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(UK) "Frenchay to lead 250,000 study into the effects of early intervention for ME"

Messages
13,774
Following on from @Sonya Chowdhury talking about Action for ME supporting research into 'prevention', I waws looking into relevant trials, and found a report of this trial, and then found this thread:

http://www.controlled-trials.com/ISRCTN72645894

Link in initial post is now down, but content is here:
http://www.nbt.nhs.uk/news-media/la...d-£250000-study-effects-early-intervention-me

Am I missing something, or is this a trial with no control group?

What does this really mean:

Dr O'Dowd said: "This is very much a feasibility study but it will provide clinicians with important information around whether early intervention has positive benefits for these patients.

It looks like they're trying to come up with something even more worthless than this one:

http://forums.phoenixrising.me/inde...o-educational-intervention-to-aid-reco.13326/
 
Messages
15,786
Am I missing something, or is this a trial with no control group?
It also looks like an Oxford fatigue trial, not an ME/CFS trial.

Even the moron clinical psychologist running the centre keeps calling it "chronic fatigue".

Please tell me that no ME/CFS charities are involved :vomit:
 

Dolphin

Senior Member
Messages
17,567
It also looks like an Oxford fatigue trial, not an ME/CFS trial.

Even the moron clinical psychologist running the centre keeps calling it "chronic fatigue".

Please tell me that no ME/CFS charities are involved :vomit:

Participants - inclusion criteria

1. Adult patients (over 18) presenting with an unexplained primary complaint of fatigue, as a new episode, lasting more than one month but less than four.

2. Patient has given written informed consent

3.The participant has a Chalder Fatigue score >4 (screened by trial manager); target gender: male and female; lower age limit: 18 no age limit or unit specified

Participants - exclusion criteria1. Patients where fatigue is due to another cause. This means that GPs will not refer patients with an active illness such as cancer, liver cirrhosis etc.
A real mixture of people will be in this I imagine.
 
Messages
13,774
Here's their earlier RCT:

http://www.ncbi.nlm.nih.gov/pubmed/17014748

Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme.
O'Dowd H, Gladwell P, Rogers CA, Hollinghurst S, Gregory A.
Author information
Abstract

OBJECTIVES:
To test the hypothesis that group cognitive behavioural therapy (CBT) will produce an effective and cost-effective management strategy for patients in primary care with chronic fatigue syndrome/myalgic encephalopathy (CFS/ME).

DESIGN:
A double-blind, randomised controlled trial was adopted with three arms. Outcomes were assessed at baseline and 6 and 12 months after first assessment and results were analysed on an intention-to-treat basis.

SETTING:
A health psychology department for the management of chronic illness in a general hospital in Bristol, UK.

PARTICIPANTS:
Adults with a diagnosis of CFS/ME referred by their GP.

INTERVENTIONS:
The three interventions were group CBT incorporating graded activity scheduling, education and support group (EAS) and standard medical care (SMC).

OUTCOME MEASURES:
The primary outcome measure was the Short Form with 36 Items (SF-36) physical and mental health summary scales. Other outcome measures included the Chalder fatigue scale, Hospital Anxiety and Depression Scale, General Health Questionnaire, physical function (shuttles walked, walking speed and perceived fatigue), health utilities index and cognitive function (mood, recall and reaction times).

RESULTS:
A total of 153 patients were recruited to the trial and 52 were randomised to receive CBT, 50 to EAS and 51 to SMC. Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up, but not both. The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline. Three outcome measures, SF-36 mental health score, Chalder fatigue scale and walking speed, showed statistically significant differences between the groups. Patients in the CBT group had significantly higher mental health scores [difference +4.35, 95% confidence interval (CI) +0.72 to +7.97, p = 0.019], less fatigue (difference -2.61, 95% CI -4.92 to -0.30, p = 0.027) and were able to walk faster (difference +2.83 shuttles, 95% CI +1.12 to +5.53, p = 0.0013) than patients in the SMC group. CBT patients also walked faster and were less fatigued than those randomised to EAS (walking speed: difference +1.77, 95% CI +0.025 to +3.51, p = 0.047; fatigue: difference -3.16, 95% CI -5.59 to -0.74, p = 0.011). Overall, no other statistically significant difference across the groups was found, although for many measures a trend towards an improved outcome with CBT was seen. Except for walking speed, which, on average, increased by +0.87 shuttles (95% CI +0.09 to +1.65, p = 0.029) between the 6- and 12-month follow-ups, the scores were similar at 6 and 12 months. At baseline, 30% of patients had an SF-36 physical score within the normal range and 52% had an SF-36 mental health score in the normal range. At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients. For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%. Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health. For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively. The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions.

CONCLUSIONS:
Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME. It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life. There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy. Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.

Abstract sounds a little suspicious to me...

140 page full paper can be dug into if anyone fancies it!

http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0008/64979/FullReport-hta10370.pdf
 

Tom Kindlon

Senior Member
Messages
1,734
Here's their earlier RCT:

http://www.ncbi.nlm.nih.gov/pubmed/17014748



Abstract sounds a little suspicious to me...

140 page full paper can be dug into if anyone fancies it!

http://www.journalslibrary.nihr.ac.uk/__data/assets/pdf_file/0008/64979/FullReport-hta10370.pdf

I'd a letter published that discussed that paper a little:

http://www.iacfsme.org/Portals/0/pdf/Kindlon Letter - vol17 n3.pdf

Letter to the Editor

A pilot study of the process of change in a group Chronic Fatigue Syndrome management programme.

Bulletin of the IACFS/ME. 2009;17(2):53-68

Group interventions based around encouraging CFS patients to increase activity levels have shown modest results.

Royle and Pimm (1) state “cognitive-behavioural therapy [CBT] and graded exercise therapy [GET] are efficacious therapies in patients with Chronic Fatigue Syndrome (CFS)”. But is this true for group programmes?

St Bartholomew's Hospital Chronic Fatigue Services (United Kingdom), proponents of CBT and GET programmes for CFS, gave the following summary of the evidence base as part of their submission on the draft NICE Guidelines for CFS/ME (2): “The only RCT of CBT using a group approach showed that the treatment was no better than either usual medical care or supportive listening in improving physical function, one of its two primary outcomes, which it was designed to improve (3). A nonrandomised waiting list control trial of group delivered CBT found only modest effects on fatigue and negative effects on function (4) … to our knowledge, no RCT of group delivered GET has been published, so there is even less evidence to support a group for GET.” The results of the (uncontrolled) Royle and Pimm study (1) could perhaps be said to be comparable to the O’Dowd study, with an improvement in fatigue levels but no statistical improvement in the SF-36 Physical Functioning scores.

O’Dowd (3) did report improvements in fitness following group CBT, although significance was only reached over Standard Medical Care when 5 “outlying observations” were omitted. The improvement was modest: at baseline an average of 24.3 shuttles were walked in the 6-minute incremental shuttle walk test. At 6 months and 12 months, the figures were 28.5 and 28.9 respectively. Given O’Dowd and colleagues report that normative data for healthy controls is an average of 67 shuttles, if one extrapolates the improvement of 0.4 over 6 months in a linear manner, it would take over 47.5 years for the mean number of shuttles for the CFS patients to reach the normal level.

Interventions based on pacing strategies have not been as widely studied as GET and CBT, but positive results with individualised therapy have been reported, including in comparison to interventions which encouraged increasing activity levels (5). Given the fact that CFS is increasingly recognized by researchers as being heterogeneous, and the modest results thus far reported for group interventions based on encouraging all participants to increase activity levels, if group methods are required (for example, due to the cost of individual therapy), perhaps there should now be more focus on programmes based around pacing or the “Envelope Theory”.

Tom Kindlon
Information Officer (voluntary position)
Irish ME/CFS Association
PO Box 3075, Dublin 2, Rep. of Ireland

REFERENCES:

1) Royle GH, Pimm JT. A Pilot Study of the Process of Change in a Group Chronic Fatigue Syndrome Management Programme. IACFS/ME Bulletin. 2009 Summer

2) National Institute for Health and Clinical Excellence (NICE), CFS/ME consultation - draft (29 September – 24 November 2006), General comments from stakeholders. Pages: 466-7. http://www.nice.org.uk/nicemedia/pdf/CFSMECommentsGeneral.pdf [Last accessed: 17th July, 2009]

3) O'Dowd H, Gladwell P, Rogers CA, Hollinghurst S, Gregory A. Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme. Health Technol Assess. 2006 Oct;10(37):1-140.

4) Bazelmans E, Prins JB, Lulofs R, van der Meer JWM, Bleijenberg G. Cognitive behaviour group therapy for chronic fatigue syndrome: a non-randomised waiting list controlled study. Psychotherapy & Psychosomatics 2005;74:218-24.

5) Jason LA, Torres-Harding S, Friedberg F, Corradi K, Njoku MG, Donalek J, Reynolds N, Brown M, Weitner BB, Rademaker A, Papernik M. Non-pharmacologic interventions for CFS: a randomized trial. J Clin Psych Med Settings 2007;14:275– 96.
 

alex3619

Senior Member
Messages
13,810
Location
Logan, Queensland, Australia
I too started as a milder patient but was always wanting to do more, and was encouraged by many to do so, including many docs. Now I qualify as severe under the ICC.

Tired? Here is my answer to tired! Does being tired cause you to fall down stairs? Has your heart ever stopped? Ever you ever been in so much muscle pain you wanted to scream? How does tired prevent you from walking at more than a slow shuffle at best, for months at a time? How does tired shut down metabolism in your brain? How does tired stop you from reading or speaking? Tell me how tired causes those, because I have experienced all of them.

The falling down stairs and heart issue were from OI, but its part of ME as I currently judge it.
 
Messages
13,774
Thanks Tom. Looks like you'd already done some digging!

I'd actually read that comment of yours today... then forgot about it when reading the abstract to this study. Oh-oh - not a good sign for my own cognitive function.
 
Last edited:

Sean

Senior Member
Messages
7,378
The improvement was modest: at baseline an average of 24.3 shuttles were walked in the 6-minute incremental shuttle walk test. At 6 months and 12 months, the figures were 28.5 and 28.9 respectively. Given O’Dowd and colleagues report that normative data for healthy controls is an average of 67 shuttles, if one extrapolates the improvement of 0.4 over 6 months in a linear manner, it would take over 47.5 years for the mean number of shuttles for the CFS patients to reach the normal level.

I look forward to enjoying robust good health in my late 90s.
 

Leopardtail

Senior Member
Messages
1,151
Location
England
I'm certainly not convinced this is a good use of funds:
There is one VERY obvious flaw in this study design. It uses only the form of therapy that is most widely found to (often) be found harmful or ineffective. It should be done with the forms of therapy that patient questionnaires have found to be most effective. Should it disprove early intervention being effective, that could be down to the form of therapy not the time of intervention.

Where did the quote come from Dolphin?
 

Dolphin

Senior Member
Messages
17,567
There is one VERY obvious flaw in this study design. It uses only the form of therapy that is most widely found to (often) be found harmful or ineffective. It should be done with the forms of therapy that patient questionnaires have found to be most effective. Should it disprove early intervention being effective, that could be down to the form of therapy not the time of intervention.

Where did the quote come from Dolphin?
There was a link at the end, but it no longer works.
However,
http://www.nbt.nhs.uk/news-media/la...d-£250000-study-effects-early-intervention-me works.
 

Leopardtail

Senior Member
Messages
1,151
Location
England
Thanks biophile. It took me five years to get diagnosed (and I got ill as a teenager also and was mildly affected for the first few years). A diagnosis would have been useful. That's not the same as any "treatments"/therapies that are associated with it being necessarily beneficial.

For ME the primary issue diagnosis wise is the mis-diagnosis of 'Depression' or 'Malingerer' being used. The problem with which is that the standard advice given 'stay as active as possible' is great for depression but the exact opposite of correct for somebody with ME where 'pacing' is the order of the day. The advice given in my case did active harm and as such was full blown negligence - I followed it to the letter and did myself severe harm causing regular and severe PEM and worsening fatigue.

I am some sympathy for GPs given the swarm of utter nonsense they are presented with. I worked in at technical profession myself though and 'I just don't understand this' was not an acceptable answer. I was required to learn and to retrain constantly at my own expense. The attitude needs to be instilled in GPs that it is not okay to fail.

The things that really ticks me off is the diagostic issue. M.E. has a unique pattern of fatigue, and for me its as easy to diagnose as the common cold. No other form of illness has PEM or delayed onset fatigue. It would take two of three well stuctured questions to work it out, long before the mass of severe symptoms presents.
 

Leopardtail

Senior Member
Messages
1,151
Location
England
But according to the (post-hoc altered protocol of the) PACE Trial, a score of 5 is indicative of a full recovery!
Given that the entry score of the PACE trial was low enough for CFS recovery that is deeply inappropriate.
For me personally P.E.M. or D.O.F. should be mandatory for any ME trial.
 

A.B.

Senior Member
Messages
3,780
250k is pretty expensive for what will most likely be a complete joke.
 
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13,774

Leopardtail

Senior Member
Messages
1,151
Location
England
Yay! Tom had already done the digging, and posted his notes up here: http://forums.phoenixrising.me/inde...-programme-odowd-et-al-200.29241/#post-445947
Well,
rather surprisingly the conclusions were not that positive indicating no improvement in mental performance of quality of life scores. That is reassuringly honest.

They don't define 'normal' for the SF-36 score in the abstract and indicate that 30% are 'normal' physically before treatment. They also report few many as normal mentally. Unless the normals are mood rather than cognitive function this does not seem ME enough.
 

peggy-sue

Senior Member
Messages
2,623
Location
Scotland
The only way this could ever be vaguely justified is if they had had a control arm of newly diagnosed folk who had 6 months of complete bed rest.
(and they used proper criteria for diagnosis. Ha!)

That way, we could tell if complete rest is better or worse than trying to do their treatments.