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.
Comment in
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
- Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. [Ann Intern Med. 2015]
Source: Smith ME, Haney E, McDonagh M, Pappas M, Daeges M, Wasson N, Fu R, Nelson HD. Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. Ann Intern Med. 2015 Jun 16;162(12):841-50. doi: 10.7326/M15-0114. http://annals.org/aim/article/2322801/treatment-myalgic-encephalomyelitis-chronic-fatigue-syndrome-systematic-review-national-institutes (Full article)
Comments
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Ellen M Goudsmit 2016 Feb 12 05:56 a.m.
Postscript 2016. The errors noted were rejected as inaccuracies by the editors and thus my comment (under Haney et al) was not published as a letter or correction. Example, they refused to accept that a trial discussed used two sets of criteria, not just the one listed. And if they had checked the reference given for the London criteria, they would have known that it does not give a list of authors. I was not named, so the citation is factually incorrect. I submit that this attitude to factual errors is inconsistent with good science.
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Ellen M Goudsmit 2015 Jun 24 10:14 a.m.
I’ve already noted some of the factual errors and misleading comments in this review online: http://annals.org/article.aspx?articleid=2322800
Due to the word limit, I could not add that Haney et al named four individuals as authors of the London criteria for ME, despite the fact that their reference, the Westcare Report, did not [1]. The people listed in the review did not write the version published in the Westcare Report and this information has been in the public domain since 1994.
I was also unable to point out that that Haney et al refer to clinical criteria (e.g., p. 834), when most of the case definitions they discussed were formulated for research.
The omission of the new research criteria for classic ME is baffling as they have already been cited in the literature, most recently by Jason et al [2]. If people are going to make decisions about ME, or ME/CFS, they need to know what ME is. I suggest readers look online or access the original paper from 2009 [3].
[1]. The UK Patient Organisations. “London Criteria”. In: Report from The National Task Force on Chronic Fatigue Syndrome (CFS), Post Viral Fatigue Syndrome (PVFS), Myalgic Encephalomyelitis (ME). Bristol: Westcare; 1994. Appendix B, Names, Definitions and Descriptions: p. 96-8. Available from: http://www.actionforme.org.uk/Resources/Action for ME/Documents/get-informed/national task force.pdf
[2]. Jason, LA., Sunnquist, M., Brown, A and Reed, J. Defining essential features of myalgic encephalomyelitis and chronic fatigue syndrome. Journal of Human Behavior in the Social Environment, 2015, 25, 6, 657-674. Online 6th May. doi:10.1080/10911359.2015.1011256
[3]. Goudsmit E, Shepherd C, Dancy CP, Howes S. ME: Chronic fatigue syndrome or a distinct clinical entity? Health Psychol Update. 2009;18(1):26-33. Available from: http://shop.bps.org.uk/publications/publications-by-subject/health/health-psychology-update-vol-18-no-1-2009.html
Alternatively see: http://www.foodsmatter.com/me_and_cfs/cfs_me_causes_general/articles/goudsmit-me-clinical entity-10-12.html
Revised article (2014): http://www.axfordsabode.org.uk/me/mecrit2014.htm
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This article was mentioned in a comment by Ellen M Goudsmit 2015 Jul 17 1:24 p.m.
See:Diagnostic Methods for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop. [Ann Intern Med. 2015.]
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Lily Chu 2016 Aug 24 04:39 a.m.
In response to public comments, Dr. Smith and her colleagues have conducted sensitivity analyses on the data, assessing the impact of CBT and GET on various outcomes when only subjects fitting Oxford criteria are considered versus when subjects fitting non-Oxford case definitions (i.e. 1994 Fukuda) are considered. They concluded in an Addendum to the original report that:
“Our sensitivity analysis would result in a downgrading of our strength of evidence on several outcomes which can be attributed to the decrease in power, dominance of one large trial, or lack of trials using criteria other than the Oxford (Sharpe, 1991) case definition for inclusion. Blatantly missing from this body of literature are trials evaluating effectiveness of interventions in the treatment of individuals meeting case definitions for ME or ME/CFS.”
Almost all patients are diagnosed in the United States and most countries using the Fukuda criteria. The United Kingdom is the only region that uses the Oxford criteria on a regular basis. This means that clinicians need to be aware of low strength of evidence or the lack of evidence behind CBT and GET when considering this treatment for their ME/CFS patients.
The full revised report may be read at: https://effectivehealthcare.ahrq.gov/ehc/products/586/2004/chronic-fatigue-report-160728.pdf