WOMEN'S HEALTH

Structural differences exist between human, synthetic and animal  hormones. In order for a replacement hormone to fully replicate the  function of hormones which were originally naturally produced and  present in the human body, the chemical structure must exactly match the  original. There are significant differences between hormones that are  natural to humans and synthetic or horse preparations. Side chains can  be added to a naturally-occurring hormone to create a synthetic drug  that can be patented by a manufacturer.

Natural hormones include estrogens, progesterone, testosterone,  dehydroepiandrosterone (DHEA), and natural thyroid hormones. Natural  hormone therapy has been prescribed in Europe since the 1950s and have  been widely used in North America since the 1990s. Our compounding  pharmacists work with patients and practitioners to provide customized  hormone therapy with the needed hormones in the most appropriate  strength and dosage form to meet each woman’s specific needs. Hormone  therapy should be initiated carefully after a woman’s medical and family  history has been reviewed. Every woman is unique and will respond to  therapy in her own way. Close monitoring and adjustments are essential.

RETHINKING HORMONE REPLACEMENT

The North American Menopause Society (NAMS) released its 2017 Hormone  Therapy Position Statement, which has been endorsed by 52 agencies  including the American Association of Clinical Endocrinologists, the  American Women’s Medical Association, and the Society of Obstetricians  and Gynaecologists of Canada, and supported as an educational tool by  the American College of Obstetricians and Gynecologists (ACOG). To quote  the statement: “Hormone therapy (HT) remains the most effective  treatment for vasomotor symptoms (VMS) and the genitourinary syndrome  of menopause (GSM) and has been shown to prevent bone loss and fracture.  The risks of HT differ depending on type, dose, duration of use,  route of administration, timing of initiation, and whether a progestogen  is used. Treatment should be individualized to identify the most  appropriate HT type, dose, formulation, route of administration, and  duration of use, using the best available evidence to maximize benefits  and minimize risks, with periodic reevaluation of the benefits and  risks of continuing or discontinuing HT. For women aged younger than 60  years or who are within 10 years of menopause onset and have no  contraindications, the benefit-risk ratio is most favorable for  treatment of bothersome VMS and for those at elevated risk for bone loss  or fracture. For women who initiate HT more than 10 or 20 years from  menopause onset or are aged 60 years or older, the benefit-risk ratio  appears less favorable because of the greater absolute risks of coronary  heart disease, stroke, venous thromboembolism, and dementia. Longer  durations of therapy should be for documented indications such as  persistent VMS or bone loss, with shared decision making and periodic  reevaluation. For bothersome GSM symptoms not relieved with  over-the-counter therapies and without indications for use of systemic  HT, low-dose vaginal estrogen therapy or other therapies are  recommended.”

Menopause. 2017 Jul;24(7):728-753.

The 2017 hormone therapy position statement of The North American Menopause Society.

Click here to access the PubMed abstract of this article.

The mortality toll of estrogen avoidance: an analysis of excess deaths among hysterectomized women aged 50 to 59 years.

Findings from the Women’s Health Initiative (WHI) published in 2002  indicated a greater risk of breast cancer and coronary heart disease  among women who used a combination of estrogen and progestin as  menopausal hormone replacement therapy. In the WHI study arm that  investigated the use of estrogen alone (no progestin in women who had  hysterectomies), there was a decrease in the risk of breast cancer and  heart disease, and a lower rate of mortality in comparison with women  who received a placebo.

The backlash from widely publicized findings frightened many women  and some physicians, and the use of hormone replacement therapy  precipitously declined. Sarrel et al. of the Yale University School of  Medicine, Yale University School of Public Health and University of  Florence (Italy) Department of Public Health examined the effect of  estrogen avoidance on mortality rates. They derived a formula to relate  the excess mortality among hysterectomized women aged 50 to 59 years  assigned to placebo in the WHI randomized controlled trial to the entire  population of comparable women in the United States, incorporating the  decline in estrogen use observed between 2002 and 2011. They calculated  that a minimum of 18,601 and as many as 91,610 postmenopausal women died prematurely because of the avoidance of estrogen therapy. “Sadly,  the media, women, and health care providers did not appreciate the  difference between the two kinds of hormone therapy,” commented lead  researcher Philip Sarrel, MD. “As a result, the use of all forms of  FDA-approved menopausal hormone therapy declined precipitously.” He  concluded that informed discussion between the women and their health  care providers about the effects of hormone therapy is a matter of  considerable urgency. “Essentially, estradiol inhibits the development  of atherosclerosis and helps maintain normal arterial blood flow.”

Am J Public Health. 2013 Sep;103(9):1583-8

Click here to access the PubMed abstract of this article.   

In September, 2017, Manson et al. published an observational  follow-up of approximately 98% of the 27,347 postmenopausal women aged  50-79 who were enrolled in two WHI randomized clinical trials  between 1993 and 1998 and followed up through 2014. They concluded that  among postmenopausal women, hormone therapy with estrogen plus progestin  for a median of 5.6 years or with estrogen alone for a median of 7.2  years was not associated with risk of all-cause, cardiovascular, or  cancer mortality during a cumulative follow-up of 18 years.

JAMA. 2017 Sep 12;318(10):927-938.

Menopausal Hormone Therapy and Long-term All-Cause and  Cause-Specific Mortality: The Women’s Health Initiative Randomized  Trials.

Click here to access the PubMed abstract of this article.

Arefa Cassoobhoy, MD, MPH, a senior medical correspondent for  Medscape, interviewed JoAnn Manson, MD, professor of medicine at Harvard  Medical School and Brigham and Women’s Hospital in Boston, and lead  author of the WHI. Dr. Manson shared the following perspectives:

• For women (below age 60) and closer proximity to onset of menopause  (within 10 years), the absolute risks of heart disease, stroke, deep  venous thrombosis (DVT), and breast cancer, related to hormone therapy,  are lower.
• Women who are at greater risk for and have a higher frequency of  hot flashes and night sweats are more likely to derive quality-of-life  benefits from hormone therapy. Thus, the benefit-risk ratio becomes much  better because of the lower absolute risk and the greater likelihood of  deriving quality-of-life benefits.
• Transdermal hormone therapy has the advantage of avoiding  first-pass liver metabolism, and therefore it’s less likely to increase  clotting protein or triglyceride levels and avoids some of the other  concerns associated with the oral route of administration. The  observational studies suggest that the risks for DVT, pulmonary  embolism, and possibly even stroke are lower with the transdermal than  the oral route. As of yet, there are no large-scale randomized trials  doing direct head-to-head comparisons.
        The risk for cardiovascular events, both heart disease and stroke,  will be greater in older women. If you are going to use hormone therapy  in women who are more distant from the onset of menopause or who have  significant risk factors such as diabetes or hypertension, it is  preferable to go with the low-dose transdermal formulation rather than  oral hormone therapy.
• In contrast to the vasomotor symptoms (hot flashes and night  sweats), genitourinary symptoms actually progress over time. About 50%  of women are seriously affected by these symptoms in terms of decreased  quality of life, poor sexual health, and discomfort with sexual  activity. Genitourinary conditions and also are associated with urinary  tract infections and physical health. These symptoms are undertreated  and under-recognized, and clinicians should ask about them because many  women are very uncomfortable bringing up the subject. Low-dose vaginal  estrogen is the most effective treatment and does not increase the blood  level of estrogen above the usual postmenopausal range. In terms of the  evidence base and the clinical trial data, there is no evidence of an  increased risk for heart disease, stroke, DVT, dementia, or breast  cancer with low-dose vaginal estrogen.
• Women with early menopause (either premature ovarian insufficiency  or early surgical menopause)—who have an increased risk for heart  disease, cognitive decline, bone loss, and osteoporosis – are  particularly good candidates for hormone therapy. 
• The WHI observational follow-up urges caution when considering  initiating hormone therapy at an older age in women with diabetes, as  these women are at the greatest risk for cognitive decline.

NAMS’ New Hormone Therapy Position Statement: Clinical Takeaways

//www.medscape.com/viewarticle/88408

REASONS FOR CHOOSING COMPOUNDED MEDICATIONS INCLUDE:

• Patient allergies or failure to respond to commercial products
• Adverse reactions to commercial preparations. For example, if a  patient has a reaction to an adhesive on a patch, we can compound the  needed medication as a transdermal cream. 
• Need for a dose or dosage form that is not commercially available.  For example, transdermal and vaginal creams may offer potential  advantages because non-oral administration bypasses first-pass hepatic  metabolism. 

Our compounding pharmacy puts patient safety first by adhering to  current regulations and compounding medications using pure ingredients  from FDA-inspected facilities.