  Finally, osteoporosis prevention using hormone replacement therapy is only recommended when all other medications for osteoporosis have failed.  This is a symptom that would have to be a serious concern in order to simply use this form of therapy as a preventative medication.

Western medicine has always had an approach to patient’s care that uses medicines that try to “correct” the internal balance of hormones within the body.  However, many supposedly alternative approaches to medicine have simply continued practices of holistic healthcare that have been around for centuries.  Although both medical practices have the same overall approach, to alleviate the discomfort of certain women experiencing menopause, the alternative approaches seem to be less invasive and do not have the same “risks” that accompany hormone replacement drugs.  The alternative medicine approaches focus on “strengthening the female body by encouraging it to balance, regulate, and normalize itself during the transition to menopause” (Holistic Online. 2007). 

There are few known complications with alternative approaches to treatment.  However, our society today tends to want treatment that is not only effective, but also a therapy that works ASASP (as soon as (superhumanly) possible).  They simply have no patience for the process of medicine to work adequately in the body.  Therefore, alternative medicine techniques may not be the best treatment for them mentally given that the process tends to take much longer than the average conventional medication.

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VI.       NON-HORMONE THERAPIES

There are a few “alternative” medications on the market today that seem to be effective depending on the individual.  One specific drug that is on the market as an alternative to current HRT, and approved by the Federal Drug Administration is Prempro by Wyeth Pharmaceuticals.  Unfortunately, as we have seen from other estrogen-progestin combination drugs, it has been found to develop lumps in women’s breasts that then provide an increase in mammogram abnormalities which prove to generally false positives.  In conventional medicine there are anti-hypertensive drugs that seem to do the trick in relieving menopausal hot flashes, but there are many women that report having severe side effects ranging from fatigue to dizziness.  If that is the women’s situation or if they have severe hot flashes as well as high blood pressure there are drugs that are available that do not have hormones such as Clondine, a generic drug that works by placing pressure on the hypothalamus to stabilize.  There are other drugs that are also suggested such as inderal, aldomet, and veralipride which have shown to alleviate discomfort with hot flashes, however, none of these drugs have been approved by the FDA for treatment of these symptoms.  However, there are drugs that are approved by the FDA to treat hot flashes such as Bellergal.  Unfortunately, this drug has barbiturate components and is highly addictive with side effects including dry mouth, fatigue, and depression.  Therefore, the drug isn’t a normal recommendation for hot flashes and should be restricted to short term usage. 

Symptoms involving vaginal dryness can be a serious everyday problem for women, especially during intercourse.  There are vaginal lubricants that are available at drug stores that would help with the problem; however, it probably would not provide a cure for it altogether.  For bone loss, there are many drugs out in the market today, but they are not as invasive as hormone replacement therapy drugs that are available.  The downfall of these drugs is that they are not FDA approved and are considered experimental.  The exception is calcitonin.  This drug is known for its ability to “inhibit bone resorption, the process by which bone is broken down and reabsorbed in the body” (Holistic Online. 2007).  This is simply a supplement of the naturally made calcitonin hormone that is made by the thyroid gland in the body.  This drug has shown through treatment to slow an individual’s bone loss and increase their bone density.  Another upside to this drug is that it has minimal side effects that affect less than 10% taking the drug.  It can be further reduced in these individuals by taking the drug at bedtime.  However, there is one significant downside to taking this drug, which is that calcitonin is very expensive.  There are other experimental drugs that one could try such as bisphosphonates, Fosamax, and parathyroid hormones which are all currently undergoing studies.  They have shown a significant increase in bone density, but the side effects are currently not known.

Although, all of these alternative therapies are available, the most common alternative therapy that was found for menopausal symptom treatment is exercise, a balanced diet, and a healthy mental well-being.  Which all seem simple, but our society today has simply overlooked all of these elements.  There is a drastically increasing waist line today due to our lack of exercise and balanced diets.  So, all things considered, the risks outweigh the benefits for women taking HRT (Holistic Online. 2007). 

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VII.      CONCLUSION

When all potential possibilities are considered, every woman should keep in mind what is in their best interest both physically and emotionally as they go through menopause.  While some women believe that alleviating the risks permanently by taking hormone replacement drugs, other will believe that those benefits will not adequately outweigh the risks of taking that drug.  Thus, each woman has a mission for the health of her own body.  What do you believe is the best option for you at that stage in your life?  If they are willing to try alternatives first and use HRT as a last resort, then that is their decision.  However, it is not the final decision that is important, it is helping these women weigh out the benefits and risks of taking these drugs and having them make a well educated decision.  I think that conventional medicine should promote drug education in an effort to better equip their patients to manage their own healthcare and exercise individual preventative healthcare.  The natural medicines that are available on the market today seem to provide hope for the future of alternative medicine in the menopause therapy field, but further study and research is needed.  Therefore, menopause and its symptoms will continue to be challenge to treat for women for some time to come. 

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VIII.     BIBLIOGRAPHY

 

Effect of Hormone Replacement Therapy on Breast Cancer Risk: Estrogen Versus Estrogen Plus Progestin. (2000). Journal of National Cancer Institute , 328-332.

Holistic Online. (n.d.). Retrieved October 28, 2007, from Alternative, Natural and Integrative Approaches for the Treatment of Menopause: http://www.holisticonline.com/remedies/hrt/hrt_alt_treatments.htm

KEEPS. (2006). Retrieved October 28, 2007, from http://www.keepstudy.org/

Mayo Clinic. (2007, September). Retrieved October 28, 2007, from Hormone Replacement Therapy: Benefits and Alternatives: http://www.mayoclinic.com/health/hormone-therapy/WO00046

Menopause- Hormone Replacement Therapy. (2007, June). Retrieved October 26, 2007, from http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/Menopause_hormone_replacement_therapy?OpenDocument

Prempro. (2007). Retrieved October 28, 2007, from http://www.prempro.com/index.aspx

Project AWARE. (2007). Retrieved October 26, 2007, from http://www.project-aware.org/Managing/Hrt/benefits-risks.shtml#risks

UCLA Health System. (2007, February 9). Retrieved October 26, 2007, from http://www.uclahealth.org/body.cfm?xyzpdqabc=0&id=477&action=detail&AEProductIDSRC=Adam2004_1&AEArticleID=007111

Use of proteomic patterns in serum to identify ovarian cancer. . (2002). The Lancet , 572-577.

 

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