Getting better from chronic fatigue

I’m a pragmatist, not a theorist. You need a good theory to test, but after that, just show me the data.

So when it comes to writing about hard-to-treat conditions like chronic fatigue syndrome, I’m mainly interested in what works, not the arguments about what causes it. I know a lot of people are very interested though, so let me start by affirming that it’s a real illness that causes real disability. It sounds dreadful and I have enormous sympathy for anyone who is unlucky enough to suffer from it.

So, what works? NICE guidelines (while admitting that the evidence is unsatisfactory) recommend cognitive behaviour therapy and graded exercise therapy. CBT helps people face their fears, challenges unhelpful beliefs and helps people take control of their situation. GET encourages people to do a little more activity every day, reconditioning muscles and increasing exercise capacity. Both are founded on the belief that people can recover from chronic fatigue, and doing more will help them recover.

But these therapies have been controversial. Some people think that, if you propose CBT, it means you think the illness is ‘all in the head’. It doesn’t. CBT helps with many pain-related and chronic conditions, by helping people manage their illness and feel more in control of their lives. And GET has been blamed for making people worse, by pushing them to do more than their bodies can manage.

The alternative, according to some patient advocacy groups, is ‘pacing’, which means adapting your activities so that you only do a certain amount each day, avoiding pushing yourself to fatigue. As pacing has not been properly studied before, it was unclear whether it helped.

The answer to that question is getting a little clearer, with a new study published last week in The Lancet. The study assigned everyone to ‘specialist care’ where they got advice and support. Three quarters of the group were then randomly assigned to either CBT, GET or pacing on top of specialist care.

The results were clear. Cognitive behaviour therapy and graded exercise therapy improve fatigue and help people to return to a more active lifestyle. Pacing, on the other hand, doesn’t help. Importantly, people having CBT or GET were no more likely to have adverse effects from their treatment, to drop out because of adverse effects, or to say their condition had got worse, than people using pacing.

Kudos to the researchers for taking seriously people’s concerns about treatment for CFS, and designing a trial that gave good, clear results that makes treatment just that bit easier to recommend. For more on the study, see my Best Health story or read the abstract.

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One comment

  1. The danger with pragmatism is the it gives a lot of power to those who are able to decide what outcomes should be prioritised.

    PACE was an open-label trial run by those who had built their careers upon the supposed efficacy of CBT and GET. Previous trials had revealed the CBT led to CFS patients filling in questionnaires more positively, but not being able to increase their activity levels (measured objectively by actometers). Actometers had been bought for the PACE trial, but were then dropped as an outcome measure, and only used at baseline as a possible predictor.

    Obviously, open-label trials that use subjective self-report measures as outcomes have long been used as an excuse for inflicting quackery upon patients. Fortunately, PACE included some more objective outcome measures. For employment levels, neither CBT or GET led to an improvement over SMC only. For fitness levels, neither CBT or GET led to an improvement over SMC only. For the 6 minute walking test, CBT led to no improvement over SMC only, while GET led to an improvement that was not clinically significant. The programme of Graded Exercise Therapy used focussed upon encouraging patients to do more walking, so it is surprising that no clinical significant improvement was seen here purely as a result of patients gaining more practice.

    Furthermore, the PACE trial researchers have refused to release results for their subjective self-report measures in the manner laid out in the trial’s protocol, and have instead used post-hoc outcome measures that serve to further exaggerate the efficacy of their interventions.

    Requests for the results of the outcomes laid out in the trial’s protocol have been turned down in so many contradictory ways (they’re due for release, they do not exist, it would cost too much to calculate them, Queen Mary’s University London would need to hire and train a new statistician in order to release them) that there is now a request for annonymised data that would allow others to perform the required analysis. This has also been turned down:

    https://www.whatdotheyknow.com/request/selected_data_on_pace_trial_part#comment-55844

    Even simple requests for information about the timing of these changes are being classed as vexatious:

    https://www.whatdotheyknow.com/request/timing_of_changes_to_pace_trial#incoming-564898

    A small point worth being aware of is that the Adaptive Pacing Therapy tested as part of PACE is quite different to any form of pacing that I have seen patients promote.

    “The results were clear. Cognitive behaviour therapy and graded exercise therapy improve fatigue and help people to return to a more active lifestyle.”

    What clear evidence was there that they helped people to return to a more active lifestyle? What makes you think that we have a reliable measure of ‘fatigue’?

    “Both are founded on the belief that people can recover from chronic fatigue, and doing more will help them recover.”

    And this trial was intended to test that belief. It would be helpful if they released results for the recovery criteria laid out in the trial’s protocol.

    “But these therapies have been controversial. Some people think that, if you propose CBT, it means you think the illness is ‘all in the head’.”

    So that’s why there’s been so much controversy. No need to bother engaging in any real discussion with any of the many patients concerned with these problems when the researchers involved are promoting these straw-man prejudices for you.

    Prof Edwards did take the time to talk to some patients about a separate research project, and rapidly came to see that many patient concerns about PACE were of value and should be recognised if medical researchers are to regain the trust of patients:

    “Apart from anything else I am saddened to see poor data of this sort being used in a way that will perpetuate the lack of trust between patients and their carers. The patients are very aware of the weaknesses of the study and I am surprised that those designing the study are not equally aware.”

    http://www.bmj.com/content/350/bmj.h227/rr-9

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