Monday, January 31, 2011

Dr. Michael Antoni Responds


CFS Central sent questions to Dr. Michael Antoni, the corresponding author of the new study, “A pilot study of cognitive behavioral stress management effects on stress, quality of life, and symptoms in persons with chronic fatigue syndrome.” Below are his responses:

CFS Central:  In your study, one group of patients received cognitive behavioral stress management (CBSM) for 12 weeks, while the controls participated in a psycho-educational seminar for one afternoon. In a placebo-controlled drug trial, one group of people would be given a drug and another group would be given a placebo for the entire length of the drug trial, not just one afternoon. Why didn’t the controls participate in some activity—say talk therapy—for the same 12 weeks, instead of only one afternoon?

Dr. Michael Antoni:  You raise a good point, which is the importance of using a time and attention-matched control when conducting trials determining the efficacy of interventions. In that this study was a pilot we were trying to determine feasibility of delivering the intervention, assuring that it would not be harmful, and that it would present a meaningful experience for the patients.  The one-day seminar “control” condition is best conceptualized as enhanced standard care in that it provided a minimal additional element to the patients’ ongoing standard medical treatment. For some patients this one-day experience was akin to learning self-help techniques.  Due to the lack of equivalent contact time between conditions, one cannot however, rule out the possibility that the effects of our stress management condition were due to the extra attention it offered.  Having completed this pilot work we are currently using a time and attention-matched control in our current work.

CFS Central:  In your study, the symptoms of the controls worsened over the course of the 12 weeks. CFS does not normally cause such deterioration in the short term. It’s a waxing-and-waning disease in the short term.  Why would all patient control symptoms deteriorate?  

Antoni:  To clarify, not ALL control patients showed a worsening of any outcomes over the 12 weeks, but rather these were the group mean or average pattern of change for those assigned to the control condition. Further, there was no evidence that patient controls showed changes in ALL symptoms over time. In terms of the time frame used, again since this was a pilot study the follow-up period was quite short.  Ongoing work is following patients over longer intervals.

CFS Central:  If the controls had not deteriorated, would the improvements in the treated patients be statistically significant?

Antoni:  The strongest effects observed in the stress management group were for an increase in quality of life, effects that are significant independent of control group changes. Other effects reported are a combination of improvements in stress management and decline in controls. 

CFS Central:  According to your study, 44.9 percent of the CFS patients in your study were on disability at the start of the study.  How many patients were on disability at the study’s completion?

Antoni:  We only measured disability, occupational status and assorted lifestyle and demographic variables at baseline, hence information on changes over time is not available.

CFS Central: In Table 2 in your study, it says that “perceived stress” decreased during the course of this study from 29 to 27.  What does “perceived stress” mean?

Antoni: The Perceived Stress Scale is a 14-item self-report measure that taps a respondent’s perception of the stress in their lives over the past month and gets at how overwhelmed they feel with the demands of life, how much they feel that things are mot going their way, etc.

CFS Central:  In your study, the authors state:  “This intervention has the potential to offer a reasonably low-cost self-regulatory approach to the management of this perplexing syndrome.” What do you mean by “management” when it comes to CFS?

Antoni: “Management” here refers to managing the demands and challenges of everyday life as well as the challenges of CFS in particular.   

CFS Central:  We know stress can exacerbate chronic diseases and that cognitive therapy or talk therapy might be helpful in some cases in dealing with chronic illnesses.  We’ve seen many studies attesting to the benefits of cognitive therapy with chronic disease, particularly in the case of CFS.  My question is why do we need another study to tell us the same thing, while patients are very ill or dying of CFS due to lack of efficacious treatments for their physical problems?

Antoni: The CBSM intervention tested here is broader that Cognitive therapy in that it blends a combination of anxiety reduction techniques with interpersonal and communication techniques with cognitive therapy in a supportive group to address “stress processing”.  This is quite distinct from most other Cognitive Therapy approaches that target physical activity and de-conditioning.  This is an entirely different approach.

CFS Central:  Four CFS patients I interviewed back in 1994 for the article "The AIDS Drug No One Can Have" for Philadelphia magazine, on the experimental HIV and CFS drug Ampligen, have since died from the disease. Patients die from rare cancers and heart failure 20 years earlier than their life expectancy should be.  Others are bed-bound or house-bound and experiencing seizures, chronic infections, heart failure and short-term memory loss. Do you see a disconnect in the cognitive therapy that your study advocates and the severe physical disease and death patients are experiencing? What should be done about helping these severely physically ill patients?

Antoni:  No disconnect at all.  Again the CBSM program that we used is designed to help people manage stress better in order to possibly influence neuroimmune processes that can exacerbate immunologic activation and symptoms.  This form of intervention has been shown to reduce stress, anxiety and negative mood states in parallel with salutary effects on neuroendocrine and immune system indicators in a range of populations including persons with HIV/AIDS and different cancers.  Whether or not bringing about such changes can influence CFS symptomatology is a major thrust of our current research. Whether or not CBSM can help persons who are house-bound and otherwise experience limited mobility is also a consideration in our work as we develop and test ways to deliver CBSM to patients’ homes via advances in telecommunication technology (e.g., telehealth).

CFS Central: In your article, it says: “Group-based CBT combined with body awareness and exercise training has also been shown to be effective for CFS in recent work [38].  In footnote 38, you reference this study:  “Cognitive behavioral therapy v. mirtazapine for chronic fatigue and neurasthenia.” Sixty-five of the 94 patients in that 2008 study met only the Oxford criteria of the disease, which excludes physical symptoms. This is an outdated definition of CFS.  Patients with true CFS—as opposed to simple fatigue or neurasthenia patients in this 2008 study—are physiologically ill, not mentally ill.  Why are you referencing an out-of-date definition of the disease and patients who do not have bona fide CFS?

Antoni: We referenced this article (38) because it used a group-based approach.  We use an updated definition of CFS in choosing the samples for our research and believe others should do so also.

CFS Central: In addition, large patient surveys as well as the findings of several studies and most CFS-literate physicians have concluded that exercise can cause patients with true CFS more harm than good. Are you aware of these findings?

Antoni: We are aware of these findings. No part of our intervention promotes an increase in physical activity and we do recommend that patients not change their physical activity levels without the explicit guidance of their physicians. It would be fruitful to compare the effectiveness of an approach like CBSM, that focuses on cognitive, behavioral and interpersonal techniques to better manage stress VS. cognitive behavioral therapy targeting physical de-conditioning, given that the latter has previously been promoted as an effective approach.

16 comments:

  1. Antoni: The strongest effects observed in the stress management group were for an increase in quality of life, effects that are significant independent of control group changes. Other effects reported are a combination of improvements in stress management and decline in controls.
    ----
    There are 3 QOLI outcome measures - which ones are being referred to?
    What statistical tests were used.
    I did unpaired t tests at:
    http://www.graphpad.com/quickcalcs/ttest1.cfm?Format=SD and there were no differences for any of the measures including those.
    Thank you.

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  2. Thank you so much, Mindy. I think this question is key. The answer Antoni gave misses the point.

    CFS Central: Do you see a disconnect in the cognitive therapy that your study advocates and the severe physical disease and death patients are experiencing? What should be done about helping these severely physically ill patients?"

    Antoni: This form of intervention has been shown to reduce stress, anxiety and negative mood states in parallel with salutary effects on neuroendocrine and immune system indicators in a range of populations including persons with HIV/AIDS and different cancers.

    He needs to answer if these interventions are used with patients with HIV/AIDS and cancer who are not receiving medical treatment. If these interventions are an adjunct to medical treatment, then please find us our medical treatment first and then your adjunct therapy might be useful to us.

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  3. Thanks Mindy for really digging into this and going straight to the source. Dr Antoni's comment underscore for me the idea that these kinds of therapies are all about quality of life.

    Here is Dr. Klimas's statement on the study

    "I pressed Dr. Antoni to get this study published in large part to rebut Dr. White’s claim to cure 25% of ME/CFS patients with CBT. Dr Antoni’s study shows that while CBT helps people with the illness as it does in every chronic disease model ever tested, it does not cure the illness. Dr. White challenged me in a meeting a year ago saying nothing else had been published to deny this finding. SO now you have a publication, written by a psychologist and well regarded CBT expert to use when you want to argue that CBT helps people with this illness (as it does in every chronic disease model ever tested) but does not cure the illness.

    It is easy to pick apart any study after the fact, but put this in the context of the time (2001 when the grant request was written) and place (the US where we were absolutely obliged to use the CDC case definition if we hoped for funding at the time.)

    I am very proud to work with a multidisciplinary team that includes experts in autonomic function, immunology, cell biology, psychoneuroimmunology, genomics, systems biology, nutrition, measurement illness state… the list goes on. Its a very exciting time and the team is very much jazzed and wants to see the work we do in all of these areas lead to both a clear understanding of the illness at the cellular level and then to effective treatments. You are going to see many papers this year from the different members of the team and taken separately you may fail to see the big picture. Don’t get sucked into too narrow a view. Wait and see… some amazing science is underway."

    Nancy G. Klimas, M.D.

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  4. It might be interesting to show CBT can't cure CFS in an actual study, but it would be more useful to use those funds to figure out what *can* cure it. Its more about using limited resources for the most useful studies. In this case, there is a lack of useful studies into the biology of CFS and treatments for the actual cause. The resources are better used for that purpose.

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  5. In other words, spending resources refuting all of the psychologists is death by a thousand cuts. Better to keep the eye on the prize and fund research into the actual cause/cure of CFS - which is a biological illness.

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  6. i wake up everyday with a 'cbt' attitide...after i grab my shower i go out and run 15 to 20 miles a day, then i go to the boxing club and train for about 4 hours straight,then i eat lunch and go to the park to feed the squirrels and then i am off to the weight gym and train for about 3 hours there...then i go and spend supper at the girfriends house and afterwards we go to see a good film and after we come home and we make 'fireworks' all night long...then in the morning i roll back out of bed and do a couple of hundred push-ups including about 300 sit-ups while my girlfriend is snoring away in la la land and off to the shower i go again...everyday i do the same protocol and i am sure this has to do with the cbt i have learned from the geniuses...i guess it helps 'i must be cured'...oh! i almost forgot, i got an invitation to go to a wedding in august and mr.wessely and mr. white are getting hitched and i am giving them away...i will let all of you know how that goes and send some photos...take care all of you and make sure you do not take to much cbt because i heard the it can make you do some very strange things...anyway i must go as i have a long run today and it is raining outside...be well everybody...sincerely aidan walsh southampton, u.k. p.s. anyone want to escort me to the wedding in august...

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  7. I have had ME for 15 years and have gone from bedridden to enjoying partial recovery. I treat my body the best I can, which includes as much passive excerize as I can can tolerate to burn off cortisol. Cortisol is a hormone produced by stress, and too much worsens my symptoms. Too much excersize also worsens my symptoms, however. It is a precarious tightrope I walk daily to be as well as can be without medical care.

    I try to avoid stress as much as I can because I cannot metabolize stress effeciently. In my view family and social support would do alot more for me than CBT, or a walk. I am all for primary prevention, which includes avoiding sources of stress and taking effective medications. CBT and excersize are not a substition for compassion, benefits, and medical treatment... just a poor offering to help patients cope. I want to do more than cope. I want to enjoy the best quality of life I can. I think about this on my walks by the way and can't walk fast and far enough to burn off the stress producing hormones the thoughts create. I wonder if CBT will help me cope with this? Change my thought patterns I mean, so I don't wish to myself that I had humane and appropriate care so I could feel better ASAP.

    I see the point Nancy Kliams is making and agree. I also agree fast tracking research and therapies is the shortest route to recovery.

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  8. Once a bloodsucking leech hooks on and starts feeding, they are not easily pursuaded to detach.

    Nothing less than a red hot branding iron is going to burn these parasites off, and dislodge the psycholeechiatrists from their favorite prey.

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  9. Dr Klimas said that her motivation was to empower patients to argue with peter white that CBT does not produce a cure for CFS. Now peter white uses the oxford criteria to diagnose what he calls CFS.This is a questionnaire which diagnoses people who are tired all the time and people with depression are also actively included. Now because people with MDD exhibit symptoms that match the core symptoms of the CDC 1994 criterea they also qualify for a diagnosis under that criteria. So all DR Klimas had to tell Dr white is that his diagnostic methods were not specific enough and the patients she dealt with displayed a worsening of symptons following even minimal levels of mental or physical exertion usually delayed by 24 or 48 hours.Dr Klimas could have told Peter White to prove that CBT decreases the severity of that symptom

    What we get however is something entirely different The use of three unvalidated scales
    Patients interviewed for eligibility using psychological questionaires

    Even worse the symptoms reported by the patients were cross referenced with a symptom inventory designed by bill Reeves and others.Klimas and her team called any symptoms reported by their patients CFS symptoms even though this questionaire was based on people who had never recieved a diagnosis of CFS. More importantly this questionaire does not even record PEM ( the inventory uses the slippery words unusual reponse to exhertion which is not the same thing because people who are suffering from deconditioning also display an "unusual" response to exertion--clever use of words just like a lawyer!)

    The study then claims that this version of CBT reduces CFS symptoms!

    So now we have two versions of CFS which can be shown to "work" where treating CFS is concerned.Moreover because Klimas and her team now claim that their version of CBT is different from the one White uses it would never have provided evidence that could argue with Peter Whites claim anyway!

    Just to be clear I think that Klimas and her team were probably trying to help but IMO they could not have done a better job for our enemies if they had been paid by them to conduct this awful study. If we are to have studies can they at least be scientific ones that dont give the other side more ammmo to shoot at us with

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  10. Thank you, Mindy, again. Thanks to Dr. Antoni and Dr. Klimas for responding; I'll try to refrain from shooting them in the head. STOP THE PSYCHOBABBLE NOW. A doctor who believes and respects a patient is the best stress-reliever; we already know that. Case closed. FUND BIOLOGICAL RESEARCH NOW. Erik's comment above is the best illustration; we need to "apply a red hot branding iron to burn these parasites off". Dr. Antoni obviously doesn't understand the disease; Dr. Klimas should know better, but she has dabbled in this before. It hurts so much to think she reserves a place in her mind that this is partly psychological. It hurts so much, and that is real stress.

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  11. It's unbearably stressful that this "study" got funded and WPI biological work did not.

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  12. "STOP THE PSYCHOBABBLE NOW. A doctor who believes and respects a patient is the best stress-reliever; we already know that. Case closed. "

    I COULD NOT HAVE PUT IT BETTER MYSELF

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  13. Thank you Mindy for confronting this study's author. It seems to me, just based on reading this interview that his approach is ok, in and of itself. I believe we all, esp people with diseases in which PEM is a sine qua non, could benefit from stress relief support and information/ guidance. I'm glad he does not promote exercise or changing "false illness beliefs". That said, you nailed it right on the head, that the last thing we need is more money going to another study on CBT. We need valid biomed research now! Frankly, I find his attitude that 'there is no disconnect' and it's ok to cite studies using fraudulent "CFS" and neurasthenia definitions to be cowardly. Everyone, including scientists must stand up for what is right! And use of Oxford criteria and continuing to pour money disproportionately into psychological research is plain wrong. Take a stand!

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  14. i did post a comment, maybe you were in a relapse again mindi...

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  15. OK... let''s see now.

    "Flu-like illness-from-Hell that doesn't go away"
    "Lost job, hobbies, friends, support of family"
    "No respect or belief from doctors"
    "Society thinks CFSers are faking it, mostly due to doctors that support the belief-system that patients are faking it"
    "Prospects bleak, survival in jeopardy"

    And they say... "reduce stress"?
    What kind of a life are they thinking of?

    Like maybe patients shouldn't worry what clothes to never pack for the imaginary vacation to Hawaii that they won't ever be able to take?

    Makes a CFSer want to do a reality check on doctor:
    "What is your name?" "Do you know what day it is?" "Can you name the 50th state to join the United States?"

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  16. Excellent post, one of the few articles I’ve read today that said something unique! One new subscriber here :)

    Seminar about stress management
    Seminar about conflict resolution
    Seminar for mental health diagnoses of youth

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