Chronic fatigue treatment trial

PACE trial authors’ reply to letter by Kindlon

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5963 (Published 15 October 2013)
Cite this as: BMJ 2013;347:f5963

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Displaying 11-20 out of 31 published

In reply to Professor Lynch, thank you, I did have a nice week-end, and I hope you did.

You were not exactly sure about my question.

What I meant was, do you think it fair or unfair not to be given the right of reply?

As far as so-called pragmatic trials are concerned, I don't know where the money would come from (1), and like PACE (2), I would not expect to see much, if any, public support:

"Pitfalls that may arise in assessing motivation may be that the patient has an undisclosed secondary gain in maintaining the sick role" (3).

1. http://www.biomedsearch.com/attachments/00/21/84/26/21842619/DialoguesCl... A pragmatic view on pragmatic trials Nikolaos A. Patsopoulos, MD, PhD Clinical research Dialogues in Clinical Neuroscience - Vol 13 . No. 2 . 2011

2. http://www.pacetrial.org/docs/participantsnewsletter2.pdf

"If you know of any friends or family who suffer from CFS/ME and who might be eligible and interested in taking part in the study and live close enough to one of these centres, please suggest they approach their GP for a referral to a PACE centre".

3. http://apt.rcpsych.org/content/1/2.toc http://apt.rcpsych.org/content/1/2/33.full.pdf+html
advances in psychiatric treatment Chronic Fatigue Syndrome Sean Lynch APT November 1994 1:33-40; doi:10.1192/apt.1.2.33

Competing interests: None declared

Douglas T Fraser, N/A

N/A, London W6 8NY

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In the 'real world', which Professor Lynch repeatedly refers to, it can take a decade to adjust to the devastation of this illness and I remain thankful there was no 'pressure' in the form of GET and CBT in the 1980s/90s when I was coping with adjusting, when I was often severely ill. The only pressure really came from myself, as like everyone else with this ilIness, I was desperate to get back to normal, and pushed myself to do so, only to experience a worsening of symptoms, time after time. I learned the hard way that recovery was elusive and in the end had no choice but to adapt to my limitations.

Although, happily, never exposed to GET, I have seen many PWME online report a worsening of their symptoms after GET. My advice to anyone with ME - and I mean classic Ramsay-defined ME - I don't honestly know what CFS/ME is, in the same way that I would not understand CFS/lupus or CFS/MS - is rest, listen to your body, don't ever force yourself beyond your limit, or you could make yourself worse, catastrophically so.

The only therapies that have ever helped me, short term, were ACTH injections and, later, intravenous vitamin C, I imagine because of their anti-inflammatory effects, but obviously I can't know for sure, there have been no studies that I am aware of. And the other factors that got me from severe to moderate were resting and pacing - and time - and that is still how I manage my illness today, it is essential.

I often wonder if I had rested sufficiently at the onset of my illness if I would still have ME to the extent I have today. Maybe I would be mild instead of moderate with severe dips. I can of course never know. Still, I feel lucky compared to those who remain constantly bedbound or housebound, year after year, for whom the concept of PACE/CBT/GET is frankly insulting.

Competing interests: None declared

Nasim Marie Jafry, author of 'The State of Me' (2008)

ME for 30 years, Edinburgh

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The tenacity with which psychiatrists are clinging to the PACE trial surely merits a study in itself.

Competing interests: None declared

Jafry Nasim Marie , author of The State of Me (2008)

ME for 30 years, Edinburgh

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I am not exactly sure about the question in the last response, but the issues of generalisability would be a possible argument for future pragmatic trials. I am not sure about the reference from the talk I gave in 2011, but this may refer to people not thought to have either CFS or ME after medical assessment but who need other help. Have a nice week-end!

Competing interests: None declared

Sean Lynch, Consultant Psychiatrisy and Honorar Associate Professor

Devon Partnership NHS Trust and University of Exeter Medical School, Winford House Hospital, Dryden Road, Exeter EX2 5AF, Devon

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I believe the Response to which Professor Sean Lynch rapidly responded with - "BEYOND PACE - MOVING THE DEBATE FORWARD" - was posted on-line by Mr Tom Kindlon, after a Letter was published in the BMJ paper edition for General Practitioners, and about which Mr Kindlon explained: "People reading the response by White and colleagues could be forgiven for thinking there were inaccuracies in my letter" (1-3).

Not least because I assume that Mr Kindlon must rely on his GP in Ireland, and having noted the comments of GP Jeremy R Luke, in the interests of fairness and as a matter of courtesy, I feel that this unfortunate lapse of equality should be responsibly addressed, and I hope that Professor Lynch feels likewise.

In his three rapid responses thus far, two bearing the above heading in capital letters, Professor Lynch has emphasised:

"I feel that there is a need for a new debate now".

"My personal view is that the focus of debate should now shift to more pragmatic trial designs to see how results of PACE apply in real world situations".

"These are the type of issues I feel need further debate" (4-6).

Speaking of pragmatism, Dr Brian Angus, Centre Leader for the PACE Trial in Oxford, has stated: "This was a pragmatic trial to help patients while there is no other treatment available ... The study was carefully conducted in the manner of a drug intervention study" (7).

And interestingly, at the CIBA Foundation Symposium of May 1992, it was reported that PACE Principal Investigator: "Sharpe (Oxford) described a trial of cognitive and behavioural therapy which he is just starting at the Warneford Hospital. The aim is to help patients re-evaluate and, if appropriate, change, unhelpful feelings about their performance and symptoms, and thus break the vicious circle. He admitted that the trial was a purely pragmatic approach without theoretical foundation" (8).

Professor Lynch feels that: "It is essential for clinicians to have an idea of the patient types or patient characteristics for these three groups", that is, there exist CBT types of people, GET types of people, and "adaptive pacing" types of individuals, who have mysteriously evolved, and Professor Lynch would like to see trials with "no exclusion criteria" (6,4).

Perhaps this brings us back to PACE for some basic insight.

Although there are probably well over a hundred Support Groups and a dozen or so ME charities in the UK, this trial experienced considerable recruitment difficulty, taking about a year longer than planned (QMUL PACE trial MRC 04-09 £2,076,363, DH Central Subvention 04-09 £1,800,600; MRC PACE trial extension 09-10 £702,975), and to this layperson at least, the 80% candidate rejection rate seemed rather high (9-11).

The PACE trial was "conducted in compliance with...MRC Good Clinical Practice (GCP) guidance" (12) wherein it is stated: "A properly randomised trial will ensure...no post-randomisation exclusions" (13).

In order to avoid awkward looking calculations down the road, clearly you do not want anyone leaving the trial.

Trialists must presumably plan very carefully to ensure they eliminate the problem of loss as far as possible, just as I imagine that is how one would proceed when identifying suitable candidates for a drug trial, who won't kill your desired results. I would also expect that some pharmaceutical companies might get a bit nervous over yet more independent trials of their products. But in order to prevent loss, how does one communicate to candidates that which might be involved in this instance?

For example, among the ingredients of PACE Cognitive Behavioural Therapy, one learns that it: ".. is helpful in a variety of illnesses, including chronic pain, diabetes and cancer ... most people acknowledge that even for conditions such as cancer, heart disease or diabetes, social, emotional, cognitive and behavioural factors play a part in causation and/or prognosis ... Patients often feel reassured when they are informed that CBT helps people with a wide range of health problems including cancer, chronic pain and diabetes ... There is some evidence to suggest that being on benefits and/or income protection (IP) are poor prognostic factors as they are contingent upon the patient remaining unwell ... Address blocks to recovery, e.g. being in receipt of benefits ... If participants are insistent that there is an ongoing “physical” problem, it is rarely helpful to directly challenge them on this point" (14).

Presumably, one would need to identify candidates for randomisation who would not be uncomfortable with the above strategy.

I can understand the withdrawals and losses in the unappealing sounding Specialist Medical Care arm of the trial, where people had only 3 to 6 appointments during the course of a year, with a strange medical doctor instructed not to challenge them if participants thought they had an "ongoing physical problem" (15), in contrast to the 12 to 15 appointments on the other trial-arms (11), who also attended 3 or 4 Specialist Medical Care appointments over the course of a year, but it is interesting and perhaps rather unsurprising that the CBT withdrawals and losses were almost twice those of Adaptive Pacing Therapy and Graded Exercise Therapy (30 vs 17 and 16).

It is of course up to people to interpret trial findings for themselves, regardless of how authoritatively they may have been analysed and publicised, or even re-analysed, but it could be that the PACE trial findings may only be of some relevance to about 20%, or even less, of some population somewhere, consisting mainly of young Caucasian women with "chronic fatigue syndrome" as defined by the broad Oxford Criteria (16).

The Minutes of the Exeter Sessional GPs Group meeting at Darts Farm on the 1st of February 2011, sponsored by Pfizer, which included the following, are most intriguing (17):

"Dr Sean Lynch ... Patients need several sessions to be persuaded of a label different from what they want / think is their label - there is a problem of potential loss of engagement with the patient".

References:

1. http://dx.doi.org/10.1136/bmj.f5963

Letter: Chronic fatigue treatment trial PACE trial authors’ reply to letter by Kindlon.

BMJ 2013; 347 doi: (Published 15 October 2013): BMJ 2013;347:f5963.

P D White, professor of psychological medicine, T Chalder, professor of cognitive behavioural psychotherapy, M Sharpe, professor of psychological medicine, T Johnson, senior statistician, K Goldsmith, clinical trials unit statistician. - Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK Academic Department of Psychological Medicine, King’s College London, London, UK Department of Psychiatry, University of Oxford, Oxford, UK Medical Research Council Clinical Trials Unit at UCL, London, UK Biostatistics Department, Institute of Psychiatry, King’s College London, London, UK.

2. http://www.bmj.com/content/347/bmj.f5963/rr/670755

PACE trial: Simply giving a reason why an outcome measure was changed is not necessarily sufficient

Tom Kindlon, Assistant Chairperson Irish ME/CFS Association, PO Box 3075, Dublin 2, Ireland 7 November 2013.

3. http://www.bmj.com/content/347/bmj.f5963/rr/667107

Author's response: Criticisms of the PACE Trial were justified 16 October 2013 Tom Kindlon.

4. http://www.bmj.com/content/347/bmj.f5963/rr/671093

Re: PACE trial authors’ reply to letter by Kindlon BEYOND PACE - MOVING THE DEBATE FORWARD 8 November 2013 Sean Lynch, Consultant Psychiatrist and Honorary Associate Professor Devon Partnership NHS Trust and University of Exeter Medical School, Wonford House Hospital, Dryden Road, Exeter EX2 5AF, Devon.

5. http://www.bmj.com/content/347/bmj.f5963/rr/671597

Re: PACE trial authors’ reply to letter by Kindlon 12 November 2013 Sean Lynch.

6. http://www.bmj.com/content/347/bmj.f5963/rr/672278

Re: PACE trial authors’ reply to letter by Kindlon 15 November 2013 BEYOND PACE MOVING THE DEBATE FORWARD Sean Lynch.

7. http://www.sciencemediacentre.org/expert-reaction-to-lancet-study-lookin...

February 17, 2011 expert reaction to Lancet study looking at treatments for Chronic Fatigue Syndrome/ME.

8. http://discovery.nationalarchives.gov.uk/SearchUI/Details?uri=C6108937

Myalgic encephalomyelitis (ME)/ postviral fatigue syndrome (PFS): papers and journal articles; correspondence and enquiries with MRC replies. 1988-1997 The National Archives, Kew.

9. http://www.rae.ac.uk/submissions/ra5a.aspx?id=137&type=hei&subid=1724

Research Assessment Exercise 2008 conducted jointly by the Higher Education Funding Council for England (HEFCE), the Scottish Funding Council (SFC), the Higher Education Funding Council for Wales (HEFCW) and the Department for Employment and Learning, Northern Ireland (DEL).

UOA 9 - Psychiatry, Neuroscience and Clinical Psychology Queen Mary, University of London
RA5a: Research environment and esteem - Mind Body interactions - White, Korszun, Bhui, Stansfeld.

10. http://www.pacetrial.org/faq/faq1.html

PACE - Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation

FAQ 1: written during the progress of the trial "Recruitment for the PACE trial started in 2005 and will continue until 2007".

11. http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2811%2960...

Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial Prof PD White MD , KA Goldsmith MPH, AL Johnson PhD , L Potts MSc , R Walwyn MSc , JC DeCesare BSc, HL Baber BSc, M Burgess PhD, LV Clark PhD , DL Cox PhD, J Bavinton BSc, BJ Angus MD, G Murphy MSc, M Murphy FRCP, H O'Dowd PhD, D Wilks FRCP[Ed], Prof P McCrone PhD , Prof T Chalder PhD , Prof M Sharpe MD, on behalf of the PACE trial management group The Lancet, Volume 377, Issue 9768, Pages 823 - 836, 5 March 2011 "We recruited ... between March 18 2005 and Nov 28 2008".

12. http://www.biomedcentral.com/1471-2377/7/6

Protocol for the PACE trial Peter D White, Michael C Sharpe, Trudie Chalder, Julia C DeCesare, Rebecca Walwyn and the PACE trial group BMC Neurology 2007, 7:6 8 March 2007.

13. http://www.mrc.ac.uk/consumption/idcplg?IdcService=GET_FILE&dID=7525&dDo...

MRC Guidelines for Good Clinical Practice in Clinical Trials 1998.

14. http://www.pacetrial.org/docs/cbt-therapist-manual.pdf

Manual for Therapists Cognitive Behaviour Therapy for CFS/ME Mary Burgess, Trudie Chalder PACE Trial Management Group: CBT Therapists Manual ISRCTN54285094 MREC version 2.1 – 08 December 2004.

15. http://www.pacetrial.org/docs/ssmc-doctor-manual.pdf

Manual for Doctors Standardised Specialist Medical Care (SSMC) Gabrielle Murphy, David Wilks, Michael Sharpe, Mary Burgess & Trudie Chalder on behalf of the PACE Trial Management Group ISRCTN54285094 MREC Version 1 02/12/04.

16. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1293107/pdf/jrsocmed00127-00...

A report - chronic fatigue syndrome: guidelines for research M C Sharpe, L C Archard, J E Banatvala, L K Borysiewicz, A W Clare, A David, R H Edwards, K E Hawton, H P Lambert, R J Lane, et al. Department of Psychiatry, University of Oxford. J R Soc Med. 1991 February; 84(2): 118–121.

17. http://www.devonsessionalgps.co.uk/wp-content/uploads/2010/11/ESGPGminut...

Minutes of the Exeter Sessional GPs Group at Darts Farm – 1 February 2011.

Competing interests: None declared

Douglas T Fraser, N/A

N/A, London W6 8NY

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BEYOND PACE MOVING THE DEBATE FORWARD

I felt that there was a need to reply to Alette Jansen’s post (1) about the ethics of a pragmatic trial and some other posts (2,3,4) about the direction of future research and the need for pragmatic trials. Firstly, although there may be some reports of harm from some of the treatment arms in the PACE trial (2) and it is important to acknowledge the experience of patients, this evidence is not yet conclusive in my view. Such evidence would need to be on the basis of evidence from randomised controlled trials, pragmatic trials and subsequent systematic reviews. If any treatment is then found to be ineffective or potentially harmful, then of course it should not be recommended. Until we have conclusive evidence, my view is that further research is potentially still valid and ethical provided there are well thought-out research questions and appropriate study design.

If the conclusive results of such research do not for example favour CBT or GET or adaptive pacing, then I am quite happy to adapt my clinical practice to what is or is not evidenced and move on. If however, treatments have possible benefit as shown in randomised controlled trials, then my main interest is finding how effective they are when applied in the real world. The corollary of finding that an intervention may be of potential benefit is that some patients may achieve no benefit at all and some may worsen. It is essential for clinicians to have an idea of the patient types or patient characteristics for these three groups. For such a complex health problem as CFS/ME (4) which is still not fully understood in my view, it would be surprising if only one or two intervention types were found effective in all patients. Further research may help clarify the need for further treatment, whether this is a new medication or a new therapy.

Bearing this in mind, it is therefore likely that in “real world” situations patients will be offered different treatment modalities either together or sequentially and a variety of other treatments which were not specifically studied in the PACE trial may be offered. To give an anecdotal example, patients that are referred to our local service may have had antidepressants, anti-inflammatory drugs or other medication with varying perceived benefit and similarly a wide range of therapies (physiotherapy, osteopathy, different psychotherapy models to CBT as used in PACE, counselling, alternative and complementary therapies).

Even if interventions as envisaged in the design of PACE are used in “real world” settings, there may be variations in how completely they are delivered (model allegiance) and some may be delivered more eclectically or combined. These are the type of issues I feel need further debate.

In conclusion, I am neither a “Reiky pedlar, snake oil salesman or UFO spotter” (5), but a clinician trying to work with a highly complex and disabling problem, who wants clearer evidence on what works for whom and when. I would commend the recent TV documentary about the Kennedys to Dr. Luke as a good example of how re-examining evidence which has too long been accepted as “gold standard” can lead to interesting new questions and directions.

1. Jansen A (2013) Re: PACE trial authors’ reply to letter by Kindlon BMJ Rapid
Response, November 14.http://www.bmj.com/content/347/bmj.f5963/rr/671954

2. Sheridan A (2013) Re: PACE trial authors’ reply to letter by Kindlon BMJ Rapid
Response, November 13. http://www.bmj.com/content/347/bmj.f5963/rr/671852
3. Kemp PF (2013) Re: PACE trial authors’ reply to letter by Kindlon BMJ Rapid
Response, November 13.http://www.bmj.com/content/347/bmj.f5963/rr/671836
4. SIMPSON R (2013) Re: PACE trial authors’ reply to letter by Kindlon BMJ Rapid
Response, November 13. http://www.bmj.com/content/347/bmj.f5963/rr/671793

5. Luke JR (2013) Re: PACE trial authors’ reply to letter by Kindlon BMJ Rapid
Response, November 12. http://www.bmj.com/content/347/bmj.f5963/rr/671605

Competing interests: None declared

Sean Lynch, Consultant Psychiatrist and Honorary Associate Professor

Devon Partnership NHS Trust and University of Exeter Medical School, Wonford House Hospital, Dryden Road, Exeter EX2 5AF, Devon

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Reply to ‘BEYOND PACE - MOVING THE DEBATE FORWARD’

Prof. Lynch claims that the changes of the outcome measures in the PACE trial should not raise any concerns (1). However, the impact of those changes on the reported results and conclusions raise legitimate questions which deserve an answer. The reported number of participants meeting the composite recovery was 32 out of 143 for both CBT and GET treatment conditions after the SF-36 PF and CFQ scores were lowered, with both of the new thresholds allowing those who had not improved or deteriorated to be counted as recovered (2). The new recovery measure is now also a statistical artefact related to population norms. This artefact is reported to be flawed by Kindlon (3). It is no longer based necessarily on participant reports of whether they functioned better and have less fatigue at the conclusion of the trial. Two questions need to be answered: a.) how many of the 32 ‘recovered’ participants who also had the same or lower SF-36 and CFQ scores than they had at the beginning of the trial were counted as recovered as a result of the new thresholds and b.) how many would have counted as recovered using the original protocol’s SF-36 and CFQ thresholds?

Lynch discusses the applicability of PACE in the ‘real world’ (1). A partial reality test of PACE is provided by the results of the 6 Minute Walking Test (6MWT). While the GET condition showed the greatest improvement in the mean of 379 metres walked, with an improvement of 67 metres after 52 weeks of training (4), this distance did not reach the distance walked by patients with heart failure and those awaiting lung transplantation (5, 6). CBT treatment was followed by no improvement in comparison with other treatments (4). No evidence is provided that ‘recovered’ participants performed better in the 6MWT than the non-recovered.

The 6MWT results are not mentioned in the recovery report and the PACE authors dispute the value of this objective test (7). The authors have observed that ‘Objective measures of physical activity have been found previously to correlate poorly with self-reported outcomes…’ (2). Given their poor performance in walking for 6 minutes, it is doubtful if these patients could perform the normal daily functions of life. A report of the patients’ freely expressed experiences, as suggested by Lynch (1), would have been valuable and would have cast light on the ‘real world’ applicability of the trial results particularly in relation to any experience of post-exertional malaise, the most exceptional symptom of ME. These 6 MWT results appear to indicate that the participants’ poor walking ability was not due to mere deconditioning, as hypothesised by the authors (4). Final distances walked would have been expected to be greater if the participants had been suffering from deconditioning only.

It seems to have been generally overlooked that the results of the PACE trial served to falsify its hypothesis rather than confirm it. At the outset the authors expressed the expectation that CFS (which appears to include ME) was reversible by treatment with CBT/GET because the condition was due to fear of activity leading to avoidance of activity, which in turn leads to the reversible physiological changes of deconditioning. These changes supposedly perpetuate the condition (4). The PACE authors report no reversal of the condition as a result of CBT/GET treatment.

Instead, in another redefinition of outcome measures, the new term of ‘recovery’ with the defects of its definition described by Kindlon (3), is freshly introduced without any explanation (2). The term ‘reversal’ and the entire explanatory framework of the PACE trial has been abandoned. The authors signal their intention of finding new factors which mediate the effect of the CBT/GET treatments – the treatments which have failed in PACE. In view of the failure of their model and other plentiful evidence of serious physiological involvement in the condition it is time that the authors acknowledged the role of the biomedical mediators of the ME/CFS. The biomedical issues call for urgent further research!

References:

1. Lynch S: Beyond PACE – Moving the debate forward
e-BMJ 8 November 2013

2. White PD, Johnson AL, Goldsmith K, Chalder T, Sharpe MC. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med 2013;1-9, published online 31 Jan. doi:10.1017/S0033291713000020.

3. Kindlon T, PACE trial: Simply giving a reason why an outcome measure was changed is not necessarily sufficient e-BMJ 7 November 2013

4. White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC,
Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G,
Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M. Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic figue syndrome (PACE): a randomised trial. Lancet 2011;377:823-36.

5. Lipkin DP, Scriven AJ, Crake T, Poole-Wilson PA (1986). Six minute walking test for assessing exercise capacity in chronic heart failure. British Medical Journal 292,
653-5.

6. Kadikar A, Maurer J, Kesten S (1997). The six-minute walk test: a guide to assessment for lung transplantation. The Journal of heart and lung transplantation 16, 313-9.

7. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Letter to the editor: response to correspondence concerning 'recovery from chronic fatigue syndrome after treatments in the PACE trial'. Psychol Med. 2013 Aug;43(8):1791-2.

Competing interests: None declared

Susanna Agardy, Retired dur to ME

nil, PO Box 6156 Hawthorn West PO 3122 Australia

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Professor Lynch personal view is that the focus of debate should now shift to more pragmatic trial designs to see how results of PACE apply in "real world situations"

In my opinion "real world situations" would mean subjecting patients to a proven harmful treatment (patient surveys have shown that numerous times). How is that ethical?

Competing interests: None declared

Alette Jansen, Patient

ME since early childhood, Delft, Netherlands

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Unfortunately, the PACE trial - in spite of its well-documented flaws - has served only to reinforce the prejudices and ignorance of doctors in some quarters.

I, personally, am very pleased about the existence of 'ME specialists' - the specialists dismissed so rudely by Dr Luke - as I was diagnosed by one in 1984 after 18 months of severe illness, triggered by Coxsackie B4 virus. I don't think this doctor was a quack. He was a consultant neurologist in Glasgow, Professor Peter Behan, the authority on ME in 1980s in Scotland. The 80s was, of course, a decade in which psychiatrists in UK had yet to unite themselves quite so vociferously with this complex neuroimmune illness.

(*Of course we had McEvedy and Beard in 1970.)

How I wish the £5 million spent on PACE had been spent on biomedical research that might actually have gone some way to improving the quality of life of people with ME. Instead, ME patients are seeing themselves being insulted, once again, on threads such as this by GPs who appear to have nothing but contempt for them.

*Speight N. Myalgic encephalomyelitis/chronic fatigue syndrome: Review of history, clinical features, and controversies. Saudi J Med Med Sci 2013;1:11-3

Competing interests: None declared

Nasim Marie Jafry, author of The State of Me (2008)

ME for 30 years, Edinburgh

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The publication of the PACE trial results was met by swift and
categorical rejection by Myalgic Encephalomyelitis (ME) charities in the
United Kingdom.1,2 This unprecedented response from patient organisations
deserves serious consideration. No treatment can be successfully implemented
without patient approval. In a recent patient survey, the largest to date,
56% of patients reported a reduction in health after Graded Exercise
Therapy, and 19% reported a reduction after Cognitive Behavioural Therapy
(CBT).3

Sean Lynch calls for a change in the debate and I completely agree. Yet while he feels that more research in this area is warranted, in my opinion a complete change in direction is now needed. There comes a point in any scientific investigation when it is right to admit that even with great expense few gains are likely. The PACE trial has already cost £5 million, and resulted in a moderate effect size with an additional 11 to 15% of patients experiencing a clinical improvement when CBT/GET were added to SMC. Similar interventions for the severely affected patients found no clinical benefit 4.

Let us now have a new research direction as well as a new debate: one which focusses on understanding the underlying physiology of the illness, which focusses for example on immunological, neurological and autonomic disturbances, and one which offers real hope to patients around the world.

References:
1 White PD, Goldsmith KA, Johnson AL, et al. Comparison of adaptive pacing
therapy, cognitive behaviour therapy, graded exercise therapy, and
specialist medical care for chronic fatigue syndrome (PACE): a randomised
trial. Lancet 2011; DOI:10.1016/S0140-6736(11)60096-2.

2 ME Association. ME Association press statement about the results of the
PACE study.*http://www.meassociation.org.uk/?p=4607(accessed March 3, 2011)

3 ME Association. Managing my ME. What people with ME/CFS and their carers
want from the UK's health and social
services.http://www.meassociation.org.uk/?page_id=1345*(accessed March 3,
2011)

4 A. J. Wearden, L. Riste, C. Dowrick, C. Chew-Graham, R. P. Bentall, R. K. Morriss, S. Peters, G. Dunn, G. Richardson, and K. Lovell, “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., vol. 4, no. 1, p. 9, 2006.

Competing interests: None declared

Anna Sheridan, Patient

Glasgow ME Meet-up Group, Glasgow

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