The Committee for Justice

 and Recognition of Myalgic Encephalomyelitis

  Learning about Myalgic Encephalomyelitis

 

The New Clinical Definition & Diagnosis

A major Advance for Patients, an Expert panel leads the way, with a modern Diagnostic criteria.   A valuable opportunity to educate your doctors.

 

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Myalgic Encephalomyelitis/

Chronic Fatigue Syndrome:

Clinical Working Case Definition,

Diagnostic and Treatment Protocols

 

Bruce M. Carruthers, MD, CM, FRCP(C)

Anil Kumar Jain, BSc, MD

Kenny L. De Meirleir, MD, PhD

Daniel L. Peterson, MD

Nancy G. Klimas, MD

A. Martin Lerner, MD, PC, MACP

Alison C. Bested, MD, FRCP(C)

Pierre Flor-Henry, MB, ChB, 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, BEd, Grad Dip Ed

 

Journal of Chronic Fatigue Syndrome, Vol. 11(1) 2003

http://www.haworthpressinc.com/store/product.asp?sku=J092

ã 2003 by The Haworth Press, Inc. All rights reserved.

10.1300/J092v11n01_02 

 

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.”

 

 

KEYWORDS. Clinical case definition, myalgic encephalomyelitis, chronic fatigue syndrome, ME, CFS, diagnostic protocol, treatment protocol

 

 

Address correspondence to: Dr. Bruce M. Carruthers,

C58, Site 25, RR 1, Galiano, BC V0N 1P0, Canada (E-mail: carruthers@gulfislands.com).

 

[Article copies available for a fee from The Haworth Document Delivery Service:1-800-HAWORTH. E-mail address: <getinfo@haworthpressinc.com> Website:<http://www.HaworthPress.com> ã 2003 by The Haworth Press, Inc. All rights reserved.]

 

 

 

 

INTRODUCTION

 

Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a severe systemic, acquired illness that can be debilitating. It manifests symptoms predominantly based on neurological, immunological and endocrinological dysfunction. While the pathogenesis is suggested to be multi-factorial, the hypothesis of initiation by a viral infection has been prominent. A wide range of viruses and other infectious agents, such as Epstein-Barr Virus (1,2,3,4,5), Human Herpesvirus-6 and 7 (6,7,8,9,10), Enterovirus (11,12), Cytomegalovirus (13,14,15), Lentivirus (16), Chlamydia (17), and Mycoplasma (18,19), have been investigated but findings are mixed and there is no conclusive support for any one pathogen. As antibody titers in standard laboratory tests usually employ a whole viral preparation or a single viral polypeptide, an incomplete or mutated pathogen replication could go undetected. It is unclear whether the pathogens play a direct causal role, accompany an underlying infection, trigger reactivation/replication of latent pathogens, represent reactivated latent pathogens, activate a neural response or modulate the immune system to induce ME/CFS (20). Possibly a new microbe will be identified. Viral involvement is supported by an infectious initiating trigger in at least half of the patients (21), and by confirmed findings of biochemical dysregulation of the 2-5A synthetase/ ribonuclease L (RNase L) antiviral defense pathway in monocytes (22,23,24,25,26), a pathway which is activated in viral disorders (27). 

Before acquiring the illness most patients were healthy, leading full and active lifestyles. ME/CFS most frequently follows an acute prodromal infection, varying from upper respiratory infections, bronchitis or sinusitis, or gastroenteritis, or an acute “flu-like” illness. Other prodromal events that may stress the neuroimmunoendocrine regulatory system include immunization, anesthetics, and exposure to environmental pollutants (28), chemicals, and heavy metals (29). Physical trauma such as a motor vehicle accident, a fall, or surgery may also trigger ME/CFS. In rare occasions, ME/CFS has developed following a blood transfusion. Within days or weeks of the initiating event, patients show a progressive decline in health and develop a cascade of symptoms. The subset of patients that have a gradual onset are less likely to show discrete triggering events.

ME/CFS is primarily an endemic disorder (30,31) but occurs in both epidemic (2,32), and sporadic forms. It affects all racial/ethnic groups, is seen in all socioeconomic strata (33,34,25). Epidemiological studies have indicated a wide range of prevalence, from 75 to 2,600 per 100,000 (36,37,38,39,40,41) in different care settings; however, in a large sample of over 28,000 adults, 422 per 100,000 or 0.42% suffered from ME/CFS (36). It is more prevalent in females (522 per 100,000), as is arthritis and rheumatism. When comparing the ME/CFS prevalence figures for women with those for other illnesses, such as AIDS (12 per 100,000), breast cancer (26 per 100,000) (36), lung cancer (33 per 100,000) and diabetes (900 per 100,000), one realizes the need for a clinical definition and research for ME/CFS.

In response to cluster outbreaks of this illness, a working case definition for CFS was published under the aegis of the Centers for Disease Control (CDC), U.S.A. in 1988 (42). Their 1994 revised definition (43) has been used as the standard in Canada. These definitions, along with the 1988 and 1990 Australian definitions (30,38), and the 1991 Oxford, U.K. definition (44) have provided a basis for inter-subjective agreement and have played an essential role in orienting clinical research.

As the CDC definition was primarily created to standardize research, it may not be appropriate to use for clinical diagnoses, a purpose for which it was never intended. There has been a growing demand within the medical community for a clinical case definition for ME/CFS for the benefit of the family physician and other treating clinicians. The CDC definition, by singling out severe, prolonged fatigue as the sole major (compulsory) criterion, de-emphasized the importance of other cardinal symptoms, including post-exertional malaise, pain, sleep disturbances, and cognitive dysfunction. This makes it more difficult for the clinician to distinguish the pathological fatigue of ME/CFS from ordinary fatigue or other fatiguing illnesses. 

Based on the consensus panel’s collective extensive clinical experience diagnosing and/or treating more than twenty thousand (20,000) ME/CFS patients, a working clinical case definition, that encompassed The pattern of positive signs and symptoms of ME/CFS, was developed. The objective was to provide a flexible conceptual framework for clinical diagnoses that would be inclusive enough to be useful to clinicians who are dealing with the unique symptomatic expression of individual patients and the unique context within which their illness arises. The panel felt there was a need for the criteria to encompass more symptoms in order to reflect ME/CFS as a distinct entity and distinguish it from other clinical entities that have overlapping symptoms. As fatigue is an integral part of many illnesses, the panel concurred that more of the prominent symptoms should be compulsory. 

Our strategy was to group symptoms together which share a common region of pathogenesis, thus enhancing clarity and providing a focus to the clinical encounter. The inclusion of more of the potential spectrum of symptomatology in the clinical definition should allow a more adequate expression of the actual symptoms of any given patient’s pathogenesis. We hope that the clinical working case definition will encourage a consideration of the ongoing interrelationships of each patient’s symptoms and their coherence into a syndrome of related symptoms sharing a complex pathogenesis rather than presenting a “laundry list” of seemingly unrelated symptoms. We believe this will sharpen the distinction between ME/CFS and other medical conditions that may be confused with it in the absence of a definite laboratory test for ME/CFS. 

Since the development of our clinical criteria, we have had an opportunity to review the analysis of symptoms in over 2,500 patients by De Becker et al. (45). They found that the Holmes definition (42) of fatigue, swollen/tender lymph nodes, sore throat, muscle weakness, re- current flu-like symptoms, post-exertional fatigue, myalgia, memory disturbance, nonrestorative sleep and replacing low-grade fever with hot flashes; and the addition of ten other symptoms (attention deficit, paralysis, new sensitivities to food/drugs, cold extremities, difficulties with words, urinary frequency, muscle fasciculations, lightheadedness, exertional dyspnea and gastrointestinal disturbance) strengthen the ability to select ME/CFS patients. Based on this study, we added exertional dyspnea and muscle fasciculations to our clinical definition. All the symptoms which the De Becker et al. study (45) recommended adding to strengthen the ability to select ME/CFS patients are in our definition except paralysis, which the panel did not consider prevalent enough for inclusion in a clinical definition. The clinical definition has additional symptoms, such as orthostatic intolerance, which we feel are important in a clinical setting.   

 

DIAGNOSTIC PROTOCOL

Although it is unlikely that a single disease model will account for every case of ME/CFS, there are common clusters of symptoms that allows a clinical diagnosis.

 

Clinical Working Case Definition of ME/CFS

A patient with ME/CFS will meet the criteria for fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, and pain; have two or more neurological/cognitive manifestations and one or more symptoms from two of the categories of autonomic, neuroendocrine and immune manifestations; and adhere to item 7.

 

1. Fatigue: The patient must have a significant degree of new onset, unexplained, persistent, or recurrent physical and mental fatigue that substantially reduces activity level.

2. Post-Exertional Malaise and/or Fatigue: There is an inappropriate loss of physical and mental stamina, rapid muscular and cognitive fatigability, post exertional malaise and/or fatigue and/or pain and a tendency for other associated symptoms within the patient's cluster of symptoms to worsen. There is a pathologically slow recovery period–usually 24 hours or longer.

3. Sleep Dysfunction:* There is unrefreshed sleep or sleep quantity or rhythm disturbances such as reversed or chaotic diurnal sleep rhythms.

4. Pain:* There is a significant degree of myalgia. Pain can be experienced in the muscles and/or joints, and is often widespread and migratory in nature. Often there are significant headaches of new type, pattern or severity.

5. Neurological/Cognitive Manifestations: Two or more of the following difficulties should be present: confusion, impairment of concentration and short-term memory consolidation, disorientation, difficulty with information processing, categorizing and word retrieval, and perceptual and sensory disturbances–e.g., spatial instability and disorientation and inability to focus vision. Ataxia, muscle weakness and fasciculations are common. There may be overload 1 phenomena: cognitive, sensory–e.g., photophobia and hypersensitivity to noise–and/or emotional overload, which may lead to “crash” 2 periods and/or anxiety.

6. At Least One Symptom from Two of the Following Categories:

a. Autonomic Manifestations: orthostatic intolerance–neurally mediated hypotenstion (NMH), postural orthostatic tachycardia syndrome (POTS), delayed postural hypotension; light-headedness; extreme pallor; nausea and irritable bowel syndrome; urinary frequency and bladder dysfunction; palpitations with or without cardiac arrhythmias; exertional dyspnea.

b. Neuroendocrine Manifestations: loss of thermostatic stability–subnormal body temperature and marked diurnal fluctuation, sweating episodes, recurrent feelings of feverishness and cold extremities; intolerance of extremes of heat and cold; marked weight change–anorexia or abnormal appetite; loss of adaptability and worsening of symptoms with stress.

c. Immune Manifestations: tender lymph nodes, recurrent sore throat, recurrent flu-like symptoms, general malaise, new sensitivities to food, medications and/or chemicals.

7. The illness persists for at least six months. It usually has a distinct onset,** although it may be gradual. Preliminary diagnosis may be possible earlier. Three months is appropriate for children.

 

To be included, the symptoms must have begun or have been significantly altered after the onset of this illness. It is unlikely that a patient will suffer from all symptoms in criteria 5 and 6. The disturbances tend to form symptom clusters that may fluctuate and change over time.

Children often have numerous prominent symptoms but their order of severity tends to vary from day to day. *There is a small number of patients who have no pain or sleep dysfunction, but no other diagnosis fits except ME/CFS. A diagnosis of ME/CFS can be entertained when this group has an infectious illness type onset. **Some patients have been unhealthy for other reasons prior to the onset of ME/CFS and lack detectable triggers at onset and/or have more gradual or insidious onset.

 

Exclusions: Exclude active disease processes that explain most of the major symptoms of fatigue, sleep disturbance, pain, and cognitive dysfunction. It is essential to exclude certain diseases, which would be tragic to miss: Addison’s disease, Cushing’s Syndrome, hypothyroidism, hyperthyroidism, iron deficiency, other treatable forms of anemia, iron overload syndrome, diabetes mellitus, and cancer. It is also essential to exclude treatable sleep disorders such as upper airway resistance syndrome and obstructive or central sleep apnea; rheumatological disorders such as rheumatoid arthritis, lupus, polymyositis  and polymyalgia rheumatica; immune disorders such as AIDS; neurological disorders such as multiple sclerosis (MS), Parkinsonism, myasthenia gravis and B12 deficiency; infectious diseases such as tuberculosis, chronic hepatitis, Lyme disease, etc.; primary psychiatric disorders and substance abuse. Exclusion of other diagnoses, which cannot be reasonably excluded by the patient’s history and physical examination, is achieved by laboratory testing and imaging. If a potentially confounding medical condition is under control, then the diagnosis of ME/CFS can be entertained if patients meet the criteria otherwise.

Co-Morbid Entities: Fibromyalgia Syndrome (FMS), Myofascial Pain Syndrome (MPS), Temporomandibular Joint Syndrome (TMJ), Irritable Bowel Syndrome (IBS), Interstitial Cystitis, Irritable Bladder Syndrome, Raynaud’s Phenomenon, Prolapsed Mitral Valve, Depression, Migraine, Allergies, Multiple Chemical Sensitivities (MCS), Hashimoto’s thyroiditis, Sicca Syndrome, etc. Such co-morbid entities may occur in the setting of ME/CFS. Others such as IBS may precede the development of ME/CFS by many years, but then become associated with it. The same holds true for migraines and depression. Their association is thus looser than between the symptoms within the syndrome. ME/CFS and FMS often closely connect and should be considered to be “overlap syndromes.”

Idiopathic Chronic Fatigue: If the patient has unexplained prolonged fatigue (6 months or more) but has insufficient symptoms to meet the criteria for ME/CFS, it should be classified as idiopathic chronic fatigue.

 

 

General Considerations in Applying the Clinical Case Definition to the Individual Patient

1. Assess Patient’s Total Illness: The diagnosis of ME/CFS is not arrived at by simply fitting a patient to a template but rather by observing and obtaining a complete description of their symptoms and interactions, as well as the total illness burden of the patient.

2. Variability and Coherence of Symptoms: Patients are expected to exhibit symptoms from within the symptom group as indicated, however a given patient will suffer from a cluster of symptoms often unique to him/her. The widely distributed symptoms are connected as a coherent entity through the temporal and causal relationships revealed in the history. If this coherence of symptoms is absent, the diagnosis is in doubt.

3. Severity of Symptoms: A symptom has significant severity if it substantially impacts (approximately a 50% reduction) on the patient’s life experience and activities. In assessing severity and impact, compare the patient’s activity level to their premorbid activity level. Establishing the severity score of symptoms is important in the diagnostic procedure (46,45), and should be repeated periodically. A chart for severity of symptoms and symptom hierarchy can be found in Appendix 3. While this numerical scale has been developed as a tool to assist the clinician and position the patient within the overall spectrum of ME/CFS severity, the severity and impact of symptoms should be confirmed by direct clinical dialogue between physician and patient over time.

4. Symptom Severity Hierarchy: Periodic ranking of symptom severity should be part of the ongoing evaluation of the clinical course. (Appendix 3) This hierarchy of symptom severity will vary from patient to patient and for an individual patient over time. Thus, although fatigue and post-exertional malaise are universal symptoms of ME/CFS, they may not be the most severe symptoms in the individual case, where headaches, neurocognitive difficulties, pain and sleep disturbances can dominate, at least temporarily. Establishing symptom severity and hierarchy helps orient the treatment program.

5. Separate Secondary Symptoms and Aggravators: It is important to try to separate the primary features of the syndrome from those that are secondary to having a poorly understood chronic illness in our society such as secondary stress, anxiety and depression and inactivity.  It is also important to consider symptom interaction and dynamics, and distinguish the effects of aggravators and triggers.
 

 

Discussion of Major Features of ME/CFS

 

Fatigue

The fatigue of ME/CFS comes in many ‘flavours’ (47). Patients learn to recognize the difference between ‘normal’ and ‘ME/CFS’ fatigue by its qualitative flavour, its temporal characteristics and its correlation with other events and activities. The patient must have a marked degree of unexplained, persistent or recurrent fatigue. The fatigue should be severe enough to substantially reduce the patient’s activity level, usually by approximately 50%. When considering the severity of the fatigue, it is important to compare the patient’s activity level to their premorbid activity level. For example, a former world class athlete could have a substantially reduced activity level and still exceed the norms for sedentary persons. Some patients may be able to do some work, but in order to do that they have had to eliminate or severely reduce other aspects of their life activities. Such interactive effects should be considered in the assessment of whether activity reduction is substantial.

Evidence of cognitive fatiguing should be sought in the history and may be evident during the clinical interview. Over the duration of the interview the patient’s responses may become slower and less coherent.  The patient may begin to have difficulty with choosing the correct words, recalling information, or become confused. Occasionally asking more than one question at a time may make the fatiguing more evident. However these changes may be quite subtle, as patients have often learned to compensate for cognitive fatigue with hyper-concentration, and have often developed strategies for taking cognitive micro-rests such as changing the subject, taking postural breaks, reducing sensory stimulation, etc. They may be quite unaware of these strategies.

 

Post-Exertional Malaise and/or Fatigue

The malaise that follows exertion is difficult to describe but is often reported to be similar to the generalized pain, discomfort and fatigue associated with the acute phase of influenza. Delayed malaise and fatigue may be associated with signs of immune activation: sore throat, lymph glandular tenderness and/or swelling, general malaise, increased pain or cognitive fog. Fatigue immediately following activity may also be associated with these signs of immune activation. Patients who develop ME/CFS often lose the natural antidepressant effect of exercise, feeling worse after exercise rather than better. Patients may have a drop in body temperature with exercise. Thus fatigue is correlated with other symptoms, often in a sequence that is unique to each patient. After relatively normal physical or intellectual exertion, a patient may take an inordinate amount of time to regain her/his pre-exertion level of function and competence. For example, a patient who has bought a few groceries may be too exhausted to unpack them until the next day. The reactive fatigue of post-exertional malaise or lack of endurance usually lasts 24 hours or more and is often associated with impairment of cognitive functions. There is often delayed reactivity following exertion, with the onset the next day, or even later. However, duration of symptoms also varies with the context. For example, patients who have already modified their activities to better coincide with the activity level they can handle without becoming overly fatigued will be expected to have a shorter recovery period than those who do not pace themselves adequately.

 

Sleep Dysfunction

Sleep and other diurnal rhythm disturbances may include early, middle or late insomnia, with reversed or irregularly irregular insomnia, hypersomnia, abnormal diurnal variation of energy levels, including reversed or chaotic diurnal rest and sleep rhythms. This results in lack of tolerance for shift work/activity or time zone shifts when travelling. Loss of the deeper phases of sleep is especially characteristic, with frequent awakenings, and loss of restorative feelings in the morning.  Restless leg syndrome and periodic limb movement disorder often accompany sleep disturbance. A very small percentage of ME/CFS patients do not have sleep dysfunction, but do not fit any other disease criteria.

Sleep Study: It is important to rule out treatable sleep disorders such as upper airway resistance syndrome, obstructive and central sleep apnea and restless leg syndrome. Indications: the patient wakes up out of breath, or there is great disturbance of the bed clothes, or a sleep partner indicates that the patient snores and/or appears to stop breathing at times and/or has significant movement of her/his legs while sleeping. If poor sleep is a troublesome symptom, which does not improve with medication and sleep hygiene, it may be appropriate to have the patient assessed at a sleep clinic.

 

Pain

Pain is often generalized and ‘nonanatomical,’ i.e., not confined to any expected structural or nerve root distribution. The pain occurs in unexpected places at unexpected times. There are pains of many qualities: sharp, shooting, burning and aching. Many patients have significant new onset headaches of many types, including tension and pressure headaches and migraines. There is often generalized myalgia and excessive widespread tenderness or pain that is usually perceived to originate in the muscles but is not limited to the classical FMS tender points. Patients have a lowered pain threshold or “chronic, widespread allodynia”(48) with approximately 75% of ME/CFS patients exhibiting positive FMS tender points (49). Pain may also spread from pressure on myo-fascial trigger points (MTP). Arthralgia without joint swelling may be experienced but is not discriminatory for ME/CFS (45,47). A very small percentage of ME/CFS patients do not have appreciable pain, but do not fit any other disease criteria. ME/CFS should only be entertained as a diagnosis for this group when otherwise classical features follow an infectious illness, and where other diseases have been adequately ruled out.

 

Neurological/Cognitive Dysfunctions

The neurological/cognitive symptoms are more characteristically variable than constant and often have a distinct fatiguing component to them. Especially common are cognitive ‘fog’ or confusion, slowed information processing speed, trouble with word retrieval and speaking or intermittent dyslexia, trouble with writing, reading, and mathematics, and short-term memory consolidation. There may be ease of interference from concomitant cognitive and physical activities, and sensory stimulation. It is easy to lose track of things and/or many things are forgotten: names, numbers, sentences, conversations, appointments, ones’ own intentions and plans, where things are in the house, where one has left the car, whether one has brought the car, where one is and where one is going. The memory dysfunction tends to primarily affect short-term memory. There are selective deficits in memory processing arising against a background of relatively normal cognitive functioning in ME/CFS patients. They experience more difficulty in recalling information under conditions of greater semantic structure and contextual cues, the opposite of what is found in controls and patients with other sorts of CNS impairments. They also experience difficulty maintaining attention in situations that cause them to divide their efforts, e.g., between auditory and visual channels.

Perceptual Disturbances: Less ability to make figure/ground distinctions, loss of depth perception or inability to focus vision and attention. One may lose portions of the visual field or one can only make sense of a small portion of it at a time. There are dimensional disturbances in timing which affect the ability to sequence actions and perceptions, and cope with complex and fast paced changes such as shift work and jet lag. Spatial instability and disorientation come in many varieties, with gait tracking problems, loss of cognitive map and inaccurate body boundaries–e.g., one bumps into the side of the doorway on trying to go through it and/or walks off the sidewalk, where the ground feels unstable.

Motor Disturbances: Ataxia, muscle weakness and fasciculations, loss of balance and clumsiness commonly occur. There may be an inability to automatically ‘attune’ to the environment, as in accommodating footfall to irregular ground while walking and temporary loss of basic habituated motor programs such as walking, brushing one’s teeth, making the bed and/or dialing a telephone.

Overload phenomena affect sensory modalities where the patient may be hypersensitive to light, sound, vibration, speed, odors, and/or mixed sensory modalities. Patients may be unable to block out background noise sufficiently to focus on conversation. There is also cognitive/informational overload – inability to multi-task, and trouble making decisions. There is emotional overload from extraneous emotional fields that unduly disturb the patient. There is motor overload – patients may become clumsy as they fatigue, and stagger and stumble as they try to walk, are not able to keep a straight line, as well as showing generalized and local weakness, and need to slow down their movements. All of these overload disturbances may form symptom clusters characteristic of the individual patient such as dizziness, numbness, tinnitus, nausea, or shooting pain. These overload phenomena may precipitate a ‘crash’ where the patient experiences a temporary period of immobilizing physical and/or mental fatigue.

 

Autonomic Manifestations

Orthostatic intolerance is commonly seen in ME/CFS patients and includes:

Neurally mediated hypotension (NMH): Involves disturbances in the autonomic regulation of blood pressure and pulse. There is a precipitous drop that would be greater than 20-25 mm of mercury of systolic blood pressure upon standing, or standing motionless, with significant accompanying symptoms including lightheadedness, dizziness, visual changes, sometimes syncope, and a slow response to verbal stimuli. The patient is weak and feels an urgency to lie down.

Postural orthostatic tachycardia syndrome (POTS): Excessive rapidity in the action of the heart (either an increase of over 30 beats per minute or greater than 120 beats per minute during 10 minutes of standing); and a fall in blood pressure, occurring upon standing. Symptoms include lightheadedness, dizziness, nausea, fatigue, tremor, irregular breathing, headaches, visual changes and sweating. Syncope can but usually does not occur.

Delayed postural hypotension: The drop in blood pressure occurs many minutes (usually ten or more) after the patient stands rather than upon standing.

Tilt Test: Further investigation by tilt test is indicated if there is a fall in blood pressure and/or excessive rapidity of heart beat upon standing, which improves when sitting or lying down. Patients often report that they experience dizziness, feeling light-headed or ‘woozy’ upon standing, or feeling faint when they stand up or are standing motionless such as in a store checkout line. Patients may exhibit pallor and mottling of the extremities. These historical symptoms and signs are sufficient for the initial diagnosis. As ME/CFS patients often have a delayed form of orthostatic intolerance, taking the blood pressure after standing may not be effective in diagnosis. Rather than having the patient stand for a period of time where there is a risk of him/her falling, we recommend using the tilt test where the patient is strapped down. The tilt test involves the patient lying horizontally on a table and then tilting the table upright to a 60°-70° angle for approximately 45 minutes during which time blood pressure and heart rate are monitored. It is recommended that orthostatic intolerance be confirmed by tilt testing prior to prescribing medication for it.

Palpitations with or without cardiac arrhythmias may be present. Further investigation by 24-Hour Holter Monitor may be indicated if a significant arrhythmia is suspected. Repetitively oscillating T-wave inversions and/or flat T-wave may be found. (Request to be informed of this pattern as it may not be reported or subsumed under non-specific T-wave changes by the interpreter.)

Other common symptoms related to ANS disturbances include breathing dysregulation–holding the breath inappropriately, irregular breathing, exertional dyspnea; intestinal irregularities and hypersensitivity to pain–irritable bowel syndrome, diarrhea, constipation, alternating diarrhea and constipation, abdominal cramps; bloating, nausea and anorexia. Bladder dysfunction and pain sensitivity can manifest as urinary frequency, dysuria, nocturia, and pain over the bladder region.

 

Neuroendocrine Manifestations

Loss of thermostatic stability may be experienced as altered body temperature–usually subnormal and/or marked diurnal fluctuation. Having patients take their temperature a number of times a day for a few days can confirm temperature fluctuation. It may be helpful to have patients note their asctivity prior to taking their temperature. Patients may have alternating feelings of hot or cold, sometimes in unusual distribution, e.g., feet are often cold, fingers may be hot, or the right side may feel hot while the left feels cold, or there may be localized feelings of heat and flushing. Many patients are intolerant of extremes in weather and experience worsening of symptoms. There are recurrent feeling of feverishness and sweating episodes. There is often a marked weight change–a reduction in some patients with loss of appetite or anorexia and a weight gain in others and an appetite that is inappropriate to their activity level.

Dysfunction of the autonomic system and hypothalamic/pituitary/adrenal axis: bodymind ‘crashing’ may lead to a general loss of adaptation to situations of overload. Excessive speed in the overloading situation or attempted response will aggravate these ‘crashes.’ Anxiety states and panic attacks may also be part of the syndrome and coherent with the other symptoms. They may not be tied to environmental events that trigger them, or they may be secondary to the symptoms. When ‘crashing,’ the patient becomes destabilized and disoriented, and thus is naturally frightened. Anxiety and panic may also appear without any external trigger. Patients with ME/CFS have worsening of their symptoms under increased stress, and with excess physical and mental activity. They also show slow recovery. 

 

Immune Dysfunctions 

Some but not all patients exhibit symptoms coming from immune system activation, which may or may not be in response to an appropriate stimulus. For many patients this type of symptom is prominent at the acute onset stage and then diminishes or becomes recurrent as the illness becomes chronic. There is often general malaise–flu like feelings of being ‘ill’ and feeling feverish. Tender lymphadenopathy in the cervical, axillary inguinal or other regions may be present. The patient may have a recurrent sore throat with or without faucial injection. Such clinical evidence of immune system activation may occur in the absence of demonstrable viral exposure and/or be associated with inappropriate events such as physical exercise and stress. New sensitivities to food, medications and/or various chemicals are common. Patients with an acute viral onset tend to show more immune dysfunction compared to those whose onset is gradual.

 

Positive Diagnosis Using Suggestive Signs

Faucial injection and crimson crescents may be seen in the tonsillar fossae of many patients but are not diagnostically specific. These red crescents are demarcated along the margins of both anterior pharyngeal pillars. They will assume a posterior position in the oropharynx in patients without tonsils. Oscillating or diminished pupillary accommodation responses with retention of reaction to light is also common.  Cervical and axillary lymph adenopathy, often tender, may be felt. Positive fibromyalgia tender points and myofascial trigger points are common. Neurological dysfunction is often seen, including hypersensitivity to vibration sense, positive Romberg test and abnormal tandem gait.

Simple mental status measures are often normal, but abnormal fatiguing on serial seven subtraction testing is common. Mutual aggravation when tandem gait and serial sevens are done simultaneously, may be evident when the baseline serial sevens test and tandem gait are both normal. As more of these signs are elicited in the same patient, the diagnosis of ME/CFS is increasingly confirmed.

There are selective deficits in memory processing arising against a background of relatively normal cognitive functioning in ME/CFS patients. The results of neurocognitive testing will depend on the focus of the test as well as many variables including the test, the milieu, schedule, pacing and duration of the test. A well controlled study (50) showed patients significantly overestimated their memory (meta memory), their performance on recall tests significantly worsened as the context increased (e.g., recognition), they made more errors when rehearsal was prevented, and had delayed mental scanning as memory load increased.  Neuropsychological testing is expensive and the cost is rarely covered by provincial health plans.

 

Features of ME/CFS in Children

Children can be diagnosed with ME/CFS if symptoms last more than three months. They tend to have numerous symptoms of similar overall severity but their hierarchy of symptom severity may vary from day to day (51). Severe, generalized pain is a common feature. Children may become dyslexic, tearful, physically weak, and exhibit exhaustion or profound mood changes. Previously active children may shun physical activity and academic standings deteriorate. They tend to do worse in mathematics and analytical subjects such as science. They are often classified as having school phobia. A British study showed that ME/CFS was the single most common cause of long-term absenteeism from school in Britain (52). 

 

 

Clinical Evaluation of ME/CFS

The clinical case definition provides the essential function of orientating the various aspects of the clinical encounter and forms an integral part of the whole clinical process. A clear diagnosis often has a considerable therapeutic benefit as it reduces uncertainty and orients therapy, both specific and nonspecific. Early diagnosis is important and may assist in lessening the impact of ME/CFS in some patients.

 

Clinical Evaluation of Myalgic Encephalomyelitis / Chronic Fatigue Syndrome

While it is a part of the discipline of differential diagnosis to exclude alternate explanations for a patient’s symptoms, it is also important to recognize the characteristic features of ME/CFS. Assess the total illness burden of the patient, taking a thorough history, physical examination and investigations as indicated to confirm clinical findings and to rule out other active disease processes. This patient evaluation is to be used in conjunction with the clinical definition. The sections on general considerations in applying the definition and the discussion of the major features give more detail.

 

1.  Patient History:  A thorough history, including a complete description of patient’s symptoms as well as their severity and functional impact must be taken before attempting to classify them.

a. Focus on the Principal Symptoms of ME/CFS: including fatigue, post-exertional malaise and/or fatigue, sleep dysfunction, pain, and symptoms from neurological/cognitive, autonomic, endocrine and immune manifestations. Examine the course of the symptoms, with special attention to the worsening of symptoms after exertion, prolonged recovery, and fluctuating course.

b. Presenting Complaints and Aggravating/Ameliorating Events

• date of onset

• trigger or prodromal event

• symptoms at onset

• progression of symptoms

• duration of symptoms

• hierarchy of quality and severity of current symptoms

• symptoms which worsen with exertion; symptoms which require prolonged recovery

• separate secondary symptoms and aggravators; consider amelioration factors

• quantify severity of total burden of symptoms, interaction effects, and current level of physical function

c. Medication History: current and past, prescribed, natural and other therapies

d. Sensitivities and Allergy History: including any new sensitivities to food, medications and/or chemicals, allergies or change in status of pre-existing allergies

e. Past History: earlier illnesses, exposure to environmental, residential and occupational toxins

f. Family History

g. System Review: many symptoms involve more than one system. Inquiry should be made for the key symptoms listed in the case definition. Careful review of the symptoms is important to exclude other conditions that may present with similar symptomatology.

• Musculoskeletal System: myalgia, muscle weakness, arthralgia

• CNS: cognitive fatigue, fatigue and post exertional exacerbation, neurocognitive complaints, headaches, and sleep disturbances

• ANS & Cardiorespiratory System: symptoms suggestive of orthostatic intolerance, neurally mediated hypotension, postural orthostatic tachycardia syndrome, delayed postural hypotension, palpitations, respiratory disturbances, vertigo, light-headedness, extreme pallor

• ANS & GI & GU System: intestinal or bladder disturbances with or without irritable bowel syndrome or bladder dysfunction

• Neuroendocrine System: loss of thermostatic stability, heat/cold intolerance, abnormal appetite, marked weight change, loss of sleep rhythm, loss of adaptability and tolerance for stress and slow recovery, emotional lability

• Immune System: tender lymph nodes, sore throat, recurrent flu-like symptoms, general malaise

 

2.  Physical Examination:  An appropriate physical examination with focus on:

a. Musculoskeletal System: including FMS tender point examination. There must be pain on palpation in 11 or more of the 18 designated tender point sites to meet the diagnosis of FMS (see Appendix 6). Determine if there are inflammatory changes in painful joints. Document muscle strength.

b. Neurological System: a thorough neurological examination with emphasis on reflexes, tandem walk forwards and backwards, and Romberg test.

• Neurocognitive Symptoms: an evaluation of cognitive symptoms including ability to remember questions, cognitive fatiguing (e.g., serial 7 subtraction) and cognitive interference (e.g., serial 7 subtraction and tandem done simultaneously).

c. Cardiorespiratory System: measure lying and standing blood pressure. Arrhythmias should be noted.

d. Endocrine System: check for signs of thyroid, adrenal and pituitary dysfunction.

e. Immune System: most positive findings of immune system involvement in a physical examination are usually only present in the acute stage and then diminish or become recurrent. Look for tender lymphadenopathy in the cervical, axillary, inguinal regions especially early in disease, and crimson crescents in the tonsillar fossae. Examine for splenomegaly.

f. GI System: check for increased bowel sounds, mild bloating and abdominal tenderness

 

3.  Laboratory and Investigative Protocol

a. Routine Laboratory Tests: CBC, ESR, Ca, P, Mg, blood glucose, serum electrolytes, TSH, protein electrophoresis screen, CRP, ferritin, creatinine, rheumatoid factor, antinuclear antibody, CPK and liver function, as well as routine urinalysis.

Additional Testing: In addition to the routine laboratory tests, additional tests should be chosen on an individual basis depending on the patient’s case history, clinical evaluation, laboratory findings and risk factors for co-morbid conditions. Clinicians should carefully consider the cost/benefit ratio of any investigative test for each patient, in addition to avoiding unnecessary duplication of tests.

b. Further Laboratory Testing: diurnal cortisol levels, 24 hour urine free cortisol; hormones including free testosterone, B 12 and folate levels, DHEA sulphate, 5-HIAA screen, abdominal ultrasound, stool for ova and parasites, NK cell activity, flow cytometry for lymphocyte activity, Western blot test for Lyme disease, hepatitis B and C, chest x-ray, TB skin test and HIV testing.

Do the 37-kDa 2-5A RNase L immunoassay when it becomes available.

c. Differential Brain Function and Static Testing:

• MRI: those with significant neurological finding should be considered for a MRI to rule out multiple sclerosis (MS), and cervical stenosis. MRI interpretation: it is important to look for changes that are easily overlooked such as dynamic disc bulges/herniation or minor stenosis, which can be important in the pathogenesis.

• Quantitative EEG, SPECT and PET Scans and Spectography: qEEG analysis of brain waves, SPECT estimation of dynamic brain blood flow and PET analysis of brain metabolism show diagnostic promise and will become more important as these techniques are refined and research confirms their diagnostic value.

d. Tilt Table Test: if there is a fall in BP and/or excessive rapidity of heart beat upon standing; and if patient is troubled by dizziness, feeling light-headed or ‘woozy’ upon standing or when they are standing motionless. Note: fall in BP when standing may be delayed by several minutes in ME/CFS patients.

e. Sleep Study: if poor sleep is troublesome and does not improve with medication or sleep hygiene. A sleep study can show poor sleep architecture, particularly the decrease in time spent in stage 4 sleep and can rule out treatable sleep dysfunctions such as sleep apnea, upper airway resistance syndrome and restless leg syndrome. Indications include: the patient wakes up out of breath, or there is great disturbance of the bedding, or sleep partner indicates that the patient snores and/or appears to stop breathing at times and/or has significant movement of their legs while sleeping.

f. 24-Hour Holter Monitoring: if a significant arrhythmia is suspected. Characteristic repetitively oscillating T-wave inversions and/or T-wave flats can be confirmed during 24-hour electrographic monitoring. This pattern may not be reported or subsumed under non-specific T-wave changes by interpreter.

g. Neuropsychological Testing: can be utilized to identify cognitive dysfunction and/or confirm diagnosis. If done, it should focus on the abnormalities known to differentiate ME/CFS from other causes of organic brain dysfunctions.

 

4.  Making a Positive Diagnosis for ME/CFS: If the patient's presentation meets the diagnostic criteria for ME/CFS, classify the diagnosis as ME/CFS except when the specified exclusions are present. If the patient has prolonged fatigue but does not meet the criteria for ME/CFS, classify the diagnosis as idiopathic chronic fatigue.

 

New Symptoms: People with ME/CFS can develop other medical problems. New symptoms need to be appropriately investigated.  

 

 

From the Journal of Chronic Fatigue Syndrome, Vol. 11(1) 2003

ã 2003 by The Haworth Press, Inc. All rights reserved.

 

 

 End of Section – Definition & Diagnosis

   Much more -  order the full document

 

 

Encourage your doctor, hospital, library, to order the Special edition of the JCFS, 2003, vol 11, # 1,  Myalgic Encephalomyelitis Clinical Working Case Definition,  from The Haworth Document Delivery Service:1-800-HAWORTH. E-mail address: <getinfo@haworthpressinc.com> Website:<http://www.HaworthPress.com>

 

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 See the Expert Panel review of the current research;  http://www.oocities.org/tcjrme/fundamentals3.html  

 

 

The Committee for Justice

and Recognition of Myalgic Encephalomyelitis

 

  Return to Fundamentals Page;   http://www.oocities.org/tcjrme/fundamentals.html

 

 

TCJRME   F - 2

 

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