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Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop
Abstract
BACKGROUND: Myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is a debilitating multisystem condition affecting more than 1 million adults in the United States. PURPOSE: To determine benefits and harms of treatments for adults with ME/CFS and identify future research needs. DATA SOURCES: MEDLINE, PsycINFO, and Cochrane databases (January 1988 to September 2014); clinical trial registries; reference lists; and manufacturer information. STUDY SELECTION: English-language randomized trials of the effectiveness and adverse effects of ME/CFS treatments. DATA EXTRACTION: 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. DATA SYNTHESIS: 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). LIMITATION: Trials were heterogeneous and were limited by size, number, duration, applicability, and methodological quality. CONCLUSION: 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.
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“Systematic reviews have shown low strength of evidence for the effectiveness of different complementary therapies [19], cognitive-behavioral therapy (CBT), counseling and behavioral therapies [14,22], and graded exercise therapy [23] for improvement of fatigue, physical functioning, sleep, and quality of life in patients with ME/CFS.”
From Systematic review of mind‐body interventions to treat myalgic encephalomyelitis/chronic fatigue syndrome (2021) · cites this paper as [19]
In the citing paper
“There is no cure for ME/CFS nor any FDA or Health Canada approved medication to treat it [14,19], therefore the focus tends to be on managing and minimizing the symptoms and improving quality of life.”
From Systematic review of mind‐body interventions to treat myalgic encephalomyelitis/chronic fatigue syndrome (2021) · cites this paper as [19]
In the citing paper
“It has long been suspected that the Oxford criteria may therefore fail to exclude individuals with other fatiguing conditions [14,19].”
From Systematic review of mind‐body interventions to treat myalgic encephalomyelitis/chronic fatigue syndrome (2021) · cites this paper as [19]
In the citing paper
“Although some studies indicate an effect by counseling and CBT, results remain inconsistent [19] spurring interest in third-wave cognitive therapies like ACT [20].”
Citations
Cites
The Chronic Fatigue Syndrome: A Comprehensive Approach to Its Definition and Study
Fukuda, K., Straus, S. E., Hickie, I., Sharpe, M. C., Dobbins, J. G., Komaroff, A., & and International Chronic Fatigue Syndrome Study Group. (1994) · Annals of Internal Medicine · doi:10.7326/0003-4819-121-12-199412150-00009 · Cited by 4,969
Chronic Fatigue Syndrome: A Working Case Definition
Holmes, G. P., KAPLAN, J. E., GANTZ, N. M., KOMAROFF, A. L., SCHONBERGER, L. B., STRAUS, S. E., Jones, J. F., DUBOIS, R. E., CUNNINGHAM-RUNDLES, C., Pahwa, S. G., et al. (1988) · Annals of Internal Medicine · doi:10.7326/0003-4819-108-3-387 · Cited by 1,713
Myalgic encephalomyelitis: International Consensus Criteria
Carruthers, B. M., van de Sande, M. I., Meirleir, K. L. D., Klimas, N. G., Broderick, G., Mitchell, T., Staines, D., Powles, A. C. P., Speight, N., Vallings, R., et al. (2011) · Journal of Internal Medicine · doi:10.1111/j.1365-2796.2011.02428.x · Cited by 1,234 · cited 1×
“There is uncertainty regarding the cause of ME/ CFS, whether it is a pathologically discrete syndrome (2, 4), whether ME should be considered a subset of CFS or its own distinct disease (6), and whether symptoms are nonspecific and shared by other disease entities.”
BackgroundCarruthers, B. M., Jain, A. K., De Meirleir, K. L., Peterson, D. L., Klimas, N. G., Lerner, A. M., Bested, A. C., Flor-Henry, P., Joshi, P., Powles, A. C. P., et al. (2003) · Journal of Chronic Fatigue Syndrome · doi:10.1300/j092v11n01_02 · Cited by 1,180
A report—Chronic fatigue syndrome: Guidelines for research
Sharpe, M. C. (1991) · Journal of the Royal Society of Medicine · doi:10.1177/014107689108400224 · Cited by 1,026 · cited 1×
“Trials enrolled predominantly middle-aged women from ME/ CFS specialty clinics; used CFS case definitions, primarily the 1994 CDC (3) or Oxford criteria (56), to determine participant eligibility; had small sample sizes (27 trials had <100 participants); and were conducted in the United States and Western Europe (16).”
MethodWhite, P., Goldsmith, K., Johnson, A., Potts, L., Walwyn, R., DeCesare, J., Baber, H., Burgess, M., Clark, L., Cox, D., et al. (2011) · The Lancet · doi:10.1016/s0140-6736(11)60096-2 · Cited by 897
Cognitive behaviour therapy for the chronic fatigue syndrome: a randomised controlled trial.
Sharpe, M., Hawton, K., Simkin, S., Surawy, C., Hackmann, A., Klimes, I., Peto, T., Warrell, D., & Seagroatt, V. (1996) · BMJ · doi:10.1136/bmj.312.7022.22 · Cited by 528 · cited 1×
“In some trials, counseling and behavior therapies improved fatigue (8, 38, 39, 41, 43, 46, 48, 62), physical function (Figure 1) (38, 40, 41, 43, 44, 48), quality of life (42, 45), work impairment (38, 48), and the clinical global impression of change scale (38, 48, 59) (low to moderate strength of evidence).”
BackgroundA LIKELIHOOD APPROACH TO META-ANALYSIS WITH RANDOM EFFECTS
Hardy, R., & Thompson, S. G. (1996) · Statistics in Medicine · doi:10.1002/(sici)1097-0258(19960330)15:6 · Cited by 522
Interventions for the Treatment and Management of Chronic Fatigue Syndrome: A Systematic Review
Whiting, P., Bagnall, A.-M., Sowden, A. J., Cornell, J. E., Mulrow, C. D., & Ramírez, G. (2001) · JAMA · doi:10.1001/jama.286.11.1360 · Cited by 509
Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial.
(1997) · American Journal of Psychiatry · doi:10.1176/ajp.154.3.408 · Cited by 491 · cited 1×
“In some trials, counseling and behavior therapies improved fatigue (8, 38, 39, 41, 43, 46, 48, 62), physical function (Figure 1) (38, 40, 41, 43, 44, 48), quality of life (42, 45), work impairment (38, 48), and the clinical global impression of change scale (38, 48, 59) (low to moderate strength of evidence).”
Background
Research works printed but not linked: 5
- Jason LA, 2013, Fatigue, 1, 168
- Öckerman PA, 2000, Clin Pract Alternat Med, 1, 88
- Chambers D, 2006, J R Soc Med, 99, 506
- Edmonds M, 2004, Cochrane Database Syst Rev, CD003200
- 10.7326/M15-03577 · DOI
Cited by
Sorted by citations
Immune-related adverse events with immune checkpoint blockade: a comprehensive review
Michot, J. M., Bigenwald, C., Champiat, S., Collins, M., Carbonnel, F., Postel-Vinay, S., Berdelou, A., Varga, A., Bahleda, R., Hollebecque, A., et al. (2016) · European Journal of Cancer · doi:10.1016/j.ejca.2015.11.016 · Cited by 2,127
“Abnormal fatigue could correspond to form of chronic fatigue syndrome, in this setting one possible remedy is exercise therapy [30].”
BackgroundLim, E., Ahn, Y., Jang, E.-S., Lee, S., Lee, S., & Son, C. (2020) · Journal of Translational Medicine · doi:10.1186/s12967-020-02269-0 · Cited by 489
“These studies may be promising; however, no therapeutics that can cure CFS/ME or objective diagnostic methods are available yet [13].”
BackgroundMyalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Comprehensive Review
Rivera, M. C., Mastronardi, C. A., Silva, C., Arcos‐Burgos, M., & Lidbury, B. A. (2019) · Diagnostics · doi:10.3390/diagnostics9030091 · Cited by 329
“Complementary and alternative medicine Nutritional supplements, Acetyl-l-carnitine, Essential fatty acids, Magnesium, Vitamins, Coenzyme Q10 plus Nutritional supplements may improve ME/CFS-related physical and mental fatigue in patients with specific nutritional deficiencies [215].”
BackgroundTLR Agonists as Vaccine Adjuvants Targeting Cancer and Infectious Diseases
Luchner, M., Reinke, S., & Milicic, A. (2021) · Pharmaceutics · doi:10.3390/pharmaceutics13020142 · Cited by 296
“In patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME), treatment with the poly-IC12U drug rintatolimod led to an improvement in exercise tolerance and showed dose-sparing effects in a Phase III clinical trial in 2012 [23].”
BackgroundInfluentialKomaroff, A. L., & Lipkin, W. I. (2021) · Trends in Molecular Medicine · doi:10.1016/j.molmed.2021.06.002 · Cited by 276
“Moreover, controlled studies of the antidepressant fluoxetine in people with ME/CFS have demonstrated no benefit [32].”
Metadata
- Authors
- Smith, M. E. B., Haney, E., McDonagh, M., Pappas, M., Daeges, M., Wasson, N., Fu, R., & Nelson, H. D.
- Affiliations
- Oregon Health & Science University (US)
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2015-06-16
- Volume
- 162
- Issue
- 12
- Pages
- 841-850
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W1601664045
- Cited by
- 142
- References
- 68
- Citations by year
- 2026: 3 · 2025: 12 · 2024: 9 · 2023: 7 · 2022: 12 · 2021: 18 · 2020: 10 · 2019: 14 · 2018: 10 · 2017: 18 · 2016: 17 · 2015: 12
- FWCI
- 2.61
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- Funders
- U.S. Public Health Service (290201200014I)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Clinical Neurology › Long-Term Effects of COVID-19
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Coenzyme Q10 studies and effects
- Keywords
- chronic fatigue syndrome, treatment effectiveness, treatment harms, immunomodulators, graded exercise therapy, counseling, complementary therapy, galantamine, cortisol, isoprinosine, valganciclovir, fluoxetine, fatigue, quality of life, case definition
- MeSH terms
- Adult, Complementary Therapies, Antiviral Agents, Counseling, Encephalomyelitis, Exercise Therapy, Humans, Immunologic Factors, Poly I-C, Poly U, Quality of Life, Fatigue Syndrome, Chronic, Cognitive Behavioral Therapy, Myalgia
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