NAMS: The 2017 Hormone Therapy Position Statement

Abstract and Introduction

Abstract

The 2017 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) updates the 2012 Hormone Therapy Position Statement of The North American Menopause Society and identifies future research needs. An Advisory Panel of clinicians and researchers expert in the field of women's health and menopause was recruited by NAMS to review the 2012 Position Statement, evaluate new literature, assess the evidence, and reach consensus on recommendations, using the level of evidence to identify the strength of recommendations and the quality of the evidence. The Panel's recommendations were reviewed and approved by the NAMS Board of Trustees.

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.

Introduction

This NAMS position statement has been endorsed by Academy of Women's Health, American Association of Clinical Endocrinologists, American Association of Nurse Practitioners, American Medical Women's Association, American Society for Reproductive Medicine, Asociación Mexicana para el Estudio del Climaterio, Association of Reproductive Health Professionals, Australasian Menopause Society, Chinese Menopause Society, Colegio Mexicano de Especialistas en Ginecologia y Obstetricia, Czech Menopause and Andropause Society, Dominican Menopause Society, European Menopause and Andropause Society, German Menopause Society, Groupe d'études de la ménopause et du vieillissement Hormonal, HealthyWomen, Indian Menopause Society, International Menopause Society, International Osteoporosis Foundation, International Society for the Study of Women's Sexual Health, Israeli Menopause Society, Japan Society of Menopause and Women's Health, Korean Society of Menopause, Menopause Research Society of Singapore, National Association of Nurse Practitioners in Women's Health, SOBRAC and FEBRASGO, SIGMA Canadian Menopause Society, Società Italiana della Menopausa, Society of Obstetricians and Gynaecologists of Canada, South African Menopause Society, Taiwanese Menopause Society, and the Thai Menopause Society. The American College of Obstetricians and Gynecologists supports the value of this clinical document as an educational tool, June 2017. The British Menopause Society supports this Position Statement.

The 2017 Hormone Therapy Position Statement of The North American Menopause Society (NAMS) provides evidence-based and current best clinical practice recommendations for the use of hormone therapy (HT) for the treatment of menopause-related symptoms and reviews the effects of HT on various health conditions at different stages of a woman's life.

The availability of new clinical trial data prompted the NAMS Board of Trustees to update the NAMS 2012 Hormone Therapy Position Statement. The new data include findings from long-term randomized, clinical trials (RCTs) and observational studies related to 1) the effects of HT during and after its use and 2) detailed analyses stratified by age and time since menopause onset. NAMS convened an Advisory Panel of clinicians and researchers expert in the field of women's health and menopause to provide recommendations for this updated Position Statement.

The term hormone therapy is used to encompass estrogen therapy (ET) and estrogen-progestogen therapy (EPT) when outcomes are not specific to one or the other treatment, although whenever possible the different effects of ET, EPT, and estrogen-receptor (ER) agonists or antagonists are included. Key to initiating or continuing HT in an individual woman is an understanding of the benefits and risks of age at initiation or time since menopause, specific formulations or types of HT, the duration of therapy, the need for monitoring during therapy, potential risks of continuation, and the need for shared decision making.

The use of HT is considered for different cultural or minority populations of women, including those with surgical menopause, early menopause, or primary ovarian insufficiency (POI) and for women aged older than 65 years.

These statements do not represent codified practice standards as defined by regulating bodies or insurance agencies.

Authors and Disclosures

Table 1. Frequency of adverse drug reactions
Very common	≥ 1/10
Common (frequent)	≥ 1/100 and < 1/10
Uncommon (infrequent)	≥ 1/1,000 and < 1/100
Rare	≥ 1/10,000 and < 1/1,000 (≤ 10/10,000 per year)
Very rare	< 1/10,000

This position statement was developed by The North American Menopause Society 2017 Hormone Therapy Position Statement Advisory Panel consisting of representatives of the NAMS Board of Trustees and other experts in women's health: JoAnn V. Pinkerton, MD, NCMP, Chair; Dr. Fernando Sánchez Aguirre; Jennifer Blake, MD, MSC, FRCSC; Felicia Cosman, MD; Howard Hodis, MD; Susan Hoffstetter, PhD, WHNP-BC, FAANP; Andrew M. Kaunitz, MD, FACOG, NCMP; Sheryl A. Kingsberg, PhD; Pauline M. Maki, PhD; JoAnn E. Manson, MD, DrPH, NCMP; Polly Marchbanks, PhD, MSN; Michael R. McClung, MD; Lila E. Nachtigall, MD, NCMP; Lawrence M. Nelson, MD; Diane Todd Pace, PhD, APRN, FNP-BC, NCMP, FAANP; Robert L. Reid, MD; Phillip M. Sarrel, MD; Jan L. Shifren, MD, NCMP; Cynthia A. Stuenkel, MD, NCMP; and Wulf H. Utian, MD, PhD, DSc (Med). The Board of Trustees conducted an independent review and revision and approved the position statement.

This position statement was made possible by donations to the NAMS Education & Research Fund. There was no commercial support.

Address correspondence to
The North American Menopause Society; 30100 Chagrin Blvd., Suite 210; Pepper Pike, OH 44124. E-mail: info@menopause.org. Website: www.menopause.org.

Financial disclosure/Conflicts of interest
For the Advisory Panel, Dr. Aguirre, Dr. Blake, Dr. Hodis, Dr. Hofstetter, Dr. Maki, Dr. Manson, Dr. Marchbanks, Dr. Nelson, Dr. Sarrel, and Dr. Stuenkel each report no financial relationships. Dr. Cosman reports Advisor for Merck and Radius; Consultant for Tarsa; Speaker/Advisor/Investigator for Amgen and Eli Lilly. Dr. Kaunitz reports Advisory Board for Mithra; Author for UpTo-Date; Consultant for Allergan and Shionogi; Investigator for Radius and TherapeuticsMD; Investigator/Advisory Board for Bayer. Dr. Kingsberg reports Consultant/Advisory Board for AMAG, Endoceutics, Novo Nordisk, Pfizer, Shionogi, Strategic Scientific Solutions, and TherapeuticsMD. Dr. McClung reports Consultant for Merck and Radius; Consultant/Speaker for Amgen. Dr. Nachtigall reports Educational Production for Pfizer. Dr. Pace reports Advisory Board for Hologic; Advisory Board/Expert Panel for Allergan; Speaker/Advisory Board for Pfizer. Dr. Pinkerton reports Consultant for Pfizer, fee paid to institution; Investigator for TherapeuticsMD, fee paid to institution. Dr. Reid reports Advisory Board for Allergan, Bayer, Mithra, and Pfizer. Dr. Shifren reports Consultant for New England Research Institutes. Dr. Utian reports Consultant/Advisory Board for Endo-ceutics, Mithra, Pharmavite, and PulseNMore.
For additional contributors, Ms. Develen and Ms. Method report no financial relationships.