Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review

Constantine, Ginger D.; Graham, Shelli; Lapane, Kate L.; Ohleth, Kathleen M.; Bernick, Brian; Liu, James H.; Mirkin, Sebastián

doi:10.1097/gme.0000000000001315

Cited by 27 publications

(20 citation statements)

References 58 publications

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“…Oral MHT was related to an increased risk of thrombotic events and stroke, whereas transdermal and vaginal MHT were comparatively safer than oral MHT in a review of observational studies 18 ; however, this information was not available for RCTs 16,17 . Our subgroup analyses of observational studies according to route of administration supported findings from the most recent review 18,42 . The recent Nurses' Health Study and the WHI Observational Study also have suggested the safety of low-dose vaginal estrogen with respect to the risk of CVD and cancer 43,44 .…”

Section: Comparison Of Findings Between Rcts and Observational Studiesupporting

confidence: 83%

A systematic review and meta-analysis of effects of menopausal hormone therapy on cardiovascular diseases

Kim

Chang

Jeong

et al. 2020

Sci Rep

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A systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies was conducted to assess the association between menopausal hormone therapy and cardiovascular disease. The PubMed and EMBASE databases were searched for articles published from 2000 to 2019, using review methods based on a previous Cochrane review. Quality assessment of RCTs and observational studies was conducted using the Jadad scale and the Newcastle–Ottawa Scale, respectively. A total of 26 RCTs and 47 observational studies were identified. The study populations in the RCTs were older and had more underlying diseases than those in the observational studies. Increased risks of venous thromboembolism [summary estimate (SE), 95% confidence interval (CI): RCTs, 1.70, 1.33–2.16; observational studies, 1.32, 1.13–1.54] were consistently identified in both study types, whereas an increased risk of stroke in RCTs (SE: 1.14, 95% CI: 1.04–1.25) and a decreased risk of myocardial infarction in observational studies (SE: 0.79, 95% CI: 0.75–0.84) were observed. Differential clinical effects depending on timing of initiation, underlying disease, regimen type, and route of administration were identified through subgroup analyses. These findings suggest that underlying disease and timing of initiation should be carefully considered before starting therapy in postmenopausal women.

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Section: Comparison Of Findings Between Rcts and Observational Studiesupporting

confidence: 83%

A systematic review and meta-analysis of effects of menopausal hormone therapy on cardiovascular diseases

Kim

Chang

Jeong

et al. 2020

Sci Rep

View full text Add to dashboard Cite

show abstract

“…Although long-term clinical trial data (i.e., beyond one year) are lacking, there is no evidence of an increased risk of endometrial cancer with low-dose topical estrogens, which confirms that concomitant progestogens are not needed [33]. Recent systematic reviews based on both RCTs and observational studies confirm the endometrial safety of topical estradiol for up to 52 weeks of follow-up [34,35]. Likewise, a systematic review of topical estriol used for up to 52 weeks (0.5-1 milligrams per dose) [36] and a 30-week study with an ultra-low-dose estriol vaginal gel (30 micrograms per dose) [37] showed no treatment-related serious endometrial adverse events.…”

Section: Risk Of Endometrial Cancermentioning

confidence: 97%

Topical estrogens and non-hormonal preparations for postmenopausal vulvovaginal atrophy: An EMAS clinical guide

et al. 2021

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Introduction: Vulvovaginal atrophy (VVA) is a chronic condition caused by estrogen deficiency. It affects around 50% of postmenopausal women, reducing their general and sexual quality of life as well as the quality of their personal relationships. Aim: The aim of this clinical guide is to set out an individualized approach to the management of VVA with topical estrogens and non-hormonal preparations. Materials and methods: Literature review and consensus of expert opinion. Summary recommendations: An individualized approach is required for the management of VVA. Topical low-dose estrogens are effective and also alleviate urinary incontinence and prevent recurrent urinary tract infections. Women should not be denied long-term use of topical estrogens as long as they feel that this treatment is of benefit to them, because the safety data are reassuring. Non-hormonal preparations (lubricants and moisturizers) should be the first-line treatment for VVA in women taking adjuvant endocrine therapies for cancers considered to be hormone-dependent. They can be used over the long term.

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“…Although vaginal ET reduces symptoms of VVA, the systemic exposure is low enough that it does not alleviate VMS or reduce the risk of osteoporosis [49]. Recent studies have not shown an elevated risk of cardiovascular disease [54, 55], cancer (endometrial [54–56], breast [54, 55], ovarian, or colorectal [54]) or hip fracture [54].…”

Section: Available Treatmentsmentioning

confidence: 99%

Practical Treatment Considerations in the Management of Genitourinary Syndrome of Menopause

2019

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Genitourinary syndrome of menopause is a condition comprising the atrophic symptoms and signs women may experience in the vulvovaginal and bladder-urethral areas as a result of the loss of sex steroids that occurs with menopause. It is a progressive condition that does not resolve without treatment and can adversely affect a woman’s quality of life. For a variety of reasons, many symptomatic women do not seek treatment and, of those who do, many are unhappy with their options. Additionally, many healthcare providers do not actively screen their menopausal patients for the symptoms of genitourinary syndrome of menopause. In this review, we discuss the clinical presentation of genitourinary syndrome of menopause as well as the treatment guidelines recommended by the major societies engaged in women’s health. This is followed by a review of available treatment options that includes both hormonal and non-hormonal therapies. We discuss both the systemic and vaginal estrogen products that have been available for decades and remain important treatment options for patients; however, a major intent of the review is to provide information on the newer, non-estrogen pharmacologic treatment options, in particular oral ospemifene and vaginal prasterone. A discussion of adjunctive therapies such as moisturizers, lubricants, physical therapy/dilators, hyaluronic acid, and laser therapy is included. We also address some of the available data on both the patient and healthcare providers perspectives on treatment, including cost, and touch briefly on the topic of treating women with a history of, or at high risk for, breast cancer.

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Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review

Abstract: Supplemental Digital Content is available in the text

Cited by 27 publications

References 58 publications

A systematic review and meta-analysis of effects of menopausal hormone therapy on cardiovascular diseases

A systematic review and meta-analysis of effects of menopausal hormone therapy on cardiovascular diseases

Topical estrogens and non-hormonal preparations for postmenopausal vulvovaginal atrophy: An EMAS clinical guide

Practical Treatment Considerations in the Management of Genitourinary Syndrome of Menopause

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