This ground-breaking letter was sent to members of the United States Department of Health and Human Services on May 12th by the newly formed National Advocacy Alliance for ME/CFS (NAAME). You can support this letter by signing NAAME's petition. Change the definition - change the name!
Date: May
12, 2013
To:
Secretary Sebelius, Dr. Howard Koh, Dr. Thomas Frieden, and Dr.
Francis Collins
CC:
Dr. Janet Woodcock, Dr. Beth Unger, Dr. Susan Maier, Dr. Nancy Lee,
CFSAC members
Subject:
Need for Focused Attention on Myalgic Encephalomyelitis (ME)
Dear
Secretary Sebelius, Dr. Koh, Dr. Friedan, and Dr. Collins
We
are writing to express
our strong concerns with the Department of Health and Human Services
(DHHS) current definition activities related to "Chronic Fatigue
Syndrome” (“CFS”). We believe DHHS is moving in a direction
that is unproductive and harmful to patients. This letter outlines
the basis for these concerns and the steps we believe must be taken
to rectify the situation.
Throughout
the twentieth century, there have been occurrences of a complex,
disabling disease characterized by unrefreshing
sleep, flu-like symptoms, impairment of memory and other cognitive
impairments, orthostatic intolerance, debilitating weakness, pain,
fever and the hallmark symptom of post-exertional malaise
(post-exertional neuroimmune exhaustion).i
This disease has been shown to cause severe dysfunction of
neurological, immune, endocrine and energy production systemsii
and, since 1969, has been classified as a neurological disease called
myalgic encephalomyelitis
(ME) by the World Health Organization.iii
The name myalgic encephalomyelitis
is still used elsewhere and is used herein to refer to this disease
and to clearly distinguish it from the non-specific term “CFS”.
Following
the outbreak in Incline Village, the CDC named the disease chronic
fatigue syndrome (CFS) instead of myalgic encephalomyelitis
and developed the first of a number of fatigue-focused case
definitions. Today, the term “ME” is rarely used in the U.S. and
instead, ME patients are almost always given a diagnosis of CFS.iv
Unfortunately,
according to the CDC website, “CFS” can be defined by at least 5
disparate CFS definitions (see Table 1). Three of these, the 2003
Canadian Consensus Criteria, the 2011 ME International Consensus
Criteria, and the Pediatric definition, describe the essential and
hallmark features of ME. But the two most commonly used definitions,
the 1994 Fukuda and 1991 Oxford definitions, focus on fatigue, do not
require core ME symptoms like post-exertional
malaise, cognitive problems and unrefreshing sleep and
allow the inclusion of primary psychiatric illness. In fact, Oxford
does not require any symptoms except for 6 months of disabling
fatigue for a patient to be given a diagnosis of CFS.
As
a result, the term “CFS” has become an amorphous umbrella
associated with a diverse set of unrelated conditions that include
depression, deconditioningv,
medically unexplained chronic fatigue, school phobia, and for some
researchers and clinicians, fatigue due to “excessive rest”vi
or “false illness beliefs”.vii
In clinical practice, doctors give a CFS diagnosis to a heterogeneous
mix of patients – those with ME, those with the varied conditions
listed above, those who have been misdiagnosed or those whose doctors
use CFS as a catchall diagnosis for fatigue.
ME
is unquestionably a complex disease and its heterogeneity is real.
But this “heterogeneity” is a manufactured artifact of the
amalgamation of diverse definitions and unrelated patient populations
into one clinical entity called “CFS”. Tragically for ME
patients, this has obscured ME in a “web of confusion”,viii
which has confounded ME research, virtually precluded drug
development and resulted in widely divergent prevalence estimates.
This confusion has also negatively impacted clinical care, led to
inappropriate and sometimes harmful “one size fits all” clinical
guidelines applied to all “CFS” patients and created a climate in
which physicians routinely dismiss ME as not real or not serious.
There
is an urgent need to stop perpetuating this confusion and start
researching and treating the disease that these patients actually
have – myalgic encephalomyelitis.
Given
the current embrace of these non-specific “CFS” definitions and
the failure to directly engage ME patients and ME experts in the
current DHHS definition initiatives, we believe that the outcome of
these DHHS initiatives will further exacerbate an already intolerable
situation.
The
following steps are necessary in order to move forward with improved
research and treatment for patients with ME:
Adopt
a disease appropriate case definition:
ME, as defined by the Canadian Consensus Criteria (CCC), must
be recognized by DHHS and the United States government for the
serious and debilitating disease that it is. ME is not a subtype of
“CFS”. The CCC must be adopted now as the baseline case
definition for this disease. It can be evolved as additional
knowledge is gained, the definition is operationalized and markers
are validated. We do not need more years of study to fix what is so
clearly broken today.
Stop
using “CFS”:
The terms "Chronic Fatigue Syndrome" and "CFS"
must be permanently abandoned along with the overly broad,
two-decades old Fukuda and Oxford definitions. By using non-specific
criteria that have become associated with such a diverse set of
unrelated conditions, these terms and the accompanying definitions
have become medically and scientifically meaningless. They are
impeding forward progress and DHHS should discontinue their use.
DHHS should also discontinue the dissemination of “CFS”
clinical information, like the ‘one size fits all’ CDC CFS
Toolkit,ix
that uses a non-specific disease description and includes clinical
findings and recommendations for all patients based on Oxford,
Empirical or chronic fatigue studies.
Manage
the transition to the Canadian Consensus Criteria: This
includes the adoption and proactive dissemination of appropriate
medical guidance like the International Association for CFS/ME
Primer,x
available through DHHS’ Guidelines.gov. It also includes the
establishment of a research program focused on ME, updated insurance
guidelines for Medicare/Medicaid, the establishment of disability
guidelines for ME and similar transition activities. Most
importantly, it must include a plan to care for those patients who
have received a diagnosis of "CFS” but do not meet the CCC
criteria for ME. These individuals should be properly evaluated and
diagnosed where possible. If unexplained conditions remain,
additional studies will be needed to understand
these conditions and establish more appropriate names and
definitions. The continued use of the overly broad “CFS” and
Fukuda for these patients is not appropriate.
Engage
ME stakeholders in the planning and implementation: In
keeping with President Obama’s commitment to Open Government, the
key stakeholders – ME patients and ME experts – must be engaged
in a full and open partnership to plan for and ensure implementation
of this change. We are the ones that best understand this disease
and will provide valuable input to these activities.
For
decades, ME patients have borne the brunt of the failure to correct
the flaws with how “CFS” has been defined. We will not accept
this situation any longer.
The
FDA Stakeholder Workshop has provided a unique opportunity to
approach this disease in new ways, starting with the definition. It
is time to adopt the Canadian Consensus Criteria as the baseline case
definition for ME research and clinical care and move forward from
there. Doing so will energize the wheels of research and drug
development and begin to directly improve the lives of the many
Americans stricken
with this devastating disease.
We
look forward to partnering with you to make this a reality for
patients.
We
respectfully request a response to our concerns along with an
explanation of how ME patients and ME experts will be engaged in this
process by June 5, 2013.
Do not hesitate to contact us if you need additional information.
Thank
you
Signed
Patient
Organizations
MAME (Mothers Against Myalgic Encephalomyelitis)
Independent
Patient Advocates
Bobbi Ausubel Denise Lopez-Majano Jean Harrison
Rich Carson Mike Munoz Meghan Shannon MS MFT
Lori Chapo-Kroger, R.N. Matina Nicolson Eileen Holderman
Kati Debelic, R.N. Donna Pearson Marly Silverman
Mary Dimmock Leela Play Suzan Jackson
Pat Fero, MEPD Justin Reilly, J.D. Rivka Solomon
Joan Grobstein, M.D. Mary Schweitzer, Ph.D. Jill Justiss
Tamara Staples Mindy Kitei Charlotte von Salis, J.D.
Michele Krisko Michael Walzer
Rationale
for these recommendations
In
October 2012, the CFS Advisory Committee (CFSAC) recommended that
DHHS convene a workshop by December 31, 2012 or as soon as possible
thereafter to “reach
a consensus for a case definition useful for research, diagnosis and
treatment of ME/CFS beginning with the 2003 Canadian Consensus
Definition.”xi
In
recommending the 2003 Canadian Consensus Criteria as a starting
point, it is clear that CFSAC was recognizing the disease, ME, as
characterized above, and intended to advance a research and clinical
definition for ME. The Canadian Consensus Criteria is already in use
both clinically and in research, was developed by well known ME
experts at the request of Health Canadaxii,
has been shown through numerous studies to better describe ME than
either Fukuda or Oxford as discussed below and is well respected by
both patients and clinicians. For all these reasons, it provides the
best option to establish a disease appropriate baseline definition in
the short term that can readily be further evolved in partnership
with ME experts as additional data, knowledge and experience is
gained, and as the definition is further operationalized and
biomarkers are validated.xiii
Based
on the available information, it is questionable whether CDC and NIH
intend to develop a definition specific for ME or instead continue
the focus on the more broadly defined CFS umbrella. Further, the NIH
and CDC initiatives are both longer-term initiatives that do not
address the significant issues that patients – and research - face
today and every day as a result of the definitional problems –
issues that could be addressed by adopting the Canadian Consensus
Criteria now as discussed by CFSAC at the October, 2012 meeting.
The
NIH has stated that they intend to establish a research case
definition by performing an evidence-based review of the literature.
But we do not know whether NIH intends to include all definitions and
criteria encompassed by the “CFS” label or whether they will
tease apart the different conditions currently lumped together in
order to
understand the nature of the separate diseases and conditions
therein.
Other CFS evidence based reviews, including the 2001 Mulrow review
from AHRQ,xiv
the review included in the 2007 NICE Guidelinesxv
and the 2008 Cochrane reviewxvi
of CBT have analyzed diverse “CFS” definitions together as one
patient group from which conclusions applicable to all could be
drawn. However, as discussed below, these definitions and criteria do
not represent the same patient population. It is essential that these
diverse “CFS” definitions and criteria be separated out. Doing
this will require the involvement of ME experts and patients from the
beginning. To date, we do not know of any ME clinical and research
experts or patients being engaged in the planning of this effort.
The
CDC has stated it intends to use the outcome of the multi-site study
to address the clinical case definition. The CDC website states that
the multi-site study includes CFS, post-infective
fatigue and ME patients and “aims to improve how we measure illness
domains of CFS”xvii
which the CDC says may allow patients to be sub-grouped. There are
two primary concerns with this study. First, the first phase of the
multi-site study does not include the measures and instruments, like
the two-day cardiopulmonary exercise test, immune markers or a valid
psychiatric screen, that are needed to demonstrate the hallmark
symptom of PEM, to demonstrate known biological markers or to exclude
psychiatric disorders. While the second phase of the study will
include an exercise test, it is not clear that CDC will follow
Snell’s recommendation to use an 2-day exercise test with gas
exchangexviii
or how the phase 1 participants will then be assessed. Secondly and
more deeply concerning, is that the language on the CDC website
suggests that CDC may be intending to develop a definition for the
broader “CFS” and consider everything else, including ME, a
subtype of CFS.
Three
other CDC-related issues reinforce the concerns with the multi-site
study. First is the CDC’s continued promotion, in the 2013 Medscape
“A
Case-Based Approach to Chronic Fatigue Syndrome”
CME, of the “one size fits all” CDC CFS Toolkit in spite of CFSAC
and patient recommendationsxix
to remove it. Second is CDC’s placement of CFS in the U.S.
ICD-10-CM in the “Symptoms and Signs” chapter as a subcategory of
chronic fatigue rather than in the Neurological chapter as designated
in ICD-10 by the World Health Organization (WHO) and as recommended
numerous times by the CFSAC since 2005.xx
But
of greatest concern is the third issue - the statements on the CDC
website (as in the CDC CME “Diagnosis and Management of CFS”)xxi
that list five different definitions for CFS (Table 1) and state that
all five definitions describe similar sets of patients for which a
single set of diagnostic and treatment guidelines is appropriate.xxii
Three of these definitions describe the essential and hallmark
symptoms and dysfunction of ME: the 2003 Canadian Consensus Criteria,
the 2011 ME International Consensus Criteria and the 2006 IACFS/ME
Pediatric Case Definition. But the two most commonly used definitions
— Fukuda developed by CDC and Oxford developed in the UK — do not
require the core symptoms of ME and allow the inclusion of primary
psychiatric illness except for schizophrenia and a few other
definition-specific psychiatric disorders. For
its part,
Oxford
doesn’t require any symptom at all except for six months of
disabling fatigue.
As
a result, CFS — the diagnosis that ME patients in the United States
are given todayxxiii
— has come to be associated with deconditioning,xxiv
depression or other psychiatric illness,xxv
a variety of “medically unexplained” fatiguing conditions, a
history of childhood abusexxvi,
“excessive rest”
xxvii,
maladaptive coping stylesxxviii,
a DSM 5 categorized mental illness called somatic symptom disorderxxix
and, for some clinicians and researchers, “fear of movement”xxx
or “false illness beliefs” that should be treated with cognitive
behavioral therapy (CBT) as asserted in the PACE trial, an Oxford
definition study.xxxi
Any of these diverse patients may be given a diagnosis of CFS.
While
not listed as one of the five definitions in the CDC “Diagnosis and
Management of CFS” CME, there is also a sixth definition, the 2005
Reeves Empirical definitionxxxii
that is the basis of the upper prevalence estimate of 4 million
Americans used by the CDC.xxxiii
Dr. Leonard Jason of DePaul University showed that the Empirical
definition resulted in a tenfold increase over earlier prevalence
estimatesxxxiv
and led to 38% of major depressive disorder patients being
misclassified as CFS.xxxv
When asked by Dr. Jason about the continued publication of Empirical
studies at the November 2011 CFSAC meeting, CDC’s Dr. Beth Unger
said that CDC had done a study comparing approaches and found that
“the patient populations are quite comparable.”xxxvi
As
patients, we disagree with the assertion that these “CFS”
definitions represent the same patients and that these patient
populations are comparable. ME experts concur. In
a study involving 143,000 patients in the UK, Dr. Luis Naculxxxvii
of the London School of Hygiene and Tropical Medicine found a
prevalence of 0.19% for patients meeting Fukuda criteria but only a
prevalence of 0.11% for those meeting the Canadian Consensus Criteria
– almost one half of that of Fukuda. He further stated that
symptoms related to issues like neurocognitive and immunological
dysfunction were significantly greater in those meeting the Canadian
Consensus Criteria. Dr. Bruce Carruthers, an ME expert, has reported
“Some symptoms of the Fukuda criteria overlap with depression,
whereas the Canadian Consensus Criteria differentiate
patients with ME from those who are depressed and identify patients
who are more physically debilitated and have greater physical and
cognitive functional impairments.”xxxviii
Jason
concurs that Fukuda symptoms - chronic fatigue plus unrefreshing
sleep, joint pain, muscle pain and impairment in concentration
– overlap with depression xxxix
He also agrees that the Canadian Consensus Criteria select “a group
of patients that have more severe functional impairments, and
physical and cognitive symptoms” than Fukuda.xlxli
Dr. Michael Maes of Maes Clinics in Thailand has used data mining to
demonstrate that Fukuda has two qualitatively different types of
patients within it – those with PEM and those without – and
showed that the roughly 50% of Fukuda CFS patients with the hallmark
PEM also had more severe illness, more severe feelings of infection,
greater neurocognitive impairment, and significantly higher levels of
immune-inflammatory variables.xlii
He concluded that Fukuda CFS patients with PEM and Fukuda CFS
patients without PEM “should be considered different case
definitions.”xliii
In a 2012 review of the definitional criteria for CFS, Yvonne
Christley maintained “The differing approaches to the
identification and definition of CFS are potentially compounding and
strengthening associations between CFS and psychiatric disorders by
taking too broad an approach to case identification.”xliv
This
takes us to the heart of the problem: ME criteria mixed in with
overly broad, non-specific definitions that allow primary psychiatric
illness; heterogeneous patient populations identified and studied as
one condition called CFS; and sloppy, inappropriate naming that
interchangeably uses the terms “CFS”, “CFS/ME”, “ME/CFS”,
“ME” and even just “chronic fatigue”. The resultant confusion
has severely impacted ME research, drug development and clinical care
and misled the medical community on the very nature of ME. Carruthers
stated it simply “Patient sets that include people who do not have
the disease [ME] lead to biased research findings, inappropriate
treatments and waste scarce research funds.“xlv
Dr.
Jason agrees. “Such blurring of diagnostic categories will make it
even more difficult to identify biological markers for this illness,
and if they are not identified, many scientists will be persuaded
that this illness is psychogenic.”xlvi
FDA’s Dr. Sandra Kweder, in a teleconference with ME patients,
acknowledged that the failure to “define the condition well”
discourages drug development investment by pharmaceutical companies.xlvii
Beyond
the impact on research and drug development is the impact on clinical
guidance. Clinical guidance, including that from CDC, uses findings
from studies based on any of these definitions and applies them
indiscriminately to all patients labeled “CFS”. The prevalence
estimates and findings of maladaptive coping skills, mentioned above,
are two examples. Other examples include the CDC recommendations for
cognitive behavioral therapy (CBT) and graded exercise therapy (GET),
provided in spite of patient reports of harm from these therapiesxlviii
and even though the supporting studies, like PACE, used Oxford
definition. PACE, whose claim of recovery is contested because of how
it was measured,xlix
did claim that CBT and GET were equally effective in patients that
met other criteria for CFS and MEl.
However, the CFS definition referenced
was the Reeves definition for CFS, diluted to only require the
presence of any four symptoms for only one week instead of six
months. The criteria for ME patients was a
modified version of the infrequently used London criteria, instead of
the more commonly accepted Canadian Consensus Criteria. Such loose
application of the definitional criteria in a study as widely
publicized as PACE only helps to magnify the confusion on the nature
of ME and its appropriate treatment.
Most
tragically for ME patients, their doctors too often do not understand
their disease or do not even believe that it is real.li
Putting a sharp point on the depth of misunderstanding, Dr. Klimas
stated "I've
had patients who met post-traumatic stress disorder criteria... where
their trauma was their interaction with their physician around this
illness. They came to a doctor with Chronic Fatigue Syndrome; they
left the doctor with PTSD."lii
This misunderstanding has been fueled by conflicting study findings
resulting from the disparate definitions and by the broad-based
publicity covering trials like PACE. A third significant contributor
is the educational
outreach of CDC and Health Resources and Services Administration
(HRSA) using clinical guidance materials like the CDC CFS Toolkit,
which even promotes the use of the same guidance for “CFS-like”
illness, defined as 6 months of fatigue but without all four symptoms
required by Fukuda.liii
Given these factors, it is not surprisingly that a CDC study of CFS
knowledge among health care providers found that 85% of healthcare
providers felt that CFS was either partly or completely a psychiatric
illness.liv
Such
grave misperceptions are seen widely in the medical literature.lv
In the
2012 American
Family Physician article, Dr. Joseph Yancey listed Oxford and Fukuda
as the appropriate definitions and stated “patients with poor
social adjustment, a strong belief in an organic cause for fatigue,
or some sort of sickness benefit (i.e., financial incentive) tend to
have worse responses to [cognitive behavioral] therapy.”lvi
Further, a 2013 IOM report on Gulf War Illnesslvii
stated that CFS is also called myalgic encephalomyelitis and listed
Fukuda and the NICE criterialviii
from Britain as the appropriate definitions. Like Fukuda, NICE does
not require the core symptoms of ME. Finally, the same misperception
on the nature of ME was evident at the Ampligen FDA Advisory
Committee when committee member Dr. Sean Hennessey asked how
the efficacy of Ampligen compares to the efficacy of cognitive
behavioral therapy.lix
Would the same question have been asked of a drug for multiple
sclerosis or cancer?
We
acknowledge that multiple research and clinical case definitions can
exist for a given disease and can evolve over time as they have in
other diseases. But this is very different. Here, the disease known
as ME has virtually disappeared and in its place, CFS has been
established as the clinical entity; an entity that is in reality a
heterogeneous collection of medically unexplained and often unrelated
fatiguing conditions. ME should never have been merged into this
group to begin with and should certainly not be considered a subtype
of this group.
There
is undoubtedly value in having a framework for studying fatigue
across diseases. Unfortunately, because Fukuda established a
framework that first eliminated fatigue due to known causes like
cancer, the opportunity to gain the types of insights seen in a
recent study comparing markers in cancer with those in chronic
fatigue syndromelx
is minimized. But even with the best framework, study of a common
symptom like fatigue or pain across diseases can never substitute for
the study of the disease itself, using a disease appropriate
definition. As Carruthers stated in the ME International Consensus
Criteria, “Research
on other fatiguing illnesses, such as cancer and multiple sclerosis,
is done on patients who have those diseases. There is a current,
urgent need for ME research using patients who actually have ME.”lxi
Similarly, there is a current, urgent need for treatments and
clinical care guidelines appropriate for this disease and a critical
need for patients to have access to doctors who believe that they are
really sick.
That
leaves the question of what to do about the clinical entity called
“CFS” once ME patients are pulled out. This complicated issue
needs to be carefully managed. First, it is likely that some of these
“CFS” patients have been misdiagnosed. They need to receive an
appropriate diagnosis. Second, if Maes is correct in saying that it
is possible to use inflammatory markers to distinguish between
chronic fatigue patients (essentially Oxford) on the one hand and
‘no-PEM’ Fukuda CFS patients on the other, then it is mandatory
that these “no-PEM” Fukuda CFS patients also be pulled out,
leaving only the symptom of chronic fatigue (equivalent to Oxford
CFS), a symptom that can be seen in many illnesses.lxii
This further calls into question the validity and utility of the
“CFS” construct as a framework for studying medically unexplained
fatiguing illnesses. Finally, the literature base associated with all
these definitions has become hopelessly intertwined through the use
of the same labels across these diverse definitions. Continuing to
use the term “CFS” for all or a portion of these conditions will
only confound forward progress for all. For these reasons, the entity
“CFS” should be dismantled as part of the plan to resolve the
definitional problems and develop more appropriate and precise
definitions and names for the conditions currently all named “CFS”.
Table
1: Summary of the primary CFS, ME/CFS and ME definitionslxiii
The
CDC CME “Diagnosis and Management of CFS” lists 5 definitions -
Oxford, Fukuda, Canadian Consensus Criteria, ME-ICC and Pediatric.
Studies using Reeves Empirical definition are still published and
Reeves is the basis of the prevalence estimate of 4 million people.
The Nice guidelines are used in Britain. Holmes is seldom if ever
used.
| Definition
Name |
Label
Used
(1)
|
Key
Symptoms in the definition |
Psychiatric
Illness |
PEM/PENE
Required |
Comment |
| Holmes
criteria (1988)lxiv |
CFS
|
6
months chronic fatigue eight symptoms out of eleven |
|
No |
Replaced
by Fukuda |
|
CFS
|
6
months severe fatigue that affects mental or physical function.
|
Schizophrenia,
manic-depressive illness excluded. Anxiety, depression allowed |
No |
PEM
not recognized. Myalgia, sleep and mood disturbance may be present
- but are not required nor are other symptoms.
|
|
|
CFS |
6
months fatigue plus any 4 of memory impairment, sore throat,
tender lymph nodes, muscle pain, joint pain, headaches of new
type, unrefreshing sleep, PEM |
Major
depressive & bipolar disorder, schizophrenia excluded. Anxiety
and other types of psychiatric disorder allowed |
No |
PEM
one of the option symptoms but not required. Includes more
depressed and less symptomatic patients than CCC
lxvii |
2003
Canadian Consensus Criteria (CCC)lxviii
|
ME/CFS
|
PEM
plus two neurological/cognitive plus 1 of autonomic, immunological
& neuroendocrine symptoms |
Primary
psychiatric illness excluded
|
Yes |
Requires
PEM plus combination of these symptoms. 6 month wait |
2005
CDC Empirical (Reeves) Criteria lxix
|
CFS |
Operationalization
of Fukuda |
Depression,
anxiety, somatoform disorders not exclusionary |
No |
Led
to ten-fold prevalence increase. Jason has shown 38% of patients
with depression fit criteria.lxx |
Pediatric
Case Definition for ME & CFS (2006)
Jason
et al lxxi |
ME/CFS |
3
months of fatigue plus PEM, unrefreshing sleep, neurocognitive,
pain plus one of autonomic, neuroendocrine, immune |
Schizophrenia,
Bipolar, depressive disorders exclusionary. May have concomitant
anxiety, depression, somatoform |
Yes |
3
month waiting period.
|
NICE
Clinical Guideline (2007)lxxii
|
CFS |
4
months chronic fatigue, PEM plus any one of 10 symptoms (similar
to Fukuda symptoms) |
Appears
to allow primary psychiatric illness |
Recommends
CFS be considered if PEM exists |
Pain,
cognitive and sleep difficulties considered key.
3
months in child |
| 2011
ME International Consensus Criteria (ME-ICC)lxxiii |
ME |
PENE
plus neurological, immunological, energy metabolism /ion
transport, infections |
Primary
psychiatric illness excluded |
Yes |
Requires
PENE plus combination of these symptoms. No waiting period |
CFS
is the official and/or usual label for Oxford and Fukuda but the
terms ME/CFS and CFS/ME are also used as synonymous in studies and
by authors that use these definitions. In
the U.S., doctors give a diagnosis of CFS even when the patient
meets CCC or the ME-ICC. ME is rarely if ever given as a diagnosis
according to participants at a 2011 National Center for Health
Statistics ICD meeting
(http://www.cdc.gov/nchs/icd/icd9cm_maintenance.htm)
References
i
The Canadian Consensus Criteria (CCC) uses the term post-exertional
malaise (PEM) and the ME International Consensus Criteria (ME-ICC)
uses the term post-exertional neuroimmune exhaustion
(PENE) to refer to post-exertional fatigability.
ii
There are numerous peer-reviewed articles that characterize this
disease and the associated dysfunctions. Selected examples of these
references include the following:
-
-
-
-
Carruthers,
B., van de Sande, M., De
Meirleir, K., Klimas, K., Broderick, G., Mitchell, T., Staines, D.,
Powles, A., Speight, N., Vallings, R., Bateman, L.,
Baumgarten-Austrheim, B., Bell, D., Carlo-Stella, N., Chia, J.,
Darragh, A., Jo, D., Lewis, D., Light. A., Marshall-Gradisbik, S.,
Mena, I., Mikovits, J., Miwa, K., Murovska, M., Pall, M., Stevens,
S. Myalgic
encephalomyelitis: International Consensus Criteria.
Journal of
Internal Medicine.
Volume
270, Issue
4, pages
327–338,
October 2011.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
-
-
Lange
G, Streffner J, Cook D, Bly B, Christodoulou C, Liu W, Deluca J,
Natelson BH. Objective evidence of cognitive complaints in chronic
fatigue syndrome: A BOLD fMRI study of verbal working memory.
NeuroImage 2005;26:513-524.
http://www.ncbi.nlm.nih.gov/pubmed/15907308
Papanicolaou
DA, Amsterdam JD, Levine S, McCann SM, Moore RC, Newbrand CH, Allen
G, Nisenbaum R, Pfaff DW, Tsokos GC, Vgontzas AN, Kales A.
Neuroendocrine aspects of chronic fatigue syndrome.
Neuroimmunomodulation 2004;11(2):65-74.
http://www.ncbi.nlm.nih.gov/pubmed/14758052
iii
The World Health Organization classified ME as a neurological
disease in the ICD-9. CFS did not exist in ICD-9 but was added to
the ICD-9-CM in the Signs and Symptoms chapter. WHO added CFS to the
neurological diseases category at G93.3 in ICD-10. However, the U.S
added CFS to the “Signs and Symptoms” chapter in ICD-10-CM, the
same chapter where it was placed in ICD-9-CM. Placement of “CFS”
in this chapter is not in compliance with WHO and only further
exacerbates medical provider confusion about the nature of the
disease.
iv
ICD-9-CM Coordination and Maintenance Committee Meeting Summary of
Volumes 1 and 2, Diagnosis Presentations September 14, 2011. Page 2.
http://www.cdc.gov/nchs/data/icd9/2011SeptemberSummary.pdf.
The moderator polled the audience and there was general agreement,
by those in the audience, that the term “myalgic
encephalomyelitis” is not seen in medical records.
vi
Pariante, C. In his December
2012 pre-publication review of “A
narrative review on the similarities and dissimilarities between
myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and
sickness behavior” by Morris, G., Anderson,
G., Galecki,
P., Berk,
M. and
Maes, M.
published in BMC Medicine
2013,
11:64. Pariante
states “For many, including this reviewer, CFS/ME is predominantly
a condition triggered by excessive rest in predisposed individuals
following acute triggers, and its interpretation requite a
psychosocial and psychiatric framework.”
vii
White, P., et al, Comparison
of adaptive pacing therapy, cognitive behaviour therapy, graded
exercise therapy, and specialist medical care for chronic fatigue
syndrome (PACE): a randomised trial. The
Lancet - 5
March 2011 ( Vol. 377, Issue 9768, Pages 823-836 )
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext.
The
PACE trial, done in patients that met the Oxford definition, tested
cognitive behavioral therapy (CBT) and graded exercise therapy (GET)
which were used “on the
basis of the fear avoidance theory of chronic fatigue syndrome”
that “assume that the syndrome is perpetuated by reversible
physiological changes of deconditioning and avoidance of activity.”
The theory underlying CBT is often described as “false illness
beliefs”. The CDC references this trial among others to support
CBT as a treatment recommendation for CFS patients.
viii
Carruthers BM, van de Sande MI, De Meirleir KL, Klimas NG, Broderick
G, Mitchell T, Staines D, Powles ACP, Speight N, Vallings R, Bateman
L, Bell DS, Carlo-Stella N, Chia J, Darragh A, Gerken A, Jo D, Lewis
D, Light AR, Light K, Marshall- Gradisnik S, McLaren-Howard J, Mena
I, Miwa K, Murovska M, Steven S. Myalgic
Encephalomyelitis International Consensus Primer for Medical
Practitioners. 2012. http://www.hetalternatief.org/ICC
primer 2012.pdf “There
is a poignant need to untangle the web of confusion caused by mixing
diverse and often overly inclusive patient populations in one
heterogeneous, multi-rubric pot called ‘chronic fatigue syndrome’.
We believe this is the foremost cause of diluted and inconsistent
research findings, which hinders progress, fosters skepticism, and
wastes limited research monies”
The IACFS/ME is an
international organization of clinicians and researchers involved in
the study of ME/CFS and the clinical care of patients with ME/CFS.
The primer was developed by them and published it in 2012. They are
currently working on an updated version of the Primer.
xii
Carruthers,
B., et al Jain, A., De Meirleir, K., Peterson, D., Klimas, N.,
Lerner, M., Bested, A., Flor-Henry, P., Joshi, P., Powles, A. ,
Sherkey, J., van de Sande, M.
Myalgic
Encephalomyelitis/ Chronic Fatigue Syndrome: Clinical Working Case
Definition, Diagnostic and Treatment Protocols. Journal of Chronic
Fatigue Syndrome, Vol. 11(1) 2003.
http://mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf
xiii
As reported by panelists at the recent FDA meeting, there are a
number of known markers in use today like VO2Max and natural killer
cell function that could be readily validated. Regarding patient
reported symptoms, Jason has published extensively on the need to
have instruments that are validated for the specific definition and
that assess not just symptom presence but also symptom severity and
frequency.
xiv
“Defining and Managing
Chronic Fatigue Syndrome. Evidence Reports/Technology Assessments”,
No. 42. Mulrow CD, Ramirez G, Cornell JE, et al. Rockville (MD):
Agency
for Healthcare Research and Quality (US);
2001 Oct. . http://www.ncbi.nlm.nih.gov/books/NBK33797/
xv
Chronic
Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy).
Diagnosis
and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis
(or Encephalopathy) in Adults and Children. NICE
Clinical Guidelines, No. 53. National
Collaborating Centre for Primary Care (UK). London: Royal
College of General Practitioners (UK);
August 2007. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0009708/
(Question 1) and
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0009708/table/appendixes.app1.tu2/
xvi
Price JR,
Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic
fatigue syndrome in adults (Review). Cochrane
Database Syst Rev.
2008 Jul 16,
http://www.ncbi.nlm.nih.gov/pubmed/18646067,
http://www.cfids-cab.org/rc/Price.pdf.
The review states that all participants had fatigue as their main or
major complaint for at least 3,6 or 12 months. Beyond fatigue,
inclusion criteria were heterogeneous. Some studies used Fukuda,
some used Oxford, some used the Australian criteria and one study
that used Fukuda dropped Fukuda’s requirement for four symptoms.
xviii
At the FDA ME and CFS stakeholder meeting, Dr. Chris Snell compared
the various exercise tests and stated the problems with indirect
measures and the importance of using a test that measures gas
exchange. He also showed that single exercise tests could not
distinguish between deconditioning and ME.
http://www.tvworldwide.com/events/fda/130425/
- Panel 3 about minute 75 - 84
xix
On June 14, 2012, the CFSAC recommended that “the
Secretary asks the CDC to take the Toolkit down off the website.”
On Sept 10, 2012, the patient community submitted a position paper
supporting the CFSAC recommendation and outlining the issues with
the Toolkit and the negative impact the Toolkit has had on patients.
At the October 2012 CFSAC meeting, in response to Mr. Krafchick’s
question on whether
the Toolkit would be removed, Dr. Unger replied that it would not be
removed. On April 19, 2013, Medscape released the “A
Case-Based Approach to Chronic Fatigue Syndrome” CME
which recommended the CDC CFS Toolkit as a useful resource. It is
not. The Toolkit is a “one size fits all” clinical guideline,
that also claims to be suitable for patients with “CFS-like’
illness, defined as fatigued for 6 months without the other symptoms
of Fukuda. The information in the Toolkit is not useful and is
potentially harmful for patients with ME. See these references for
further information:
xx
In the draft version of the ICD-10-CM, the National Center for
Health Statistics (NCHS) within the CDC has placed CFS in the “Signs
and Symptoms” category under chronic fatigue. CFSAC has
consistently recommended (as early as August of 2005) that CFS be
classified as a neurological disease in compliance with WHO’s
ICD-10. The Coalition 4 ME/CFS presented a proposal to NCHS in
September of 2011 and again in September of 2012 asking the NCHS to
comply with these recommendations and move CFS back to the
neurological category. To date, CFS is still listed in “Signs and
Symptoms” in ICD-10-CM and unless it is changed by June 2013, CFS
will be listed under Signs and Symptoms when ICD-10-CM is published
in October 2014. Given this and CDCs continued embrace of CFS as the
overly broad collection of fatiguing illnesses as evidenced by the
inclusion of Oxford (essentially chronic fatigue), it is clear that
the CFS umbrella needs to be broken apart and ME classified as a
separate disease.
Sept
2012 -
http://www.cdc.gov/nchs/data/icd9/Topic_packet_for_September_19_2012.pdf
xxii
The CDC CFS Toolkit states that one set of clinical guidelines is
suitable for CFS patients and CFS-like illness (6 months of fatigue
but does not meet the rest of the symptom requirements for CFS).
Other documents, like the 2012 CDC “Diagnosis and Management CFS”
CME referenced above also give a single set of guidelines for all 5
definitions. http://www.cdc.gov/cfs/toolkit/index.html
xxiv
Joyner, M. Standing
up for exercise: should deconditioning be medicalized? August
1, 2012 The Journal of Physiology, 590, 3413-3414.
http://jp.physoc.org/content/590/15/3413.full
xxv
Every ME patient tells of doctors who have insisted they are
depressed, not physically sick - even today in 2013. A number of
references in this paper speak to this issue, which is also
highlighted in the following extract from Griffith, J., Zarrouf, F.
A Systematic
Review of Chronic Fatigue Syndrome: Don't Assume It's Depression.
Prim Care
Companion J Clin Psychiatry. 2008; 10(2): 120–128)
“She
is depressed,” her physician wrote when referring Ms. A, a
65-year-old married woman, for a psychiatric consult. “She has
been feeling tired for more than a year and described being
exhausted most of the time, with headaches, joint pain, and
problems with her concentration and memory. Her fatigue is
frustrating for her and for her family; she cannot function well
even in the morning. She denied being depressed, and does not have
any previous mental or medical illnesses. Every lab I checked was
normal. I still think that she is hiding her depression and
manifesting it with all these somatic complaints.”
xxvi
CDC CFS Website, “Childhood
Adversity as a Risk Factor for Adult CFS”
http://www.cdc.gov/cfs/news/features/childhood_adversity.html
xxvii
Pariante, C. In his December
2012 pre-publication review of “A
narrative review on the similarities and dissimilarities between
myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and
sickness behavior” by Morris, G., Anderson,
G., Galecki,
P., Berk,
M. and
Maes,
M.
published
in BMC Medicine
2013,
11:64. Pariante
states “For many, including this reviewer, CFS/ME is predominantly
a condition triggered by excessive rest in predisposed individuals
following acute triggers, and its interpretation requite a
psychosocial and psychiatric framework.”
xxix
Somatic Symptom Disorder (SSD) in the DSM-5, due to be released in
May, 2013, can be diagnosed for any patient that meets the following
criteria as determined by the health care provider:
a) somatic symptoms that
are distressing or significantly disrupt life
b)
an excessive concern with the medical seriousness of his or her
symptoms
c)
experienced persistent symptoms, typically for at least 6 months
xxx
Nijs J, Roussel N, Van
Oosterwijck J, De Kooning M, Ickmans K, Struyf F, Meeus M, Lundberg
M.
Fear of movement and
avoidance behaviour toward physical activity in chronic-fatigue
syndrome and fibromyalgia: state of the art and implications for
clinical practice. Clin Rheumatol. 2013 May 3.
xxxi
White, P., et al, Comparison
of adaptive pacing therapy, cognitive behaviour therapy, graded
exercise therapy, and specialist medical care for chronic fatigue
syndrome (PACE): a randomised trial. The
Lancet - 5
March 2011 ( Vol. 377, Issue 9768, Pages 823-836 )
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2/fulltext.
The
PACE trial was done in patients that met the Oxford definition. PACE
tested cognitive behavioral therapy (CBT) and graded exercise
therapy (GET), which were, used “on the
basis of the fear avoidance theory of chronic fatigue syndrome”
that “assume that the syndrome is perpetuated by reversible
physiological changes of deconditioning and avoidance of activity.”
The theory underlying CBT is often described as “false illness
beliefs”.
xxxii
Reeves, W.,
Wagner, D., Nisenbaum, R., Jones, J.,
Gurbaxani, B.,
Solomon, L.,
Papanicolaou, D., Unger, E., Vernon, S., Heim, C. Chronic Fatigue
Syndrome – A clinically empirical approach to its definition and
study. BMC
Medicine 2005,
3:19
http://www.biomedcentral.com/1741-7015/3/19
xxxiv
Carruthers, B.,
van de Sande, M., De
Meirleir, K., Klimas, K., Broderick, G., Mitchell, T., Staines, D.,
Powles, A., Speight, N., Vallings, R., Bateman, L.,
Baumgarten-Austrheim, B., Bell, D., Carlo-Stella, N., Chia, J.,
Darragh, A., Jo, D., Lewis, D., Light. A., Marshall-Gradisbik, S.,
Mena, I., Mikovits, J., Miwa, K., Murovska, M., Pall, M., Stevens,
S. Myalgic
encephalomyelitis: International Consensus Criteria.
Journal of
Internal Medicine.
Volume
270, Issue
4, pages
327–338,
October 2011.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
Carruthers
states “The Centers for Disease Control prevalence estimates
increased tenfold from 0.24% using the Fukuda criteria [17]
to 2.54% using the Reeves empirical criteria”
xxxv
Jason, L., Najar, N., Porter, N., Reh, C. Evaluating the Centers for
Disease Control’s Empirical Chronic Fatigue Syndrome Case
Definition. Journal of Disability Policy Studies Oct 2008,
http://www.co-cure.org/Jason-7.pdf
xxxvi
November 9, 2011 CFSAC meeting minutes exchange between Dr. Jason
and Dr. Unger. Dr. Jason asked about the continued publication of
Empirical study results (the 2005 Empirical definition has been
discredited) and how the CDC intended to evolve the criteria? Dr.
Unger’s response that they had done a study comparing “the
standardized approach to applying the Fukuda definition [1994
definition] and the approach that we had used in the past in the
Wichita studies. Everyone will find it very reassuring that the
patient populations are quite comparable.” A study was to have
been published in early 2012 but so far that study does not appear
to be available.
http://www.hhs.gov/advcomcfs/meetings/minutes/cfsac_min-11092011.pdf
- page 24
xxxvii
Nacul, L.,
Lacerda, E., Pheby, D., Campion, P., Molokhia, M., Fayyaz, S.,
Leite, J., Poland, F., Howe, A., Drachler, M.
Prevalence
of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) in
three regions of England: a repeated cross-sectional study in
primary care. BMC
Medicine
2011, 9:91 doi:10.1186/1741-7015-9-91.
http://www.biomedcentral.com/1741-7015/9/91
xxxviii
Carruthers, B.,
van de Sande, M., De
Meirleir, K., Klimas, K., Broderick, G., Mitchell, T., Staines, D.,
Powles, A., Speight, N., Vallings, R., Bateman, L.,
Baumgarten-Austrheim, B., Bell, D., Carlo-Stella, N., Chia, J.,
Darragh, A., Jo, D., Lewis, D., Light. A., Marshall-Gradisbik, S.,
Mena, I., Mikovits, J., Miwa, K., Murovska, M., Pall, M., Stevens,
S. Myalgic
encephalomyelitis: International Consensus Criteria.
Journal of
Internal Medicine.
Volume
270, Issue
4, pages
327–338,
October 2011.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
xl
Contrasting
Case Definitions for Chronic Fatigue Syndrome, Myalgic
Encephalomyelitis/Chronic
Fatigue Syndrome and Myalgic Encephalomyelitis
Jason,
L., Brown, A. Clyne, E. Bartgis, L, Evans, M., Brown, M.
Eval
Health Prof published
online 7 December 2011
http://ehp.sagepub.com/content/early/2011/10/18/0163278711424281
Brown
et al examined the ME-ICC and the Fukuda and found that the ME-ICC
identified a much tighter group of patients (39 compared to 113 for
Fukuda) with more functional impairments and physical, mental and
cognitive problems than in those patients meeting the Fukuda
criteria. The paper also raised a concern that ME-ICC included more
psychiatric co-morbidities than Fukuda because of the number of
symptoms required and concluded that a focus on a smaller number of
hallmark symptoms like post-exertional malaise would be critical.
Finally, the paper acknowledges the need for more study because
this study used a questionnaire designed for Fukuda CFS, that they
were unable to assess one of the key ME-ICC criteria because of the
available data and the study did not look at homebound or bedbound
patients. Such study will help to refine the CCC over time.
xliii
Maes,
M. Anderson, G., Morris, G. Berk, M. Editorial: Diagnosis of Myalgic
Encephalomyelitis:
where are
we
now? informahealthcare.com
by 203.208.104.132
http://informahealthcare.com/doi/abs/10.1517/17530059.2013.776039
xlv
Carruthers, B.,
van de Sande, M., De
Meirleir, K., Klimas, K., Broderick, G., Mitchell, T., Staines, D.,
Powles, A., Speight, N., Vallings, R., Bateman, L.,
Baumgarten-Austrheim, B., Bell, D., Carlo-Stella, N., Chia, J.,
Darragh, A., Jo, D., Lewis, D., Light. A., Marshall-Gradisbik, S.,
Mena, I., Mikovits, J., Miwa, K., Murovska, M., Pall, M., Stevens,
S. Myalgic
encephalomyelitis: International Consensus Criteria.
Journal of
Internal Medicine.
Volume
270, Issue
4, pages
327–338,
October 2011.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
xlvi
Jason, L., Najar, N., Porter, N., Reh, C. Evaluating the Centers for
Disease Control’s Empirical Chronic Fatigue Syndrome Case
Definition. Journal of Disability Policy Studies Oct 2008,
http://www.co-cure.org/Jason-7.pdf
xlix
A number of patients and researchers have contested the PACE claims
of recovery. Further, at the FDA ME and CFS stakeholder meeting, Dr.
Chris Snell discussed the use of the exercise tests in the PACE
trial. http://www.tvworldwide.com/events/fda/130425/
- Panel 3 about minute 70-75
The recent publication from
PACE states
that they analyzed the data using ME criteria and the International
(CDC) criteria. The International criteria was referenced as the
Reeves 2003 publication “Identification of ambiguities in the 1994
chronic fatigue syndrome research case definition and
recommendations for resolution” This is one of the publications
that led to the Empirical definition. Further, they only required
that patients had the symptoms for 1 week prior to assessment, not 6
months, to qualify for a diagnosis of CFS. Regarding the ME
criteria, they used a 1994 report from Westcare for the ME
diagnosis. It is not clear why they did not use Fukuda, why they
only required 1 week and why they did not use the much more widely
accepted Canadian Consensus Criteria or the newer ME International
Consensus Criteria.
In addition to using
modified versions of criteria that were either largely abandoned or
seldom used to begin with, the PACE trial also used measures of
recovery that are broadly disputed by the patient community. It
remains to be seen how the research community will respond to the
latest PACE paper but it is important to note that PACE style CBT
and GET have been rejected by a number of researchers and clinicians
as well as by the IACFS/ME Primer
(http://www.iacfsme.org/Portals/0/PDF/PrimerFinal3.pdf
- p23 for CBT comments.)
li
Every patient tells stories of doctors who told them they were
depressed, dismissed their illness as made up, refused to treat them
or recommended treatments that were inappropriate or harmful for
ME/CFS patients. The sheer prevalence of these stories is evidence
enough that there is a serious issue. The following references
highlight these issues: Bernhard,
T. The Stigma of Chronic Fatigue Syndrome. April 10, 2011
http://www.psychologytoday.com/blog/turning-straw-gold/201104/the-stigma-chronic-fatigue-
syndrome
Bernhard,
T. The Stigma
of Chronic Fatigue Syndrome II: Readers Respond. May 6, 2011
http://www.psychologytoday.com/blog/turning-straw-gold/201105/the-stigma-chronic-fatigue-
syndrome-ii-readers-respond
Montoya,
J. Stanford University talk on Chronic Fatigue Syndrome, March 11,
2011 - http://www.youtube.com/watch?v=Riybtt6SChU
Minute
6.50 – 7:30 Dr.
Montoya said
“it is my dream that our medical community will produce a formal
apology to patients for not having believed them all these years
that they were facing a real illness.”
lii
Nancy
Klimas, M.D., Miami Herald, March 24, 2009. Reported on
http://chronicfatigue.about.com/b/2009/10/15/doctor-caused-ptsd-in-fibromyalgia-chronic-
fatigue-syndrome.htm
liii
The CDC CFS Toolkit uses Fukuda as the basis of disease description
and diagnosis and as stated above, also states that one set of
clinical guidelines are suitable for CFS patients and CFS-like
illness (6 months of fatigue but does not meet the rest of the
symptom requirements for CFS.)
http://www.cdc.gov/cfs/toolkit/index.html
lv
There are many examples of this misperception in the literature over
the years. Some of these are current publications such as the
referenced publication by Yancey. Others are older as is this
example from Nisenbaum. Unfortunately, it is impossible to tell
whether the authors of these older studies still support these
statements or not.
Nisenbaum,
R. Jones, J., Unger, E., Reyes, M., Reeves, W. A
population-based study of the clinical course of chronic fatigue
syndrome. Health
Qual Life Outcomes. 2003;
1:
49. 2003
October 3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC269990/
This study states “Patients
who recovered or improved were younger, did not have a co-morbid
psychiatric disorder, and did not believe that the illness was due
to a physical cause.”
lvii
Gulf War and Health. Volume
9: Treatment for Chronic Multisymptom Illness.
Institute of Medicine. 2013 report.
http://www.nap.edu/catalog.php?record_id=13539
lix
FDA Arthritis Advisory Committee Hearing on Ampligen. Dec 20, 2012
at 2 hours 19 minutes.
http://www.fdatracker.com/2012/12/20/20121220-fda-arthritis-advisory-committee-meeting-webcast-audio-recording-heb-ampligen/.
Dr. Hennessey asked Hemispherix “to summarize the data on
cognitive behavioral therapy which I understand to be effective
against chronic fatigue.” CBT has been studied most extensively in
studies that use the Oxford definition. One of these studies is the
highly publicized PACE trial referenced above, which states “CBT
was done on the basis of the fear avoidance theory of chronic
fatigue syndrome. This theory regards chronic fatigue syndrome as
being reversible and that cognitive responses (fear of engaging in
activity) and behavioural responses (avoidance of activity) are
linked and interact with physiological processes to perpetuate
fatigue.” The
PACE trial report states that the aim of CBT is “to
change behavioural and cognitive factors assumed to be responsible
for perpetuating symptoms and disability” and claims that CBT as a
therapy leads to recovery. Yancey’s
statement that patients that believe they have an organic illness
have the poorer response to therapy was referring to CBT as the
therapy.
lxi
Carruthers, B.,
van de Sande, M., De
Meirleir, K., Klimas, K., Broderick, G., Mitchell, T., Staines, D.,
Powles, A., Speight, N., Vallings, R., Bateman, L.,
Baumgarten-Austrheim, B., Bell, D., Carlo-Stella, N., Chia, J.,
Darragh, A., Jo, D., Lewis, D., Light. A., Marshall-Gradisbik, S.,
Mena, I., Mikovits, J., Miwa, K., Murovska, M., Pall, M., Stevens,
S. Myalgic
encephalomyelitis: International Consensus Criteria.
Journal of
Internal Medicine.
Volume
270, Issue
4, pages
327–338,
October 2011.
http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02428.x/full
lxiii
Similar tables have been
published in the following sources and were used to validate the
information in this table
Table
1 in “Defining and Managing Chronic Fatigue Syndrome. Evidence
Reports/Technology Assessments”, No. 42. Mulrow CD, Ramirez G,
Cornell JE, et al. Rockville (MD): Agency
for Healthcare Research and Quality (US);
2001 Oct. http://www.ncbi.nlm.nih.gov/books/NBK33797/
Chronic
Fatigue Syndrome/Myalgic Encephalomyelitis (or Encephalopathy).
Diagnosis
and Management of Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis (or Encephalopathy) in Adults and Children. NICE
Clinical Guidelines, No. 53. National
Collaborating Centre for Primary Care (UK). London: Royal
College of General Practitioners (UK);
August 2007. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0009708/
(Question 1) and
http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0009708/table/appendixes.app1.tu2/
lxiv
Holmes,
G., Kaplan, J., Gantz, N., Komaroff, A., Schonberger, L., Straus, S.
Jones, J., Dubois, R. Cunningham-Rundles, C., Pahwa, S. Tosato, G.,
Zegans, L., Purtilo, D., Brown, N., Schooley, R. Brus, I.
Chronic Fatigue Syndrome: A Working Case Definition. Holmes GP
et.al. Annals of Internal Medicine.
http://annals.org/article.aspx?articleid=701163,
http://www.ncf-net.org/patents/pdf/Holmes_Definition.pdf
lxv
Sharpe
M, Archard L, Banatvala J., Borysiewicz, L., Clare, A., David, A.,
Edwards, R., Hawton, K., Lambert, H., Lane, R., McDonald, E.,
Mowbray, J., Pearson, D., Peto, T., Preedy, V., Smith, A., Smith,
D., Taylor, D., Tyrrell, A., Wessely, S., White, P. A
report—chronic fatigue syndrome. J Roy Soc Med 1991; 84: 118-121.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1293107/.
The criteria for the Oxford CFS are:
A
syndrome characterized by fatigue as the principal symptom
A
syndrome
of definite onset that is not life long
The
fatigue is severe, disabling and affects physical and mental
functioning the symptom of fatigue should have been present for a
minimum of 6 months during which it was present for more than 50%
of the time
Other
symptoms may
be present, particularly myalgia, mood and sleep disturbance
lxvi
Fukuda K, et al Straus SE, Hickie I, Sharpe MC, Dobbins JG, Komaroff
A. The chronic fatigue syndrome: a comprehensive approach to its
definition and study. International Chronic Fatigue Syndrome Study
Group. Ann Intern Med 1994;121:953-9.
http://www.ncf-net.org/patents/pdf/Fukuda_Definition.pdf
lxvii
Jason,
L, Torres-Harding, S, Jurgens, A, Helgerson, J. Comparing the Fukuda
et al. Criteria and the Canadian Case Definition for Chronic Fatigue
Syndrome, Journal of Chronic Fatigue Syndrome, Vol 12, 2004
http://www.cfids-cab.org/cfs-inform/CFS.case.def/jason.etal04.pdf.
lxviii
Carruthers,
B., et al Jain, A., De Meirleir, K., Peterson, D., Klimas, N.,
Lerner, M., Bested, A., Flor-Henry, P., Joshi, P., Powles, A. ,
Sherkey, J., van de Sande, M.
Myalgic
Encephalomyelitis/ Chronic Fatigue Syndrome: Clinical Working Case
Definition, Diagnostic and Treatment Protocols. Journal of Chronic
Fatigue Syndrome, Vol. 11(1) 2003.
http://mefmaction.com/images/stories/Medical/ME-CFS-Consensus-Document.pdf
lxix
Reeves, W.,
Wagner, D., Nisenbaum, R., Jones, J.,
Gurbaxani, B.,
Solomon, L.,
Papanicolaou, D., Unger, E., Vernon, S., Heim, C. Chronic Fatigue
Syndrome – A clinically empirical approach to its definition and
study. BMC
Medicine 2005,
3:19
http://www.biomedcentral.com/1741-7015/3/19
lxx
Jason, L., Najar, N., Porter, N., Reh, C. Evaluating the Centers for
Disease Control’s Empirical Chronic Fatigue Syndrome Case
Definition. Journal of Disability Policy Studies Oct 2008
http://www.co-cure.org/Jason-7.pdf
lxxi
Jason L, Jordan K, Miike T, Bell DS, Lapp C, Torres-Harding S.,
Rowe, K., Gurwitt, A., DeMeirleir, K., Van Hoof, E. A Pediatric Case
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