Genitourinary syndrome of menopause : a systematic review / Elisheva Danan [and seventeen others].

Format:

Book

Author/Creator:

Danan, Elisheva, author.

Series:

Comparative effectiveness review ; 272.

Comparative Effectiveness Review ; 272

Language:

English

Subjects (All):

Menopause.

Outcome assessment (Medical care).

Physical Description:

1 online resource.

Other Title:

Genitourinary syndrome of menopause

Place of Publication:

Rockville, MD : Agency for Healthcare Research and Quality, 2024.

Summary:

OBJECTIVES: To conduct a systematic review of evidence regarding genitourinary syndrome of menopause (GSM) screening, treatment, and surveillance. DATA SOURCES: Ovid/Medline(r), Embase(r), and EBSCOhost/CINAHL(r) 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:

Preface

Acknowledgments

Key Informants

Technical Expert Panel

Peer Reviewers

Executive Summary

Main Points

Background and Purpose

Methods

Results

Limitations

Implications and Conclusions

References

1. Introduction

1.1. Background

1.2. Purpose of Review

2. Methods

2.1. Review Approach

2.2. Key Questions

2.3. Analytic Framework

2.4. Study Selection

2.5. Assessment of Risk of Bias

2.6. Data Extraction and Data Management

2.7. Data Synthesis

2.8. Grading the Strength of Evidence

3. Results

3.1. Overview

3.2. Findings for Key Question 1

3.3. Findings for Key Questions 2 and 3

3.4. Findings for Key Question 4

3.5. Findings for Key Question 5

3.6. Non-Hormonal Interventions Evidence Map

4. Discussion

4.1. Overview

4.2. Broader Context

4.3. Strengths and Limitations of the Evidence Base

4.4. Strengths and Limitations of the Review Process

4.5. Implications for Clinical Practice

4.6. Implications for Future Research

4.7. Conclusions

Abbreviations and Acronyms

Appendixes

Appendix A. Methods

Appendix B. References Excluded at Full Text

Appendix C. Evidence Tables

Appendix D. FDA Information for Included Interventions

Appendix E. PCORI® Methodology Standards Checklist

Appendix F. Appendix References.

Notes:

Description based on publisher supplied metadata and other sources.