The PACE Trial. How MECFS Treatment Went Wrong?
PACE was a trial designed to test the efficacy of GET (Graded Excercise Therapy) and CBT (Cognitive Behavioral Therapy)
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From the start, the trial was funded by scientists working with insurance funds with the [bold] goal of getting people off of social services and disability. (A conflict of interest that they failed to disclose)
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The study found that using GET and CBT an astounding 22% of patients recovered!
But...
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The study changed the recovery metrics so that even patients who got worse over the course of the study were marked as recovered! Not to mention, it was also found that 6-7% of the groups told to live within their limits or given standard medical treatment recovered.
Additionally...
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A follow-up survey by ME Association in 2012 found that 74% of patients experienced worsening of symptoms following GET.
In contrast, the PACE study found no statistical difference between adverse events in different groups calling into question whether the GET group increased their activity substantially enough to see any effect at all. The lack of change in objective measures such as a step test would indicate this to be true.
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In summary following court orders release of the data and reanalysis by numerous objective groups, it was concluded "The PACE trial provides no evidence that CBT and GET can lead to recovery from CFS. The recovery claims made in the PACE trial are therefore misleading for patients and clinicians."
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However this didn't change the massive effect that PACE had on the treatment, mistreatment, gaslighting, and abuse of MECFS patients over the following decades.
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Due to PACE doctors have been advised for years that patients should be prescribed GET and CBT and with these treatments should expect their condition to improve.
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As the ME Association study showed that 74% of patients decline under GET this advice likely harmed many more patients than it helped. Here is how:
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1.) GET wrongly assumes that patient fatigue is due to deconditioning. Studies by the Workwell Institute prove that exercise intolerance and fatigue are not adequately explained by deconditioning.
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2.) According to the International Consensus Criteria for diagnosing MECFS* Post Exertional Malaise (PEM) or a worsening of symptoms and fatigue after exercise is a required symptom for an MECFS diagnosis. Therefore it is irrational to assume a patient would be able to increase their activity when suffering from PEM.
*notably not the criteria used in the PACE Trial
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3.) Cognitive Behavioral Therapy assumes that the patient has unhealthy thought patterns related to exercise and that changing these thought patterns will lead to improvement. However, in MECFS a negative thought pattern around exertion is a rational reaction to PEM. Therefore, ignoring this rationale thought leads to worsening of symptoms due to not avoiding PEM.
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4.) CBT is a useful therapy in the treatment of anxiety and depression. Therefore patients with comorbid psychiatric conditions (as many PACE trial participants had) could improve confusing trial results on both large scale and personal levels.
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"In short, the PACE study is a sham, with meaningless results. In this case, the emperor truly has no clothes. Dr. Horton and his editorial team at The Lancet are stark naked." -Vincent Racaniello, Virologist at Columbia University
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1 in 100 people are estimated to suffer from MECFS worldwide
3 in 4 people with ME are unable to work even part-time
1 in 4 are permanently bedbound or housebound
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Due to PACE these patients have been ignored and neglected. Help us change that by donating to The Open Medicine Foundation to help find a blood test, treatment, and cure for MECFS.
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The PACE trial has had such a long-lasting and negative effect on the MECFS community and is a clear example of how the psychological lobby has managed to derail and defund legitimate research and treatment for myalgic encephalomyelitis a neuroimmunological disease that due to PACE spent years being cast as psychological.
The way that this trial failed to disclose conflict of interest, manipulated data and generally practiced bad science should be used as an example everywhere in med school around the country to show how corrupt interests can make a trial show what they like and use that data to manipulate policy and practice.
ME or Myalgic Encephalomyelitis (rebranded CFS chronic fatigue syndrome largely around the time of this trial a name that trivializes a neurological condition with fatigue being only a small aspect of it) Will always be a contentious disease. It affects 1 in 100 individuals and 3 in 4 affected cannot work, even part-time. This gives governments a huge interest in keeping ME patients suppressed and discouraged from having their disease recognized or claiming disability. Studies like PACE show just how far lobbyist groups will go to protect capitalist interests from the reality of chronic illness and severe disability.
We must never forget what happened during PACE, a trial where later estimates suggest 96% of participants may have been harmed. Not to mention the endless gaslighting benefit denial and medical trauma it has caused in the decades since.
NiCE is finally planning to update its guidelines to report that the PACE trial is unreliable and that GET and CBT should not be used as a treatment for MECFS. Sign the petition (link in bio) to tell them to publish the guidelines as written by scientists and not to let the psychological lobby get away with manipulating the guidelines again.
Finally, remember that a corrupt trial should have no bearing on your belief in the real suffering of persons with ME. Make sure you support persons with ME in their doctors' offices and now that you know the #truthabout PACE make sure they give ME the respect it deserves.
This post shows how harmful GET and CBT were and are to MECFS patients. How these treatments lead to gaslighting and medical trauma as well as the overall decline of persons with ME.
Perhaps most tragically the study falsely taught doctors that patients would recover from ME when in reality only 5% of patients fully recover with 80% relapsing-remitting and 15% declining. These false expectations can make patients feel that they are failing when in reality they are just living with a severe neuroimmunological chronic illness that can't be cured with a bit of exercise and toxic positivity.
In fact, a follow-up study by the ME Association showed that 74% of patients declined under GET and CBT. Indicating most patients were actively harmed by the treatment.
The only treatment we currently have for MECFS that is evidence-based is pacing or as I call it rationing life. You must not do more than your body can handle because we do not know how to effectively treat PEM or crashes. You must accept that your body has limits and learn to live the best life you can within these limits. This mindset is known as ACT or Acceptance Commitment Therapy. These two treatments are the opposite of GET and CBT. Yet current guidelines still tell physicians to recommend the latter.
NICE has run a full review of the evidence and found that
1.) PACE was bad science
2.) GET and CBT don't work
3.) Most patients will not recover from MECFS
Now the same psychological lobby that ran the PACE trial wants to sabotage these guidelines to continue to harm and deny benefits to the huge population of people with ME including those with severe ME and very SevereME whose quality of life is as bad as patients on chemotherapy or with late-stage AIDS. Sign the petition (link in bio) to tell them their time of screwing over these vulnerable patients is over.
