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Management of Uterine Fibroids
Comparative Effectiveness Review, No. 195
Investigators: Katherine E. Hartmann, M.D., Ph.D., Christopher Fonnesbeck, Ph.D., Tanya Surawicz, M.P.H., Shanthi Krishnaswami, M.B.B.S., M.P.H., Jeffrey C. Andrews, M.D., Jo Ellen Wilson, M.D., M.P.H., Digna Velez-Edwards, Ph.D., M.S., Shannon Kugley, M.L.I.S., and Nila A. Sathe, M.A., M.L.I.S.
Structured Abstract
Objectives:
We assessed the evidence about management of uterine fibroids. Specifically, we sought to determine effectiveness of interventions, risks of harm, and whether individual or fibroid characteristics influence outcomes.
Data sources:
We searched MEDLINE® via PubMed® and Embase® to identify publications, as well as reviewed the reference lists of included studies.
Methods:
We included studies published in English from January 1985 to September 2016. We identified randomized clinical trials to assess outcomes and harms of interventions. We used data from trials in a meta-analysis to estimate probability and timing of subsequent interventions for fibroids based on initial type of intervention. To describe risk of unrecognized leiomyosarcoma, we included studies that allowed calculation of prevalence of leiomyosarcoma discovered at the time of surgery for masses believed to be fibroids. We also identified publications that indicated operative approaches to removal of leiomyosarcoma tissue and built models to estimate survival. We extracted data, assessed risk of bias, and rated the strength of evidence for informing care.
Results:
Of 97 included randomized trials, 43 studies assessed medications, 28 assessed procedures, and 37 assessed surgeries. Gonadotropin-releasing hormone (GnRH) agonists, mifepristone, and ulipristal reduced fibroid size and improved fibroid-related symptoms, including bleeding and quality of life (moderate strength of evidence [SOE] except quality of life for GnRH agonist [low SOE]). Several other medications have promise but are not supported by sufficient evidence. Uterine artery embolization (UAE) (high SOE) as well as high intensity focused ultrasound (low SOE) are effective for decreasing fibroid size/volume. Few other outcomes are well investigated for high intensity focused ultrasound. UAE studies reported improved outcomes for bleeding (moderate SOE), and quality of life (moderate SOE). Myomectomy and hysterectomy improved q uality of life (both low SOE). Few well-conducted trials directly compared different treatment options. No studies were designed to evaluate expectant management, and evidence is insufficient to guide clinical care. Subsequent intervention ranged from 0 to 44 percent in studies that followed women after initial fibroid treatment. At 2-year followup, subsequent intervention rates were lowest for initial medical management and higher for UAE and myomectomy, especially among younger women. No individual characteristics of women or their fibroids were definitely associated with likelihood of intervention benefits or patient satisfaction. These findings were limited by the number and size of available studies. Using data from 160 studies, we estimated that among 10,000 women having surgery for presumed fibroids, between 0 and 13 will have a leiomyosarcoma detected. Of the surgical approaches, the 5-year survival after leiomyosarcoma diagnosis was 30 percent with power morcellation (95% Bayesian credible interval [BCI]: 13% to 61%), 59 percent with scalpel morcellation (BCI: 33% to 84%), and 60 percent with intact removal (BCI: 24% to 98%).
Conclusion:
A range of interventions are effective for reducing fibroid size and improving symptoms. Some medications and procedures also improve quality of life. Few studies directly compare interventions. The risk of encountering a leiomyosarcoma at the time of fibroid surgery is low, and the method of fibroid removal may influence survival. Evidence to guide choice of intervention is likely best when applied in the context of individual patient needs and preferences.
Contents
- Key Messages
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Evidence Summary
- Introduction
- Methods
- Results
- Content of the Literature About Effectiveness
- Key Question 1. Effectiveness of Treatment for Uterine Fibroids
- Expectant Management: Overview
- Medical Management: Overview
- Procedures for Fibroid Intervention: Overview
- Surgical Intervention: Overview
- Comparative Effectiveness Studies
- Analysis of Subsequent Treatment Following Initial Treatment for Uterine Fibroids
- Key Question 2. Influence of Patient/Fibroid Characteristics on Effectiveness
- Key Question 3. Risk of Leiomyosarcoma When Mass Thought To Be a Fibroid
- Key Question 4. Influence of Morcellation and Patient/Fibroid Characteristics on Leiomyosarcoma Survival
- Discussion
- References
- Abbreviations
- Appendixes
- Appendix A. Search Strategy
- Appendix B. Population, Intervention, Comparator, Outcomes, Timing, and Setting
- Appendix C. Screening Forms
- Appendix D. Reasons for Exclusion
- Appendix E. Risk of Bias Form and Summary
- Appendix F. Registered Study Protocols
- Appendix G. Study Outcome Data
- Appendix H. Estimates of Subsequent Treatment for Uterine Fibroids
- Appendix I. Summary of Existing Systematic Reviews
Suggested citation:
Hartmann KE, Fonnesbeck C, Surawicz T, Krishnaswami S, Andrews JC, Wilson JE, Velez-Edwards D, Kugley S, Sathe NA. Management of Uterine Fibroids. Comparative Effectiveness Review No. 195. (Prepared by the Vanderbilt Evidence-based Practice Center under Contract No. 290-2015-00003-I.) AHRQ Publication No. 17(18)-EHC028-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2017. www.effectivehealthcare.ahrq.gov/reports/final.cfm. doi: https://doi.org/10.23970/AHRQEPCCER195.
This report is based on research conducted by the Vanderbilt Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2015-00003-I). 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. Therefore, no statement in this report should be construed as an official position of 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 health care decisionmakers—patients and clinicians, health system leaders, and policymakers, among others—make well-informed decisions and thereby improve the quality of health care 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. This report may be used and reprinted without permission except those copyrighted materials that are clearly noted in the report. Further reproduction of those copyrighted materials is prohibited without the express permission of copyright holders.
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.
This report may periodically be assessed for the currency of conclusions. If an assessment is done, the resulting surveillance report describing the methodology and findings will be found on the Effective Health Care Program Web site at www.effectivehealthcare.ahrq.gov. Search on the title of the report.
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