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The US Preventive Services Task Force (USPSTF) Draft Recommendation statement on Menopausal Hormone Therapy: Primary Prevention for Chronic Diseases, released in May 2017, perpetuates a major disconnect between the primary population affected, women within roughly 10 years of menopause, and the data cited. Furthermore, major elements of the evidence relied upon have been misinterpreted or misstated, particularly in regard to coronary heart disease and breast cancer, for which there is no statistically significant evidence of harm. As currently drafted, the recommendations reiterate the USPSTF statements of 2012, 2005 and 2002, and will perpetuate egregious harm to the public health. In an attempt to avoid that outcome and to facilitate a return to rational discourse regarding menopausal hormone therapy, an ad hoc group of experts in menopausal health submitted this comprehensive response to the USPSTF. [ABSTRACT FROM AUTHOR]

Prior to 1996, the use of postmenopausal estrogen was not believed to increase the risk of venous thrombosis. Subsequent studies, particularly the prospective, randomized, double-blind, clinical trial of the Women's Health Initiative, have clearly shown an increase in the incidence and risk of venous thrombosis in postmenopausal women using conjugated equine estrogens with or without medroxyprogesterone acetate. The risk of venous thrombosis in postmenopausal women is also increased by obesity and age. Oral hormone therapy has been used principally for management of menopausal symptoms. Transdermal estrogens have not been used as extensively in the United States but have a significant use in Europe. Recent observational studies have indicated no increased risk of venous thrombosis with use of transdermal estrogens. Norpregnane derivatives have been associated with an increased risk of venous thrombosis, suggesting that progestins may contribute to the increased risk in postmenopausal women using estrogen plus progestin therapy. [ABSTRACT FROM AUTHOR]

Prior to 1996, the use of postmenopausal estrogen was not believed to increase the risk of venous thrombosis. Subsequent studies, particularly the prospective, randomized, double-blind, clinical trial of the Women's Health Initiative, have clearly shown an increase in the incidence and risk of venous thrombosis in postmenopausal women using conjugated equine estrogens with or without medroxyprogesterone acetate. The risk of venous thrombosis in postmenopausal women is also increased by obesity and age. Oral hormone therapy has been used principally for management of menopausal symptoms. Transdermal estrogens have not been used as extensively in the United States but have a significant use in Europe. Recent observational studies have indicated no increased risk of venous thrombosis with use of transdermal estrogens. Norpregnane derivatives have been associated with an increased risk of venous thrombosis, suggesting that progestins may contribute to the increased risk in postmenopausal women using estrogen plus progestin therapy. [ABSTRACT FROM AUTHOR]

Prior to 1996, the use of postmenopausal estrogen was not believed to increase the risk of venous thrombosis. Subsequent studies, particularly the prospective, randomized, double-blind, clinical trial of the Women's Health Initiative, have clearly shown an increase in the incidence and risk of venous thrombosis in postmenopausal women using conjugated equine estrogens with or without medroxyprogesterone acetate. The risk of venous thrombosis in postmenopausal women is also increased by obesity and age. Oral hormone therapy has been used principally for management of menopausal symptoms. Transdermal estrogens have not been used as extensively in the United States but have a significant use in Europe. Recent observational studies have indicated no increased risk of venous thrombosis with use of transdermal estrogens. Norpregnane derivatives have been associated with an increased risk of venous thrombosis, suggesting that progestins may contribute to the increased risk in postmenopausal women using estrogen plus progestin therapy. [ABSTRACT FROM AUTHOR]

Premature menopause and bilateral oophorectomy in young women are associated with an increased incidence of cardiovascular disease, myocardial infarction and overall mortality, Observational studies suggest an interval of 5-10 years between loss of ovarian function and the increased risk of cardiovascular disease. This finding is consonant with a published autopsy study of women who had undergone bilateral oophorectomy. The progression of atherosclerosis is retarded with the use of estrogen replacement therapy in non-human primates and women. Hormone therapy reduced the incidence of cardiovascular disease in women following bilateral oophorectomy. These findings support the use of hormone therapy in young women who have lost ovarian function. [ABSTRACT FROM AUTHOR]

Premature menopause and bilateral oophorectomy in young women are associated with an increased incidence of cardiovascular disease, myocardial infarction and overall mortality. Observational studies suggest an interval of 5-10 years between loss of ovarian function and the increased risk of cardiovascular disease. This finding is consonant with a published autopsy study of women who had undergone bilateral oophorectomy. The progression of atherosclerosis is retarded with the use of estrogen replacement therapy in non-human primates and women. Hormone therapy reduced the incidence of cardiovascular disease in women following bilateral oophorectomy. These findings support the use of hormone therapy in young women who have lost ovarian function. [ABSTRACT FROM AUTHOR]

Objective To evaluate the efficacy of two ultra-low-dose 17β-estradiol plus norethisterone acetate (NETA) treatment regimens for relieving menopausal symptoms. Design A total of 577 postmenopausal women were enrolled, in three treatment groups in a double-blind, randomized, placebo-controlled study of 0.5 mg 17β-estradiol + 0.1 mg NETA or 0.5 mg 17β-estradiol + 0.25 mg NETA or placebo. Participants returned at weeks 4, 8, 12 and 24 for climacteric complaint evaluation based on a daily diary vasomotor symptom record. Patients were assessed by the Greene Climacteric Scale and urogenital symptoms were also evaluated. Results Treatment with ultra-low-dose 0.5 mg 17β-estradiol + 0.1 mg NETA (0.1 Group) or 0.5 mg 17β-estradiol + 0.25 mg NETA (0.25 Group) effectively reduced the severity and number of hot flushes within the initial weeks of therapy. Compared to placebo, a rapid, statistically significant decrease in the frequency and severity of hot flushes was achieved by week 3, followed by further improvement which continued throughout the study. There were no statistically significant differences between the active treatment arms. Conclusions The data show that both ultra-low-dose regimens are effective in reducing the severity and number of hot flushes compared to placebo, with good safety profiles. [ABSTRACT FROM AUTHOR]

The efficacy of estrogen with or without a progestogen as hormone replacement therapy (HRT) for menopausal symptoms is well-established. Recent large-scale randomized studies with combined estrogen/progestogen therapy (EPT) have raised a number of safety issues, specifically the potential risk for coronary heart disease. Subsequent analyses and other studies have indicated that HRT may be cardioprotective in younger postmenopausal women. A new continuous EPT combines natural 17β-estradiol (E2) 1 mg with the novel progestin, drospirenone (DRSP) either 0.5 or 2 mg. DRSP has a physiological profile closer to that of natural progesterone than any other synthetic progestin. This paper reviews recent clinical trial data demonstrating the efficacy and safety of combined DRSP/E2 therapy as EPT in postmenopausal women. DRSP/E2 provides symptomatic relief of vasomotor symptoms and improvement in genitourinary atrophy. DRSP/E2 protects against endometrial hyperplasia and reduces the risk of osteoporosis. Combined DRSP/E2 therapy has a favorable impact on cholesterol and triglyceride levels, and decreases blood pressure in women with elevated blood pressure. The favorable efficacy and safety profile of DRSP/E2, and potential for long-term health benefits, represents a new option for the effective management of menopause and its clinical sequelae. [ABSTRACT FROM AUTHOR]

Objective: This study was undertaken to evaluate the effects on hemostatic factors of a low-dose preparation of levonorgestrel and ethinyl estradiol in a 12-cycle study.Study Design: Thirty healthy women began taking 100 microg levonorgestrel and 20 microg ethinyl estradiol on the first day of the menstrual cycle, continued to take the preparation for the next 21 days, and then took placebo for 7 days. Mean changes in prothrombin time, partial thromboplastin time, and levels of factors VII and X, antithrombin, plasminogen, fibrinogen, protein S, thrombin-antithrombin complexes, and D-dimer were analyzed at baseline and at cycles 3, 6, and 12 with paired Student t tests.Results: Factor X, plasminogen antigen and activity, and D-dimer levels were significantly increased (P Conclusion: The effects on hemostatic factors in healthy women of a monophasic preparation of 100 microg levonorgestrel and 20 microg ethinyl estradiol were similar to those of other low-dose oral contraceptives. [ABSTRACT FROM AUTHOR]

Menopause is merely a clinically discernible clue symbolic of the multitude of changes preceding or following the cessation of menses by many years. Because of the time span involved, separating changes observed in the menopausal transition from other age-related maturational events presents serious methodologic problems. Of the host of psychologic and psychosomatic symptoms, only hot flushes and associated sweats occur more frequently in this epoch, while an interplay between hormonal and age-related maturational events presents serious methodologic problems. Of the host of psychologic and psychosomatic symptoms, only hot flushes and associated sweats occur more frequently in this epoch, while an interplay between hormonal and age-related effects is assumed in atrophic changes involving the genitourinary organs. The relation between menopause and osteoporosis is suggestive but by no means proven, as is the risk for cardiovascular disease. Empiric evidence points to the usefullness of estrogen for the management of vasomotor instability, the symptoms associated with atrophy of the genitourinary tract, and in the prophylaxis of osteoporosis, but not in the treatment of anxiety, depression, and other psychiatric disorders. [ABSTRACT FROM AUTHOR]