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Treatments for Fibromyalgia in Adult Subgroups
Comparative Effectiveness Reviews, No. 148
Investigators: Mary L Forte, PhD, DC, Mary Butler, PhD, MBA, Katherine E Andrade, MPH, Ann Vincent, MD, John T Schousboe, MD, PhD, and Robert L Kane, MD.
Author Information and AffiliationsStructured Abstract
Objective:
We conducted a systematic literature review of clinical trials to assess the comparative effectiveness of treatments for fibromyalgia in subgroups of highly affected or clinically complex adults. We focused on patient subgroups rather than overall treatment effects to complement a large systematic review being conducted on fibromyalgia treatments at McMaster University.
Data sources:
We searched Medline®, Embase®, PsycINFO®, AMED, and the Cochrane Central Register of Controlled Trials (CENTRAL) plus reference lists of included studies and recent systematic reviews.
Methods:
Two investigators screened abstracts of identified references for eligibility (enrolled adults with fibromyalgia, examined treatment effects, had a control group, and assessed outcomes at least 3 months after treatment initiation). Full-text articles were reviewed to identify outcomes reporting for at least one adult subgroup: women, older or obese adults, individuals with coexisting mental health conditions, high severity or longer fibromyalgia duration, multiple medical comorbidities, or other chronic pain conditions. Primary outcomes included pain, symptom improvement, function, fatigue, sleep quality, participation, and health-related quality of life. We extracted data, assessed risk of bias of individual studies, and evaluated strength of evidence for each comparison and outcome.
Results:
We identified 22 randomized controlled trials (RCTs), 8 pooled analyses of patient-level RCT data, and 4 observational studies that met inclusion criteria; 59 percent were drug trials. Adults with fibromyalgia and major depressive disorder (MDD) were studied most often; drug studies also reported outcomes by age, sex, race, and anxiety. Most drug trials examined duloxetine effects on pain and global improvement; trial duration was typically 3 months. Low-strength evidence for duloxetine suggests that subgroups of adults with fibromyalgia and MDD do not experience differential short-term treatment effects. Other subgroup evidence is largely insufficient. For nearly all comparisons, treatment-by-subgroup interactions were not significant. Most interaction results were reported in text; only two RCTs and five pooled RCT analyses displayed data on subgroup outcomes. Losses to followup were considerable; dropout reporting was not subgroup specific. Adverse effects were reported for the MDD subgroup in one duloxetine pooled analysis; these were similar to overall adverse effects. Studies were not powered to detect subgroup effects.
Conclusion:
Despite the prevalent belief that fibromyalgia treatments may behave differently in subgroups, evidence to date is largely insufficient for fibromyalgia subgroup effects of interventions other than duloxetine in adults with concomitant MDD. Future studies should be designed to support subgroup analysis to improve clinical applicability.
Contents
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Discussion
- References
- Abbreviations
- Appendix A Medications Used Off Label for Fibromyalgia Syndrome in the United States
- Appendix B Fibromyalgia Search Strings
- Appendix C Treatments for Fibromyalgia in Adult Subgroups Risk of Bias Assessment for Observational Studies
- Appendix D Excluded Studies
- Appendix E Evidence Tables
Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services1, Contract No. 290-2012-00016-I, Prepared by: Minnesota Evidence-based Practice Center, Minneapolis, MN
Suggested citation:
Forte ML, Butler M, Andrade KE, Vincent A, Schousboe JT, Kane RL. Treatments for Fibromyalgia in Adult Subgroups. Comparative Effectiveness Review No. 148. (Prepared by the Minnesota Evidence-based Practice Center under Contract No. 290-2012-00016-I.) AHRQ Publication No. 15-EHC006-EF. Rockville, MD: Agency for Healthcare Research and Quality; January 2015. www.effectivehealthcare.ahrq.gov/reports/final.cfm.
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. 290-2012-00016-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.
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.
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.
None of the investigators have any affiliations or financial involvement that conflict with the material presented in this report.
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540 Gaither Road, Rockville, MD 20850; www
.ahrq.gov
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