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Dutch propaganda from SOLK on PACE reanalysis

Discussion in 'General ME/CFS News' started by Yogi, Oct 27, 2016.

  1. Yogi

    Yogi Senior Member

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    This is from SOLK.NL

    De kritiek op de PACE-trial naar effectieve behandelingen bij CVS

    24 oktober 2016 4 reacties
    Auteur: Lineke Tak.

    Vanuit verschillende hoeken werden we gevraagd commentaar te geven op de discussie rondom de PACE-trial bij het chronischevermoeidheidssyndroom (CVS). In 2011 werd door de onderzoekers gesteld dat de PACE-trial, de grootste behandelstudie bij CVS ooit, een succes was. Patiënten met CVS zouden kunnen herstellen door cognitieve gedragstherapie of graded exercise therapie. Patiënten en patiëntenverenigingen voor CVS uitten echter direct al kritiek. De afgelopen maanden hebben ook sommige wetenschappers zich verzet tegen de in the Lancet gepresenteerde resultaten van de PACE-trial.


    http://www.solk.nl/2016/10/de-kritiek-op-de-pace-trial-naar-effectieve-behandelingen-bij-cvs/



    English translation. Can anyone @Valentijn perhaps be able to translate this better?



    The criticism of the PACE trial to effective treatments for CFS
    October 24, 2016

    From different angles, we were asked to comment on the debate surrounding the PACE trial in chronic fatigue syndrome (CFS). In 2011, asked by investigators that the PACE trial, the largest treatment study in CFS ever, was a success. Patients with CFS may recover by cognitive behavioral therapy or graded exercise therapy. Patients and patients' organizations for CVS however voiced direct criticism already. In recent months, some scientists have also opposed the results of the PACE trial presented in the Lancet.

    The PACE trialLet's start with a brief overview of the PACE trial. The rationale for this study by the researchers was described as follows: " Trial findings show cognitive behavior therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisaties have Reported That thesis treatments can be harmful and favor pacing and specialist healthcare. We Aimed to Assess effectiveness and safety of all four treatments . "

    In total, 641 patients with chronic fatigue who were recruited met the Oxford criteria for CFS of six second-line clinics. Four treatments were compared, for which participating patients were randomized: (1) specialist medical care by a physician (SMC); (2) graded exercise therapy (GET) + SMC; (3) cognitive behavioral therapy (CBT) + SMC; (4) adaptive pacing therapy (APT) + SMC.Primary outcomes were fatigue, measured with the Chalder Fatigue Questionnaire, and physical function, measured with an SF-36 subscale. Secondary outcome measures include physical fitness measured by a stress test, return to work and care costs.

    It was found that after one year the treatment with CGT + + GET SMC and SMC were more effective than either alone or SMC APT + SMC. These treatments also seemed safe, since only 1-2% of all groups occurred severe symptoms (such as critical illness, hospitalization, increased severe physical disability longer than four weeks, self-harm). In addition, it was not known whether these symptoms were severe adverse effects of the treatment effects of CFS or that they acted independently of them (White et al 2011).

    Later, a follow-up study was published which examined how the results were at least two years to participate. It concluded that the effects of CBT and GET were maintained. Interestingly, the patients from the condition had improved SMC alone or APT + SMC to the same level.Researchers signs that these latter two groups often had followed additional therapies in the meantime (Sharpe et al 2015).

    Criticism of the PACE trial, there could be written a thick book about all the criticism that has appeared in the PACE trial.Detailed criticism of researchers came ao David Tuller ( link ), Rebecca Goldin ( link ) and James Coyne ( link ). The principal investigators of the PACE trial have also repeatedly responded to the criticism in this link is a representation of the response to criticism of David Tuller.

    I limit myself to a few most notable criticisms:

    - 1. Not valid diagnostic criteria . The Oxford criteria were used to establish CFS. This definition focuses on fatigue, and less on exercise intolerance and other associated symptoms. It is feared that possibly patients were enrolled with fatigue and depression. It was also mentioned that patients with CFS according to other possible definitions would not benefit from this treatment, while GET and CBT it would come in the guidelines as effective for every patient with CFS. There is a controversy about the difference between CFS and myalgic encephalitis (ME). Some consider this to be different names for the same phenomenon, others consider ME as a serious form of CFS which also immunological and neurological abnormalities were found. The criticism that the patients with the most severe symptoms (eg completely bedridden patients) could not participate is true. Authors respond that they do not pretend to GET or CBT would help this group; This is also mentioned as early as at the limitations of their paper.

    - 2. Questionable primary outcome measures. Outcome measures fatigue and physical functioning are entirely based on subjective self-reporting. Actigraphy (measuring physical activity) has been deleted during the investigation and physical fitness were no statistically significant differences between the groups. The researchers defend them self-reporting correctly regarded as an added value, because it is about whether patients consider themselves better.However, patients mention that they are not a scale of fatigue is important, but whether they can do great things again and feel restored.

    - 3. No blinding possible. Patients obviously knew what kind of therapy they received. Critics of the study suggest that the participants of GET and CBT were more enthusiastic approached with the promise that they would be better and there has occurred a placebo response. However, it should be noted that the degree of placebo response rate in patients with CFS turns out to be correct quite low, especially when they take part in psychologically oriented therapies such CGT (Cho et al 2005). In addition, the researchers mention that in advance of GET and CBT precisely the lowest expectations were among the participants.

    - 4. Lack efficacy secondary endpoints . There was no statistically significant difference of GET and CBT compared with the other treatment arms on outcomes such as return to work and taking care consumption. Critics of the study are those seen as important measures, but this was not effective. Healthcare costs were correct for all groups higher.

    - 5. Change of outcomes at long-term follow-up . In the follow-up study in which the effect was observed after two years, the cut-off points were those according to researchers 'recovery' defined adjusted. They describe that they found this clinical cut-off points more valuable and that they have submitted these amendments to have a committee and adjusted before they analyzed the data. Critics doubt this argument and believe that this cut-off (artificial) would lead to increased recovery. In addition, it is appointed as remarkable that all four groups are as much improved after two years, but the researchers did not clearly specify and analyze what therapies have followed patients in the meantime.

    - 6. Investigators will not release data . There have been many requests to release the data so that they can be independently analyzed. Researchers call that was promised in the informed consent process that personal medical data should be monitored and that this is ethically binding. Eventually they became after various procedures required by the court to release the data.

    Polarization of the debatein my view it is unfortunate that the debate is so polarized. It seems as if opponents only see shortcomings. It is often put forward as an argument that the authors were more in favor of these therapies and so were biased and wanted to get their way. However, it is equally well known that opponents of each study GET or CBT for CFS, and therefore in their criticism could also be biased.

    It is on the other hand understandable that some CFS patient groups show great resistance, especially if they have seen people they know with therapies like CBT or GET deteriorated: it emerges from survey studies they hold themselves. In addition, in society there is a stigma attached to CVS (it is wrongly thought to affectation or a purely psychological illness). If therapies as GET and CBT then so hailed as the press took place after the publication of the PACE trial, while these treatments are not nearly effective for everyone, it can lead to further stigmatization ( "It's your own fault if you not better).

    I think it is striking that the researchers of the PACE trial to defend their research tooth and nail, and do not seem to be very susceptible to the effects of sincere suggested criticisms. This may be a result of the fierce criticism which they were made personally suspect, as if it were criminals.

    Unfortunately, the PACE trial is often used to settle the debate about what CVS. That does not seem constructive. Researchers who investigate CBT as a treatment for CFS do this because it is one of the known active treatments. CBT is also effective in somatic said diseases such as cancer (Strong et al 2011; Larkin et al 2014). It says nothing about the cause of CFS. In the discussions I read that sometimes studies on CBT or GET be considered a denial of CFS, CFS laziness would be whether it is a mental illness. This is obviously onfundeerd; The cause of CFS is unknown fact.Studies on the effectiveness of a treatment of a disease are in fact independent of the cause.

    Even though there are patients who have just deteriorated by CBT and GET, these examples can not be used to shoot the therapies as a whole (to draw the comparison again: not every patient with cancer is better to chemotherapy, some are even worse, but that does not mean that the therapy is bad for everyone). In my own clinical practice, I see patients with CFS that are better GET and CBT, which is not scientific evidence.

    The Way ForwardThe PACE trial was indeed the biggest treats rial at CVS, but not the only one. A Cochrane review found that there is evidence that exercise therapy have a small to medium effect (Larun et al, 2015), as well as another meta-analysis (Marques et al 2015). In both of them was, however, included the PACE trial. There is also a Cochrane review which concluded that CBT is effective for CFS (Price et al 2008), not taken into account the PACE trial was. It should be mentioned that authors of all these reviews to compare the results with each other heterogeneous and difficult found, particularly in the area of long-term follow-up.

    It would be a great step forward if there would be a consensus CFS research protocol that is widely accepted by various independent researchers and patients. It seems to me at this time namely very difficult to make such treats rial for CVS, given the many possible case definitions and outcome measures. CFS knows many criteria, in addition to the Center for Disease Control and Prevention (CDC) criteria (Holmes et al., 1988), there are also the Oxford criteria (1991), the revised CDC criteria (1994), the London-criteria (1994), the Canadian criteria (2003), the Australian criteria (2004), the standardized CDC criteria (2005), the Nightingale definition (2006), the pediatric criteria (2006), the international consensus criteria (2011) and Institute of Medicine criteria (2015) (Brurberg et al 2014). There are also numerous outcome measures (which in some cases can be both more objectively measured by self-report) in the field of fatigue, exercise intolerance, activity, additional symptoms, physical and mental functioning, cut-off for recovery, medical expenses, return to work, et cetera. In each study primary outcome measures should be chosen, probably always will give debate.

    ConclusionIt seems that the PACE trial not as a definitive study can be considered, in which the most effective therapy for CFS can be based. For this, there seem to be serious flaws in the methodology, which has called the study too much doubt in the broader scientific community.However, outside of this trial, there are also other studies that effectiveness of therapies based on physical exertion or CGT demonstrated in a part of the patients with CFS. Even though the PACE trial is now considered methodologically questionable, that does not mean that this trial shows that CBT and GET are not effective. Hopefully gradually becoming more known about who GET and CBT can and will not be effective (so. Personalized medicine), or there may have found new treatments.
     
    Last edited: Oct 27, 2016
  2. alex3619

    alex3619 Senior Member

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    Actually, it does. The null results on long term follow up show that. Only sustained, long-term, objective outcome measures can be relied upon.
     
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  3. Yogi

    Yogi Senior Member

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    This is SOLK.nl

    http://www.solk.nl/wie-zijn-wij/

    Surprised to see three young woman involved in this project. It usually is middle aged old men going on about somatoform disorders.


    Who are we?

    Founders SOLK.nl, from left to right:

    Birgit Bax-to Stegge is now a neurologist and psychiatrist in training at Dimence, with a special interest in the elderly Sölk and sleep and movement disorders.

    Marieke Goossens is a psychologist at the clinic Anxiety and Mood Dimence and has a special interest in children and adolescents with internalizing symptoms.

    Lineke Branch is a psychiatrist at the clinic at Sölk Dimence and promoted the role of stress responsive systems of somatization in the UMCG.

    Editor at SOLK.nl (not in picture)

    Neelke Tromp is a psychiatrist in training at Dimence and has a special interest in cultural aspects of Sölk.

    On SOLK.nl we inform weekly about news around Somatic insufficiently explained physical complaints (Sölk). We also invite guest writers from doing research or clinical experience with Sölk.
     
  4. Solstice

    Solstice Senior Member

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    Ugh, foggy. Well, it's a piece of crap but I guess you don't need to be dutch to reach that conclusion. Hoping I feel well enough to comment on it on a later day. I'll be sure to bring it under the attention of a dutch ME-forum i'm somewhat frequenting though. Maybe someone there is more capable of commenting.
     
  5. A.B.

    A.B. Senior Member

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    It's sad that the PACe authors can write things they know to be false and the rest of the world will blindly believe it.
     
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  6. Snowdrop

    Snowdrop Rebel without a biscuit

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    Sadly, I think we'll see more of this as newly minted young adults come through the system who have absorbed the current zeitgeist of the 'underprivileged/disabled/and select minorities' are all in need of some 'pruning'.

    And I don't mean to be dark and gloomy about it but that's the situation we're in presently. That is one reason why we must no put up with dodgy dealings (nor should other groups) and speak out because the trend is in the direction of harm not help.
     
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  7. Esther12

    Esther12 Senior Member

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    I didn't think that this was propaganda so much as a bit confused and ill informed.

    If they're going to try to support claims about the efficacy of CBT/GET with reference to earlier trials then they should really look at the details of those trials.

    The 'CBT is used for cancer' line seems to be a good sign that the writer has gone more for a story than a really detailed analysis. It's just utterly irrelevant to the details of this debate.

    If this article represents what slightly thoughtless 'sensible' outsiders consider the current situation to be, then that's a sign of progress, but also a sign that more work needs to be done.
     
  8. NL93

    NL93 Senior Member

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    I thought that line was really amusing because everyone can see CBT for cancer doesn't alter the disease in any way. The best it can do is help people cope with having cancer.

    Which is pretty much the same for PWME, although she doesn't seem to realize that yet. CBT doesn't alter the disease (might even make it worse if patient is encouraged to push through fatigue), but if CBT is offered in a right way, it might help people cope with having ME.
     
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  9. Yogi

    Yogi Senior Member

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    They are not in the inner circle such as wessely white etc but I would not categorise then as outsiders. They are part of the wider somatoform, MUPS , functional illnesses industry.

    The website is devoted solely to somatoforms etc- very odd indeed. I wonder what their motive is for this promotional website for somatoforms.

    Therefore they are aware of the details and i can only regard this as propaganda.

    See the about section and comment above.
     
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  10. Effi

    Effi Senior Member

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    The main author on solk.nl is Lineke Tak (not Branch, Google is being naughty with Dutch names again! ;) ). She seems to have finished her phd on the relationship between stress and MUPS, and during her preparation for that she has studied at the Institute of Psychiatry in London. I believe that is where Wessely himself teaches.

    Tak's alma mater is the University Medical Center in Groningen, where Judith Rosmalen teaches at the same psychiatry department. Rosmalen is a member of the highly contested Dutch Health Council that is supposed to be drawing up new guidelines for ME in the Netherlands. The Council is full of MUPS fanatics, which is why Dutch patients still need us to sign the petition to change the members of the Council. (If you haven't yet, please take a moment to sign! link to petition)

    So absolutely not an outsider. And this is only ONE of the three people openly behind the solk.nl website. This article looks a lot like a way to meander around the PACE debris while still pushing the exact same MUPS agenda.

    I am wondering what this entire website even means, not sure if anyone even pays attention to it. e.g. they have a facebook page with very little followers, and have to like their own posts cause otherwise they'd have zero. I had also noticed a few patients had reacted (nicely but firmly) to this article about PACE on their website, but one by one all their comments were removed a few hours after posting. Classic MUPS I'd say - whatever you do, never ever listen to patients.
     
  11. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    Seems pretty straightforward to me. Three young girls wearing blue cardigans saying don't knock the PACE trial too much - that's our job, psychotherapy. And we have written this piece so that patients with ME can see that we don't really understand a word of the science (oops that was not supposed to go into the translator!).

    What does Sölk mean?
     
  12. Yogi

    Yogi Senior Member

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    Have copied the comments incase their propaganda machine deleted them.


    1. Marjan - October 26, 2016 - 1:27 pm
      Reply /
      Dear Mrs. Branch,

      I would like from experience (unfortunately) some things to notice. Your conclusion that CBT and GET are still working on some of the CFS patients despite the Pace Trial shows a placebo effect, I can not completely follow.

      In front of your argument you CFS patients see better in your practice is exactly what one sees in the natural history of this disease. Within 14 months, "recovered" about 30% (Prince et al Lancet 2001). In contrast, about the same percentage of patients who reported continued strong backward by this treatment (Nivel report 2008).

      Well I agree with you that the right treatment for the right patient (lens!) Must be investigated. Unfortunately this does not happen. This creates a lot of frustration for both patients and caregivers.

      Sincerely, Marjan

      • [​IMG]
        Lineke - October 27, 2016 - 9:15 am
        Reply /
        Best Marjan,

        What to you that you are an expert by experience, and what good that you are still committed to the right treatment for the right patient and less frustration for patients and care providers.

        I will make my conclusion about the PACE trial (ie. That it both can not say whether CBT / GET or employed, but this as well can not say dar CBT / GET not working). If a study concerns about the methodology used (as in the PACE trial), it is difficult to interpret the results, by definition, Be it unreliable. As well as the positive (has an effect) and negative ( "there is no effect) results would relate. For example, if it is mentioned that the patientseslectie for this study is not good, then one can be reanalyze these data, but the fact remains that the initially geonduleerde patients do not seem to be representative of the larger population of patients with CFS, such as in the criticisms is made.
        to make a comparison, if rotten apples sitting in an apple pie (inclusion), you can make this cake in many different baking methods (reanalysis), of which one might be better than another (discussion on the implications of use method, also for future studies is very useful I think), but it is never a really good, salable apple pie (all conclusions about the significance of this study on the impact unreliable; there are always bad apples in the pie).

        It's true what you write that some patients I see indeed would recover spontaneously, and then the applied therapy there so anticipates no role. We (and / or the patient) would or may be inclined to think that the therapy 'works'. A spontaneous recovery I see in some cases also sometimes happen - someone recovers and I really can not attribute good to our applied therapy. This shows in my view that CFS is a complex disorder, and CBT and / or GET not always be 'comprehensive'.

        Sincerely,
        Lineke
    2. [​IMG]
      Lisete - October 27, 2016 - 8:06 am
      Reply /
      And how many cancer patients would have to agree .. if told that their chemo had only 4% chance of success? Do the same with placebo or nothing.
      If the scientific world told time and again that CBT & GET not work with ME / CFS who are you than to tell you that it works ???

      Realize rather something causing you short-sighted view.
      Namely that parents / children accused of child abuse because you proven worldwide CFS / ME = Sölk rubbish refuse to follow.

      Rather than insist stiff would apologize for the years of misdiagnosis are very much in place!

      • [​IMG]
        Lineke - October 27, 2016 - 8:42 am
        Reply /
        There are just quite a lot of treatments in the somatic medicine which is also (only) have a small or medium-size effect - also, perhaps par excellence, in the treatment of cancer. in other diseases too often many people must be treated to have the desired effect in a few people. That is a very difficult truth in medicine. It is indeed important to consider whether efforts should be made to follow such treatment, possible risks, and the likelihood of positive effects outweigh each other.

        If the diagnosis of CFS is made and it turns out to be incorrect because there are some other somatic cause (eg. A hormonal disorder or autoimmune disease), which can indeed be very harmful. Just as it can be harmful when a somatic cause is diagnosed incorrectly (eg. Lyme and one gets prolonged heavy antibiotics without having any effect), and it turns out to be CFS. I fully agree with you that a careful examination must take place before any diagnosis can therefore be made.

        To be honest I do not shortsighted my point in this article, but I just try to look open in all directions, restrictions and question marks are still there. I say no very general 'it works', but I say that there are several studies that show an effect on group level. As long as there is no other effective treatment is known, it is unethical for me would be the treatment option (with possible risks) not to submit to patients.

        • [​IMG]
          Marjan - October 27, 2016 - 11:17 am
          Reply /
          Dear dr. Branch,

          Apologies for forgetting to write your title 'Dr' in my previous post.

          You wrote: "As long as there is no other effective treatment is known, it would be unethical this treatment option for me (with possible risks) not to submit to patients."

          Unfortunately, I am one of those CFS / ME patients is pretty run down by CGT and in particular by GET. Without going too much here in has disturbed me greatly that doctors do nothing for this group of patients.Indeed, mention of decline is denied or (wrongly) attributed to the patient.This creates a lot of anger and frustration.

          Personally, I think-but I can not bewijzen- that this therapy my recovery opportunities have reduced tremendously.

          During the time, my anger 'paved the way for wisdom. By seeing the shortcomings in the medical world are the eyes open. Especially thinking monochrome nobody brings further.

          CBT with the right angle has certainly place into a chronic disease. Proper guidance starts to really recognize this disease -and this, as long as the cause is unknown is- not automatically be seen as a psychosomatic (very short-sighted).

          The problem in the Netherlands is that there is no somatic scientific research carried out to look further and learn what is really going on in the somatic level. It can not be that if the doctor with the now existing resources and ideas "can not find" there is "nothing" is going on? Oh, it's psychosomatic. I've always found a curious way of reasoning. Indeed, 100 years ago, doctors knew a lot yet. Autism may be caused by "refrigerator mothers," MS was hysteria, the ulcer was stress etc ... There are numerous examples.

          My point is, you and your colleagues to set in once the "bad apples" in your apple pie? This can be done by your medical colleagues to make them aware that more research is needed. Currently abused your profession, in fact, as a sort of bin all unexplained physical symptoms by moving to psychiatry. Your should refer the rotten apples to the outpatient somatic!Just as science comes forward. What is happening is truly a major medical scandal. These political factors also play a role as monetary interests and disability claims.

          Let's hope that one day will end this nightmare for thousands of patients.You will only 10- 20- or 30 year home and bed bound or sick without assistance, benefits and social contacts.

          "Primum non nocere".

          Sincerely,

          Marjan
     
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  13. Jonathan Edwards

    Jonathan Edwards "Gibberish"

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    They repeat this weird idea of Knoop etc. that CBT works the way a placebo works but there is no placebo effect in CFS. Which makes it hard to understand how the PACE trial could have had a positive result from CBT! Reminds me of the theory of klebsiella/B27 cross reactivity in ankylosing spondylitis where if there actually was cross reactivity the patients would have tested negative for their own B27 because the absence of anti-B27 (self) is how you know someone is B27 on the old tissue type test. A theory that bites its own backside is always a bad idea.
     
  14. Esther12

    Esther12 Senior Member

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    Oops - I forgot who these people are. I have read other bits from them.

    Yeah, it does seem more like propaganda then. Although still a good sign that this is now what propoganda looks like imo!
     
  15. Effi

    Effi Senior Member

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    I agree it looks more ok than other truly horrendous things we have seen in the past, but let's not let them fool us: the entire SOLK/MUPS debate in the Netherlands is 100% focused on keeping ME in the psychiatric corner: all CBT/GET and no biomed research. Different wording, same old shit.
     
  16. Yogi

    Yogi Senior Member

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    SOLK stands for Somatisch Onvoldoende verklaarde Lichamelijke Klachten

    It means:
    Somatic insufficiently explained physical complaints (Sölk)

    Apart from the UK the Dutch are the biggest in MUPS somatoform research.
     
  17. A.B.

    A.B. Senior Member

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    When will society realize that these "experts" on somatoform or psychogenic illnesses are just talking nonsense?

    We have all these different unexplained illnesses and these people have created a niche for their careers by pretending to have answers, holding themselves to suchg low standards that it becomes nearly impossible to fail, or faking results as last resort.
     
    Last edited: Oct 28, 2016
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  18. Grigor

    Grigor Senior Member

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    I thought this was very odd . Also asked her. Haven't had a reply but my comment has not been removed .

    There is more and more proof ME might be an auto immune disease . So is it still wise to offer these treatments .
    Curious what she has to say.
     
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  19. Snow Leopard

    Snow Leopard Hibernating

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    There was a meta analysis by Wessley/Cho et al. in 2005 that claimed that there was a low placebo response in ME/CFS.

    I don't want to cause too much offence to the members of this forum, but well... I repeatedly see behaviour within the community that suggests placebo biases by ME or CFS patients are just as strong as in any other group of people.
     
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