M.E. Beth Smith, DO; Elizabeth Haney, MD; Marian McDonagh, PharmD; Miranda Pappas, MA; Monica Daeges, BA; Ngoc Wasson, MPH; Rongwei Fu, PhD; Heidi D. Nelson, MD, MPH
Disclaimer: The findings and conclusions in this document are those of the authors, who are responsible for its content, and do not necessarily represent the views of the Agency for Healthcare Research and Quality (AHRQ). No statement in this report should be construed as an official position of AHRQ or the U.S. Department of Health and Human Services.
Acknowledgment: The authors thank following individuals for their contributions to this project: Richard Bryant, MD, for providing expert consultation throughout the report; Andrew Hamilton, MLS, MS, for conducting literature searches; and Spencer Dandy, BS, for assistance with preparing this report (all are located at the Oregon Health & Science University). They also thank Suchitra Iyer, PhD, Task Order Officer at the Agency for Healthcare Research and Quality; Carmen Green, MD, National Institutes of Health (NIH) Working Group Chair; the NIH Working Group; the Technical Expert Panel; and reviewers of the draft report.
Financial Support: By the Agency for Healthcare Research and Quality (contract 290-2012-00014-I, task order 4), Rockville, Maryland.
Disclosures: Dr. Fu reports funds under contract for the Evidence-based Practice Centers IV Program from Oregon Health & Science University during the conduct of this study. Ms. Daeges reports grants from Agency for Healthcare Research and Quality during the conduct of this study. Dr. Nelson reports grants from Agency for Healthcare Research and Quality during the conduct of the study. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0114.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer.
Requests for Single Reprints: M.E. Beth Smith, DO, 3181 SW Sam Jackson Park Road, Mail Code BICC, Portland, OR 97239; e-mail, email@example.com.
Current Author Addresses: Drs. Smith, Haney, McDonagh, Fu, and Nelson; Ms. Pappas, Ms. Daeges, and Ms. Wasson: 3181 SW Sam Jackson Park Road, Mail Code: BICC, Portland, OR 97239.
Author Contributions: Conception and design: M.E.B. Smith, E. Haney, M. McDonagh, M. Pappas, H.D. Nelson.
Analysis and interpretation of the data: M.E.B. Smith, E. Haney, M. McDonagh, M. Pappas, N. Wasson, R. Fu, H.D. Nelson.
Drafting of the article: M.E.B. Smith, M. McDonagh, M. Pappas, N. Wasson, H.D. Nelson.
Critical revision of the article for important intellectual content: M.E.B. Smith, E. Haney, M. McDonagh, M. Pappas, N. Wasson, R. Fu, H.D. Nelson.
Final approval of the article: M.E.B. Smith, E. Haney, M. McDonagh, M. Pappas, R. Fu, H.D. Nelson.
Provision of study materials or patients: M. Daeges.
Statistical expertise: R. Fu.
Obtaining of funding: M.E.B. Smith, M. McDonagh, H.D. Nelson.
Administrative, technical, or logistic support: M. Pappas, M. Daeges, N. Wasson, H.D. Nelson.
Collection and assembly of data: M.E.B. Smith, E. Haney, M. Pappas, N. Wasson, H.D. Nelson.
Myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is a debilitating multisystem condition affecting more than 1 million adults in the United States.
To determine benefits and harms of treatments for adults with ME/CFS and identify future research needs.
MEDLINE, PsycINFO, and Cochrane databases (January 1988 to September 2014); clinical trial registries; reference lists; and manufacturer information.
English-language randomized trials of the effectiveness and adverse effects of ME/CFS treatments.
Data on participants, study design, analysis, follow-up, and results were extracted and confirmed. Study quality was dual-rated by using prespecified criteria; discrepancies were resolved through consensus.
Among 35 treatment trials enrolling participants primarily meeting the 1994 Centers for Disease Control and Prevention and Oxford case definitions of CFS, the immune modulator rintatolimod improved some measures of exercise performance compared with placebo in 2 trials (low strength of evidence). Trials of galantamine, hydrocortisone, IgG, valganciclovir, isoprinosine, fluoxetine, and various complementary medicines were inconclusive (insufficient evidence). Counseling therapies and graded exercise therapy compared with no treatment, relaxation, or support improved fatigue, function, global improvement, and work impairment in some trials; counseling therapies also improved quality of life (low to moderate strength of evidence). Harms were rarely reported across studies (insufficient evidence).
Trials were heterogeneous and were limited by size, number, duration, applicability, and methodological quality.
Trials of rintatolimod, counseling therapies, and graded exercise therapy suggest benefit for some patients meeting case definitions for CFS, whereas evidence for other treatments and harms is insufficient. More definitive studies comparing participants meeting different case definitions, including ME, and providing subgroup analysis are needed to fill research gaps.
Agency for Healthcare Research and Quality. (PROSPERO: CRD42014009779)
Smith MB, Haney E, McDonagh M, et al. Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015;162:841–850. doi: https://doi.org/10.7326/M15-0114
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Published: Ann Intern Med. 2015;162(12):841-850.
Chronic Fatigue Syndrome/Fibromyalgia, Rheumatology.
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