Sunday, May 6. Power Surge: History and Current Treatment Options for Hot Flashes 3/28/2012

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1 Power Surge: History and Current Treatment Options for Hot Flashes 2012 Regional Osteopathic Medical Education (ROME ) Southeast Conference Sunday, May 6 Power Surge: History and Current Treatment Options for Hot Flashes William T. Hudson, M.D. Henderson & Walton Women s Center, P.C. Birmingham, AL Power Surge: History and Current Treatment Options for Hot Flashes Financial Disclosure I have no significant financial interests or other relationships with industry relative to the subject of this lecture. 1

2 Learning Objectives At the conclusion of this presentation, attendees should be able to: Identify signs and symptoms of menopause Understand the implications of the WHI study, and know its criticisms Understand treatment options for menopause Know risks and benefits to alternative therapies for the treatment of menopausal symptoms MENOPAUSE Average age naturally is: 50.5 Permanent end of menstration Surgically Induced Signs & Symptoms: Hot flashes and Night sweats Vaginal dryness Decrease libido Sleep disturbance Mood changes Bone loss 2

3 Feminine Forever HRT has been used for about 70 years Universal panacea for women s problems starting midlife forward Challenged in the 1990 s by WHI study Evolving use today HORMONE REPLACEMENT THERAPY (HRT) ESTROGEN REPLACEMENT THERAPY (ERT) To take or not to take? The Estrogen Question 3

4 WHAT S THE CONTROVERSY?? WOMEN S HEALTH INITIATIVE National Institute of Health to run for 15 years 161,808 patients/40 medical ceters Assess impact of intervention Drug Studied Prempro/Premarin Cost: $7,000, Multiple arms WOMEN S HEALTH INITIATIVE 1 st reports on MSNBC July 9, NOT to physicians or medical journals JAMA July 17, 2002 Criticism 4

5 WOMEN S HEALTH INITIATIVE HRT results PANIC Risk of cardiovascular disease Risk of breast cancer Risk of blood clots Risk of strokes Risk of osteoporosis Risk of colon cancer Take lowest dose maximum 5 years Criticism of the WHI Age of women enrolled Asymptomatic Obese/ CV disease Inappropriate preparation/dose High dropout and unblinding rate Poor Compliance Risks exaggerated by media WHI: Other Considerations Quantification of Risk (Absolute vs Relative Risk) Perspective of population being studied Differences between hormone therapy regimens Distinctions in risk profile for oral vs transdermal therapy 5

6 WHI: Other Considerations Timing of Hormone therapy Critical time window Premature menopause Duration of Therapy TODAY POST WHI Pendulum has swung back Individualize each case to minimize risk If you need it, you take it. If you don t need it, don t take it. Quality of life issue Strategies to Minimize Risk Timing hormone therapy Minimize the dose Delivery method Add a progestin Consider high risk factors 6

7 Increased Risk of CVD Age of Initiation Estrogen Only (per wmn) Estrogen + P (per wmn) less less Combined (per wmn) more Time Since Menopause 0-9 years 4 less 6 less years 14 less 7 more 4 more >20 years 7 more 30 more 16 more Total Mortality Associated with HRT in Younger vs Older Postmenopausal Women Hormone therapy versus controls OR (95% CI) >60 years of age Mean age 66 years 1.03 ( ) <60 years of age Mean age 54 years 0.61 ( ) All ages 0.98 ( Salpeter et al. Mortality Associated with Hormone Replacement Therapy in Younger and Older Women: A Meta Analysis. J Gen Intern Med(7), (2004). 7

8 Benefits Associated With HRT Established benefits Bone loss/osteoporotic fracture Urogenital Atrophy Menopausal symptoms (hot flashes) Strong Evidence CVD prevention Dementia/Alzheimer s prevention Decreased Mortality Benefits Associated With HRT Multiple Studies- Decreasing: Memory loss Colon cancer Arthritis Fat redistribution Tooth loss Parkinson s Disease Collagen Loss in Skin/Wrinkling North American Menopause Society 2010 Guidelines revised in Feb 2012 Distinguishes the emerging differences in the therapeutic benefit-risk ratio between ET and combined EPT Supports use of HT when balance of risks-benefits is favorable for the individual woman More favorable risk-benefit ratio favors extending duration of use beyond previous recommendation of 3-5 years. 8

9 Decreasing Breast Cancer Risk? Lancet Oncol. Published online Mar 7, 2012 Subgroup of 10,739 women in WHI with median follow-up of 11.8 years Estrogen alone after hysterectomy Decreased risk of developing breast cancer Decreased risk of death from breast cancer ESTROGEN - TERMINOLOGY Commercial Products Prescription Soy Products OTC Natural Hormones Herbal Bio-Equivalent Hormones Bio-Identical Hormones Custom Compounded Hormones Oral HRT 9

10 Transdermal HRT Transvaginal Preparations Bioidentical Hormones Chemical and molecular structure Rise in popularity Advantages? Alternative to conventional hormone therapy Why? 10

11 Bioidentical Hormones Biest 20% Estradiol (E2) 80% Estriol (E3) Triest 10% Estrone (E1) 10% Estradiol (E2) 80% Estriol (E3) Bioidentical Hormone Misconceptions Bioidentical does not mean natural Bioidentical does not mean customcompounded Advantages over FDA-approved products Concept of an absolutely safe hormone Conventional HT does not include bioidenticals Bioidentical Hormones Benefits not established Monitoring Estriol (E3) risks Bioidentical progesterone and synthetic progestins are structurally and functionally different DHEA and Testosterone controversy 11

12 Bioidentical Hormones Individualized therapy is it really? Salivary testing Labeling Risks intrinsic to compounding Scientific evidence...concerning THE BIO-IDENTICAL METHOD There is no evidence, absolutely underline the word no, that there is any advantage over the traditional approach. -Dr. Ken Muse, associate professor at the University of Kentucky and director of the division of reproductive endocrinology Alternative Medicine / Botanicals Biologic 1998 exceeded visits to conventional primary care providers Theories Dissatisfaction More empowering Personal values religious or ethical 12

13 Botanicals ½ of all FDA approved drugs derived from botanical material Herbs Oils Pills Teas Tinctures Dietary Plant Estrogen/Phytoestrogens Consume mass quantities Isoflavones Lignins Coumestans Botanicals Neither foods nor drugs FTC not FDA Cannot make disease claims High degree of variation 13

14 Botanicals for Menopausal Women Soy products Black Cohosh Evening Primrose Dong Quai St John s Wort Valerian Root Chasteberry Ginseng Wild Yam Counseling Women About Complementary and Alternative Medicine Ask and document Potentially dangerous drug-herb interactions Variability of content Lack of quality control and regulation Errors in compounding Pregnancy concerns Known adverse effects and toxicities Infants, children, and elderly Reporting adverse events Placebo response Hormone replacement will not add years to your life, but it may add life to your years. -Me 14

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