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Genitourinary Syndrome of Menopause: A Systematic Review
Comparative Effectiveness Review, No. 272
Investigators: Elisheva R. Danan, M.D., M.P.H., Susan Diem, M.D., M.P.H., Catherine Sowerby, B.A., Kristen Ullman, M.P.H., Kristine Ensrud, M.D., M.P.H., Adrienne Landsteiner, Ph.D., M.P.H., Nancy Greer, Ph.D., Nicholas Zerzan, M.P.H., Maylen Anthony, M.P.H., Caleb Kalinowski, M.S., Mary Forte, Ph.D., D.C., Hamdi I. Abdi, M.P.H., Jessica K. Friedman, Ph.D., Rahel Nardos, M.D., M.S., Cynthia Fok, M.D., M.P.H., Philipp Dahm, M.D., M.H.Sc., Mary Butler, Ph.D., M.B.A., and Timothy J. Wilt, M.D., M.P.H.
Structured Abstract
Objectives:
To conduct a systematic review of evidence regarding genitourinary syndrome of menopause (GSM) screening, treatment, and surveillance.
Data sources:
Ovid/Medline®, Embase®, and EBSCOhost/CINAHL® from database inception through December 11, 2023.
Review methods:
We employed methods consistent with the Agency for Healthcare Research and Quality Evidence-based Practice Center Program Methods Guidance to identify studies and synthesize findings for Key Questions related to screening for GSM, effectiveness and harms of U.S.-available interventions for GSM, appropriate followup intervals for patients using GSM treatments, and endometrial surveillance for patients using hormonal GSM treatments. For vaginal estrogen and vaginal or systemic non-estrogen hormonal interventions, energy-based interventions, and vaginal moisturizers, we first assessed study quality and then, for moderate or high-quality studies, reviewed outcomes related to GSM symptoms, treatment satisfaction, and adverse effects. For low-quality studies, we described limited study characteristics only. For studies of other non-hormonal interventions, we created an evidence map describing study characteristics without assessing study quality.
Results:
After assessing 107 publications for risk of bias (RoB), we extracted and synthesized effectiveness and/or harms outcomes from 68 publications describing trials or prospective, controlled observational studies that were rated low, some concerns, or moderate RoB (24 estrogen publications, 35 non-estrogen, 11 energy-based, and 4 moisturizers). Of 39 high, serious, or critical RoB publications, we extracted long-term harms from only 15 uncontrolled studies of energy-based interventions (all serious or critical RoB due to confounding). An additional 66 publications evaluating 46 non-hormonal interventions, including natural products, mind/body practices, and educational interventions, were described in an evidence map. Across all 172 publications, studies differed in GSM definitions, diagnosis, enrollment criteria, and outcomes assessed. Few studies enrolled women with a history of breast or gynecologic cancers. Overall, we found that vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), vaginal moisturizers, and oral ospemifene may all improve at least some GSM symptoms, while evidence does not demonstrate the efficacy of energy-based therapies, vaginal or systemic testosterone, vaginal oxytocin, or oral raloxifene or bazedoxifene for any GSM symptoms. Harms reporting was limited, in part, by studies not being sufficiently powered to evaluate infrequent but serious harms, though most studies did not report frequent serious harms. Common non-serious adverse effects varied by treatment and dose. No studies evaluated GSM screening or directly addressed appropriate followup intervals or the effectiveness and harms of endometrial surveillance among women with a uterus receiving hormonal therapy for GSM. The longest followup period for active endometrial surveillance in an included trial was 12 weeks (vaginal estrogen) or 1 year (non-estrogen hormonal interventions).
Conclusions:
This systematic review provides comprehensive, up-to-date information to guide patients, clinicians, and policymakers regarding GSM. Despite the breadth of included studies, findings were limited by several factors, including heterogeneity in intervention-comparator-outcome combinations. Future studies would be strengthened by a standard definition and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant populations and intervention comparisons. Lack of long-term data assessing efficacy, tolerability, and safety of GSM treatments leaves postmenopausal women and clinicians without evidence to guide treatment longer than 1 year.
Contents
Suggested citation:
Danan ER, Diem S, Sowerby C, Ullman K, Ensrud K, Landsteiner A, Greer N, Zerzan N, Anthony M, Kalinowski C, Forte M, Abdi HI, Friedman JK, Nardos R, Fok C, Dahm P, Butler M, Wilt TJ. Genitourinary Syndrome of Menopause: A Systematic Review. Comparative Effectiveness Review No. 272. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 75Q80120D00008.) AHRQ Publication No. 24-EHC022. PCORI® Publication No. 2024-SR-02 Rockville, MD: Agency for Healthcare Research and Quality; July 2024. DOI: https://doi.org/10.23970/AHRQEPCCER272. Posted final reports are located on the Effective Health Care Program search page.
This report is based on research conducted by the Minnesota Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 75Q80120D00008). The Patient-Centered Outcomes Research Institute® (PCORI®) funded the report (PCORI® Publication No. 2024-SR-02). The findings and conclusions in this document are those of the authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ or PCORI®, its Board of Governors or Methodology Committee. Therefore, no statement in this report should be construed as an official position of PCORI®, AHRQ, or of the U.S. Department of Health and Human Services.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
The information in this report is intended to help healthcare decision makers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of healthcare services. This report is not intended to be a substitute for the application of clinical judgment. Anyone who makes decisions concerning the provision of clinical care should consider this report in the same way as any medical reference and in conjunction with all other pertinent information, i.e., in the context of available resources and circumstances presented by individual patients.
This report is made available to the public under the terms of a licensing agreement between the author and the Agency for Healthcare Research and Quality. Most AHRQ documents are publicly available to use for noncommercial purposes (research, clinical or patient education, quality improvement projects) in the United States, and do not need specific permission to be reprinted and used unless they contain material that is copyrighted by others. Specific written permission is needed for commercial use (reprinting for sale, incorporation into software, incorporation into for-profit training courses) or for use outside of the United States. If organizational policies require permission to adapt or use these materials, AHRQ will provide such permission in writing.
PCORI®, AHRQ, or U.S. Department of Health and Human Services endorsement of any derivative products that may be developed from this report, such as clinical practice guidelines, other quality enhancement tools, or reimbursement or coverage policies, may not be stated or implied.
A representative from AHRQ served as a Contracting Officer’s Representative and reviewed the contract deliverables for adherence to contract requirements and quality. AHRQ did not directly participate in the literature search, determination of study eligibility criteria, data analysis, interpretation of data, or preparation or drafting of this report.
AHRQ and PCORI® appreciate appropriate acknowledgment and citation of their work. Suggested language for acknowledgment: This work was based on an evidence report, Genitourinary Syndrome of Menopause: A Systematic Review, by the Minnesota Evidence-based Practice Center Program at the Agency for Healthcare Research and Quality (AHRQ) and funded by the Patient-Centered Outcomes Research Institute (PCORI®).
- Genitourinary Syndrome of Menopause: A Systematic ReviewGenitourinary Syndrome of Menopause: A Systematic Review
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