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Hormones and Breast Cancer Risk
Over the past decade, there has been considerable and contradictory media reporting on both the benefits and health risks of hormone replacement therapy. Some of this has been caused by misunderstandings or incomplete reporting of study results. This page gathers some information and published medical opinion on the reported risk of breast cancer from hormone treatments from the 2002 Women's Health Initiative study, and follow-up studies in 2010.
Original Publications
Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women. Principal Results From the Women's Health Initiative Randomized Controlled Trial. (2002). Writing Group for the Women's Health Initiative Investigators. JAMA. 288:321-333.
The 2002 Womens Health Intiative Study included results from 16608 postmenopausal women aged 50-79 years, from 1997-2002. The study involved women taking estrogen only, and women taking estrogen and the drug Prempro (equine progestin). This article reported that among the study participants taking estrogen plus Prempro, overall health risks exceeded benefits for an average 5.2-year follow-up. The risks reported included an increase in breast cancer and mortality.
Medical Commentary on The Reporting of Study Results
Comments from Dr. Alan Altman, President, ISSWSH Consultative Gynecologist for Menopause and Sexual Dysfunction, on the 2010 JAMA Article:
Many healthcare professionals have been asking for the opinions and/or responses of menopause experts to the recent JAMA article [October 2010].
My comments follow as well as a link to the web site of Wulf Utian, MD, founder and long-time executive director of NAMS who recently stepped down from that post after 30 years.
- This is still the same WHI Study with one drug, Prempro, in one dose only, given to women averaging 64 years of age when the study began. The wrong drug, in the wrong doses, to the wrong women.
- This study has absolutely NO impact on you if you are not taking Prempro!
- As the WHI has previously shown years ago, and repeated in this study, there is a very small increase in the risk of occurence of breast cancer when taking Prempro, which as of late did not reach any statistical significance at all. This increase was not seen in the Premarin (estrogen-only) part of the study. In fact, in the Premarin-only part of the study, regardless of their age, the women who were greater than 80% compliant with their use of the drug...meaning they took their dose when they were supposed to...had a statistically significant decreased risk of breast cancer!
- This emphasizes once again that something about the progestin used in Prempro, called MPA, helped cause the small increase in breast cancer not seen in the Premarin-only arm. This has been shown in many other studies over the past 30 years:
estrogen alone = no increase in breast cancer risk
estrogen plus MPA = small increase in breast cancer risk
This is why most clinicians do not use this MPA any longer, and haven't for some time.
- The increase in the risk of death from breast cancer while taking Prempro compared to placebo, in this newest report, was one woman per 10,000 women per year...a level described as "extremely rare" by the FDA.
- Every study is a piece of a puzzle. Sometimes that puzzle can have 50 to 100 pieces to complete and learn the real association or outcome. Unfortunately, the media treats each puzzle piece as a completed puzzle, hence the confusion and potential for panic. In discussing this study, there has been no attempt to put it into context so women can better understand the whole picture of risk vs benefit of taking this drug or any other Hormone Therapy (HT) for menopause. Benefits of HT, shown in WHI and many other studies prior to as well as since WHI, in the appropriate women using the appropriate doses of the appropriate HT begun at the appropriate time, include a decreased risk of heart attack (by far the biggest killer of women each year), diabetes, osteoporotic fracture, colon cancer, and the risk of dying from any cause at all (total mortality). These potential benefits are above and beyond the symptom relief of hot flashes, night sweats, sleeplessness, palpitations, headaches, mood disorders, joint pains, vaginal dryness and pain with intercourse commonly associated with menopause, that can be so disruptive.
- Within this context of risk vs benefit, as with any medication or drug, a woman can properly discuss her own individual situation with her doctor or nurse practitioner and make educated decisions without the fear and panic that comes from such irresponsible and alarmist reports and media coverage.
- There is a growing body of data demonstrating that the use of non-oral estrogen, via patch, gel, or vaginal ring, is safer to use than estrogen pills by mouth, taking away the risk of blood clots, and stroke from blood clots, seen with the pills used in WHI, as well as other benefits.
- This is why we made the documentary movie, Hot Flash Havoc, to expose how these studies can be misrepresented, and to empower women with the knowledge to make better healthcare decisions.
Comments from Dr. Wulf H. Utian, Executive Director Emeritus and Honorary Founding President of The North American Menopause Society (NAMS) on the 2010 JAMA Article:
Full text at http://utianllc.com/index.php/2010/10/21/whi-and-breast-cancer-here-we-go-again/
"... So what do I take away from this? Firstly, the combined continuous use of estrogen plus progestin (at least the products used in the WHI) have an adverse effect on the breast, slightly increasing both the incidence of [breast cancer] and possibly the chance of dying from it. ... Fortunately, the good news is that the same WHI investigators just reported ... that estrogen when administered alone appears to have the opposite effect. That is, they apparently reported that the [estrogen] alone group had a lower incidence of [breast cancer] and mortality from [breast cancer] compared to placebo.
...
Bottom line is that after all the hullabaloo over the past 9 years since the initial termination of the [hormone therapy] arm of the WHI, estrogen turns out to be quite safe, the MPA has a cloud of suspicion, and the future recommendation is for careful assessment on an individual basis for every women transiting menopause to determine health status, future risk for disease, and a decision based on a clear indication whether hormones are truly needed and recommended in her situation. If the affirmative, then current knowledge should be used to determine what dose, type, and route of administration should be used.
The WHI has succeeded finally in showing that postmenopausal hormone therapy has clear risks and rewards. The risks are rare, and it is up to every women for herself to decide based on a transparent explanation to her about the facts."
More information on menopause, and the possible risks and benefits of hormone therapy can be found at menopause.org.
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