{"id":15454,"date":"2018-02-06T10:17:48","date_gmt":"2018-02-06T10:17:48","guid":{"rendered":"http:\/\/wames.org.uk\/cms-english\/?p=15454"},"modified":"2018-02-06T10:17:48","modified_gmt":"2018-02-06T10:17:48","slug":"the-failure-of-clinical-guidance-for-people-with-me","status":"publish","type":"post","link":"https:\/\/wames.org.uk\/cms-english\/the-failure-of-clinical-guidance-for-people-with-me\/","title":{"rendered":"The failure of clinical guidance for people with ME"},"content":{"rendered":"

ME Action<\/strong> blog post, 5 February 2018, by Mary Dimmock: The failure of clinical guidance for people with ME<\/a><\/h3>\n

 <\/p>\n

ME advocate Mary Dimmock has written a comprehensive report about the\u00a0flawed science that led to the recommendation of cognitive behavioral\u00a0therapy (CBT) and graded exercise therapy (GET) for people with\u00a0Myalgic Encephalomyelitis.<\/p>\n

The patient community has long reported these treatments to be\u00a0ineffective and harmful, and, yet, health societies and governments\u00a0across the world continue to recommend them as treatment, including\u00a0the Mayo Clinic and UK government.<\/p>\n

Below is a two-page excerpt from Dimmock\u2019s report. Read her full paper: Clinical Guidance for ME: \u201cEvidence-Based\u201d Guidance Gone Awry<\/a><\/p>\n

This article is intended as a high-level summary of key issues in the\u00a0conduct of ME \u201cevidence- based\u201d reviews and clinical guidance that\u00a0have resulted in flawed guidance. This has misled medical providers on\u00a0the nature of ME and its appropriate treatment and put people with ME\u00a0at risk of harm.<\/p>\n

Comments can be sent to\u00a0medimmock@gmail.com<\/a><\/p>\n

Summary<\/strong><\/h3>\n

For many years, ME evidence-based reviews and clinical guidance\u00a0globally, such as those from Cochrane, UpToDate, Mayo, NICE, and\u00a0various medical journals and societies around the world have\u00a0recommended cognitive behavioral therapy (CBT) and graded exercise\u00a0therapy (GET) as effective and safe treatments for ME. Further, these\u00a0sources have sometimes claimed that disease risk and poor prognosis is\u00a0the result of behavioral and psychological factors such as maladaptive\u00a0coping, a history of abuse, perfectionism, and the patient\u2019s belief\u00a0that the disease is organic. In spite of patient surveys and ancedotal
\nreports that these treatments were not only ineffective but harmful,\u00a0these recommendations and statements have remained.<\/p>\n

Since 2015, a growing chorus of international journalists and\u00a0scientists, along with reports by the U.S. Health and Human Services\u00a0have documented serious deficiencies in the supporting studies that\u00a0call into question the validity of these recommendations. In parallel,\u00a0the U.S. Institute of Medicine (IOM, now called the National Academy\u00a0of Medicine) published a report that directly contradicts the disease\u00a0theory underpinning these studies. These deficiencies and\u00a0contradictions include the following (Further details in Appendix II):<\/p>\n

    \n
  1. Lack of external validity:<\/strong>
    \nAccording to the US Agency for Healthcare Research and Quality (AHRQ),\u00a0the use of an overly broad definition (the Oxford definition) in many\u00a0of these studies resulted in the inclusion of \u201cpatients who may have\u00a0an alternate fatiguing illness.\u201d The 2016 AHRQ report also noted that\u00a0studies using more specific definitions requiring hallmark symptoms of\u00a0ME such as an abnormal response to exertion were \u201cblatantly missing.\u201d\u00a0 After excluding Oxford studies from its analysis, AHRQ found no\u00a0evidence of effectiveness for GET and barely any for CBT. This raises
    \nserious questions about the validity of applying CBT and GET\u00a0recommendations to people with ME.<\/li>\n
  2. Study design and conduct issues:<\/strong>
    \nThe CBT and GET evidence base is biased by unblinded studies that\u00a0relied on subjective outcome measures, ignored or dismissed objective\u00a0findings that contradicted subjective reports, switched outcomes,\u00a0inflated claims of improvement and recovery, and contained other\u00a0significant problems in the design and conduct of studies. The issues\u00a0in these studies, including the UK\u2019s flagship \u00a35 million PACE trial,\u00a0call into question the quality and reliability of claims of CBT and\u00a0GET effectiveness.<\/li>\n
  3. Inadequate reporting of harms:<\/strong>
    \nConclusions that these therapies are safe are based on studies that\u00a0inadequately reported adverse effects and did not monitor treatment\u00a0compliance. Further, neither the evidence reviews such as Cochrane nor\u00a0the individual studies adequately account for patient survey reports\u00a0of harm from these therapies. Nor do they account for the published\u00a0biomedical evidence and the IOM report demonstrating the disease\u2019s\u00a0abnormal physiological response to exertion, a response that supports\u00a0concerns with the risk of harm from exertion. Claims of CBT and GET\u00a0safety are not supported by the evidence.<\/li>\n
  4. Flawed disease theory:<\/strong>
    \nThe disease theory underlying the use of CBT and GET in this disease\u00a0is that the symptoms and the debility are not the result of an organic\u00a0disease but rather the result of deconditioning which in turn is the\u00a0result of false cognitions and a fear of activity. This disease theory\u00a0also links a predisposition to the disease and poor prognosis with\u00a0behavioral and psychological factors such as those described above.\u00a0This theory is unproven and the studies cited to support it have most
    \noften used the overly broad Oxford definition which could include\u00a0patients with a primary mental illness. But more importantly, this\u00a0psychogenic theory cannot be reconciled with the 2015 Institute of\u00a0Medicine report which found that ME is not psychological or a problem\u00a0of deconditioning. Instead, the IOM found substantial evidence of\u00a0neurological, immunological, autonomic, and energy metabolism
    \nimpairment. In no other disease would such impairment be treated by\u00a0talk therapy intended to convince the patients they are not really\u00a0sick. The ethicality of doing do in this disease must be questioned.<\/li>\n<\/ol>\n

    In July 2017, the US Centers for Disease Control and Prevention (CDC)\u00a0removed long-standing recommendations for CBT and GET from its\u00a0website. Yet, today, the vast majority of providers for clinical\u00a0guidance for ME globally still continue to use these flawed studies as\u00a0the basis of CBT and GET recommendations and conclusions about poor
    \nprognosis.<\/p>\n

    In Japan, recommendations for CBT and GET are scheduled to be\u00a0published in a widely read medical journal in March. In the UK, NICE\u00a0has agreed to review its guidelines but the current CBT and GET\u00a0recommendations remain. In the US, even clinical guidance that has
    \nadopted the IOM criteria with its hallmark abnormal response to\u00a0exertion still\u00a0recommends CBT and GET. For instance, one medical\u00a0education provider has adopted the IOM criteria and IOM-derived\u00a0statements about neurological, immunological, and metabolism\u00a0impairment but then goes on to recommend PACE-style CBT and GET and
    \nlink poor prognosis to a patient\u2019s belief that the disease is\u00a0physical.<\/p>\n

    It is stunning that such highly regarded organizations continue to\u00a0produce \u201cevidence-based\u201d guidance for ME using such poor-quality,\u00a0contested, and inappropriate evidence. Doing so not only misleads\u00a0medical providers on the nature of ME and its appropriate treatment\u00a0but puts people with ME at direct risk of significant harm by their\u00a0medical providers.<\/p>\n

    To best protect patients from further harm, it is essential that\u00a0evidence review publishers such as Cochrane and providers of\u00a0evidence-based clinical guidance such as Uptodate, Healthwise, Mayo,\u00a0and various medical societies reevaluate the quality and validity of\u00a0the evidence that they are using to support their conclusions and\u00a0recommendations for ME. It is essential that these organizations\u00a0update their reviews and guidance to remove the erroneous conclusions\u00a0and recommendations based on poorly conducted, invalid studies and to\u00a0incorporate what is known today about the biopathology of ME and its\u00a0proper treatment.<\/p>\n

    Read the full report<\/a><\/p>\n

     <\/p>\n

     <\/p>\n","protected":false},"excerpt":{"rendered":"

    ME Action blog post, 5 February 2018, by Mary Dimmock: The failure of clinical guidance for people with ME   ME advocate Mary Dimmock has written a comprehensive report about the\u00a0flawed science that led to the recommendation of cognitive behavioral\u00a0therapy … Continue reading →<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"jetpack_post_was_ever_published":false,"_jetpack_newsletter_access":"","_jetpack_dont_email_post_to_subs":false,"_jetpack_newsletter_tier_id":0,"_jetpack_memberships_contains_paywalled_content":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":true,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[1],"tags":[],"class_list":["post-15454","post","type-post","status-publish","format-standard","hentry","category-news"],"jetpack_publicize_connections":[],"jetpack_featured_media_url":"","jetpack_sharing_enabled":true,"jetpack_shortlink":"https:\/\/wp.me\/p5qkYK-41g","_links":{"self":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/15454","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/comments?post=15454"}],"version-history":[{"count":3,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/15454\/revisions"}],"predecessor-version":[{"id":15457,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/posts\/15454\/revisions\/15457"}],"wp:attachment":[{"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/media?parent=15454"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/categories?post=15454"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/wames.org.uk\/cms-english\/wp-json\/wp\/v2\/tags?post=15454"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}