The Women's Health Initiative: addressing vaginal and sexual health

The Women's Health Initiative: addressing vaginal and sexual health Menopause: The Journal of The North American Menopause Society Vol. 25, No. 3, p. 249 DOI: 10.1097/GME.0000000000001051 2018 by The North American Menopause Society EDITORIAL n 1991, when the National Institute of Health (NIH) for the hysterectomized group, there was trending toward an launched the Women’s Health Initiative (WHI), a 15- increased risk of probable dementia and mild cognitive I year multimillion-dollar, multicenter clinical trial, it was impairment, but no increased risk of breast cancer or stroke hailed as the study that would finally bring older women’s and no increased or decreased risk of CHD. There was also a health care to the next level. The clinical trial protocol was to decreased risk of hip fracture. address common causes of impaired quality of life, disability, In hindsight, vaginal and sexual health measures probably and actual death in the older woman and the impact that should have been included in the WHI, but were not. At that estrogen plus progestin (EþP) would have on these. The time, for example, it was known that vaginal atrophy detracted major interests of the study centered on the impact of from the postmenopausal woman’s well-being, especially as it ‘‘replacement’’ estrogen on three major organ systems: breast related to sexual health and activity and specifically to (and risk of cancer), bone (and risk of osteoporosis), and heart dyspareunia. Yet, it was only after the study was stopped, (and risk of cardiovascular disease and stroke). Common as noted in Gass et al’s paper, that sexual health and vaginal assumptions from available data to that time point suggested symptoms were comprehensively assessed. In the present that hormonal therapy would probably decrease risk of coro- study, the authors reported on a cohort of 13,902 women nary heart disease and fracture, whereas it would possibly who had participated in the WHI study and who were con- increase the risk of breast cancer and venous thromboembo- tacted after the study had officially ended to participate in lism/pulmonary embolism (PE). Despite the enormity of the their survey study. The women reported on their current trial, aspects of sexuality were not one of the primary end- sexual health, after they had discontinued either their hor- points. That vaginal and sexual health did not make the ‘‘cut’’ monal therapy arm or placebo. Like the results of the primary for inclusion in the actual clinical trial is unfortunate, consid- clinical trial, these data, however, leave some unanswered ering the large number of women recruited and the robust questions. From our perspective, valuable data that this paper vaginal and sexual health data that would have resulted. reinforces are the truism that sexual health is determined by Sincere congratulations to Gass et al and their paper published many variables, including partner availability, ovarian status, in this issue of Menopause, which attempted to evaluate microbiome, route of delivery of hormonal therapy (local sexual health in this cohort of postmenopausal women after vs systemic), premenopausal sexual activity patterns, and the trial had been terminated and participants were no longer comorbid conditions. taking estrogen/progestin therapy or estrogen therapy versus In summary, despite the large sample size of this survey placebo. That is, to determine whether those previously on study, the data reflect past, not current, use of E or EþP. And active intervention would have different sexual health profiles despite the large number of study participants who responded as compared with those who had been on placebo. after the clinical trial had ended, the full risk/benefit profile of From September 1993 through December 1998, the WHI hormonal therapy on sexual function and vaginal health could hormone clinical trial randomized 16,608 nonhysterectomized not be fully answered. women to receive either EþP or placebo and 10,739 hysterec- Financial disclosure/conflicts of interest: None reported. tomized women to receive either E or placebo in the hormonal protocol of the study. As clinicians who care for postmeno- Gloria Bachmann, MD pausal women know, the WHI with its selected study objectives Nancy Phillips, MD Rutgers Robert Wood Johnson Medical School minus sexual health and gneitourinary syndrome of menopause New Brunswick, NJ endpoints was prematurely halted. This was due to increased adverse events in the EþP arm and due to no significant findings (either positive or negative) in the E arm that study REFERENCES leaders felt would justify the WHI costs. And so, 15 years ago, 1. Gass M, Larson J, Cochrane B, et al. Sexual activity and vaginal symptoms the EþP arm (2002) was stopped and for the E arm, 13 years ago in the postintervention phase of the Women’s Health Initiative Hormone (2004). Data in 2002 noted that for the nonhysterectomized Therapy Trials. Menopause 2018;25:252-264. women, in the EþP arm, there were 7 more with coronary heart 2. Grimes DA, Lobo RA. Perspectives on the women’s health initiative trial of hormone replacement therapy. Obstet Gynecol 2002;100:1344-1353. disease (CHD), 8 more with stroke, 8 more with PE, and 8 more 3. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine with breast cancer versus 6 fewer colorectal cancers and 5 fewer estrogen in postmenopausal women with hysterectomy: the Women’s hip fractures per 10,000 person-years. Data in 2004 noted that Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712. Menopause, Vol. 25, No. 3, 2018 249 Copyright @ 2018 The North American Menopause Society. Unauthorized reproduction of this article is prohibited. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Menopause Wolters Kluwer Health

The Women's Health Initiative: addressing vaginal and sexual health

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Wolters Kluwer
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© 2018 by The North American Menopause Society
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1072-3714
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10.1097/GME.0000000000001051
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Abstract

Menopause: The Journal of The North American Menopause Society Vol. 25, No. 3, p. 249 DOI: 10.1097/GME.0000000000001051 2018 by The North American Menopause Society EDITORIAL n 1991, when the National Institute of Health (NIH) for the hysterectomized group, there was trending toward an launched the Women’s Health Initiative (WHI), a 15- increased risk of probable dementia and mild cognitive I year multimillion-dollar, multicenter clinical trial, it was impairment, but no increased risk of breast cancer or stroke hailed as the study that would finally bring older women’s and no increased or decreased risk of CHD. There was also a health care to the next level. The clinical trial protocol was to decreased risk of hip fracture. address common causes of impaired quality of life, disability, In hindsight, vaginal and sexual health measures probably and actual death in the older woman and the impact that should have been included in the WHI, but were not. At that estrogen plus progestin (EþP) would have on these. The time, for example, it was known that vaginal atrophy detracted major interests of the study centered on the impact of from the postmenopausal woman’s well-being, especially as it ‘‘replacement’’ estrogen on three major organ systems: breast related to sexual health and activity and specifically to (and risk of cancer), bone (and risk of osteoporosis), and heart dyspareunia. Yet, it was only after the study was stopped, (and risk of cardiovascular disease and stroke). Common as noted in Gass et al’s paper, that sexual health and vaginal assumptions from available data to that time point suggested symptoms were comprehensively assessed. In the present that hormonal therapy would probably decrease risk of coro- study, the authors reported on a cohort of 13,902 women nary heart disease and fracture, whereas it would possibly who had participated in the WHI study and who were con- increase the risk of breast cancer and venous thromboembo- tacted after the study had officially ended to participate in lism/pulmonary embolism (PE). Despite the enormity of the their survey study. The women reported on their current trial, aspects of sexuality were not one of the primary end- sexual health, after they had discontinued either their hor- points. That vaginal and sexual health did not make the ‘‘cut’’ monal therapy arm or placebo. Like the results of the primary for inclusion in the actual clinical trial is unfortunate, consid- clinical trial, these data, however, leave some unanswered ering the large number of women recruited and the robust questions. From our perspective, valuable data that this paper vaginal and sexual health data that would have resulted. reinforces are the truism that sexual health is determined by Sincere congratulations to Gass et al and their paper published many variables, including partner availability, ovarian status, in this issue of Menopause, which attempted to evaluate microbiome, route of delivery of hormonal therapy (local sexual health in this cohort of postmenopausal women after vs systemic), premenopausal sexual activity patterns, and the trial had been terminated and participants were no longer comorbid conditions. taking estrogen/progestin therapy or estrogen therapy versus In summary, despite the large sample size of this survey placebo. That is, to determine whether those previously on study, the data reflect past, not current, use of E or EþP. And active intervention would have different sexual health profiles despite the large number of study participants who responded as compared with those who had been on placebo. after the clinical trial had ended, the full risk/benefit profile of From September 1993 through December 1998, the WHI hormonal therapy on sexual function and vaginal health could hormone clinical trial randomized 16,608 nonhysterectomized not be fully answered. women to receive either EþP or placebo and 10,739 hysterec- Financial disclosure/conflicts of interest: None reported. tomized women to receive either E or placebo in the hormonal protocol of the study. As clinicians who care for postmeno- Gloria Bachmann, MD pausal women know, the WHI with its selected study objectives Nancy Phillips, MD Rutgers Robert Wood Johnson Medical School minus sexual health and gneitourinary syndrome of menopause New Brunswick, NJ endpoints was prematurely halted. This was due to increased adverse events in the EþP arm and due to no significant findings (either positive or negative) in the E arm that study REFERENCES leaders felt would justify the WHI costs. And so, 15 years ago, 1. Gass M, Larson J, Cochrane B, et al. Sexual activity and vaginal symptoms the EþP arm (2002) was stopped and for the E arm, 13 years ago in the postintervention phase of the Women’s Health Initiative Hormone (2004). Data in 2002 noted that for the nonhysterectomized Therapy Trials. Menopause 2018;25:252-264. women, in the EþP arm, there were 7 more with coronary heart 2. Grimes DA, Lobo RA. Perspectives on the women’s health initiative trial of hormone replacement therapy. Obstet Gynecol 2002;100:1344-1353. disease (CHD), 8 more with stroke, 8 more with PE, and 8 more 3. Anderson GL, Limacher M, Assaf AR, et al. Effects of conjugated equine with breast cancer versus 6 fewer colorectal cancers and 5 fewer estrogen in postmenopausal women with hysterectomy: the Women’s hip fractures per 10,000 person-years. Data in 2004 noted that Health Initiative randomized controlled trial. JAMA 2004;291:1701-1712. Menopause, Vol. 25, No. 3, 2018 249 Copyright @ 2018 The North American Menopause Society. Unauthorized reproduction of this article is prohibited.

Journal

MenopauseWolters Kluwer Health

Published: Mar 1, 2018

References

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