Another Side To The HRT Story, Bio-Identical Hormones Show Positive Health Effects
By Wendy Wells, NMD.
I found some interesting pieces of information worth sharing. To date there is no published study using bio-identical hormones vs. a placebo, however, there are some preliminary findings found here below. One recent study showed the results of using progesterone cream application vs. taking a progesterone pill were the same. According to the results, there was no difference between the two groups in the amount of progesterone exposure in the body. 1
Taking a closer look at the Heart and Estrogen/progestin Replacement Study (HERS)
A four year study of 2763 women participated in HERS using Conjugated Equine Estrogen and synthetic Progestin (non bio-identical hormones) vs. a placebo published in the 1998 Journal of American Medical Association, HERS, Heart and Estrogen/Progestin Replacement Study. 2
The focus of HERS was to investigate the possibility that hormone replacement therapy (HRT) could prevent cardiovascular artery disease. The short duration of the study made this difficult to assess. Only patients who had previous heart disease were allowed in the study. Participants' heart attacks were monitored and there was one non-fatal heart attack. In the first year of the study, the risk of a cardiac event remained the same at 9.5% between the the HRT vs the placebo groups. Each year the relative risk decreased. The HRT treatment increased risk for stroke, pulmonary embolisms, and blood clots. The conclusion was that HRT did not prevent cardiovascular artery disease.
HERS - Bio-Identical Hormones Are Not Synthetic
The number of deaths between those receiving HRT and the placebo groups were the same. The number of events (good or bad) was 2.5%, so 97.5% of the women were not affected by the study. This does not mean the participants received no benefit because the symptoms of menopause were not studied. The problems that occurred were with synthetic, conjugated estrogen (Premarin) and the synthetic hormone progestin. Bio-identical hormones are not synthetic, but plant-derived. The study reported synthetic hormones caused an increased risk of heart attack, however the normal risk is 3 out of 1000 women. HERS showed this increased to 3.7 per 1000. Women not taking HRT have a statistical risk of breast cancer of 3 per 1000. On hormones, the risk was 3.8 per 1000 after 4 years. There was no significant increased risk during the study.
There are many factors that affect breast cancer risk. For example, not exercising DOUBLES your risk of breast cancer. Stroke risk of women not taking HRT was 2.1 per 1000. On HRT, the risk increased to 2.9 per 1000. Risk of blood clots was 1.6 per 1000. On hormones, the risk was 3.4. The majority of blood clots that occurred were not serious and in the leg. Flying in an airplane also increases one's risk of forming a clot. The study found two benefits from hormone treatment. Colon cancer was reduced from 1.6 to 1.0 per 1000 and hip fractures reduced from 1.5 to 1.0 per 1000. This study did not look at the increased quality of life issues.
Women's Health Initiative (WHI)
This study had over 27,000 women, including those without previous history of heart disease. The WHI study duration was 12 years. It looked at the long term effects of hormones on not only heart disease, but fractures, breast health, and endometrial cancers.
In April 2000, the Data Safety Monitoring Board (DSMB) of the WHI requested that hormone therapy participants in the WHI study be informed that there was a small increase in the number of heart attacks, blood clots and strokes in women who were receiving active hormones compared to the placebo (the findings of the HERS study). In June 2001, the WHI DSMB required that all HRT participants be informed that after an average of 4 years, there was a greater occurance of heart attacks, strokes and blood clots in women on HRT than in the women receiving the placebo.
In May 2002, the National Institutes of Health (NIH) accepted the DSMB recommendations to stop the WHItrial because the risks outweighed the benefits. However, the participants taking only estrogen were asked to continue the study. By 5.2 years, there was no increase in breast cancer risk in women taking estrogen vs. the placebo. 3
In July 2002 the data of the prematurely stopped Estrogen plus Progestin study of the Women's Health Initiative (WHI) were presented in the Journal of the American Medical Association. The results of the Heart and Estrogen/Progestin Replacement Study (HERS/HERS II) were published in the same issue.
In March 2004, after following the WHI participants for 7 years, the NIH informed patients taking conjugated estrogens, that treatment with estrogen did not appear to affect increased risk of cardiovascular disease, stroke, and breast cancer, but the risk of hip fracture was reduced, and may have some increased risk for dementia in women over 65 years of age.
Looking at Compounded Bioidentical Hormones: Immune, Inflammatory, and Cardiovascular Biomarker Effects (CHOIICE)
Bio-Identical Hormone Study: 1st Year Results
Dr. Kenna Stephenson recently presented the first-year results of her Compounded Bioidentical Hormones: Immune, Inflammatory, and Cardiovascular Biomarker Effects (CHOIICE) study to the American Heart Association 2008 Scientific Sessions. 4
Dr. Stephenson did her research under the auspices of the University of Texas Health Science Center. Her distinguished academic career nm includes clinical research and professional publications on women's health, cardiovascular pharmacology, aging, prevention, and holistic medicine. She is a Fellow in the American Academy of Family Physicians, and is board certified in Family Medicine.
Results and Overview
Cardiovascular disease is the leading cause of death and disability in American women. Dr. Stephenson states, "Our concern is that there are hormonal factors involved, and our research suggests that if we address those hormonal factors primarily, then there's a downstream effect on the cardiovascular biomarkers showing a benefit. The WISE, Women and Ischemic Events studies by NIH Heart, Lung and Blood Institute, and others over the last decade suggest there is a gender-specific pathophysiology as it relates to cardiovascular disease. 5
This clustering effect in peri-menopausal and post-menopausal women of an elevated fasting glucose, elevated triglycerides, elevated CRP and elevated pulse pressure, all contribute strongly to cardiovascular disease risk, along with psychosocial factors of anxiety and depression."
Dr. Stephenson continues, "We saw benefit in all of these domains both at eight weeks and at 12 months. We saw improvement in their depression and anxiety scores, we saw a decrease in fasting glucose and fasting triglycerides, we saw a decrease in C reactive protein, we saw a decrease in systolic pressure and pulse pressure."
This means women using bio-identical hormones not only lowered their risk of heart disease, but also lowered their risk of diabetes and weight gain.
Bio-Identical Hormone Replacement References
1. Over-the-Counter Progesterone Cream Produces Significant Drug Exposure Compared to a Food and Drug Administration-Approved Oral Progesterone Product PMID:15901742
2. Heart and Estrogen/progestin Replacement Study (HERS):PMID:9683309
3. NIH 2002 WHI update nhlbi.nih.gov/health/women/upd2002
4. Compounded Bioidentical Hormones: Immune, Inflammatory, and Cardiovascular Biomarker Effects .pdf iacprx.org
5. Women and Ischemic Events. onlinejacc.org
6. Hormone mechanisms affecting bone health PMID:24045394
7. Compilation of women receiving benefit from BHT PMID:19995152
Menopause and Hormone Health
Alternative medicine topics, perimenopause life stages, progesterone cream, and estriol lotion.