Date sent: Tue, 3 Dec 2002 from: Lydia Neilson, President CEO NATIONAL ME/FM ACTION NETWORK 3836 Carling Avenue Nepean, ON K2K 2Y6 Canada Tel/Fax: (613) 8296667 Email: ag922@ncf.ca Web: http://www.mefmaction.net ```````````````````````````````````` New Canadian clinical definition - ME/CFS Myalgic Encephalomyelitis/ Chronic Fatigue Syndrome: Clinical Working Case Definition, Diagnostic and Treatment Protocols Bruce M Carruthers, MD, CM, FRCP(C) Anil Kumar Jain, B Sc, MD Kenny L De Meirleir, MD, Ph D Daniel L Peterson, MD Nancy G Klimas, MD A Martin Lerner, MD, PC, MACP Alison C Bested, MD, FRCP(C) Pierre FlorHenry, MB, Ch B, MD, Acad DPM, FRC, CSPQ Pradip Joshi, BM, MD, FRCP(C) A C Peter Powles, MRACP, FRACP, FRCP(C), ABSM Jeffrey A Sherkey, MD, CCFP(C) Marjorie I van de Sande, B Ed, Grad Dip Ed ABSTRACT. Recent years have brought growing recognition of the need for clinical criteria for myalgic encephalomyelitis (ME), which is also called chronic fatigue syndrome (CFS). An Expert Subcommittee of Health Canada established the Terms of Reference, and selected an Expert Medical Consensus Panel representing treating physicians, teaching faculty and researchers. A Consensus Workshop was held on March 30 to April 1, 2001 to culminate the review process and establish consensus for a clinical working case definition, diagnostic protocols and treatment protocols. We present a systematic clinical working case definition that encourages a diagnosis based on characteristic patterns of symptom clusters, which reflect specific areas of pathogenesis. Diagnostic and treatment protocols, and a short overview of research are given to facilitate a comprehensive and integrated approach to this illness. Throughout this paper, "myalgic encephalomyelitis" and "chronic fatigue syndrome" are used interchangeably and this illness is referred to as "ME/CFS". Journal of Chronic Fatigue Syndrome 11(1), 2003. © 2003 by The Haworth Press, Inc. All rights reserved. Reprinted with permission from The Haworth Press, Inc. Article copies available for a fee from The Haworth Document Delivery Service: 16077225857, ext. 391 or 1800HAWORTH. Email address: docdelivery@haworthpressinc.com Website: http://www.HaworthPress.com The publication can also be purchased online at http://www.haworthpressinc.com/store/product.asp?sku=4958 ] [ The consensus document in J of CFS 11(1) is expected to be released the beginning of February, 2003. ] `````````````````````` NEWS RELEASE CANADA LEADS THE WORLD WITH A CLINICAL DEFINITION FOR MYALGIC ENCEPHALOMYELITIS / CHRONIC FATIGUE SYNDROME (ME/CFS) A Clinical Definition (clinical diagnostic criteria) for ME/CFS has been developed by an Expert Consensus Panel. Although created to standardize research, the American Centers of Disease Control (CDC) Definition is being used in Canada and most other countries to diagnose ME/CFS. There has been a growing demand for diagnostic criteria designed for a clinical setting. In response to a survey by the National ME/FM Action Network, doctors across Canada overwhelming concurred that a clinical definition, along with diagnostic and treatment guidelines, would be the most helpful items in diagnosing and treating ME/CFS patients. In addition to the clinical definition, the consensus document includes a discussion of the prominent symptoms, clinical practice diagnostic and treatment guidelines based on the best available research evidence, and an overview of research on ME/CFS. Dr. Bruce M. Carruthers of B. C., lead author, stated that "The Clinical Definition will enable clinicians to make an early diagnosis which may assist in lessening the impact of ME/CFS in some patients. It will reduce the expensive problem of patients being sent to many specialists before being diagnosed, and will allow patients to receive appropriate treatments in a timely fashion." A definition was developed and published in 1988 and later revised in 1994 under the aegis of the CDC. These definitions along with the Australian and Oxford, U.K definitions were developed to standardize research and not designed to be used for clinical settings. The CDC definition requires that the patient must have persistent or relapsing fatigue that lasts more than six months and four of eight other criteria. One problem with this definition is that fatigue is a symptom of many diseases. By making other cardinal symptoms optional, it increases the diagnostic difficulty of distinguishing the pathological fatigue of ME/CFS from other fatiguing illnesses with overlapping symptoms. The Expert Consensus Panel developed a clinical case definition that provides a flexible, comprehensive framework. More of the prominent symptoms are compulsory and symptoms that share a common region of pathogenesis are grouped together to give clarity and completeness. In addition to severe prolonged fatigue, the definition includes the hallmark symptoms of postexertional malaise and/or fatigue, sleep dysfunction, pain, two or more of the given neurological/ cognitive manifestations, and at least one of the given symptoms from two of the categories of autonomic, neuroendocrine and immune manifestations. The illness must persist for at least six months. Diagnostic exclusions and common comorbid entities are also mentioned. The Expert Consensus Panel felt that the Clinical Case Definition more adequately expresses the complexity of symptoms in a given patient's pathogenesis. It should reflect ME/CFS as a distinct medical entity and help distinguish it from other overlapping medical conditions in the absence of a definitive laboratory test. The eleven physicians, who made up the Expert Consensus Panel, have between them diagnosed and/or treated more than 20,000 ME/CFS patients. All authors approved the Consensus Document. According to a large American study by Dr. Leonard Jason, approximately 422 per 100,000 people (approximately 150,000 Canadians) suffer from ME/CFS compared to 26 per 100,000 women who have breast cancer. ME/CFS is a severe illness that can be debilitating. There is no known cure. It often begins with a viral type infection such as an acute respiratory or flulike illness. But instead of recovering, the person's health deteriorates and many other symptoms appear. A number of viruses have been studied but so far there is no conclusive support for any one pathogen causing the illness. Numerous studies have confirmed that there is a biochemical breakdown of one of the body's defense pathways used to fight viruses, which supports the theory that ME/CFS is triggered by an infection. Other triggers and mechanisms are also being investigated. The development of a clinical definition, and clinical diagnostic and treatment guidelines is a milestone in the fight against this complex and often debilitating illness! Many credits must be given: * The National ME/FM Action Network: for spearheading the drive for the development of a clinical definition, and diagnostic and treatment protocols. Lydia Neilson, President, has lobbied Health Canada for years to make this a reality. * Dr. Bruce Carruthers and Dr. Anil Jain: who kindly donated their time and expertise to write the draft document. Dr. Carruthers also spent countless hours on the revisions and editing. * The Expert Consensus Panel (Dr. Carruthers, Dr. Jain, Dr. Kenny De Meirleir [Belgium], Dr. Daniel Peterson [USA], Dr. Nancy Klimas [USA], Dr. Martin Lerner [USA], Dr. Alison Bested, Dr. Pierre FlorHenry, Dr. Pradip Joshi, Dr. Peter Powles, and Dr. Jeffrey Sherkey): for their genuine concern for the ME/CFS patient, for donating their time and expertise to the development of the Clinical Definition and Clinical Protocols, and their determination to make the Consensus Document a reality. * Marjorie van de Sande, Consensus Coordinator, (and Director of Education for the National ME/FM Action Network): for the countless hours she spent working with Dr. Carruthers and the other members of the Expert Consensus Panel, for compiling the consensus document, and getting information back and forth between the panel members. * Health Canada: for the selection of the Expert Consensus Panel, and establishing the Terms of Reference for the panel. * Crystaal: for sponsoring the Expert Consensus Panel Workshop. * James McSherry: MB, ChB, CCFP, FCFP, FABMP, FAAFP, who was a member of the Expert Consensus Panel and participated in the review process, but was unable to attend the consensus meeting. We regret that Dr. McSherry has since passed away. * Kim Jones: RNC, PhD, FNP, exercise physiologist, for her input in the exercise/treatment section. * Kerry Ellison: OT (nonpracticing), for her input in the patient management/ treatment and assessing disability sections. · Hugh Scher: LLP, for his input in the assessing disability section. * All the members of the National ME/FM Action Network: for their continuing encouragement and support. * The Haworth Press Inc.: for bringing the publication of the ME/CFS Consensus Document to fruition. COPYRIGHT NOTICE: The National ME/FM Action Network newsletter "QUEST" is published every two months. Its contents are © 2002 by the National ME/FM Action Network, EXCEPT where authors of articles are indicated. These items are copyrighted by the authors and written permission must be obtained from the author in order to reprint them. Other articles may be reproduced by other nonprofit publications as long as copyright notices are included and items are clearly attributed to the NATIONAL ME/FM ACTION NETWORK, citing its name, address, telephone number, and website address.. ~~~~~~~~~~~~~~~~~~~~ ~JvR: essentials of the four definitions mentioned in the article below: CDC 1988 (Holmes et al.) = Fatigue + Other symptoms: 8 or more of 11 minor symptom criteria had to be met. 1) mild fever or chills, 2) sore throat, 3) painful lymph nodes, 4) unexplained generalized muscle weakness, 5) myalgia, 6) postexertional fatigue (lasting more than 24 hrs), 7) new onset generalized headaches, 8) migratory arthralgia without joint swelling or redness, 9) neuropsychiatric complaints (one or more of the following: photophobia, forgetfulness, excessive irritability, confusion, difficulty in thinking or concentrating, depression), 10) sleep disturbance (hypersomnia or insomnia), and 11) acute onset (over a few hours to a few days) of main symptom complex. To count, physical criteria had to be documented by a physician on at least two occasions, at least one month apart. Physical criteria included: 1) low grade fever, 2) nonexudative pharyngitis, and 3) palpable or tender anterior posterior cervical or axillary lymph nodes. ```````````````````````````````````````````````````````````````````````` CDC 1994 (Fukuda et al.) = Fatigue + Other symptoms: 4 of 8 minor symptom criteria had to be met. 1) substantial impairment in shortterm memory or concentration; 2) sore throat; 3) tender lymph nodes; 4) muscle pain; 5) multijoint pain without swelling or redness; 6) headaches of a new type, pattern or severity; 7) unrefreshing sleep; 8) and postexertional malaise lasting more than 24 hours. `````````````````````````` Oxford (Sharpe et al 1991) = Fatigue (Other symptoms = Not specified) ```````````````````````````````````` Australian (Lloyd AR et al. 1990) = Fatigue (Other symptoms = Not required, but other symptoms may be present, particularly myalgia, mood and sleep disturbance) `````````````````````````````````````````` The CDC criteria were based on a consensus viewpoint from many of the leading CFS researchers and clinicians from all over the world. The intention and the agreement was that all scientists should use these criteria, so that it would be possible to compare the international research. The CDC1994 (Fukuda) definition is the most commonly used definition now, although criticised by many ME/CFS experts, because these criteria are too much diluted in comparison with the CDC1988 definition. Patients who fulfill the CDC criteria are classified in the "International Classification of Diseases" (ICD) of the World Health Organisation (WHO) as "ICD10: G93.3" as a neurological disorder. The Oxford (Sharpe) definition is only used by a small group of English psychiatrists (the Wessely-school) and by the university of Nijmegen, Netherlands (Van der Meer et al.) Patients who fulfill the Oxford criteria are classified in the "International Classification of Diseases" (ICD) of the World Health Organisation (WHO) as "ICD10: 48.0" as "Mental and Behavioural Disorders"; subtitled "Other Neurotic Disorders" All countries who are members of the WHO have to follow the rules of the WHO, included the ICD code. So the use of these Oxford criteria for selecting ME/CFS patients is a gross violation to the "International Classification of Diseases" (ICD) of the World Health Organization (WHO), and therefore at the same time a serious case of discrimination. In terms of 'who has ICD ME/CFS' ?, research has shown: CDC1998 criteria 80% plus may have ME/ICD-CFS CDC1994 criteria 40% may have ME/ICD-CFS 'Oxford' criteria 10% may have ME/ICD-CFS The Australian criteria will roughly give the same results as the Oxford criteria. The "success" of Cognitive Behaviour Therapy / Graded Exercise Therapy for ME/CFS patients is only 'proved' with patients, selected with the Oxford criteria. (idiopathic chronic fatigue). "....If a patient improves with exercise, that person does not have ME....." ``````````````````````````````````