Tag: Pathways to Prevention Workshop

National Institutes of Health Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Abstract:

The National Institutes of Health (NIH) Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome was cosponsored by the NIH Office of Disease Prevention and the Trans-NIH Myalgic Encephalomyelitis/Chronic Fatigue Syndrome Research Working Group. A multidisciplinary working group developed the agenda, and an Evidence-based Practice Center prepared an evidence report through a contract with the Agency for Healthcare Research and Quality to facilitate the discussion. During the 1.5-day workshop, invited experts discussed the body of evidence and attendees had the opportunity to comment during open discussions. After weighing evidence from the evidence report, expert presentations, and public comments, an unbiased, independent panel prepared a draft report that identified research gaps and future research priorities. The report was posted on the NIH Office of Disease Prevention Web site for 4 weeks for public comment.

 

Source: Green CR, Cowan P, Elk R, O’Neil KM, Rasmussen AL. National Institutes of Health Pathways to Prevention Workshop: Advancing the Research on Myalgic Encephalomyelitis/Chronic Fatigue Syndrome. Ann Intern Med. 2015 Jun 16;162(12):860-5. doi: 10.7326/M15-0338. http://annals.org/aim/article/2322804/national-institutes-health-pathways-prevention-workshop-advancing-research-myalgic-encephalomyelitis (Full article)

 

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.

Comment in

 

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

  • 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

  • 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.]

  • 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

Diagnostic Methods for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop

Abstract:

BACKGROUND: The diagnosis of myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS) is based on clinical criteria, yet there has been no consensus regarding which set of criteria best identifies patients with the condition. The Institute of Medicine has recently proposed a new case definition and diagnostic algorithm.

PURPOSE: To review methods to diagnose ME/CFS in adults and identify research gaps and needs for future research.

DATA SOURCES: MEDLINE, PsycINFO, and Cochrane databases (January 1988 to September 2014); clinical trial registries; and reference lists.

STUDY SELECTION: English-language studies describing methods of diagnosis of ME/CFS and their accuracy.

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, and discrepancies were resolved through consensus.

DATA SYNTHESIS: Forty-four studies met inclusion criteria. Eight case definitions have been used to define ME/CFS; a ninth, recently proposed by the Institute of Medicine, includes principal elements of previous definitions. Patients meeting criteria for ME represent a more symptomatic subset of the broader ME/CFS population. Scales rating self-reported symptoms differentiate patients with ME/CFS from healthy controls under study conditions but have not been evaluated in clinically undiagnosed patients to determine validity and generalizability.

LIMITATIONS: Studies were heterogeneous and were limited by size, number, applicability, and methodological quality. Most methods were tested in highly selected patient populations.

CONCLUSION: Nine sets of clinical criteria are available to define ME/CFS, yet none of the current diagnostic methods have been adequately tested to identify patients with ME/CFS when diagnostic uncertainty exists. More definitive studies in broader populations are needed to address these research gaps.

 

Source: Haney E, Smith ME, McDonagh M, Pappas M, Daeges M, Wasson N, Nelson HD. 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 Jun 16;162(12):834-40. doi: 10.7326/M15-0443. http://annals.org/aim/article/2322800/diagnostic-methods-myalgic-encephalomyelitis-chronic-fatigue-syndrome-systematic-review-national (Full article)

Comments

  • Ellen M Goudsmit 2015 Dec 02

    Sad to note today that the journal chose to publish letters, favouring opinion above the correction of factual errors. How can science progress if editors collude in the perpetuation of inaccuracies and myths? Who will know that there ARE research criteria for ME as described by Ramsay? That there are helpful alternatives to CBT and GET?

    Postscript 2016. The editors decided not to publish the comment as a letter in the journal as they rejected the view that there were factual errors. Thus while I was not a co-author of the criteria cited in the article, and I’m not named in the reference given, listing me as a co-author is not a ‘factual error’ in their eyes. Nor is the claim that a trial I discussed selected patients using two sets of criteria, not just the one referred to in the article. In my view, this failure to correct errors and misleading information is inconsistent with good science.

  • Ellen M Goudsmit 2015 Jul 17

    As someone who has studied myalgic encephalomyelitis (ME) and chronic fatigue syndrome (CFS) since the 1980s, I appreciate the work completed by The National Institutes of Health Pathways to Prevention Workshops on what is now known as ME/CFS. Unfortunately, some of the information in the two reviews is inaccurate, incomplete and misleading (1,2). For example, in the report on diagnostic methods, the reviewers included the London criteria for ME but gave details in the table based on a version written by a layperson, rather than the four individuals cited in their reference (3). Moreover, they did not consider the updated criteria for ME (4), although one of the authors had emailed the panel on two separate occasions during the consultation phase to alert them to their existence.

    The second review (2) encourages further research on subgroups and outcomes other than fatigue and function but did not identify one of the few controlled studies which had employed such a design (5). For instance, in the Appendix, Table 1 lists the programme evaluated by Goudsmit and colleagues under ‘counseling and behavioural therapies’, and describes the treatment as ‘counseling’. It also states that patients were selected using the Oxford criteria, that the duration of follow-up was six months and that the outcomes were function and fatigue.

    In fact, the trial evaluated a physician-led multi-component programme comprising medical care, information on the illness, diet and relaxation, as well as advice on activity management and some counselling (5). It was conducted in the naturalistic setting of an NHS hospital clinic, patients were diagnosed using criteria for post-viral fatigue syndrome as well as the Oxford criteria, and data were available for a number of symptoms including cognitive impairment, as well as other variables. Fatigue improved as noted in the review but the latter did not convey that 82% of the patients rated themselves as ‘better’, that 23% were well enough to be discharged at six months and that the improvements were maintained at 1 year. Given the missing details, the study’s rating as ‘poor’ is understandable.

    The reviewers concluded that “more definitive studies comparing participants meeting different case definitions, including ME… are needed to fill research gaps”. It was therefore disappointing that they did not recognise the positive aspects of a study that used a different case definition and assessed a range of symptoms, not just fatigue.

    1. Haney E, Smith MEB, McDonagh M, Pappas M, Daeges M, Wasson N, et al. 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;162: 834-40. [PMID: 26075754] doi:10.7326/M15-0443
    2. Smith MEB, Haney E, McDonagh M, Pappas M, Daeges M, Wasson N, 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-
    3. [PMID: 26075755] doi:10.7326/M15-0114
    4. Dowsett E, Goudsmit E, Macintyre A, Shepherd C. London Criteria for myalgic encephalomyelitis. In: Report from The National Task Force on Chronic Fatigue Syndrome (CFS), Post Viral Fatigue Syndrome (PVFS), Myalgic Encephalomyelitis (ME). Westcare. 1994. 96-98. Available from: http://www.actionforme.org.uk/Resources/Action for ME/Documents/get-informed/national task force.pdf
    5. 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
    6. Goudsmit EM, Ho-Yen DO, Dancey CP. Learning to cope with chronic illness. Efficacy of a multi-component treatment for people with chronic fatigue syndrome. Patient Educ Couns. 2009;77:231–6. [PMID: 19576714 ] doi:10.1016/j.pec.2009.05.015

    Ellen M Goudsmit PhD FBPsS

    Comment also on Annals of Internal Medicine website under Haney et al.