The FINE Trial. BMJ ARTICLE. Nurse led, home based self help treatment for patients in primary care

[Cort]

I wonder if this trial could prove to be a turning point in ME/CFS research, unlikely though that might seem? It is, by far, the largest clinical trial ever published with nearly 300 participants. In a lot of ways it's more rigorous than previous trials - they even had a statistician as a co-author.

The result for this trial was negative, while the smaller, less rigorous pilot trial of the same approach claimed over 60% of patients 'recovered' versus under 10% for the waiting list control group.

I think maybe the therapy was proved unsuccessful because it was a good, robust trial. Also, the therapy uses a model that assumes deconditioning is the main factor underlying this illness. The therapy failed: what does that say about the deconditioning model?

And as the trial used the Oxford Criteria rather than one of the more tightly defined criteria eg CDC, the failure is even more striking.

Negative results can sometimes be as telling as positive ones.

The PACE trial is due to publish later this year and I'm optimistic that it will be a rigorous trial giving a reliable result. They've recruited 600 patients and the protocol alone runs to 13 pages. Many of the authors have suspect research records but I think the PACE trial will be in a different league. Time will tell.

I'm not up on the UK stuff but I'm more inclined to think this is a big blow to these types of efforts; its a big expensive study - they threw everything they had at it - they rigorously trained the nurses, they videotaped them and they brought in a more representative set of patients. This study demonstrates that its impossible to do this type of therapy effectively on a large scale on the broad swath of CFS patients - its basically stating in my view, since CBT done by therapists is so expensive, that that branch of the medical community has little to offer CFS patients.

It can only hurt; now the government has to contemplate (a) spending massive amounts of money for trained therapists to do this type of work -something they probably would never do (b) going in a different direction (c) forgetting about the public health aspect of CFS. The possibility of treating CFS patients on a broad scale using these therapies just got a heck of a lot harder to do in the UK.

 

[Cort]

The authors will get to now to do more studies because it was a failure. That's good for them, as it gives them a job, a salary. A cure would mean that people would be ticked off the list, eventually there would be no patients to treat, no job, no salary. The decondition theory will still hold up based on this, as they say you need to be a specially trained therapist not a nurse with four months training.

Here a link where you can find magical medicine. It is long, about 400 pages, but you can skip around and get the idea. http://www.investinme.org/Article400%20Magical%20Medicine.htm

I disagree. Yes those authors may get more work - its a big field but their big project failed and failure is typically rewarded with no further studies. Training nurses to deliver CBT-like courses is not going to happen in the UK. That's a big thing because the government presumably could have afforded something like that and that would have been the new 'answer' to CFS. Sure, they'll try other things but this big possibility - which UK officials must have dearly hoped for - is probably over.

 

[oceanblue]

The authors will get to now to do more studies because it was a failure. That's good for them, as it gives them a job, a salary. A cure would mean that people would be ticked off the list, eventually there would be no patients to treat, no job, no salary. The decondition theory will still hold up based on this, as they say you need to be a specially trained therapist not a nurse with four months training.

If this was just another small clinical trial, then that would probably be the case. But FINE was altogether different as the largest ever clinical trial, with nearly 300 participants, it was 7 years in the making and cost well over 1m. Failure on this scale is surely anything but a case for more funding?

Authors' weak defence
Two arguments have been used to explain why the trial didn't work but both are undermined by the trial itself.
1. The therapy wasn't done correctly. The model itself and the detail of the therapy were designed by the trial authors so the only let out was that it wasn't applied correctly. However, as the paper spells out, training was rigorous, nurses were checked in 'live' therapy situations before the trial began and all sessions were recorded. Crucially, independent assessors were asked to listen to sessions and rate how well the nurses applied the therapy during the trial (another example of a well-designed trial). Assesors gave an average rating of 5.5 out of 7, equivalent to very good. So according to both the authors and the independent assessors, the therapy was carried out correctly. Sure, experienced therapists might have got slightly better results but not changed the overall result. Remember, the pilot study showed a huge different between the therapy group and the controls.

2. The intervention was too little given the illness of the participants. Well, before the results came out the authors were pleased to point out that their study was based in primary care with patients treated at home and no exclusions because that's a better sample of the real world than a specialist hospital clinic. They knew what they were letting themselves in for, so it's a bit odd to now suggest that the protocol was wrong.

More importantly, if it really was the case that illness severity was the issue, where is the analysis to back this up? It would be easy to divide patients into two groups based on how ill they were at the start of the study: say the most ill half versus the least ill half. No new research is needed. I suspect that the reason no such analysis was published was because it doesn't support their case.

So neither of the excuses for the trial up to examination, and I think the authors know it. They have, unwittingly I suspect, provided good evidence to undermine their own theories, and it seems a shame to let this evidence go to waste.

As I see it, the authors are currently wriggling on a hook. Dismissing the study risks letting them off this hook when it might be more in our interests to tell the world that they have had a truly impressive failure.

Thanks for all the links to magical medicine, looks like quite a read.

 

[Marco]

Taking a slightly different tack on this, there's quite a bit of evidence that the CBT psychs have been busily empire building and have indeed received criticism from within their own ranks for pushing the 'therapy' beyond its original premise and onto unsuitable patient groups/illnesses. Meanwhile the NHS have been gleefuly ramping up the capacity to deliver CBT to more and more patients e.g. :

http://www.psychminded.co.uk/news/news2008/feb08/depression004.htm

I find it interesting that the PACE trial uses a VERY ill defined version of pacing as one of the control therapies (no guesses how succesful this will be compared to CBT and GET) and the nurse delivered CBT/GET has failed.

My cynical take on this is that pacing, usual GP care (non-existent) and nurse delivered CBT/GET were set up to fail. In contrast, the psych led CBT and GET will be a roaring success leading to a further tranche of CBT trainees funded by the NHS.

The usual suspects will probably be knighted for their contribution to medicine.

 

[Bob]

I disagree. Yes those authors may get more work - its a big field but their big project failed and failure is typically rewarded with no further studies. Training nurses to deliver CBT-like courses is not going to happen in the UK. That's a big thing because the government presumably could have afforded something like that and that would have been the new 'answer' to CFS. Sure, they'll try other things but this big possibility - which UK officials must have dearly hoped for - is probably over.

Cort, the PACE trial is the big one to watch out for in the UK... I think it's been running for years and I think it's had more funding than the FINE trial...
It involves comparing: "adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and standardised specialist medical care."
In other words, it's comparing CBT, GET, standard medical care, and a form of Pacing (Adaptive Pacing Therapy, which is a perverted form of pacing, adapted by psychologists, maybe to fit their own world view of ME - it's not pacing as we know it anyway).
I would be very surprised if it was allowed to fail, as they have done everything in their power to set it up to 'succeed'. (It's using the unofficial, unpublished, Oxford criteria for starters! The Oxford criteria doesn't exclude psychiatric patients.)

 

[Bob]

My cynical take on this is that pacing, usual GP care (non-existent) and nurse delivered CBT/GET were set up to fail. In contrast, the psych led CBT and GET will be a roaring success leading to a further tranche of CBT trainees funded by the NHS.

This is an interesting observation Marco, and I wouldn't be entirely surprised if this was the case, but I can't quite bring myself to believe that the FINE trial was set up to fail... but I think that the FINE trial will quickly be brushed under the carpet and conveniently forgotten anyway, once the PACE trial is published with the biggest publicity and PR event that we've ever seen in the ME community.

 

[Cort]

I doubt the originators of the study set their own study up to fail - particularly since it was predicated on the success of an earlier study they had engaged in. I agree PACE is more important - altho I think its a big deal that a nurse based intervention is out - since the UK clearly would have loved to go that route, and it would have been devastating to UK CFS patients.

I see recruitment for PACE ended Nov of 2008, the one year followup ended in March 2010 and they're writing up the results.

Call me naive but I believe the results will be reported accurately and then, as every researcher does, massaged as best as they can to support their beliefs. That's what happened with the FINE trial - which had terribly disappointing results. It also happened with a Belgian, I think it was, study that was reported at the Reno Conference last year.

I would note that yes the study used Oxford Criteria but so did the FINE study and the PACE trial will be broken up into people meeting the CDC and other criteria. The FINE study indicated that many members had other co-occurring conditions ie researchers using that definition do not necessarily exclude people with other co-ocurring conditions from the studies - as is often reported here.

In any case we'll be able to tell: PACE will give us full demographics and clinical information including the level of co-morbid diseases. If there aren't any we'll know!

I didn't realize that this was present

Adaptive Pacing Therapy
APT will be based on the illness model of CFS/ME as a currently undetermined organic disease, with the assumption that APT can improve quality of life, although not affect the core disease, other than providing the best conditions for natural recovery. APT is essentially an energy management approach, which involves assessment of the link between activity and subsequent symptoms and disability, establishing a stable baseline of activity using a daily diary, with advice to plan and pace activity in order to avoid exacerbations. Strategies include developing awareness of early warning of exacerbations; limiting demands; regular planned rest and relaxation, and alternating of different sorts of activities. The aim is to achieve optimal adaptation to the illness [4,16,17]. The patient charity Action for M.E. have helped in the design of the APT manual and have endorsed this version of pacing, which is based on what is published and what patients and clinicians have reported as helpful. Both therapists and participants will receive separate manuals.

 

[Bob]

Call me naive but I believe the results will be reported accurately and then, as every researcher does, massaged as best as they can to support their beliefs.

It has been suggested that they may have already manipulated their data, by subtly manipulating the patients, as per Prof Hooper's 'Magical Medicine' report.
http://www.meactionuk.org.uk/magical-medicine.pdf

 

[oceanblue]

By chance, I was taught pacing by one of the Action for ME occupational therapists who was involved in producing the manuals for APT for the PACE trial. She's very good, knows her stuff and as far as I'm aware the APT approach was not adapted by pyschologists, as Bob suggests, since it's not their therapy and I don't think it will be a perverted form of pacing - though I haven't seen the APT manual so I don't know for sure.

 

[Bob]

By chance, I was taught pacing by one of the Action for ME occupational therapists who was involved in producing the manuals for APT for the PACE trial. She's very good, knows her stuff and as far as I'm aware the APT approach was not adapted by pyschologists, as Bob suggests, since it's not their therapy and I don't think it will be a perverted form of pacing - though I haven't seen the APT manual so I don't know for sure.

I thought I'd read about their APT and it didn't look very healthy to me... but it was a long time ago, and now I can't remember exactly what I read... so I may well be mistaken... maybe I should look it up and post some info about it.

 

[V99]

Oceanblue.

So did the therapist get you to increase what you were doing? How often?

 

[Marco]

The APT 'manual' was discussed extensively in Magical Medicine. The conclusion was that it was a hastily thrown together sop with pages being filled by banal repitition and full page cartoons. Hardly representative of a therapy given the same opportunity for success as the non control therapies.

 

[V99]

Here are some sections of magical medicine.

The Trial Identifier states at section 2.5 that the results of this trial will provide the first test of pacing against usual medical care. Testing this theory hardly requires a multi‐million pound trial. Most ME/CFS patients learn from experience that they must pace rather than push themselves and, as far as ME/CFS is concerned, usual medical care is non‐existent.

Wessely School psychiatrists are disparaging about pacing as a method of self‐management. At Section 2.3 the Trial Identifier states:

Pacing has been described in the scientific literature as a lifestyle management that allows optimal adaptation to the illness. It has been advocated by exponents of the envelope theory of CFS, which states that a patient has a fixed and finite amount, or envelope, of energy that they must adapt to by managing activity. A non‐randomised comparison of adaptive (rather than rehabilitative) CBT, which included adaptive pacing therapy (APT) based on this model, found that this treatment was no more effective than the control condition (the control condition was primary depression). A recent systematic review concluded that there was insufficient evidence to recommend adaptive pacing at present.

It seems that the Trial Investigators may hope to show that pacing is ineffective (especially in returning people to gainful employment) but that CBT and GET are effective in returning people to work.

page 239

In 2002, the same year that he applied for funding for the PACE Trial, Professor White explained why he and some of his like‐minded colleagues resigned from the Chief Medical Officers Working Group that reported on CFS/ME in 2002: some clinicians could not agree to recommend pacing on the basis of patient group experience alone.....some clinicians believed that the report over‐emphasised the severity and chronicity of CFS to the extent of suggesting that recovery was unlikely, when the evidence shows that not to be true. The reports recommendation omitted any suggestion that cognitive behaviour therapy and graded exercise therapy should be more readily available. These recommendations were obfuscated by equally promoting pacing. The theoretical risk of pacing is that the patient remains trapped by their symptoms in the envelope of ill‐health (Postgraduate Medical Journal 2002:78:445‐446).
However, in his PACE Trial Protocol (2006 version), Professor White states: All the participating clinicians regard all the four treatments (including pacing) as potentially effective, which contradicts his published views.

In relation to APT, the PACE Trial literature informs participants that Adaptive Pacing Therapy (APT) is strongly recommended by the patients charities, but on searching the Action for ME website for either adaptive pacing therapy or APT, neither term comes up.

To misinform participants in such a manner is surely unacceptable, but misleading material occurs throughout the PACE Trial literature.

Notably, whilst therapists are trained to psych‐up patients on the CBT and GET arms of the Trial for their triumphant return to work, patients on the APT arm of the Trial are not to be psyched‐up to return to work.
265

It seems that, in comparison with CBT and GET, the Trial Investigators do not mind if APT fails in getting participants back to work (which might more readily occur if there is no up‐beat enthusiasm conveyed to participants in the APT arm of the PACE Trial).

pages 264/5

The PACE Trial Identifier states at Section 2.3:

Because CBT and GET are based on graded exposure to activity or exercise, they may preferentially improve disability, whilst APT, being based on the theory of staying within the limits of a finite amount of ʺenergyʺ, may improve symptoms, but at the expense of disability (emphasis added).
Thus there is clear antipathy shown by the Trial Investigators towards APT, yet while the PACE Trial Protocol states that pacing has no scientific basis, the therapists Manuals (though not the participants Manuals) state that SSMC, CBT and GET may nevertheless all be considered to be forms of pacing.
This is an extraordinary notion. Pacing is common sense and it does not involve planned exercise.

Common sense cannot be turned into a therapy.

APT, however, seems not to be pacing, since it seems to involve achieving and sustaining targets; it seems that the Trial Investigators were seeking to placate participants by referring to APT as pacing (which participants know to be helpful) when in reality APT is a vehicle for incremental aerobic (or, according to the Investigators, paced) exercise.

There was obvious concern about APT expressed at the Joint meeting of the Trial Steering Committee and the Data Monitoring and Ethics Committee held on 27th September 2004 with members showing doubt about how APT should be defined and how it could be assessed in a trial:

As this is a therapy being designed specifically for PACE that has never been previously tested in a randomised trial for patients with CFS/ME, this manual requires slightly more thorough piloting than the more established therapies. As a consequence, the manual might be altered even after the MREC submission has been made (Minutes, section 9).

page 265

 

[V99]

This is from the section called, Quotations from the Therapists Manual on APT, page 359

The Investigators claim that APT has been used in response to patient feedback and support from various groups, but APT is not pacing; there is no description of APT in the public domain, so the claim that it was included because patients find it helpful is difficult to understand (Co‐Cure RES: 4th February 2010).

APT Therapists are told: The aim is to provide the best conditions for natural recovery to occur. A lessening of activity‐related symptoms is regarded as evidence of recovery which may permit an increase in activity and that The pacing therapy used in this trial is based on that reported as useful by people with CFS/ME and collated by the patient organisation Action for ME (AfME 2002, 2003).

The key words appear to be based on the pacing reported as useful by people with CFS/ME because it appears that APT is different from the pacing reported as useful: APT is adaptive pacing, which is substantially different from pacing.

As noted above in the introduction to Section 4 of this Report: Activity is therefore planned, which indicates a structured activity/rest regime, and the APT Therapists Manual lists requirements for APT including plan set activity in advance (so activity must be set activity, not simply what the patient may be capable of

doing at the time); there must be activity analysis; APT participants must constantly review model, diaries and activity and there is the requirement to involve relatives, which is nothing like doing what you can when you can.

To reiterate: the PACE Trial version of pacing (APT) requires homework and practice and includes planned relaxation and activity, practised regularly and consistently (ie. effectively to a timetable) and the use of daily diaries in which participants must analyse their own activities. Participants must undertake breathing exercises and APT involves its own targets and methods. Its aim is that the participants do not remain at a fixed activity level.

The Theoretical Model of APT is The concept of fixed limits and this is explained: The basic underlying concept of adaptive pacing is that CFS/ME is an organic disease that the person can adapt to but cannot change.

This is clarified for the therapists: Because people with CFS/ME are likely to be particularly sensitive to, and fearful of, a perceived over‐emphasis on psychological factors, a physical model of disease that limits energy is emphasised and used throughout treatment.

Does this mean that the PIs acknowledge CFS/ME to be an organic disease in one arm of the PACE Trial but not in two other arms of the same trial, or are APT participants being misled about the PIs beliefs, (because in the other Manuals, a physical model of disease equates with deconditioning)?

pages 370/1

It is notable that the PACE Trial Investigators are willing to accept the AfME survey results on pacing as reliable but dismiss the AfME survey results on GET.

page 371

On page 23 of the APT Manual for Therapists, they are informed that: ...the person with CFS/ME alternates from relative symptom‐free rest to activity‐induced symptoms; this again, is assumption presented as fact, because people with ME/CFS may not be relatively symptom‐free at rest. People with true ME may be in constant pain when at rest; they may experience nausea, dizziness, sweating, shivering, breathlessness,
372

cardiac arrhythmia, shaking, muscle spasms, leaking blood vessels resulting in spontaneous bleeds, vascular spasms, and intense malaise (feeling terrible) even at rest.
Therapists are told that participants should ensure that activities are interspersed with periods of proper rest and that Another (way) that may enable the person with limited energy to achieve more is to alternative (sic) activities (one can only wonder if anyone proof‐read this Manual).

Therapists are advised that: As natural recovery occurs the person with CFS/ME may find that they feel able to increase activity. When such recovery occurs the person may wish to establish a new baseline. Activity...(is) built up as tolerance increases. Not only is there no guarantee that natural recovery will occur, neither is there any evidence that tolerance will increase in patients with ME/CFS (who may be struggling to maintain enough energy necessary for basic survival).

The Manual then informs APT Therapists about Therapists Preparation and tools and about General Adherence to Protocol; cancellations or failure to attend must be rearranged within 5 working days if possible; Telephone contact between sessions ...is not banned but should be discouraged; if a participant no longer wants to participate in the trial...the centre leader...should be informed on the same day...; each session should be audio/or video taped.

Therapists are instructed in the Knowledge and skills required, which include empathy, warmth, rapport, supportive encouragement, interactive communication, active engagement between therapist and participant, problem solving, involvement of family members, and liaison with employers, other health professionals and other outside agencies; therapists are instructed that it is important they convey to participants their belief in the reality of their symptoms and therapists are told they are required to demonstrate a sound knowledge of CFS/ME as participants will generally be well‐informed about their illness (many occupational therapists, including those working in the CFS Centres from which PACE Trial participants were referred, are known to believe that ME/CFS is a behavioural disorder ‐‐ see RiME NHS Clinics Folder at www.erythos.com/RiME ).

The authors then re‐instruct the APT Therapists that: People with CFS/ME are often sensitive to the over‐ emphasis of psychological factors, a curious statement, given that the APT therapists are supposed to be working on the assumption that CFS/ME is an organic disease.

Notwithstanding, the CBT Therapists Manual cautions: In order to maintain participants engagement throughout treatment, it is important that you continue to use an integrative model and avoid promoting a rigidly dichotomous view of physical and psychological illness.

APT Therapists are informed that participants may find that their symptoms initially worsen when they start their APT programme, but if true pacing is used (which APT is not), symptoms are unlikely to worsen when patients pace themselves.

On page 31 of the Manual, APT Therapists are told: Collaboration is an essential skill when working with people with CFS/ME: (surely collaboration is essential with all patients, whatever disorder they may be suffering from?) and that: It is essential that you demonstrate positive reinforcement when you work with people with CFS/ME. Often they will be very good at pointing out what they havent achieved.

This seems to convey the message that CFS/ME patients are somehow different and even psychologically aberrant; indeed, the PACE Trial Manuals disparagingly refer to these people as though participants are a different and difficult species. Perhaps this explains why APT Therapists are advised that: Another useful communication technique to assist in problem solving is the broken record technique where you repeat the ...statement frequently within a session to emphasise a... point.

pages 371/2

 

[V99]

I will leave you with one more gem from magical medicine, page 374

The next section of the Manual addresses “Frequently Asked Questions, comments and issues”. There are a number of questions that participants may ask during treatment. Below are a number of those potential questions and the possible responses you could consider to bring the person back to the APT model” (it is unclear if this is just badly written or if it amounts to coercion to keep the participant engaged in the trial at all costs). Some illustrations include the following:

“Is this a cure?

• Be honest, the answer is no” (APT has never been trialled before, so how do the authors know that it
is not a cure? CBT/GET participants are told that they can “overcome” their “CFS/ME” but the APT participants are told that they cannot; this is unacceptable in an MRC clinical trial because it would inevitably have a nocebo effect – nocebo being the antonym of placebo)
• Aim of APT is to enable/facilitate a natural recovery response
• Aids natural recovery (surely this is the same as the aim directly above?)
• Recovery is achieved by balancing rest and activity (bullet point 1 states that APT is not a cure, whilst the final bullet point says that with APT, recovery is achieved by balancing rest and activity).

“How do I deal with a set‐back?
• Adjust any programme...rather than increase your activity
• Main advice = rest (it is important to recall that the Oxford [ie. the trial entry] criteria allow
participants with psychiatric disorders such as depression to be enrolled in the PACE Trial; if depressed people are told to rest, they may become even more depressed and the result will be that APT appears ineffective, an outcome which many people believe would suit the Principal Investigators, whose views on pacing are known to be unfavourable)
• Make realistic goals • Listen to your body
• Re‐consider balance....needs versus wants”; participants are to be advised to “re‐read the

Adaptive pacing model of CFS/ME”. “What is an exacerbation of symptoms?
• When symptoms have increased beyond your normal range
• Symptoms level stops you doing your baseline”.

“What do I do on a bad day?
• Rest, relax, sleep
• Consider reasons
• Re‐assess baseline.

“My illness is physical?
• Yes” (participants with the same disorder but in different arms of the same MRC clinical trial are
considered not to have a “physical” illness).

 

[Bob]

APT, however, seems not to be “pacing”, since it seems to involve achieving and sustaining “targets”; it seems that the Trial Investigators were seeking to placate participants by referring to APT as “pacing” (which participants know to be helpful) when in reality APT is a vehicle for incremental aerobic (or, according to the Investigators, “paced”) exercise.

Ah yes, thanks V99... I remembered correctly... APT is indeed a perverted form of pacing... It seems to be more like GET than pacing.

“As this is a therapy being designed specifically for PACE that has never been previously tested in a randomised trial for patients with CFS/ME, this manual requires slightly more thorough piloting than the more established therapies. As a consequence, the manual might be altered even after the MREC submission has been made” (Minutes, section 9).

So it's not pacing, as we know it, that they are trialing in the PACE trials... but they will try to promote the results of the trial to us as though they used pacing... and if the APT is found to be ineffective in helping the patients, then they will declare that pacing is ineffective as a therapy approach for ME.

 

[justinreilly]

Ah yes, thanks V99... I remembered correctly... APT is indeed a perverted form of pacing... It seems to be more like GET than pacing.

So it's not pacing, as we know it, that they are trialing in the PACE trials... but they will try to promote the results of the trial to us as though they used pacing... and if the APT is found to be ineffective in helping the patients, then they will declare that pacing is ineffective as a therapy approach for ME.

Causing confusion and muddying the science worked so well by perverting the meaning of ME with "CFS" and "CFS" with the oxford criteria, they're applying this verbal slight of hand to other areas like "pacing".

 

[justinreilly]

I disagree. Yes those authors may get more work - its a big field but their big project failed and failure is typically rewarded with no further studies. Training nurses to deliver CBT-like courses is not going to happen in the UK. That's a big thing because the government presumably could have afforded something like that and that would have been the new 'answer' to CFS. Sure, they'll try other things but this big possibility - which UK officials must have dearly hoped for - is probably over.

I agree, Cort.

 

[Bob]

I disagree. Yes those authors may get more work - its a big field but their big project failed and failure is typically rewarded with no further studies. Training nurses to deliver CBT-like courses is not going to happen in the UK. That's a big thing because the government presumably could have afforded something like that and that would have been the new 'answer' to CFS. Sure, they'll try other things but this big possibility - which UK officials must have dearly hoped for - is probably over.

Just to let you know what's going on over here in England, in terms of health care, and the authorities' view of CBT... The authorities are already convinced that CBT and GET should be the first line of treatment for ME (psychologists like our Simon Wessely made sure of that)... CBT and GET are the only treatments offered officially on the NHS... and it is set in stone in the NICE guidelines (National Institute of Clinical Excellence)... each locality of England has it's own health authority which is supposed to implement the NICE guidelines, but due to a perpetual lack of resources in the NHS, and the low priority that ME takes, the services available range from inadequate to non-existent.

A combination of CBT and GET is the standard approach to treatment by the NHS in England... (Scotland might be different.)
Generally, the only treatment available to us is a 10 week symptom management course (1 or 2 hours per week) which is based on CBT and GET techniques.

The authorities will not be dropping GET or CBT anytime soon, as much as we are trying to move them away from the psychological view of ME.

 

[Dolphin]

BMJ Rapid Response

Other people can post them also
http://www.bmj.com/cgi/eletters/340/apr22_3/c1777#235156

To be honest, I think the editorial:

Pragmatic rehabilitation for chronic fatigue syndrome
Rona Moss-Morris and William Hamilton
BMJ 2010 340: c1799. [Extract] [Full Text]

is more worthy of replies - the spin, etc. in it should be challenged.

From: Tom Kindlon

Missing Data

The authors took the time to write up and publish the protocol for this study back in 2006[1]. So it is somewhat strange that they do not mention many of the measures in this paper[2].

Probably the most significant omission is one of the outcome measures, the step test: “time to take 20 steps, (or number of steps taken, if this is not achieved) and maximum heart rate reached on a step-test”[1].

Another omission is the number of patients who satisfy the CDC CFS criteria [3] which they also announced they would measure (along with the Oxford criteria and London ME criteria). The CDC criteria remain the most widely used research criteria and many researchers and clinicians would be interested to know the proportion of the cohort who satisfied this set of criteria.

Of course, even when we are told how many people satisfied the London ME criteria, we are not given information about how they fared following the interventions. Just because the trial was largely unsuccessful (the protocol paper said: "the primary outcome point is 70 weeks"), does not mean such data is not of interest. For example, the ME patients in the pragmatic rehabilitation arm of the trial could have done worse at 20 weeks – there is certainly a large increase in the standard deviation of the Chalder Fatigue Scale scores at that stage.

The paper doesn’t make clear whether data from some of the other measures will be published in the future: “CALPAS measure of therapeutic alliance” (which was measured at three time points), “Visual analogue scale: treatment expectation”, “Symptom interpretation questionnaire”, “Brief social support measure” [5], “Brief Supportive Listening (SL) process measure” (self-report questionnaire (SRQ)) and “Brief belief measure” (SRQ)].

Given the cost of this trial to the taxpayer [1.3m was the figure previously reported on the National Research Register (NRR) website[6]], it would be useful if all the data was made available.

References:

[1] Wearden AJ, Riste L, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Dunn G, Richardson G, Lovell K, Powell P. Fatigue Intervention by Nurses Evaluation--the FINE Trial. A randomised controlled trial of nurse led self-help treatment for patients in primary care with chronic fatigue syndrome: study protocol. [ISRCTN74156610]. BMC Med. 2006 Apr 7;4:9.

[2] Wearden AJ, Dowrick C, Chew-Graham C, Bentall RP, Morriss RK, Peters S, Riste L, Richardson G, Lovell K, Dunn G; Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group. Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trial. BMJ. 2010 Apr 23;340:c1777. doi: 10.1136/bmj.c1777.

[3] Fukuda K, Straus S, Hickie I, Sharpe M, Dobbins J, Komaroff A, The International Chronic Fatigue Syndrome Study Group: The chronic fatigue syndrome: A comprehensive approach to its definition and study. Ann Int Med 1994, 121:953-959.

[4] Gaston L, Marmar C: The California Psychotherapy Alliance Scales. In The Working Alliance: Theory, research and practice. Edited by: Horvath A, Greenberg L. Toronto: John Wiley & Sons; 1994:85-108.

[5] Dalgard O, Bjork S, Tambs K: Social support, negative life events and mental health. Br J Psychiatry 2005, 166:29-34.

[6] http://www.nrr.nhs.uk/2005AnnualRep...?Code=5G9&Title=Mental+Health+in+Primary+Care [Last Accessed: October 4, 2007]

Competing interests: None declared