ANNOUNCEMENT: IACFS/ME PRESIDENT ON PACE TRIAL
by Lydia Neilson
February 24, 2011
IACFS/ME Statement on the PACE Trial:
The Issue of Illness “Reversal”
The much publicized UK-based PACE trial (Lancet, Feb. 18th; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60096-2...) reported positive outcomes for patients with CFS/ME who were treated with cognitive-behavior therapy (CBT) or graded exercise therapy (GET) in comparison to a standard medical care condition or an adaptive pacing condition. The adaptive pacing condition was intended to help patients adjust their activity levels according to their available energy (based on envelope theory). The findings were similar to previous CBT and GET studies in CFS. This trial was unique in incorporating a pacing condition and recruiting a very large sample.
We certainly support any effective treatment for CFS/ME, medical or behavioral. Behavioral interventions are helpful for a number of major medical conditions (cardiovascular disease, diabetes).
Illness “Reversal” and Behavioral Intervention
The most fundamental concern we have is focused on the type of causal model that was linked to the CBT and GET conditions in this study. The model, based on the application of cognitive-behavioral and physical conditioning principles, predicts that properly designed behavioral or exercise interventions will “reverse” the CFS illness. Not improve symptoms/functioning or provide better management, but “reverse” the illness. This term implies that the illness can be cured (or something close to it) with behavioral techniques.
If one assumes such a direct correspondence between behavioral treatment and curative outcomes, then the illness is by implication a psychiatric condition. Once this assumption is made, then research efforts to assemble a biomedical model of CFS are more likely to be delegitimized. And the public’s perception of the illness as simply being tired is again reinforced. Perhaps this is the most unfortunate aspect of the PACE trial: The omission of any reference to the medical complexity of this illness.
Furthermore, when one compares the study goal of illness “reversal” to the reported outcomes, the support for such reversal is modest at best: 30% of GET and CBT patients achieved normative physical functioning-- but the 30% figure was in comparison to 15% who achieved such normative function in the standard medical care control condition.
Thus a more accurate statement of this finding would be: An additional15% of patients in the CBT and GET conditions achieved normal functioning in comparison to standard medical care. The critical standard of clinical significance is that a therapy results in restoration of normal function. But their own data do not support reversal outcomes above and beyond standard medical care for the vast majority of their subjects in the CBT and GET conditions.
Question of CFS/ME Diagnosis
In addition, the 15% advantage over standard care for patients in CBT and GET can be further questioned given that at least 1/3 of all patients did not meet the strict international criteria for CFS (Table 1 in study)—the diagnostic protocol most often used in published studies. Strict criteria for CFS are linked to poor prognosis and conversely, subjects who don’t meet strict criteria for CFS have better outcomes. So the PACE trial folded in a significant number of subjects who do not have CFS according to standard criteria. Again this dilutes the significance of their findings as it makes it more difficult to generalize to the population of people who do have CFS.
To put behavioral approaches in context—they can be quite helpful, but they hardly meet the standard of clinical significance that would elevate them to curative interventions. If this had been made clear in the study, it would have provoked far less controversy and debate.
Media Mis-reports
Finally, the media message from this study has often been: “Exercise is good; Rest is bad.” Although the PACE trial authors did not issue such a statement, I think there is some responsibility to explain to the media that this type of recommendation is simplistic and potentially harmful for patients with CFS/ME. Activity and exercise recommendations must be based on a thorough evaluation and a sensitive individualized approach, not the broad brush that has become the take home message of this study.
Fred Friedberg, PhD
President
IACFS/ME
Lydia
Lydia E. Neilson, M.S.M. , Founder
Chief Executive Officer
NATIONAL ME/FM ACTION NETWORK
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. 613.829.6667
Fax 613.829.8518
Email: mefmaction(a)ncf.ca
www.mefmaction.net
NATIONAL ME/FM ACTION NETWORK - HOST OF THE IACFS/ME INTERNATIONAL RESEARCH & CLINICAL CONFERENCE - OTTAWA, CANADA
SEPTEMBER 22 - 25, 2011
Visit: www.iacfsme.org
13 years, 2 months
ANNOUNCEMENT: INTRODUCING THE JOURNEY
by Lydia Neilson
WEDNESDAY, FEBRUARY 23, 2011
ANNOUNCEMENT
Our quarterly newsletter QUEST has just been published and mailed to all those who subscribe. However, we now have added a new section to QUEST entitled THE JOURNEY which deals with treatment, concerns and support issues. In view of this, we are making this issue available to anyone who would like a copy.
Please contact me and I will email you a copy as an attachment or provide me with your mailing address and I will send you a copy via the postal service free of charge.
Lydia
Lydia E. Neilson, M.S.M. , Founder
Chief Executive Officer
NATIONAL ME/FM ACTION NETWORK
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. 613.829.6667
Fax 613.829.8518
Email: mefmaction(a)ncf.ca
www.mefmaction.net
NATIONAL ME/FM ACTION NETWORK - HOST OF THE IACFS/ME INTERNATIONAL RESEARCH & CLINICAL CONFERENCE - OTTAWA, CANADA
SEPTEMBER 22 - 25, 2011
Visit: www.iacfsme.org
13 years, 2 months
ANNOUNCEMENT: OPEN ACCESS RESEARCH SITE
by Lydia Neilson
IN THE NEWS
OTTAWA Medical researchers from Ottawa and Britain want all their colleagues to tell the world what studies they’re working on. They indicated that the left lab doesn’t know what the right lab is doing. That applies to new drugs, how to vaccinate in a flu pandemic, research etc. “And so there is no place in the world where you can go and see who’s doing what in the world and what’s going on.” States Dr. David Moher of the Ottawa Hospital Research Institute. There is much duplication in systemic reviews and money wasted on duplications which could be spent on useful work somewhere else. Dr. Moher and colleagues in Britain have set up a website where scientists can announce their studies in the earliest stages at no cost to prevent such waste. An open access website is to start operating today (February 22, 2011) at the University of York in England at http://www.crd.york.ac.uk/prospero.
Reporter, Tom Spears, Ottawa Citizen, February 22, 2011
Reed more at Read more: http://www.ottawacitizen.com/technology/Share+knowledge+health+researcher...
Lydia
Lydia E. Neilson, M.S.M. , Founder
Chief Executive Officer
NATIONAL ME/FM ACTION NETWORK
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. 613.829.6667
Fax 613.829.8518
Email: mefmaction(a)ncf.ca
www.mefmaction.net
NATIONAL ME/FM ACTION NETWORK - HOST OF THE IACFS/ME INTERNATIONAL RESEARCH & CLINICAL CONFERENCE - OTTAWA, CANADA
SEPTEMBER 22 - 25, 2011
Visit: www.iacfsme.org
13 years, 2 months
ANNOUNCEMENT: NAMES WANTED
by Lydia Neilson
Dear Legal Professionals:
WANTED:
NAMES & ADDRESSES OF DOCTORS, NURSES AND HEALTH CARE & LEGAL PROFESSIONALS
Dear Friends:
We will shortly be sending out invitation to medical, healthcare and legal professionals to the IACFS/ME clinical and research conference for ME/CFS, FM and related illnesses Translating Evidence into Parace that the National ME/FM Action Network is hosting in Ottawa in September 2011.
This is the opportunity to let us know who you would like us to invite to this event. Please submit the names and addresses of those individuals and we will add them to our list. You can send us the list by email, fax, or through regular mail.
Please do this as soon as you can.
Thanks so much.
Lydia
Lydia E. Neilson, M.S.M. , Founder
Chief Executive Officer
NATIONAL ME/FM ACTION NETWORK
512 - 33 Banner Road
Nepean, ON K2H 8V7 Canada
Tel. 613.829.6667
Fax 613.829.8518
Email: mefmaction(a)ncf.ca
www.mefmaction.net
NATIONAL ME/FM ACTION NETWORK - HOST OF THE IACFS/ME INTERNATIONAL RESEARCH & CLINICAL CONFERENCE - OTTAWA, CANADA
SEPTEMBER 22 - 25, 2011
Visit: www.iacfsme.org
13 years, 2 months