Breast Cancer and Hormone Replacement Therapy; is there really a Link or is hormone replacement saving lives?

Breast Cancer and HRT; is there really a Link?

There are some fascinating findings coming out in research lately.  The Journal of Family Planning and Reproductive Health Care published a 13 section article called ‘Does Hormone Replacement Therapy (HRT) Cause Breast Cancer?’  An Application of Causal Principles to Three Studies in which the authors examine the data from the Women’s Health Initiative (WHI), the Collaborative Reanalysis (CR) and the Million Women Study (MWS) shows there are statistical problems with the assumptions that the researchers made and that the conclusions do not fit with the published finding of an increased risk of breast cancer with HRT.  Interestingly, Dr. Wulf Utian, a founder and past president of the North American Menopause Society states “This is not the first paper to demonstrate that the way the WHI interpreted their results and presented them to the media has resulted in far more death and disability than it prevented”.  He further states that these results are part of an ongoing effort to repair damage caused by early reports from the WHI.

Another study soon to be published (published online ahead of print July 18, 2013) in the American Journal of Public Health by Dr. Philip Sarrel from Yale University examined the effect of estrogen avoidance on mortality rates among hysterectomized women aged 50 to 59 years old; this is the same age group of preliminary data that were studied by the WHI researchers in 8/2002.  However, the conclusions from Dr. Sarrel’s work show that over a 10 yr span, starting in 2002,and examining national hospital discharge data, a minimum of 18,601 and as many as 91,610 postmenopausal women died prematurely because of the avoidance of estrogen therapy (ET).  His paper concludes that ET in younger postmenopausal women is associated with a decisive reduction in all-cause mortality, but estrogen use in this population is low and continuing to fall.  Their data indicate an associated annual mortality toll in the thousands of women aged 50 to 59 years.  Thus informed discussion between these women and their health care providers about the effects of ET is a matter of considerable urgency.

Dr. Holly Thacker, Cleveland Clinic comments that the results show that clinicians should not be reluctant to prescribe estrogen for women who have undergone hysterectomy and are estrogen deficient. Dr. Thacker was quoted by MedPage Today: “It’s not only going to improve the quality of their life but likely the longevity of their life.  It’s really kind of a game changer, in that we’re not just talking the use of estrogen for the lowest dose for the shortest amount of time for treatment of symptoms.  We’re also thinking in terms of prevention and lifespan and quality of life and work productivity.  Women and their doctors need to stop being fearful of treating estrogen deficiency.”

A New WHI Analysis by Charles Bankhead from MedPage Today states “In fact, a subgroup analysis in 2004 showed a reduction in mortality risk among WHI participants who had undergone hysterectomy and were treated with estrogen alone.  Follow-up analysis in 2001 confirmed a decreased morality risk of 13 per 10,000 per year among hysterectomized women 50 to 59 treated with estrogen.”

Dr. David Katz, co-author with Dr. Sarrel states ‘The finding is so dramatic – reporting thousands of women dying every year – if this gets the attention that it deserves, we hope it will change clinical practice.  We hope that clinicians will start routinely talking to their patients who have had a hysterectomy and bringing up the issue that taking estrogen may save your life.  We have the data to show that it can save your life.”

Interestingly, this new data are all coming out about estrogen alone.  Dr. Wulf Utian has publicly stated that the type of progesterone used in the WHI trial was responsible for the increased risks (of breast cancer, heart attack and stroke) and that natural progesterone in lower doses can minimize these risks (from Wall Street Journal, Sept 27, 2011).  The European based research has already shown that Estrogen plus natural progesterone (Prometrium) has a 0% incidence of breast cancer in a Swedish 10 year study; and the American KEEPS study, presented at the North American Menopause Society (NAMS) annual meeting 10/04/12 demonstrated many beneficial effects across multiple body systems in a 4 year study with transdermal estradiol (estrogen) and Prometrium (see previous blog entry on KEEPS study).  Interestingly, the British Medical Journal (BMJ) on 10/09/12 also published a 10yr study of 1,000 Danish women using a triphasic estradiol (compounded) and a synethetic progesterone (different synthetic than the Provera used in the WHI); this study concluded that the early postmenopausal women in this study showed a significantly decreased mortality without any apparent increased risk of cancer, blood clot or stroke.  This is a powerful conclusion; however the studies need to be done to show how natural progesterone impacts women’s health.  Researchers have successfully challenged the conclusions of WHI and other major studies regarding estrogen; now we need to take a hard look at challenging these same conclusions regarding progesterone.