Editorial in British Medical Journal

Dolphin

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Kati, you ask what sort of evidence there is that CBT and GET works. There is a Dutch study I somehow downloaded from the BMJ site. I can only find the abstract now, but I may have attached it below, first time I've tried that..:confused:

They took 71 consecutively referred patients age 10 - 17., using CDC criteria. 36 were assigned to therapy, one session a fortnight for five months. 35 controls did nothing.

Six of the therapy group dropped out in the first half of the study time. Here's a cut and paste extract

"Active patientsFor relatively active patients treatment started with them learning to recognise and accept their current state of fatigue and impairment. Subsequently, they reduced their levels of activity and learnt to respect the limitations. After achieving this balance, the patient started to build up activity levels. This protocol was used in the trial of Prins et al.4

Passive patientsFor passive patients we started a systematic programme of activity building as soon as possible. To assure adherence, we first addressed and challenged their beliefs that activity would aggravate symptoms. In such patients it is thought to be counterproductive to reduce activity levels any further or reinforce the patients need to respect limitations."

I love that - the active patients were taught to accept their need to respect their limitations, while the passive ones were told to reject their perceived need for limitation.

For the younger kids, the parents were trained as cheerleaders. Over 15's did it for themselves.

At the end of the five month study, they show that the therapy group had significant improvement in school attendance, symptom distress...I don't have the brain to understand their method of scoring, see if you do -
--------------------------------------------------------------------------------------------------
Table 4 Clinically significant improvement at five months in fatigue severity
(checklist individual strength), functional impairment (SF-36), and school
attendance (mean percentage) and self rated improvement by treatment
group
Condition No (%) improved------------ Treatment effect (95% CI)----------P value (whatever that is)
Fatigue severity*
Cognitive behaviour --21/35 (60)----------0.39 (0.17 to 0.61-------------------0.01
Waiting list 7/34 (21)

Physical functioning
Cognitive behaviour -----22/35 (63)------- 0.39 (0.17 to 0.61)------------------0.01
Waiting list ----------------8/34 (24)

Full school attendance
Cognitive behaviour -----19/33 (58)--------0.29 (0.06 to 0.53)------------------0.02
Waiting list ----------------10/34 (29)

Self rated improvement
Cognitive behaviour ------25/35 (71)--------0.27 (0.04 to 0.78)-----------------0.02
Waiting list ----------------- 15/34 (44)

*Reliable change index >1.96 and cut off score of ≥35.7.
Increase of ≥50 or end score of ≥75.
Two participants were left out of analyses because they had taken their final examinations
and therefore were not required to attend school at five months.
Answer yes to statement I have completely recovered or I feel much better but still
experience some symptoms.
------------------------------------------------
They are a bit better - or they just wanted to please the nice doctor. I would want to know how things were three months after the therapy. And what was the story for the six that dropped out. That's 15% of the group, a fair percentage.

Don't know about you, but I've given up trying to pull myself up by my bootstraps, because the damage I suffer afterwards shows me that that is the slippery slope to severe ME.
This Stulemeijer et al study was one of the three studies in this review.
The authors didn't release the actometer data when they first published it (actometers tells one how much activity the wearer did)

How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity.

Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G.

Psychol Med. 2010 Jan 5:1-7. [Epub ahead of print]

Expert Centre Chronic Fatigue and Department of Medical Psychology, Radboud University Nijmegen Medical Centre, The Netherlands.

BACKGROUND: Cognitive behaviour therapy (CBT) is known to reduce fatigue severity in chronic fatigue syndrome (CFS). How this change in symptomatology is accomplished is not yet understood. The purpose of the present study was to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity.

Method: Three randomized controlled trials were reanalysed, previously conducted to evaluate the efficacy of CBT for CFS. In all samples, actigraphy was used to assess the level of physical activity prior and subsequent to treatment or a control group period. The mediation hypothesis was analysed according to guidelines of Baron & Kenny [Journal of Personality and Social Psychology (1986)51, 1173-1182]. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect.

RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.

CONCLUSIONS: The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity.

PMID: 20047707 [PubMed - as supplied by publisher]
 

MEKoan

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RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.
Does this sound completely nonsensical to anyone else? Am I just deep in a dense fog? I'm assuming this results from participants saying, "Yes, yes, I'm less fatigued! Please can I stop now?!"
 

PoetInSF

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CFS experts know, as Bell stated, if you get out of the house, do some shopping and begin to feel better, then that is likely depression. If you push yourself to get out, do some shopping and you feel worse, you likely have CFs.
In other words, if you improve, you don't have true CFS. Conversely, if you have true CFS, you are not going to improve. I'm sure people like Bell intend well for CFS patients. They just don't realize the damage they do in the process.
 
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No, that's not what I meant. He was saying that depression is improved by getting out of the house and some activity. But CFs patients see symptoms get worse if they get out and are active. Basically, CFS has PEM, but depression doesn't.

Of course, some people with CFS improve, in fact, I would say majority see some improvement in years. But, they likely improved by pacing, reducing stress, improving sleep quality, etc. They didn't see improvement because they got more active and got around people and went out shopping more.

Tina
 

Dolphin

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tomk said:
RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.
Does this sound completely nonsensical to anyone else? Am I just deep in a dense fog? I'm assuming this results from participants saying, "Yes, yes, I'm less fatigued! Please can I stop now?!"
That is one possibilty. Also, generally fatigue is pretty subjective so you might convince yourself you feel a bit less fatigued without it really meaning very much.

But they have claimed that CBT leads to full recovery in 23% of cases (we don’t have actometer data for that study) and generally is an effective rehabilitation strategy while this data looks like this is a joke: people may walk a bit more as part of the program, but they end up cutting other activity from their lives to do it.

Personally, a lot of people I know with ME/CFS don’t have lots of energy to waste. Dropping other activity may mean other people have to do more work for them around the house, they have less energy for their kids and/or less energy for their partner, less energy for paid employment, etc. In this context, giving up these things just so you feel you are doing something by going for a walk (and your doctor/therapist feels good), seems like it could be a waste of "good" energy in many cases.
 

Dolphin

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Link to rapid responses so far

Rapid responses so far

http://www.bmj.com/cgi/eletters/340/feb11_1/c738

It would be worth picking holes in the original piece - some points have not been made yet. The more people that do this, the worse the original piece looks and the more likely they are to feel that they should publish one or more responses (I would hope).
 

MEKoan

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But they have claimed that CBT leads to full recovery in 23% of cases (we don’t have actometer data for that study) and generally is an effective rehabilitation strategy while this data looks like this is a joke: people may walk a bit more as part of the program, but they end up cutting other activity from their lives to do it.
Yes, and, given that ME is a remitting and relapsing illness, at any given time a certain percentage of people would be entering remission which would account for some of these people. In addition, in a poorly identified cohort, a percentage of people would be suffering from clinical depression which might respond in this way. And, some pay have been suffering from post viral fatigue which was resolving. It is not difficult to account for this 23%.
 

PoetInSF

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He was saying that depression is improved by getting out of the house and some activity.
Yes, but getting out of the house for a light activity, if they are able to manage, can also help some CFS patients feel better. However well intentioned, I'm afraid putting too much emphasis on the organic nature (and infection) in this fashion can have a side effect of misleading patients into thinking that they cannot be helped.

No Christmas shopping for CFS patients though, I agree. It almost killed me for a few days!

Of course, some people with CFS improve, in fact, I would say majority see some improvement in years. But, they likely improved by pacing, reducing stress, improving sleep quality, etc. They didn't see improvement because they got more active and got around people and went out shopping more.
I mostly agree.
 
G

Gerwyn

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Does this sound completely nonsensical to anyone else? Am I just deep in a dense fog? I'm assuming this results from participants saying, "Yes, yes, I'm less fatigued! Please can I stop now?!"
there is no statistical dfference at all .THAT IS WHY THEY USE THE TERM CLINICALLY SIGNIFICANT an old trick subjective self report answers they can manipulate even this is rubbish you could drive a bus through the confidence intervals .once again no improvement in any objectively measued parameter
 

jace

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How factual is this part?

"the media has largely portrayed the condition as a progressive, paralysing, and commonly fatal illness"
Off the top of my head, and bearing in mind that I am following media coverage with great interest, I would say that statement was b**ls. There have been accurate reports of Lynn Gilderdale's decline, bless her soul, but most media coverage assumes that most people get better within a few years, and we are constantly told of people who have fully recovered within a year or three including the Minister of State of the Department of Work and Pensions and Colin thingy who runs the Sussex ME/CFS society (measussex.org.uk) Interestingly, he states he was running a hotel while he was ill with ME.

The psychologists and psychiatrists lobby, in general, have the floor, with a few notable exceptions. They are showing signs of paranoia. Interesting times.
 
G

Gerwyn

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Kati,

I had a very similar experience as you reading this. My heart lifted... and then sank - deep!
I have written to the BMJ

refer to the article "Air of defeatism exists within the medical profession that chronic fatigue syndrome can be treated" This article trivialises the severity of the illness and contains a number of factual inaccuracies.

NICE is selectively quoted.Nice actually point out that CFS/ME is a very serious real illness of yet unknown origin and can be more disabling as multiple sclerosis or late stage aids---There is no known cure or effective treatment.

This should have been quoted.

NICE specifically make the point that CBT is not a treatment for the symptoms but an aid to help patients come to terms with their illness. Is this what is meant by" working"?

CBT has never shown any objective benefit

Some studies, using self reporting, have shown a subjective benefit on fatigue i.e as assessed by the patient, but no effect at all on activity levels when measured scientifically.

The confidence intervals in these studies are so wide as to make extrapolation into a general ME/CFS population impossible.The studies are clearly underpowered.

Many sufferers take their lives because living with the symptoms is unbearable These symptoms cannot be treated

There is no robust scientific evidence to support GET although there was a recent heart attack!

Would any pharmaceutical product obtain a product licence based on patient self evaluation----or with the confidence interval values associated with CBT studies.The answer is a resounding No!

Why therefore are sufferers of ME/CFS classified by the WHO as a neurological disorder only offered CBT

Why were NICE instructed to ignore all the biomedical evidence when draughting their guidelines

Yours Sincerely,
G J Morris BSc(Psych) LLB(Lond) Dip Law
 

Dolphin

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I have written to the BMJ

refer to the article "Air of defeatism exists within the medical profession that chronic fatigue syndrome can be treated" This article trivialises the severity of the illness and contains a number of factual inaccuracies.

NICE is selectively quoted.Nice actually point out that CFS/ME is a very serious real illness of yet unknown origin and can be more disabling as multiple sclerosis or late stage aids---There is no known cure or effective treatment.

This should have been quoted.

NICE specifically make the point that CBT is not a treatment for the symptoms but an aid to help patients come to terms with their illness. Is this what is meant by" working"?

CBT has never shown any objective benefit

Some studies, using self reporting, have shown a subjective benefit on fatigue i.e as assessed by the patient, but no effect at all on activity levels when measured scientifically.

The confidence intervals in these studies are so wide as to make extrapolation into a general ME/CFS population impossible.The studies are clearly underpowered.

Many sufferers take their lives because living with the symptoms is unbearable These symptoms cannot be treated

There is no robust scientific evidence to support GET although there was a recent heart attack!

Would any pharmaceutical product obtain a product licence based on patient self evaluation----or with the confidence interval values associated with CBT studies.The answer is a resounding No!

Why therefore are sufferers of ME/CFS classified by the WHO as a neurological disorder only offered CBT

Why were NICE instructed to ignore all the biomedical evidence when draughting their guidelines

Yours Sincerely,
G J Morris BSc(Psych) LLB(Lond) Dip Law
Well done.

Fingers crossed it goes up.

As I said, people might increase their chances by quote at least one reference.
For example, you quoted the NICE Guidelines (1).

Reference:
1. National Institute for Health and Clinical Excellence. NICE clinical guideline 53: Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy). 2007. www.nice.org.uk/CG53.
(borrowed that one from the bottom of the article).

The reference wouldnt have to be exactly in the right format, just put something down the bottom and it looks more like a letter to the editor of a medical journal and harder to turn it down.
 
G

Gerwyn

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Well done.

Fingers crossed it goes up.

As I said, people might increase their chances by quote at least one reference.
For example, you quoted the NICE Guidelines (1).

Reference:
1. National Institute for Health and Clinical Excellence. NICE clinical guideline 53: Chronic fatigue syndrome/myalgic encephalomyelitis (or encephalopathy). 2007. www.nice.org.uk/CG53.
(borrowed that one from the bottom of the article).

The reference wouldn’t have to be exactly in the right format, just put something down the bottom and it looks more like a letter to the editor of a medical journal and harder to turn it down.
good point
 

Dolphin

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tomk said:
But they have claimed that CBT leads to full recovery in 23% of cases (we dont have actometer data for that study) and generally is an effective rehabilitation strategy while this data looks like this is a joke: people may walk a bit more as part of the program, but they end up cutting other activity from their lives to do it.
Yes, and, given that ME is a remitting and relapsing illness, at any given time a certain percentage of people would be entering remission which would account for some of these people. In addition, in a poorly identified cohort, a percentage of people would be suffering from clinical depression which might respond in this way. And, some pay have been suffering from post viral fatigue which was resolving. It is not difficult to account for this 23%.
Good points - the trial in question was uncontrolled (Knoop, 2007).
Also the definition of recovery was just not very low (bottom 15 percentiles) scores on a few questionnaires doesnt mean they were really recovered.
 

V99

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More responses to the editorial.

http://www.bmj.com/cgi/eletters/340/feb11_1/c738#231202


ill cooper,
Non-militant ME campaigner who does not have ME
Teacher cv214hl
Send response to journal:
Re: Biomedical Research not Wastepaper basket diagnoses

Patients and their families are 'fatigued' with the medical profession's sloppy attitude towards diseases which the medical profession call 'syndromes'. Instead of admitting that these conditions are, as yet, not understood, the medical profession have invented hypotheses about mind/body manifestations which can only be treated by correction of thinking on the part of the patient.

Cognitive Behavioural Therapy is promoted to 'help patients manage their symptoms' and to cure 'abnormal illness beliefs'. Graded Exercise Therapy is aimed at reversing 'de- conditioning'.

The best help a medic can give a patient is to respect that patient's intellect and admit that not everything is understood about the human body.

Instead, we seem to have a group of very powerful psychiatrists who adopted the Royal Free Disease in the late 60s, ignored all the evidence of physical symptoms, and have presented it ever since as a form of hysteria.

As a result, we have patients who are severely physically ill who are choosing suicide rather than to further endure the cruelty doled out to them by the medical profession and the rest of society.

I do not include all medical professionals in the above accusation but I do include many of them.

I urge all medical professionals to look at the already existing evidence which shows immune, endocrine and neurological abnormalities.

I urge you to support the MRC initiative, led by Professor Stephen Holgate, to do biomedical research to establish the underlying causes of this range of 'syndromes' so that these patients can receive suitable care.

Competing interests: None declared





Do CBT and GET really work for Chronic Fatigue Syndrome? 12 February 2010

Tom Kindlon,
Information Officer (voluntary position)
Irish ME/CFS Association
Send response to journal:
Re: Do CBT and GET really work for Chronic Fatigue Syndrome?

Santhouse and colleagues claim that treatments such as cognitive behavioural therapy (CBT) and graded exercise therapy (GET) “have been shown to work” in Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME)(1). However, what the literature actually shows is that such therapies have an effect, which is not necessarily the same thing as “working”: a meta-analysis calculated the average Cohen’s d effect size across various CBT and GET studies to be 0.48, which would generally be described as a small effect size(2).

A recent review of three Dutch CBT studies found that while patients’ fatigue did improve, their activity levels did not and remained low, calling into question claims that CBT is an effective rehabilitative strategy(3).

Systematic reviews tend to ignore “real world” data. An audit of 5 Belgian rehabilitation clinics, where the treatments offered were CBT and GET, found that while improvements were recorded in various subjective outcome measures, there was negligible change in the results from the exercise test and the average number of hours in paid employment decreased at the end and at follow-up(4). This was unlikely to be due to under- treatment, as an average of 41 sessions were undertaken.

Given all this data, and the high rates of adverse reactions from GET that have reported in surveys(5), patients and their clinicians are entitled to hope that in the future a greater range of interventions will be available.

Tom Kindlon

References:

1. Santhouse AM, Hotopf M, David AS. Chronic Fatigue Syndrome. BMJ 2010;340:c738

2. Malouff JM, Thorsteinsson EB, Rooke SE, Bhullar N, Schutte NS. Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: a meta-analysis. Clin Psychol Rev. 2008 Jun;28(5):736-45.

3. Wiborg JF, Knoop H, Stulemeijer, M, Prins JB, Bleijenberg, G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med, 2010 Jan 5:1 -7. [Epub ahead of print]

4. Rapport d'valuation (2002–2004) portant sur l'excution des conventions de rducation entre le Comit de l'assurance soins de sant (INAMI) et les Centres de rfrence pour le Syndrome de fatigue chronique (SFC) (2006) http://www.inami.fgov.be/care/fr/revalidatie/general- information/studies/study-sfc-cvs/pdf/rapport.pdf (Date last accessed: 11 February 2010).

5. Kindlon T, Goudsmit EM. Graded exercise for Chronic Fatigue Syndrome: Too soon to dismiss reports of adverse reactions. J Rehabil Med. 2010 Feb;42(2):184-6.

Competing interests: None declared






Re: Why do doctors refuse to believe patients? 12 February 2010

Ellen Goudsmit,
Registered Psychologist (Health)
London TW11 9QX
Send response to journal:
Re: Re: Why do doctors refuse to believe patients?

Re my post 11th February 2010.

I'd like to apologise to Dr. Santhouse for misspelling his name after the first citation, which was correct. I also wish to note that reference 1 in the text relates to reference 2 in the list.

Ellen Goudsmit PhD C.Psychol. FBPsS

Competing interests: None declared





Defeatism and Chronic Fatigue 12 February 2010

Alastair C Young,
Neurologist
Bolton BL1 4QR
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Re: Defeatism and Chronic Fatigue

Santhouse and colleagues comment on the defeatism of clinicians with regard to the chronic fatigue syndrome.Much of the blame for this reaction is the bullying and badgering from a pwerful lobby,predominantly lay but partly medical, which will not accept any role for psychological factors in the cause of this disorder.

If there is a physical cause then there is certainly no standard medical treatment available at present.To encourage the unfortunate victims to pursue the purely physical approach is to deny them the benefits of the treatments outlined by Santhouse and his colleagues.

Competing interests: None declared

More light needed 12 February 2010

Neil H Riley,
Chairman of The ME Association
7, Apollo Office Court, Gawcott, Buckingham MK184DF
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Re: More light needed

As both a patient with ME/CFS and the Chairman of a National Charity whose purpose is to inform, fund research and support those with the illness I have found little defeatism amongst the medical professionals I have met. There are those who are perplexed; those who accept the chronicity; those who believe they know a treatment that will help.

What is missing in this debate is the need to examine more closely the huge range of patients lumped together under the CFS/ME diagnosis. I have attended many support groups for this illness and the variety of presentations of symptoms is wide. Some clearly need active psychiatric help; others counselling; some are in recovery. But there is a core of chronically unwell members who are not depressed, whose illness began with a severe viral infection and who have not recovered. Despite the NICE Guideline recommended treatments of CBT and GET, those patients remain ill and we simply do not know why.

Until money is spent and researchers encouraged to look more closely at that group then this illness will continue to generate much heat but painfully little light. I and many thousands of others like me have an illness that limits our lives hugely but we do not have an air of defeatism. We have the intelligence, the drive and the belief that medical science will eventually find out why we are so ill.

Neil Riley

Chairman of the ME Association Buckingham. MK18 4DF

Competing interests: None declared





Severely affected - severely neglected 13 February 2010

Dr Charles B Shepherd,
Hon Medical Adviser
The ME Association, 7 Apollo Office Court, Radclive Road, Gawcott, Bucks MK18 4DF
Send response to journal:
Re: Severely affected - severely neglected

Santhouse et al (1) are correct to say that therapeutic defeatism is not the answer to ME/CFS and that suicidal intentions must always be taken seriously. However, they make a number of conclusions and observations that are over-simplistic, premature or inaccurate.

First, the media have, quite rightly, used the tragic case of Lynn Gilderdale to highlight the fact that severe ME/CFS exists and that there is a desperate need for biomedical research into the underlying cause. But the media coverage did not imply that ME/CFS is a 'commonly fatal' condition, and it was premature of the authors to then go on and conclude - without the benefit of robust epidemiological data - that mortality is not increased.

Second, a considerable amount of accumuating patient evidence (2) indicates that a significant proportion of people with ME/CFS find that the two behavioural treatments being recommended - cognitive behaviour therapy (CBT) and graded exercise therapy (GET) - are either ineffective (ie CBT) or harmful (ie GET). And the only research so far to investigate potential risk factors which are involved in the development of severe ME/CFS (3) has concluded that there is no evidence to implicate personality or neurotic traits. It is therefore disingenuous to claim that the use of these two behaviour-based therapies, in a group of patients who cannot normally travel to hospital to access them, is going to produce a 'dramatic recovery'.

Third, having dealt with the families of a number of people with ME/CFS who have committed suicide in recent years, the reasons for doing so are often related to a combination of factors which predominently involve lack of medical care and social support, failure to control key symptoms, and inadequate financial help.. While depression may be a factor in some cases it is not always present.

People with severe ME/CFS require multidisciplinary services in both a domiciliary and accesible hospital based setting that matches their complex individual needs. Having strongly criticised the current lack of care that is available, we question whether the NHS trusts the authors work for are in fact putting words into action and supplying domiciliary and in patient facilities for their severely affected ME/CFS patients.

References

1 Santhouse AM, Hotopf M, David AJ. Chronic fatigue syndrome. BMJ 2010; 340: 738 (13 February)

2 Report of the CFS/ME Working Group. Department of Health; January 2002. http://www.dh.gov.uk/dr_consum_dh/g...@dh/@en/documents/digitalasset/dh_4059506.pdf

3 Pheby D and Saffron L. Risk factors for severe ME/CFS. Biology and Medicine 2009; 1: 50 -74.http://biolmedonline.com/Articles/vol1_4_50- 74.pdf

Competing interests: Medical Adviser to an ME/CFS patient support and research funding charity. Member of MRC Expert Group on ME/CFS research.





CBT/GET is ineffective and potentially harmful. ME/CFS patients seem to die considerably younger. 13 February 2010

Frank N.M. Twisk,
Patient and literature researcher
Limmen, the Netherlands
Send response to journal:
Re: CBT/GET is ineffective and potentially harmful. ME/CFS patients seem to die considerably younger.

As has been established by the Bagnall et al. (1) and the Price et al. (2), the solution proposed by Santhouse (3) cognitive behavioural therapy (CBT)/graded exercise therapy (GET) reduced "fatigue severity" in 40% of chronic fatigued people, in contrast with 26% in usual care.

Taking into consideration the placebo effect, the fact that a reduction in "fatigue" is not reflected by objective improvement (4, 5), the fact that the evidence base for CBT and GET is almost non-existent, etc. one must conclude that CBT and GET is not effective.

Moreover, as established by large patient surveys, e.g. (6, 7), and by clinical practice (5), CBT/GET has a negative effect on the symptomology of many ME/CFS patients (pain, muscle weakness, neurocognitive impairment etc.)

This can be explained by the fact that exertion, and thus GET, intensifies the pre-existing pathophysiology: inflammation, immune dysfunction, immunosuppression, (persistent) infections, oxidative and nitrosative stress and their sequels, e.g. mitochondrial damage/dysfunction and a disturbed circulation (8, 9).

All in all, CBT/GET is a non-evidenced based therapy and even potentially harmful for many ME/CFS patients (10).

Santhouse also asserts incorrectly that 'the greatest risk to life is likely to be suicide' and 'this is often linked to depression that can be effectively treated'.

A study into the causes of death by a Jason (11) established that 20% of the patients had died from cancer, 20% had died as the consequence of heart failure, and 20% as a result of suicide.

The mean age of those who died from cancer and suicide was 47.8 and 39.3 years, respectively, which is 24 years younger than those who died from cancer and suicide in the general population.

The pathological abnormalities established in ME/CFS repeatedly plausibly explain an increased risk for cancer (12)and heart failure (13).

Certainly it is warranted to treat depression in ME/CFS.

However, succesfully treating depression, e.g. by antidepressants, has no effect on characteristic physical and cognitive ME/CVS symptoms (14, 15, 16).

In conclusion, the comments made by Santhouse do not seem to be very appropriate.

Ironically, the CBT/GET mantra by Santhouse and colleagues and denial of serious biological aberrations is exactly the reason why many patients feel that 'the medical profession has given up to them'.

It is about time the medical profession takes this devastating illness seriously by exploring the biological abnormalities in depth and developing effective therapies aimed at these aberrations.

So the death of Lynn Gilderdale and many others will not be in vain.

  1. Bagnall A, Hempel S, Chambers D, Orton V, Forbes C. The Treatment and Management of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis in Adults and Children. Centre for Reviews and Dissemination (CRD), University of York. 2007; CRD Report 35:161.

2. Price JR, Mitchell E, Tidy E, Hunot V. Cognitive behaviour therapy for chronic fatigue syndrome in adults. Cochrane Database Syst Rev. 2008 Jul 16;(3):CD001027.

3. Santhouse AM, Hotopf M, David AS. Chronic fatigue syndrome. BMJ. 11 February 2010. doi:10.1136/bmj.c738.

4. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Jan 5:1 -7.

5. Council of approval with regards to rehabilitation contracts with CFS reference [Akkoordraad in het kader van de revalidatieovereenkomsten inzake ten laste neming door Referentiecentra van patinten lijdend aan het Chronisch vermoeidheidssyndroom] [Dutch]. Evaluation Report (2002- 2004) with respect to Rehabilitation Contracts between the RIZIV and the CFS Reference Centers [Evaluation Report 2002-2004 with respect to rehabilitation contracts between the RIZIV and the CFS Reference Centers] [Dutch). 2006, July.

6. Action for M.E./AfME. Scotland M.E./CFS Scoping Exercise Report. 2007.

7. Bjrkum T, Wang CE, Waterloo K. [Patients' experience with treatment of chronic fatigue syndrome] [Article in Norwegian]. Tidsskr Nor Laegeforen. 2009 Jun 11;129(12):1214-6.

8. Kerr JR, Petty R, Burke B, Gough J, Fear D, Sinclair LI, Mattey DL, Richards SC, Montgomery J, Baldwin DA, et al. Gene expression subtypes in patients with chronic fatigue syndrome/myalgic encephalomyelitis. J Infect Dis. 2008 Apr 15;197(8):1171-1184.

9. Gow JW, Hagan S, Herzyk P, Cannon C, Behan PO, Chaudhuri A. A gene signature for post-infectious chronic fatigue syndrome. BMC Medical Genomics 2009, 2:38. doi:10.1186/1755-8794-2-38.

10. Twisk FNM, Maes M. A review on cognitive behavorial therapy (CBT) and graded exercise therapy (GET) in myalgic encephalomyelitis (ME)/chronic fatigue syndrome (CFS): CBT/GET is not only ineffective and not evidence-based, but also potentially harmful for many patients with ME/CFS. Neuro Endocrinol Lett. 2009 Aug 26;30(3):284-299.

11. Jason LA, Corradi K, Gress S, Williams S, Torres-Harding S (2006). Causes of death among patients with chronic fatigue syndrome. Health care for women international. 2006; 27 (7): 615–26. doi:10.1080/07399330600803766.

12. Meeus M, Mistiaen W, Lambrecht L, Nijs J. Immunological similarities between cancer and chronic fatigue syndrome: the common link to fatigue? Anticancer Res. 2009 Nov;29(11):4717-26.

13. Maes M, Twisk FNM. Why myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) may kill you: disorders in the inflammatory and oxidative and nitrosative stress (IO&NS) pathways may explain cardiovascular disorders in ME/CFS. Neuro Endocrinol Lett. 2009;30(6):677- 93.

14. Vercoulen JH, Swanink CM, Zitman FG, Vreden SG, Hoofs MP, Fennis JF, Galama JM, van der Meer JW, Bleijenberg G. Randomised, double-blind, placebo-controlled study of fluoxetine in chronic fatigue syndrome. Lancet. 1996 Mar 30;347(9005):858-61.

15. White PD, Cleary KJ. An open study of the efficacy and adverse effects of moclobemide in patients with the chronic fatigue syndrome. Int Clin Psychopharmacol. 1997 Jan;12(1):47-52.

16. Wearden AJ, Morriss RK, Mullis R, Strickland PL, Pearson DJ, Appleby L, Campbell IT, Morris JA. Randomised, double-blind, placebo- controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. Br J Psychiatry. 1998 Jun;172:485-90.

Competing interests: None declared





There's none so blind as those who will not see 13 February 2010

Louise E Ellis,
Chair of the Manchester M.E. Society
M24 1JX
Send response to journal:
Re: There's none so blind as those who will not see

When is the medical profession in the UK going to wake up to the fact that CBT and GET are not effective treatments for M.E? They may be effective for some patients whose fatigue is of a psychiatric origin. However, as patient surveys repeatedly show, CBT and GET are either of no use or result in worsening symptoms for the majority of M.E. patients.

M.S. was proven not to be ‘hysterical paralysis’. How long do we have to wait before the medical profession admits that M.E. is not a treatable psychosocial illness?

What M.E. patients would like to see is biological research into the condition. Repetition of the erroneous claim that CBT and GET are the answer to the condition is only making the situation worse for us.

Competing interests: None declared





Using the correct tool for the right job 13 February 2010

Kelly Latta,
medical writer
27601
Send response to journal:
Re: Using the correct tool for the right job

It is unfortunate that neither the editorial staff or Drs. Santhouse, Hotopf, and David have anything new to add in terms of relevant information.

Like talk therapy, CBT has also been shown to help some patients in some cases with other organic diseases as well as those who may not even have a disease. It is not the secret they seem to think it is. But neither is it the only tool in the shed.

Unfortunately CFS has come to be an umbrella term used to describe anything from people who are merely tired and weary all the way to severely sick patients with an organic brain disease (CFS WHO ICD-10 G93.3 Vol.3 pg 528).

It is illogical to assume that any one treatment is going to meet the needs of such a heterogenous group.

Nor do the authors mention that research with anti-virals and immune system modulators show that in appropriate subgroups these may be the most effective treatments. Nor do they mention pacing.

As to causes of death in CFS, there is not much research, but the research that exists shows that patients are most likely to die of cancer, heart failure and suicide decades sooner than their contemporaries in the general population. (Patients with AIDS don't die of AIDS either, but they do die.)

As for suicide, it is always unfortunate when stigmatization by the medical community has such a negative iatrogenic effect.

Kogelnik AM, Loomis K, Hoegh-Petersen M, Rosso F, Hischier C, Montoya JG. Use of valganciclovir in patients with elevated antibody titers against Human Herpesvirus-6 (HHV-6) and Epstein-Barr Virus (EBV) who were experiencing central nervous system dysfunction including long-standing fatigue. J Clin Virol. 2006 Dec;37 Suppl 1:S33-8.

Propsner NM.Fatigue that doesn't go away. N J Med. 1999 Jun;96(6):29- 31.

Suhadolnik RJ, Reichenbach NL, Hitzges P, Adelson ME, Peterson DL, Cheney P, Salvato P, Thompson C, Loveless M, Mller WE, et al.Changes in the 2-5A synthetase/RNase L antiviral pathway in a controlled clinical trial with poly(I)-poly(C12U) in chronic fatigue syndrome. In Vivo. 1994 Jul-Aug;8(4):599-604.

Fluge , Mella O. Clinical impact of B-cell depletion with the anti- CD20 antibody rituximab in chronic fatigue syndrome: a preliminary case series. BMC Neurol. 2009 Jul 1;9:28.

Staines DR, Brenu EW, Marshall-Gradisnik S. Postulated vasoactive neuropeptide immunopathology affecting the blood-brain/blood-spinal barrier in certain neuropsychiatric fatigue-related conditions: A role for phosphodiesterase inhibitors in treatment? Neuropsychiatr Dis Treat. 2009;5:81-9. Epub 2009 Apr 8.

Jason LA, Corradi K, Gess S, Williams S, Torres-Harding S. Causes of Death Among Patients With Chronic Fatigue Syndrome. Health Care for Women International, 27:615–626, 2006

Levine, P. H., Atherton, M., Fears, T., & Hoover, R. (1994). An approach to studies of cancer subsequent to clusters of chronic fatigue syndrome: Use of data from the Nevada State Cancer Registry. Clinical Infectious Diseases, 18(Suppl. 1),S49–S53.

Peckerman, A., LaManca, J. J., Dahl, K. A., Chemitiganti, R., Qureishi, B., & Natelson, B. H. (2003). Abnormal impedance cardiography predicts symptom severity in chronic fatigue syndrome. The American Journal of the Medical Sciences, 326(2),55–60.

Green, J., Romei, J., & Natelson, B. J. (1999). Stigma and chronic fatigue syndrome. Journal of Chronic Fatigue Syndrome, 5, 63–75.

Competing interests: None declared





No room for complacency 13 February 2010

Derek FH Pheby,
Visiting Professor of Epidemiology, and Project Coordinator, National ME/CFS Observatory
Faculty of Society and Health, Bucks. New University, 106, Oxford Road, Uxbridge, UB8 1NA
Send response to journal:
Re: No room for complacency

Santhouse et al (1) quoted with approval Mr. Justice Simon’s judgment in the judicial review of the NICE guidelines on CFS/ME, that there is "... a perception that this is an area of medicine where contrary views are not to be voiced, and where scientific enquiry is to be limited, [that] is damaging to science and harmful to patients" (2). They will therefore not object if I venture an opinion contrary to theirs.

They cite a recent systematic review (3) as evidence of the effectiveness of behavioural interventions such as cognitive behaviour therapy and graded exercise in CFS/ME, yet that same review states: “The protocols for many clinical studies require patients to attend a clinic for treatment and/or assessment. These conditions may exclude people severely affected with CFS/ME from taking part and hence bias the sample towards those with less severe symptoms.” Indeed, the only evidence cited by Santhouse et al that such interventions may benefit the severely affected is an uncontrolled pilot study of only nineteen patients, published more than a decade ago (4).

There is no evidence at all that such interventions would have benefited Lynn Gilderdale, or others in a similar position, or averted the tragic outcome of this case. A recent large-scale survey by the ME Association found that over 50% of respondents reported that behavioural treatments such as cognitive behaviour therapy and graded exercise therapy were either ineffective or made their condition worse (5). This is consistent with my own recently published study (6), which indicated that inappropriate treatment in the early stages of the illness was an important factor in the development of severe disease, and a survey by Action for ME in which a clear majority of severely affected respondents reported delays in diagnosis and lack of care and support from healthcare professionals (7).

It is not so much that “...an air of defeatism exists within the medical profession about this condition, particularly for those who are severely affected.” It is rather that a realistic assessment is that we do not yet have sufficient understanding of this very unpleasant illness to treat it effectively, and to suggest that we do is unjustifiably complacent. A much more positive note was struck by a letter in the “Daily Telegraph”, published in the aftermath of the acquittal of Kay Gilderdale, which was signed by twenty authorities in the field, including clinicians, researchers, politicians, and leaders of voluntary organisations (8). This stated clearly that, if any positive lesson was to be learned from the death of Lynn Gilderdale and the subsequent trial of her mother, it was that there is an urgent need for better services for people with ME, and more research, in order to disentangle once and for all the underlying pathology of this disease and to develop effective treatments.

References

1. Santhouse AM, Hotopf M, David AS. Chronic fatigue syndrome (editorial). BMJ 2010; 340: 738.

2. R (Fraser and Short) v NICE Case numbers CO/10408/2007 and CO/10435/2007 (2009).

3. Chambers D, Bagnall AM, Hempel S, Forbes C. Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med 2006;99:506-20.

4. Essame CS, Phelan S, Aggett P, White PD. Pilot study of a multidisciplinary inpatient rehabilitation of severely incapacitated patients with the chronic fatigue syndrome. J Chronic Fatigue Syndr 1998;4:51-60.

5. Shepherd C. Mind or Body? (Letter). New Scientist 2009; no. 2702 (2nd. April).

6. Pheby D, Saffron L. Risk factors for severe ME/CFS. Biology and Medicine (2009); 1(4):50-74.

7. “Severely Neglected”, London, Action for ME, 2001.

8. The Countess of Mar et al. Breaking the ME enigma (letter). Daily Telegraph, 6 February 2010.

Competing interests: None declared
 

Dolphin

Senior Member
Messages
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The BMJ hasn’t put up any responses to this article in the last two days (but has for others).

I know at least two people who sent in replies (one asked me about references so I presume they included one or more).

So it’s probably best not to waste one’s time sending in a reply until we see that more appear.

In the past, the BMJ let lots and lots of responses through in reply to other articles and papers.
 

Dolphin

Senior Member
Messages
17,556
Likes
28,245
The BMJ hasn’t put up any responses to this article in the last two days (but has for others).

I know at least two people who sent in replies (one asked me about references so I presume they included one or more).

So it’s probably best not to waste one’s time sending in a reply until we see that more appear.

In the past, the BMJ let lots and lots of responses through in reply to other articles and papers.
Back to normal again. Four comments went up there now (they usually put up comments once per day and had already put comments up today so I thought it was it for today)