Discussion in 'Latest ME/CFS Research' started by Dolphin, Mar 1, 2012.
* I gave each sentence its own paragraph.
* I gave each sentence its own paragraph.
Accompanying editorial by Peter White and Trudie Chalder
I've created a thread on the accompanying editorial by Peter White and Trudie Chalder at: http://forums.phoenixrising.me/show...-Trudie-Chalder-CFS-treatment-without-a-cause
No ME patients participated in this study.
I know this because I was among those asked to comment on the project proposal, several years ago. All our criticism was ignored and the project still received funding.
But this outcome makes you wonder how horribly wrong the treatment named 'usual care' must have been...
EDIT: New paper shows that at follow up there was no difference between intervention and control groups: http://forums.phoenixrising.me/inde...-rct-nijhof-et-al-12.14931/page-8#post-354752
Isn't the criteria for adolescent CFS often really weak (I'm not sure which they used for this), and with a high rate of natural improvement? It wouldn't surprise me if 'normal care' made things worse, or if those collected within this 'CFS' wastebasket were more likely to find on-line chatting helpful.
Looks like another media blitz on 'positive thinking'.
Criteria can vary. Maybe you are thinking of the Esther Crawley study where she used NICE criteria which are weak (which are probably a significant reason for the high prevalence she found). However, this is a Dutch study so don't think they used those criteria. Haven't checked the details yet.
ETA: criteria for children can require a shorter duration of the symptoms before it's counted as being CFS, so it is a bit broader in that way.
There is certainly a high rate of natural improvement in adolescent CFS (can be seen from mono studies, for example). It seems possible to me that people in the control group could be cautious and might be able to do a bit more. However, that's not to complain about them - sometimes with this illness "discretion is the better part of valour".
Interesting, Guido. And I couldn't agree more with your final sentence. It does make one wonder about the effectiveness of 'conventional' therapy when the internet can seemingly prove so much more effective. Maybe it's just teenagers? Who knows?
Still, it seems to have prompted some concern among those practising in the 'traditional' manner. Imagine PACE was delivered via the internet? I wonder how adults would have responded?
I did note from the BBC article that graded exercise was a feature too but seemingly only with the standard care package which seems 'odd':
'A total of 135 adolescents with chronic fatigue were involved in the study - half were given standard treatment, normally individual or group psychotherapy and exercise therapy, while the remainder were enrolled into Fitnet.'
You'd think 'Fitnet' would involve graded exercise too. Perhaps I haven't read it through well enough yet. I will get the full papers hopefully later and give them a whirl...
Hmm... Fatigue In Teenagers reminded me of that muppet take-off Pigs In Space for some strange reason. Like you could compare Star Trek (the real deal) to anything else pretending to be it without laughing out loud. Still if it helped these undefined teenagers get back to school and to a better level of health - then so be it. But do stop messing and try this approach on some properly defined cohorts please
Hmmm, first create a therapy that is designed to fail, a strawman. THEN compare your favourite therapy to it.
For the PACE trial they created Adaptive Pacing, which is their own highly dubious technique with a similar name to pacing.
Here they used standard medical care, which was therapy and exercise. Say what? This is the usual care you would pick if you wanted to make them WORSE.
I wonder if my interpretation is wrong? This would clearly make this study a breach of ethics, which means the ethics review failed amongst other things. However the same argument could be made against the PACE trial and almost nobody cares.
I am getting a distinct impression, which may be wrong as I don't know all the facts, that they know exercise fails. This is a step back to CBT. I wonder if this is what is happening generally?
A quote from one of the articles (medpage today):"Usual care, which included CBT in person (66%), individual or group rehabilitation programs (22%), or graded exercise therapy (49%)"
I would like to see a breakdown of responses from patients with every combination of treatments used.
'...Peter D. White, MD, of St. Bartholomew's Hospital in London, and Trudie Chalder, PhD, of King's College London, in an accompanying commentary...
They said that advantages of FITNET were its systemic approach and complex and frequent interventions. However, they pointed out that the researchers used a liberal definition of recovery, and that some individuals in the study were already attending school fairly frequently.'
Lol. Lol. Lol. Lol. Pigs in Spaaaaccccceeeee!!
Also what treatment did these kids have first before the trial were they doing GET - which as we know would hold them back from recovery. Maybe the improvement was a result of dropping GET. Who knows but even those commenting on the study say that some of the results look odd. If part of the results look odd then the rest come into question. Ignoring the fact it's CBT for a minute, the stats look way way too good to be true. As someone who works heavily in statistics, it looks well dodgy to me...
I haven't been able to access the full text, but here are a few comments:
First off, the results appear to be exceptionally good, certainly compared with PACE:
- Self-reported normal physical function rates were 3.8-times higher with the intervention as well 78% versus 20%, P<0.0001
- Full-time school attendance (missing less than 10% of school days): 75% versus 16%, P<0.0001.
- Numbers needed to treat for all the outcomes were in the 1.7 to 2 range (PACE 7-8)
- 63% of patients reporting full recovery compared with just 8% with usual care
They used Fukuda for case definition. http://www.biomedcentral.com/1471-2377/11/23
Second, the results for the control group seem exceptionally poor, for a group of adolescents (who usually have a better prognosis than adults) who had been ill for only 2 years (think that's right, can't remember where I read that).
Particularly as the control group used CBT/GET (medpage today) "Usual care, which included CBT in person (66%), individual or group rehabilitation programs (22%), or graded exercise therapy (49%)". And as the authors state "Cognitive Behavioural Therapy (CBT) has proven to be effective".Professor Anthony Cleare, a consultant psychiatrist at the Institute of Psychiatry, Kings College London, said that although the effectiveness of cognitive behavioural therapy for chronic fatigue syndrome was beyond doubt. So why such poor results?
So were the therapy group attending school more frequently than controls at baseline?
Nice to see recognition of the problems of self-report, and the need for more objective measures such as school attendance. However, the poor results for contols fail to fit with the good prognosis for adolescents reported in other studies.
Here's the Lancet's Press Statement: http://www.meassociation.org.uk/?p=10606
Just for additional material. Some of it/much of it is repeated elsewhere of course.
Dr Shepherd is equally astounded by the claimed results:
Dr Charles Shepherd, honorary medical adviser to the ME Association, says:
I find it hard to believe that an internet-delivered cognitive behaviour therapy (CBT) programme can produce a 63% recovery rate over a six month period even if those involved were very carefully selected.
The success rate is far in excess of any other published clinical trial involving the use of any form of CBT in ME/CFS and is not consistent with the results from several large patient surveys carried out in the UK, the largest of which* found that only 2.8% were greatly improved whereas 54.6% reported no change in their condition. (19.5% reported being slightly worse or much worse total number = 997).
It should also be noted that a wide variety of clinical presentations and pathologies come under the ME/CFS umbrella and that while CBT may be of help to some people with this diagnosis it is not an appropriate or effective form of treatment for others.
Web MD have just put something up too: http://www.webmd.com/chronic-fatigu...apy-helps-teens-with-chronic-fatigue-syndrome
'...researcher Sanne L. Nijhof, MD, of the University Medical Center Utrecht in the Netherlands, says teens may be particularly responsive to web-based behavioral treatments because they have grown up using the Internet.
Most teens eat, sleep, and breathe the Internet, so it is not terribly surprising that they would embrace a therapy delivered in this way, she says.
Shortage of Trained CFS Therapists
Chronic fatigue syndrome is a complex condition characterized by intense, unrelenting fatigue, combined with other symptoms that can include muscle or joint pain, lymph node tenderness, and headache.
The condition is much less common in teens than adults, but by some estimates as many as 1 in 100 adolescents suffers from it.
While the cause of CFS is not known, talk therapy has been shown to be effective for relieving symptoms in both adults and teens.
But a shortage of specialized behavioral therapists qualified to deliver the treatment has limited its use...
'...What is exciting about this trial is that these researchers have made the delivery of an effective treatment for CFS more convenient, more accessible, and possibly more cost-effective, says longtime chronic fatigue researcher Peter D. White, MD, of St. Bartholomews and the London School of Medicine and Dentistry.
White tells WebMD that the greater accessibility and more frequent interaction with therapists may explain the better results for Internet-delivered treatment.
Patients sent their therapists an average of 66 emails over the course of treatment, and therapists sent an average 29 email consults per patient.
He adds that if greater accessibility improves outcomes, an Internet-based treatment strategy may be as effective in adults as it is in teens.
It is important to repeat this study in adults, he says.'
Action for ME comment: http://www.actionforme.org.uk/get-informed/news/our-news/action-for-me-comment-on-new-cbt-study
'Sir Peter Spencer, Chief Executive, Action for M.E., says: "FITNET appears to have shown up well in this trial but we would not agree that it puts effective treatment within reach of any adolescent as is claimed. It is good news for some but should not be exaggerated. CBT is not a miracle cure even when delivered online.
"We do strongly agree with the emphasis on the need for proper and rapid diagnosis in adolescents. The teenagers who took part in this study had to rate themselves as being completely recovered or as feeling much better. Action for M.E. welcomes research that values patient-reported outcomes alongside fatigue severity and physical functioning scores.
"Empirical research into therapies has merit but it is no substitute for the more fundamental research that is urgently needed into the biology of M.E. Only this will establish the cause of the condition and help us to find much more effective treatments."'
Errr... I appreciate this is becoming (due in part to moi) more media than research thread. Shall I request a split into two threads perhaps?
I believe the full paper is available for the moment at http://press.thelancet.com/FITNET.pdf
Is it only the 1st of March, I thought it must be April, what a fool I am.
As per usual we have the controversey of selection, were they or wern't they ill in the same sense we hold ourselves to be, strikes me we'll continue to go around in circles with this until one or more difnitive tests, at a price the NHS are willing to pay, come in to play. Until then the Psyc's are always going to muddy the watters and self reporting will be the rule.
But, just to cheer you all up, back in the early days of my involvement with this site, as some may recall, I was direcly mailing Mr. Wesseley, that began when I along with countless others were prompted to mail him directly to critisize his immediate dismissal of the XMRV resutls from WP.
During that chain of mails I asked him directly why, in the absence of contrary evidence he would immediatly critisize the results, to which he replied, the results were to astounding, that any good scientist would treat with sceptisism such dramatic statistics. The statistic in question was that 67% of ME/CFS patients were testing positive for XMRV.
Well, I'm with Simon on this one, that 'recovery' rate is just way to high to be taken seriously but then Simon is probably saying the same thing because if it's right then we can sack all the Psyc's and therapists and tell GP's just to send their patients down to PC World with an NHS chitty.
Health services accross the world should be oppening their own studies to see if talking by internet can cure all manner or expesive illnesses.
What a load of tosh, I can't get my head around why anyone of any scientific integrity would even entertain this!
I did 13 sessions of CBT under my empolyers health scheme, during session 2 we went over my illness history then I was asked what I wanted to get out of the sessions, to set my goals as it were, straight faced I just looked at the therapist and said, 'I want to be cured'. I then picked her up off the floor and used smelling salts to get her back in the room, once conscious she in no uncertain terms told me that she wouldn't be able to do that.
All credit to her, money or no money she wasn't going to be miss sold and made out a liar, she really did help with some very usefull advice on coping and never for a moment pretended she'd be able to do more. She'd been a therapist for over 25 years and came highly recommended by my employer, and you'll like this, a leading US based, international Health Insurer.
Did they report baseline school attendance? In previous trials, there have been significant variance in school attendance or employment status in each group and so the change must be compared, rather than merely one group vs the other.
Also consider self-selection bias for participation in the trial in the first place.
Thanks to user 9876 for the link to full text
Physical activity was measured by the Child Health Questionnaire (CHQ-CF87 subscale physical functioning):
This broadly similar to the SF-36 Physical Functioning sub-scale, though it merges walking/stairclimbing, and has the extra questions in italics. This is all I could find on scoring: "Response options also vary from 4-6 levels for the scales"
[td]Usual Care n=67[/td]
[td] Continious [/td]
[td] 395% (294)[/td]
[td] 451% (326) [/td]
[td]4 (6%) [/td]
[td]64 (94%) [/td]
I would read this as the first row suggesting the % of time spend at school with the standard deviation. The next are those greater or less than 85%. What they don't seem to give is how many were not able to attend school (it may be buried in the text).
In terms of there and the control groups results after 12 monts 10 from the control group attend >90% of school (hard to compare with the 9 at >95%). However for their FITNET treatment group they claim 50 of the 67 attended school full time. Some of the figures particularly in table 4 seem inconsistant the table caption says 12 months but some of the headings say 6 months.
I'd love to see clear figures of how many of each group and if they were going to school full time in the first place.
The one good thing (probably only good thing lol) I saw about this study was the fact they judged improvement based on something the participants actually started doing eg full time school rather then it just being subjective.
As was said and others mentioned.. the usual care.. 50% of those in the usual care group were doing GET, so is it surprising that this group who got their therapy from home and not doing GET improved more then the other group? (even if bad diagnostic criteria were used). Most of us are aware GET isnt good for many.
My other thought is on why maybe this group CBT only group improved???.
I think that probably these ones were previously doing GET (normal care) before this study started.... and hence with the stoppage of "normal care" and GET.. well yeah.. many improved esp since they were early CFS cases (of just under 2 years and still having a fair chance of recovery). Previous GET was probably holding some back from improving. (that's going to be my theory till I know otherwise).
CBT I personally think could be good if they knew how to teach it right.. (in not over doing it.. eg you arent lazy and need to look after your body and energy etc etc). Id love to know what these children were actually being told in this CBT were they taught to be kind to theirselves and pace well so not in that constant push crash cycle so much which ends up affecting many of us and making us worst early ME/CFS??
Not really an answer but these are the CBT module titles
Cognitive Behavioural Treatment Modules
1. To introduce myself
2. How does this treatment work?
3. Assessing my present possibilities
4. My parents
5. My goals
6. My sleep routine
7. My thoughts
8. Changing my attention to fatigue
9. Step up my physical activities (passive patients)
10. Balance between activity and rest (relative active
11. Step up my physical activities (relative active
12. Recognizable problems with the treatment
13. Step up my mental activities
14. My schedule for school
15. My social activities
16. To reach goals
17. My schedule for work
18. To have a night out
19. Do I still see myself as a patient with CFS?
20. My evaluation
Separate names with a comma.