Methodological problems in studies of
cognitive behavioral therapy and gradually
increased training for the treatment of ME / CFS
Cognitive behavioral therapy and gradually increasing exercise is sometimes recommended
as therapy for ME / CFS from a treatment model that involves
change patients' thoughts about the disease and allow them to practice healthy.
There are studies that claim positive treatment results, but
they have serious methodological flaws. The lack of objective data and
patient group unclearly defined. Negative physiological consequences
is demonstrated in other studies and independent evaluations of patient organizations
confirms the negative consequences. Patients with ME / CFS
should be dissuaded from cognitive behavioral therapy and gradually increase the training
according to this model.
Facts checked by Gottfries Clinic AB, Mölndal
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Introduction
ME / CFS - sometimes also referred to as chronic fatigue syndrome - is a seriously debilitating
disease [1]. It is classified since 1969 as a neurological disease of
The World Health Organization (WHO) [2]. Etiology and pathogenesis are unknown, but one
have demonstrated immunological and autonomic disturbances, neuroendocrine dysregulation,
abnormalities in the brain and in mitochondrial function and cognitive impairment
of ME / CFS patients [3].
There is no effective treatment for the disease. In the 1990s, a group of
British consulting psychiatrist - the so-called Oxford School - hypothesized
that ME / CFS patients may misinterpret the body's signals. Patients erroneous attitude
changed by the treatment with cognitive behavioral therapy (CBT). This therapy
often combined with gradually increased exercise (Graded Exercise Therapy GET), which
means that patients increase their activity levels according to a predetermined schedule to
practicing healthy. GET should not be confused with the pacing, which means that the patient
learn to balance rest and activity, and listen to your body's signals.
It has published several studies of cognitive behavior therapy and gradually increased
training for ME / CFS patients, such as British PACE study from 2011 [4]
attracted much media attention. The results have been unclear, but several of
studies claiming positive treatment results. These studies have had
serious methodological flaws and has been heavily criticized by scientists, physicians and patient organizations
[5-12]. This article provides an overview of the methodological
problems and shows that CBT and GET according Oxford model have no positive
effect on ME / CFS, but on the contrary often leads to a deterioration of the patients.
Lack of objective data in studies
Treatment outcomes in the studies performed with cognitive behavioral therapy and gradually
increased training has typically been evaluated with form, where patients themselves report
how they are doing according to a predetermined scale. [4] It is well known that there is a
placebo effect in subjective reporting. The placebo effect has multiple causes, but
influenced by the investigator's attitudes. The bias can
therefore expected to be large at cognitive behavioral therapy according to the Oxford model, because
treatment is to convince patients that the method works.
Double-blind testing is not possible at the psychological intervention, but patients
activity can be measured by a so-called aktometer, an apparatus size of a wristwatch
attached to the wrist or ankle. It is important that the activity is continuously measured
over time, as ME / CFS patients tend to offset the increased activity
within an area by pulling down on other activities. Most studies of
cognitive behavioral therapy and gradually increasing exercise as published has been waived
from making objective measurements of activity levels before and after treatment. this
makes it difficult to assess the patients' level of function affected.
Objective measurements have just been presented on two occasions. In one of these
Studies made a Dutch group a review of three previous studies of cognitive
behavioral therapy and gathered data from aktometrar afterwards. The analysis showed
that no objective increase in patients' activity levels were, although they reported
2 -
ed a subjective reduction in the fatigue in the forms [13]. In another publication
compared the neuropsychological test results before and after treatment with CBT. the
self-reported cognitive impairment decreased with CBT, but the objective
test results remained unchanged [14].
There have been attempts in some studies to evaluate the treatment results of
cognitive behavioral therapy and gradually increasing exercise in a more objective manner, but
measures have been insufficient. The UK PACE study measured how far
patients were able to walk in six minutes, and they managed to show a modest increase
for CBT and GET group [4]. Walking The test, however, is a blunt measure of objective
improvement, because it is not possible to check how much the patients effort
itself. The overall level of activity was recorded not with aktometrar, so one can
not determine whether the patients' overall level of functioning improved. In a Dutch
study of Internet-based CBT for adolescents registered school attendance. [15] one
measured not study results and verified nor whether the increased presence
was compensated by pulling down on other activities. It is therefore not possible
draw any firm conclusions as to whether the patients level of functioning improved.
The end result of walking test in PACE averaged 354 m for those who have undergone
CBT and 379 m for those who followed the GET program. It should be noted that this is
far from the reversal of a state investigator claimed is possible. as
comparison, a healthy person can handle about 600 m in a walk test.
The limit for it to be justified by the transplantation of a consumptive
person is 400 m [16], in a US study of older people with chronic
heart problems were the most severely ill group profit of 402 m [17].
Unclear populations
Another problem is that the diagnostic criteria and thereby the selected patient group
has been unclear in many studies. Centers for Disease Control and Prevention (CDC)
published the first criteria for chronic fatigue syndrome in 1988 after an epidemic
Lake Tahoe and introduced the concept of Chronic Fatigue Syndrome (CFS) [18]. criteria
updated in 1994 [19], and this set of criteria - sometimes called
"Fukudakriterierna" after the first author - is the most used in research articles
ME / CFS. The disease is considered here not only as a form of long-term
fatigue. Patients must be in addition to long-lasting fatigue meet additional four
symptoms from a list of eight symptoms of neurological and immunological characteristics.
Oxford School in 1991 published its own criteria, although the name CFS was already occupied.
The so-called Oxford criteria only requires prolonged severe fatigue [20], although
of the patients may have other symptoms. Thus describes a larger and more
heterogeneous patient population than with Fukudakriterierna. This includes many patients
with psychiatric diagnoses.
An expert committee drafted in 2003 on behalf of Health Canada, a consensus document
ME / CFS and published in connection with this a new and more rigorous
set of criteria, which become known as "the Canadian consensus criteria"
or simply "Canada criteria" [21]. The aim was to define a more homogeneous
of patients. Among other things, highlighted the post exertional malaise ("exertional
deterioration ") as a compulsory symptom. In addition, it must be the patients
3 -
na exhibit a wide range of neurological, immunological and endocrine symptoms. This
set of criteria used by the international research and läkarorganisationen
IACFS / ME [3] and is recommended by most biomedical scientists in the field.
Evaluation and comparison of treatment studies of ME / CFS has been hampered, not
only a few of the various kriterieuppsättningarna, but also by many authors
have "operationalized" diagnostic criteria. Operationalisation typically involves
it interprets the various abstract formulations, in order to apply a user
practical in an actual trial. In many treatment trials of CBT / GET has
stretched the concept and change, or remove some of the conditions that must be met,
so that there is uncertainty about the results truly reflect the selected
The Criteria.
Most initial studies of CBT / GET was made with the Oxford criteria [22] or
with operationalized Fukudakriterier [23]. Recently, it has also been
studies using the complete Fukudakriterierna [24]. It is unclear whether the results
for a large heterogeneous group of patients also can be extrapolated to a stricter defined
group, such as those that meet the criteria Canada. A study from the
British primary care showed that the prospect of a positive treatment outcome of CBT
and GET by prolonged fatigue greatly reduced if the patients met criteria
for ME / CFS (in this case Fukudakriterierna) [25].
The PACE study used the Oxford criteria, but alongside this they made a
Comparing the results for patients simultaneously satisfy the so-called London Criteria
[26] and Reeves criteria [27]. Unfortunately, it is difficult to draw good
conclusions from this comparison, as well as subjective only result was that
available, and partly because the most stringent definition (Canada criteria) were not included.
Physiological disturbances indicate deterioration after exertion
There are a number of studies that suggest that exercise may trigger a worsening of
patients with ME / CFS. A research team in the United States led by Christopher Snell has studied
the oxygen uptake of ME / CFS patients repeatedly effort tests. Testing
has been carried out every 24 hours. During the first test showed
patients normal values, whereas in test two, unlike the control subjects
showed significantly reduced oxygen uptake, both at maximal uptake (VO2
max) and at the anaerobic threshold [28]. These findings are completely in line with
the exercise-induced degradation that patients often complained of, and that is a
mandatory symptoms according Canada criteria. Similar results have recently been published
by another American group headed by Betsy Keller [29].
The evidence suggests that it is the aerobic energy system that works poorly at
ME / CFS and that deteriorates after exercise [30]. Patients should especially avoid
"Oxygen debt". The gradual increase in training as Oxford School advocates are aerobic.
The results of Snell's group stresses the importance of distinguishing between different types of
chronic fatigue. Tired patients with primary depression improved by aerobic exercise.
Patients with ME / CFS is deteriorating, and if they also have secondary depression becomes
the worse even in their depression [30].
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An American study has demonstrated changes in gene expression in ME / CFS patients
for 48 hours after exercise [31]. A British study has shown elevated levels of
the inflammatory cytokine TNF-a (tumor necrosis factor?) at two moments measured three
hours and three days of training. [32]
Patient Evaluations show problems with CBT and GET
Patient organizations have long considered different forms of treatment in the polls.
There are data available from ten independent surveys conducted in four
different countries with more than 13,700 patient responses [33,34]. The surveys confirm that gradually
increased training entails a high risk of deterioration. More than 4600 patients were tested
on this form of treatment and a total of 52% reported they felt worse.
The main survey was conducted by The ME Association in the UK. IN
comparison of different therapies showed a gradual increase in training the second-lowest proportion
patients who experienced an improvement and the highest percentage who experienced a
deterioration [35]. More than 56% of the patients became worse in treatment and 33%
stated that they have become much worse. Both the gradual increase in training and in cognitive
behavioral therapy reported a lower proportion of patients that improved and higher
proportion to the deteriorated than when treated with homeopathy. Homeopathy is considered today
as a pseudo-science, and reading the results of this method therefore provides a
indication of the level of the placebo effect is on. The same pattern was repeated in
a Norwegian patient study [34].
The PACE study investigated the potential for deterioration at gradually increasing exercise. no
recurrences were reported, and the authors concluded that the treatment is safe.
This result is in sharp contrast to all patient exams. However, it is not
to determine whether the patients increased their activity level according to the protocol of PACE, as
aktometrar not used. Walking test showed that patients were able to walk
379 meters in six minutes, which is far below the goal of practicing healthy. If the activity level
is higher, the risk of a backlash to increase. This may explain why
gradually increase the training so often leads to deterioration when it is put into practice. The conclusion
gradually increased exercise is a sure treatment is therefore questionable.
The underlying theory lacks scientific support
Oxford School's treatment model is based on two basic hypotheses, fear avoidance
Theory and deconditioning and exercise intolerance theory. The first hypothesis
assumes that patients are afraid of activity and avoid exertion, and that
This behavior perpetuates the symptoms. The second hypothesis assumes
that patients' poor condition due to the low activity causes symptoms.
The condition can be reversed by the patient to change their thinking and behavior patterns
[4].
These hypotheses seem reluctant even at first glance. the adopted
Activity phobia are misaligned with the push-crash cycles that both patients
and doctors testify. [36] Patients recovering from a deterioration becomes
active (push), leading to a new exercise-induced degradation (crash), and so
Gradually a new recovery and so on. If lack of condition would lead
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to ME / CFS symptoms assuming in the second hypothesis, should the corresponding
symptoms are observed in people who are inactive for other reasons, such
persons in plaster for a long time or prisoners in isolation cells. No reversal
of ME / CFS by changing thoughts have not been detected in either the PACE
or in any other study. The hypotheses thus contradicted by the approving their own
research.
Oxford school has not been able to provide a theoretical basis for their assumptions, even
there have been several attempts. Others Vercoulen published a structural equation model
ME / CFS and concluded that behavioral and cognitive factors
helps to perpetuate the disease [37]. However, this is a misinterpretation of the results.
Structural equation modeling can be used to test causal assumptions,
but not to validate causal conclusions [38]. Can not decide which of the
biological, behavioral and cognitive factors in ME / CFS is cause and
effect without having an understanding of the underlying mechanisms, which is not
mediated by the model. In addition, using Vercoulen a heterogeneous group of patients.
When the results would be replicated by other researchers, sued the model bad for
patients with ME / CFS, but good for patients with depression [39]. Harvey and Wessely
has published a "model for understanding the etiology of CFS". [40] The model consists
a figure showing how various factors interact with each other in ME / CFS, but
the authors do not describe any underlying mechanisms and does not explain how
to determine what is cause and effect in an interaction. This "model" is therefore
not an explanation in the scientific sense, but is just a graph of
unfounded assumptions of the authors.
Conclusions
It has published a number of studies of cognitive behavior therapy and gradually increased
training according to the Oxford model for patients with ME / CFS, and some of the studies
claims that this gives a modest but statistically significant improvement. Are any
together the evidence, however, there is good reason to question the benefits of treatment
methods and to draw attention to the risk of injury. No objective improvement
has been detected in any of the studies. The only objective evaluations made by
CBT suggests that the level of activity and the neuropsychological functioning level has not
improved. The patient group has been unclearly defined in many studies. It is
maximum unclear whether studies of patients with general chronic fatigue is also
representative of patients with neurological, immunological and endocrine symptoms
besides fatigue.
It was demonstrated delayed physiological abnormalities in ME / CFS patients after exercise,
For example, changes in gene expression and impaired oxygen uptake.
This is confirmed by the results of extensive independent patient surveys,
showing that a large proportion of patients have been degraded - by gradually increasing training
more than half. The proportion of patients who experienced an improvement is in line with
the expected placebo effect.
There is no theoretical support for cognitive behavioral therapy and gradually increase the training
According to the Oxford model. The underlying assumptions are contradicted by the approving
own research.
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Treatment benefits for ME / CFS patients with cognitive behavioral therapy and gradually
increased training according to the Oxford model can not be considered to be evidence-based, and
the risk of adverse effects means that care should advise patients and physicians
from these treatments. Patients should be encouraged to be physically active in
Insofar as the disease allows, for example, using pacing to find
a balance between activity and rest. Cognitive behavioral therapy, which aims to teach
patients living with a serious illness can also be helpful in many cases.
None of the methodological shortcomings discussed above are usually made on literature reviews
or Cochran Compilations. Health authorities making
systematic reviews will normally from such summaries, and they will therefore be
often misleading. It is important to have access to biomedical expertise, such as critical
can view the original works.
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