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Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Evidence Reports/Technology Assessments, No. 219
Investigators: M E Beth Smith, DO, Heidi D Nelson, MD, MPH, Elizabeth Haney, MD, Miranda Pappas, MA, Monica Daeges, BA, Ngoc Wasson, MPH, and Marian McDonagh, PharmD.
Author Information and AffiliationsStructured Abstract
Objectives:
This systematic review summarizes research on methods of diagnosing myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and benefits and harms of multiple medical and nonmedical treatments. It identifies evidence gaps and limitations to inform future research.
Data sources:
Searches of electronic databases included MEDLINE® (1988 to September 2014), PsycINFO® (1988 to September 2014), and the Cochrane Library (through the third quarter of 2014). The searches were supplemented by reviewing reference lists, seeking suggestions from reviewers, and requesting scientific information from drug and device manufacturers.
Review methods:
Two investigators reviewed abstracts and full-text articles for inclusion based on predefined criteria. Discrepancies were resolved through discussion and consensus, with a third investigator making the final decision.
Results:
A total of 6,175 potentially relevant articles were identified, 1,069 were selected for full-text review, and 71 studies in 81 publications were included (36 observational studies on diagnosis and 35 trials of treatments). Eight case definitions have been used to define ME/CFS; those for ME, requiring the presence of postexertional malaise, represent a more symptomatic subset of the broader ME/CFS population. Researchers are unable to determine differences in accuracy between case definitions because there is no universally accepted reference standard for diagnosing ME/CFS. The Oxford criteria are the least restrictive and include patients who would not otherwise meet criteria for ME/CFS. Self-reported symptom scales may differentiate ME/CFS patients from healthy controls but have not been adequately evaluated to determine validity and generalizability in large populations with diagnostic uncertainty. Fourteen studies reported the consequences of diagnosis, including perceived stigma and the burden of misdiagnosis, as well as feelings of legitimacy upon receiving the diagnosis of ME/CFS.
Of the 35 trials of treatment, rintatolimod compared with placebo improved measures of exercise performance; counseling therapies and graded exercise treatment (GET) compared with no treatment, relaxation, or support improved fatigue, function, and quality of life, and counseling therapies also improved employment outcomes. Other treatments either provided no benefit or results were insufficient to draw conclusions. GET was associated with higher numbers of reported adverse events compared with counseling therapies or controls. Harms were generally inadequately reported across trials.
Limitations:
Diagnostic methods were studied only in highly selected patient populations. Treatment trials were limited in number and had small sample sizes and methodological shortcomings.
Conclusions:
None of the current diagnostic methods have been adequately tested to identify patients with ME/CFS when diagnostic uncertainty exists. Rintatolimod improves exercise performance in some patients (low strength of evidence), while counseling therapies and GET have broader benefit but have not been adequately tested in more disabled populations (low to moderate strength of evidence). Other treatments and harms have been inadequately studied (insufficient evidence). More definitive studies are needed to fill the many research gaps in diagnosing and treating ME/CFS.
Contents
- July 2016 Addendum
- Preface
- Acknowledgments
- Key Informants
- Technical Expert Panel
- Peer Reviewers
- Executive Summary
- Introduction
- Methods
- Results
- Results of Literature Searches
- Description of Included Studies
- Key Question 1. What methods are available to clinicians to diagnose ME/CFS, and what conditions are required to be ruled out or excluded before assigning a diagnosis of ME/CFS?
- Key Question 1a. What are the accuracy and concordance of methods used to diagnose ME/CFS?
- Key Question 1b. How does the use of these methods vary by patient subgroups?
- Key Question 1c. What harms are associated with diagnosing ME/CFS?
- Key Question 2. What are the (a) benefits and (b) harms of therapeutic interventions for patients with ME/CFS, and how do they vary by patient subgroups?
- Key Question 2c. What are the characteristics of responders and nonresponders to interventions?
- Discussion
- References
- Abbreviations and Acronyms
- Appendix A. Search Strategies
- Appendix B. Inclusion and Exclusion Criteria
- Appendix C. List of Included Studies
- Appendix D. List of Excluded Studies
- Appendix E. Quality Rating Criteria
- Appendix F. Strength of Evidence Criteria
- Appendix G. Data Abstraction Tables
- Appendix H. Quality Assessment Tables
- Appendix I. Published Case Definition Criteria
- Appendix J. Standardized Measures Tables
- Appendix K. Strength of Evidence
Addendum July 2016
Suggested citation:
Smith MEB, Nelson HD, Haney E, Pappas M, Daeges M, Wasson N, McDonagh M. Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Evidence Report/Technology Assessment No. 219. (Prepared by the Pacific Northwest Evidence-based Practice Center under Contract No. 290-2012-00014-I.) AHRQ Publication No. 15-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality; December 2014. Addendum July 2016. www.effectivehealthcare.ahrq.gov/reports/final.cfm. DOI: https://doi.org/10.23970/AHRQEPCERTA219.
This report is based on research conducted by the Pacific Northwest Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Rockville, MD (Contract No. 290-2012-00014-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 inform a National Institutes of Health Pathways to Prevention Workshop on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). The purpose of the Workshop is to develop a research agenda. 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.
None of the investigators have any affiliations or financial involvement that conflicts with the material presented in this report.
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- Diagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue SyndromeDiagnosis and Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
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