Are things taking off?

Just recently, I was in the town centre, watching people, full of life, walking around, and it occurred to me that if it wasn't for their false gravity beliefs, they would be able to fly. Really fly that is, not in planes or hang-gliders, but swoop through the air like Superman.

Excitedly, I rushed home. Well, to be honest, it wasn't exactly a rush, or even a stroll, but it was the best I could do. My first task was to come up with a hypothesis, then a treatment, then a method of testing it out.

So my hypothesis that the Cannot Fly Syndrome is based on a false belief in the powers of so-called gravity, a force which just does not fit into the known structure of atomic forces. Now I have lived on this planet for a very long time, and in observing people over that period, I have come to a lot of disturbing conclusions. One of these is that people can, under pressure, forget almost anything (even, as one Prime Minister discovered, forgetting a daughter when leaving a pub). So I propose to use a Clapping Bats Technique, to startle people into forgetting their perceived limitations. It is my belief, based on no evidence whatsoever, that this will work.*

Then I needed a good way of determining who could be classified as “people”. Using the Oxymoron Criteria to define people – living creatures capable of walking around for sustained short periods on two legs – I realised that I was fortunate in that my garden was visited by a constant procession of people, particularly if I had scattered some seed or breadcrumbs.

Before conducting the study, I produced my statistical analysis plan and published it in a very secure place: I can't remember where, but that isn't important, because I have no intention of actually using it: it seems that the only important point of such a plan is to pre-publish it. But I did calculate that I needed 720 people to take part in the study, so that even utterly minimal changes could be shown to be statistically significant**.

I employed random testing procedures, looking out of the window each morning and tossing a coin. If it came down heads, I would burst out of the door, clap my table tennis bats together and observe the reaction. Sure enough, virtually every time, the people would rise into the air and fly away. If I did not burst out and use CBT, they would remain in the garden, ostensibly inspecting the seed and breadcrumbs.

There were a couple of exceptions to this though. Neither my son nor my wife actually managed to take flight, although on occasions they did jump a bit. It was clearly a case of Pervasive Refusal Syndrome: I thank Esther Crawley for coming up with the term.

But I would like to emphasise that the ability to fly is not a simple state of affairs: rather it is the process towards that ability that is important. Consequently, I have reduced my targets in a very minor way, and now include an ability to have both feet off the ground at the same time as being indicative of the ability to fly. This minor modification to the criteria used to define flying has been approved by my trial committee, and defended by my good friend who pointed out that even transatlantic aircraft have to modify their flight plans according to local conditions.

You will be pleased to hear that I am now able to report a 100% success rate for CBT, and am now attempting to have my paper printed in that bastion of flight analysis, The Javelin. I'm already lining up my friends to give it a quick peer-review. I have also set up the Aviation Media Centre who will prime the media.

Of course, there will be naysayers: cynics who doubt the results of rigorous scientific studies such as these. I would simply like to point out that there is a precedent. In the study of M.E., a small group of psychiatrists created their own set of criteria that allowed them take the people suffering from ME and to add people with fatigue that was due to depression, anxiety, undiagnosed sleep problems, along with unusual and difficult to diagnose conditions such as hemechromatosis. Studies of this group showed that psychological therapies may have helped some of the group's thoughts about their illness, so recommended that this was an effective way to treat everyone in the group, including those with ME. They even managed to claim recovery by setting targets below the level that many scored at the start of the trial.

You don't believe that could have happened? Well, surprisingly enough, nor does it seem do many of the UK medical hierarchy or the media, despite the facts. I guess we will have to wait another thirty years for a proper tribunal to investigate the matter. At least they have come to their senses in America, and have decided to completely ignore any study involving the UK psychiatrists and their weird selection criteria for ME.

*The Department of Transport has funded this study in the hope that they will no longer need to maintain roads.

** For an explanation of this, wait for the next blog.

Is being a member of an ME support group holding you back?

 

Some medical professionals seem to believe that being in an ME support group is bad for us. I believe that they have misunderstood the studies, and that they fear that support groups make us feel that we have no hope of improving. I think that, in fact, being a member of a support group is good for us, and that the data supports this.

Why do some medical professionals view ME support groups with suspicion? This puzzles me because I help to run a small local group, and I am often told by members how helpful it is. Where does this negativity come from?

The first study that I came across which looked at the issue was one by Sharpe, Hawton, Seagroatt and Pasvol, published in the BMJ back in 1992. It said that "Functional impairment was significantly associated with … belonging to a self-help organisation". This is a formal way of saying that patients who did not improve much were more likely to be members of a support group. Many people would read that and think that it stated, quite clearly, that being a member of a support group held patients back. But that isn't what is says: it is easy to jump to a wrong conclusion.

For example, there is an "association" between smoking and heart disease: that doesn't mean that everyone who smokes will have a heart attack, nor that all those who suffer heart attacks have been smokers. It simply says that people who smoke more are more likely to have heart attacks (or that people who have had heart attacks are more likely to have been smokers). Back in the 50s and 60s lots of doctors (most of whom smoked) argued that it could simply be that people with demanding or stressful lives were more likely to get heart attacks, and that these people were also more likely to smoke more. It took a lot of further investigations to prove the real link.

On the other hand, there is also an "association" in the UK between the number of consonants in the name of each month how cold it is. Months like December and January have more consonants than June or August, and are colder. No-one has yet suggested that re-naming January as Jaary will make it warmer. Sometimes statistics throw up meaningless "associations". Sometimes the association is not what it seems at first sight. Statistical analysis is very useful for showing up patterns that could easily be hidden in complex data, but it is not a substitute for clear and logical thought.

(There is a better explanation of this confusion here at phoenix rising.)

There were 144 patients in the study. They were assessed at the start, then again once more, anywhere between a few months later and 4 years later. 41 patients belonged to self-help groups, and it turned out that these patients did not seem to improve as much as the others did. But, and this is an enormous "but", you have to read the full report to find that people were only asked about membership of a self-help group at the end, not at the start. In other words it could simply have shown that people who found they were not improving much were more likely to join a support group: that makes sense to me!

A number of doctors believe that mental attitude is a key factor to recovery from ME/CFS, so it was easy for them to assume that being in a support group was harmful. They assumed that patients in such groups could get depressing views about the illness, and could be encouraged to do very little but rest. Simon Wessely (who was not involved in the study) wrote that although the authors emphasised that being a member of a support group wasn't necessarily why they didn't improve as much, a possible explanation for these "disturbing findings" are that patients' beliefs are an important factor in holding them back from improvement. Despite the more obvious assumption that patients who aren't getting better are more likely to join a support group, he instinctively read it the other way.

After this, there were a number of studies that asked at the start whether patients were members of support groups. The study in 2002 by Bentall, Powell, Nye and Edwards, published in the British Journal of Psychiatry, is an example. There were 95 patients who completed the study. As usual, the assessments were by questionnaire. Only 17 patients were members of a self-help group, but their statistical tests suggested that they made less of an improvement than those that were not in a group. We could challenge the strength of the statistics, but let's assume that the link is true. Does this now mean that membership of a support group is a bad thing? Well, no. Interestingly, the results of an earlier study by Powell and Bentall in 2000, and the 2011 PACE study show us that a very different interpretation is possible.

In 2000 the BMJ published a study by Powell, Bentall, Nye and Edwards with 127 patients. They were given sessions where symptoms were explained and a graded exercise programme was designed for them. They found that it made little difference whether a group received just two face-to-face sessions, or whether they had seven further sessions either by telephone or face to face. They also assessed patients after three, six and twelve months, and found that most of the improvements happened between the start and the next assessment.

The PACE trial had many more patients (640), and it too found that most of the improvements occurred between start and the next assessment. In both cases we have a rapid improvement after getting a diagnosis, having the illness explained, and a couple of therapy sessions. In other words, talking about the illness, understanding a little more about it, knowing that your symptoms were typical, and getting advice about exercise led to an improvement in the way they answered the questionnaires. But that's as far as it went. The improvement did not continue over time with further Cognitive Behaviour Therapy or with Graded Exercise Therapy.

Isn't that type of support pretty much what goes on in self-help groups? People meet others with the illness and discover that the symptoms that worry and puzzle them are, in fact, quite common; that it isn't early onset dementia; that it can be both unpredictable and difficult to manage. They get advice on how to plan their lives, how to avoid boom and bust, how to get the best out of things.

Surely the logical conclusion is that any people who have joined support groups during the very long wait to get an appointment at a specialist centre, have, thanks to contact with others with the illness, already worked through much of the help that the specialist centres have to offer. They will already have gained more knowledge and confidence about the illness, and already have reaped those benefits; the specialist ME centres will have little to offer in addition to that.

I am guessing that the reasons why some medical professionals can't or won't see it that way are that they do not accept that people with lots of experience with the illness have much to offer people new to ME/CFS (which I think is reflected in the way in which medical professionals favour the term "self-help" group). They may believe that all "self-help" groups are really offering is reassurance and some understanding of the illness, and, are suspicious that these groups may give the impression that nothing can be done, and that the outlook is utterly bleak. Most importantly, they have the idea that after patients have seen them and made some progress, these improvements steadily continue long after they have been seen: something that is shown not to be so by the PACE trial. This isn't unique to those treating ME/CFS of course. How many of us have been treated for something by a specialist, assured that the problem is all sorted, only never to see a clinician again for a follow-up appointment to see if there were any long-term side-effects?

In addition, a minority of those who specialise in ME/CFS appear to see support groups as a threat to their authority: this is particularly noticeable in the specific criticisms that patients have of the PACE trial (now supported by a number of researchers), where the reaction to these criticisms from some quarters is very defensive/aggressive.

So my thoughts are simple: being a member of a support group gives people with ME/CFS significant help in the long wait for an appointment at an ME/CFS centre, and that ME/CFS centres actually do not offer much more than the advice and social support available from good support groups. After all, no medical treatments whatsoever are available on the NHS for the treatment of ME/CFS.

By the way, please remember that all of these "improvements"
are improvements in the answers to questionnaires – subjective assessments. Psychologists have spent years showing how easy it is to manipulate people into giving the kind of answers they want to questionnaires: in particular, patients who spend time and effort (and often money) in treatments, often delivered by kind and thoughtful professionals, may feel that they ought to report an improvement even if there is no measurable improvement. This is a well-known effect: people feel "ungrateful" if they say that the efforts of the kindly therapist have been worthless, particularly if they have been told, repeatedly, how effective it is and how the patient themselves focus too much on their symptoms. The big question of course is whether there were any real improvements (objective improvements) such as with walking, climbing stairs, working full-time or part-time, or in general activites. It will not come as any surprise to you to discover that not many studies on ME/CFS have used real, objective assessments, and that these assessments show very little or no improvement. More of that later.

2: Unfit and afraid?

Generally psychiatrists avoid any discussion of what actually sets off ME in the first place, but a small core argue that the reason that the condition continues is purely psychological. A very small minority of people with ME take offence at this, thinking it is a way of trivialising the condition, but that would be wrong and unfair. Anyone with any experience of depression, or any other condition labelled as "mental illness", is only too aware of how devastating and difficult such conditions are. Sadly, many psychiatrists also confuse that wrong attitude, held by a very small minority, with the scientific scepticism of many others about the validity of their suggestions. Unfortunately, others in society, including much of the media and some doctors, have taken the opinions of those psychiatrists to mean that ME is relatively trivial, and is simply a result of a lack of will-power: I am not convinced that the psychiatrists who put forward these ideas have done enough to counter that misunderstanding.

One of the ideas held by this small group of psychiatrists is that it is our fear that is holding us back: they believe that for some reason we have a deep dread of pushing ourselves, and any natural aches and pains that would normally occur on the road to recovery, are taken as confirmation that we are still very ill. They argue that such an attitude can also make us more sensitive to such pains. Again, it is important to realise that this is not an attempt to judge us, any more than it would for people suffering from post-traumatic disorder.

Their other idea is simply that we are deconditioned: too unfit to do much without getting tired. Actually they are linked, because the first one implies that the fear itself would make us become deconditioned.

Of course, fear and deconditioning can be part of any illness. I'm sure if anyone went down with food poisoning after eating a dodgy kebab, fear might well be something that holds them back from repeating the experience: and, of course, many older folk lose their confidence if they start to fall over regularly. Anyone who is in bed with a vicious bug for a week or more will be a little deconditioned, and if someone has a broken leg, it will take a while to get back to normal. Some will have their confidence shaken: some will wonder if they are quite ready to get back to work.

But this is very, very different here: the argument is not that some sessions of CBT can help us adjust to ME, but that most or all of our symptoms are due purely to fear or deconditioning. They are not talking about the way that CBT can help some people cope with heart conditions, asthma, MS etc. They mean that the level of fear and deconditioning described must very severe and deep-rooted, in order to be the sole reason for our symptoms.

These two suggestions have been described as hypotheses, but that really rankles with me from a scientific point of view. When a scientist has an idea or a theory that fits the known facts, it doesn't command any respect until it can be tested by predicting something that is previously untested and that fits specifically with that theory.

Here's a silly example, just to explain what I mean. Suppose you have a little electronic number pad, and when you press 2 the answer 4 pops up. When you press 4 the answer 8 pops up. Pretty obviously it is just doubling the number you pressed. But I could come up with the suggestion that it takes 2 from the number, squares that, then adds 4 to it. They both give the same results, but doubling predicts that pressing 3 will give a 6, but my method would give a 5. So trying it with a 3 is a test that would show the difference between the suggestions.

That is, of course, a silly example, and is so easy to test, but think of scientists puzzling about climate change. They cannot perform experiments, so when they come up with ideas, they must find ways to show that their idea is a good one: they have to come up with something new to be measured that would distinguish their new idea from existing ones: something that clearly shows that they are on the right track. Anything worthy of being called a hypothesis must add something new to the understanding, and, most importantly, predict something that has yet to be tested that will confirm its unique ideas.

Now contrast that with these two "hypotheses" about ME. It could be argued that they add some deeper insight into the condition. But it is easy to speculate about what ME could be. I could offer a suggestion that ME is caused when some of the millions of neutrinos, that pass through our bodies every minute, hit and disturb processes within our cells: it is simply that some of us are more sensitive to these disturbances than others. Would you like to have a go producing one? What do you fancy? How about childhood abuse, stresses at work, chemical additives to chicken, electromagnetic radiation from the sun, visits by the tooth fairy, or imbalances of cosmic energies? None of these would deserve to be called hypotheses: they are just ideas. Some might be educated ideas, some random, and some downright weird, but that's all they are

So how have they tested the fear hypothesis? Getting people to fill in a questionnaire to measure their fear isn't going to impress anyone. Some people get confused and think that measuring whether CBT helps actually tests the hypothesis. It doesn't, for two good reasons. The first is that CBT does not only address fear, and there is no proof that it addresses fear efficiently: if CBT worked brilliantly for ME it would not confirm the fear factor, and if it was utterly ineffective it wouldn't disprove it either, any more than taking aspirin would.

It's not up to me to suggest a test, but I'll give it a go. I would expect that, if fear is such a major factor in ME, when people with ME suffer from another health problem it will show up very clearly in their recovery. Remember that we aren't talking about the apprehension many people feel after a really bad illness: we are talking about fear so strong that many patients become housebound: they lose contact with most of their friends, and are often shunned by their own families. So when, for example, 6 years ago I fell over and broke my hip, fear of putting weight back on it during the recovery process should have been a significant problem. (In case you are wondering, it wasn't. In fact the biggest problem was not beating people about the head with my crutches when they were being really sympathetic, trying to get them to understand that in comparison with ME, a broken hip was just a temporary inconvenience.)

What about deconditioning? Here the suggestion is that there is no difference between people with ME and people who are very deconditioned. Now obviously anyone who has been ill for a while becomes deconditioned. The important part about this suggestion is not that we are deconditioned, but that that is our only problem. Not only that, but this is the case for all patients caught by the Oxford Criteria for Chronic Fatigue Syndrome, which, in effect, means medically unexplained fatigue for 6 months or more.

There have been a large number of small studies over the years looking at muscles that have shown a variety of interesting and relevant results: if you try this link and click on "Documented muscle abnormalities" in the Contents page, it will give you a lot to look at. More recently, studies carried out with Julia Newton at Newcastle showed that, when exercised, the muscles of people with ME produce on average 20 times as much acid as healthy folk. This almost contradicts the supposition of deconditioning being the simple cause of fatigue, but a pedantic sort (like me) would say that strictly speaking patients with ME have to be compared, not with the healthy, but with those who really are deconditioned – with couch potatoes. To prove their point, perhaps supporters of this "deconditioning hypothesis" should demonstrate that people who are simply deconditioned display the same (inconsistent) range of abnormalities in these tests as people with ME. Now that would be an unexpected and untested prediction.

This is where the recent run of "2-day treadmill exercise" tests could come in but unfortunately these tests are hard to set up, and carry out consistently. What is more, they are normally matched with relatively healthy volunteers: I can imagine that it would be quite difficult to get some very deconditioned people to volunteer.

You could argue that if our only problem was deconditioning, then Graded Exercise Therapy should do the trick. That still doesn't satisfy my requirements though, because many studies fail to see whether patients are actually exercising more, or simply doing less of other things to fit in the required exercises. On the few occasions that pedometers were used to track patients, it was found that the overall level of activity didn't increase. But then, a large number of people with ME report that GET harmed them.

So there aren't any studies that actually confirm these suppositions, and, strictly speaking, there aren't any that prove they are false: but then surely the important question, before bothering to test whether they are true or false, is whether the suppositions actually match the facts. No scientist would waste her or his time testing something that didn't match known events. I would find it very hard to fit these suppositions to my situation. I went down with ME very abruptly after an infection in 1999. I changed virtually overnight from being able to cycle the 8 (very hilly) miles to work and back twice a week, to struggling to walk a couple of hundred metres to the staffroom.

But without a diagnosis, and with none of the standard tests showing any abnormalities, I had to carry on working for two-and-a-half years. It was terrible. Fortunately I was in a brilliant, supportive, and very concerned department. I am certainly not the only one who has been in that sort of situation. How could the assumption of fear or deconditioning be applied in cases like that? Could I become that deconditioned so quickly? Could I stay deconditioned for two-and-a-half years while still struggling to work? How could the concept of fear be applied here? If the explanations cannot fit the situations, then how can they even be worth considering?

These two suppositions certainly don't deserve to be called hypotheses, and that fact that some doctors choose to claim they are true simply indicate that these are, in fact, belief systems; belief systems that feed on people's bigotry. The fact that they don't even cover many circumstances make it even more of a "faith above reality" situation. What difference is there between doctors saying that they believe these to be true, based on their "clinical experience" then advocating treatment that, of course, helps pay their salary, and a preacher that assures you that he has talked with God and knows that He wants you to hand over your money to his particular church?


So the next time that a doctor suggests that deconditioning is your problem, and that CBT or GET would solve your problem, point out that you are an atheist, Buddhist, Methodist,... and that you do not subscribe to his particular form of unquestioning faith in the god-like wisdom of the medical hierarchy. Unless of course he can produce the hard evidence. In which case, please let me know and I will rewrite this blog (with apologies).

Scientific analysis and ME psychosocial research:

will they ever meet?

I get frustrated by the endless recycling of unsubstantiated claims and opinions about ME, and can fully understand why many people get quite angry about it. So I intend to write a short series of blogs looking at the claims that some people make and studies that people believe support them. It will involve a certain amount of statistics, but I do not intend to get bogged down in the numbers: you only need common sense and logic to see where these studies fall down. I used to teach maths, and I get very annoyed with researchers who use what I call “spreadsheet statistics.” In the old days (my youth), before even calculators were around, we had to think very, very carefully about which forms of analysis to use, because the calculations involved took ages. Now researchers just click on a function button on a spreadsheet and get all sorts of complex calculations performed.

I could instruct a spreadsheet to work out the average of my height, weight, shoe size, age, waist measurement, and house number. It doesn't know such a calculation is meaningless: press the button, it will do it. But if the researchers involved do not understand the fundamental assumptions behind any statistical technique and exactly what they are dealing with, then they might just as well be predicting the future with animal entrails. It's just a shame that journalists don't check the original sources any more, and are happy to take the word of people who have financial interests in their interpretations being printed as fact.

1: “Those who report a diagnosis of CFS/ME have increased levels of psychiatric disorder prior to the onset of their fatigue symptoms.”

This quote comes from a study, by Harvey, Wadsworth, Wessely and Hotopf, published online in 2007 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3196526/). At first it sounds a pretty impressive investigation, with a total of 3035 subjects, using terminology like “There was a dose–response relationship between the severity of psychiatric symptoms and the likelihood of later CFS/ME,” or “Logistic regression analysis was then used to calculate odds ratios (ORs) corrected for known sociodemographic confounders, such as gender.” No wonder few people dig into it to find out what is really going on.

What happened was that there were 5362 subjects selected for the Medical Research Council National Survey of Health and Development in one week of March 1946. In 1999, 3035 of these, by then aged 53, were followed up. But only 34 of them had ME/CFS. So this wasn't some enormous study, but one on a mere 34 patients. Now in my book, a survey of 34 people just isn't worth doing, no matter how fancy a set of statistical spreadsheet buttons you have. But, let's go with it. 

Roughly the expected number of those 34 had not had any previous psychiatric or psychological problems, and again the expected number had some prior lesser psychiatric or psychological problems, such as more moderate depression or anxiety. But instead of finding 2 people in the group with severe psychiatric problems, there were 6. From a statistical point of view, that is quite unexpected: it is significant. But is it significant in the real world sense?

The key part is a little more buried: these were not diagnoses of ME/CFS, but were simply notes made by the interviewing nurses that the subjects said that they had ME/CFS. So, in essence, all of this hinges on a statement by 4 people, who had suffered severe psychiatric problems in the past, that they now had ME/CFS.

The explanation by the authors here is interesting. “Clinical experience suggests that it is uncommon for a patient to complain of CFS or ME and to not have sufficiently severe symptoms to warrant the diagnosis.” It is interesting to note the faith that these authors have of the validity of patients' self assessments of their symptoms. Presumably patients are much better at this than GPs, with reports coming out from Newcastle and London ME centres saying that around half of the patients sent to them with suspected ME/CFS in fact were suffering from a different condition that their GP had not detected.

So, out of an original sample of 3035 people, the certainty that “Those who report a diagnosis of CFS/ME have increased levels of psychiatric disorder prior to the onset of their fatigue symptoms,” is based on the statement by those 4 subjects. Those 4 subjects who told the nurse that they had ME/CFS, but no attempt was made to check that diagnosis. Notice too that 30 out of the 34 patients “with ME/CFS” were not at all out of the ordinary, but the conclusion was applied to all.

In science, it is important to aim for the simplest explanation that covers the facts. A large proportion of the sample of patients with ME had no background of psychological problems: the conclusion cannot be appropriate for them. The simplest and most logical conclusion to draw from these results is that, if indeed all 34 patients had a diagnosis of ME/CFS (which is questionable), the criteria generally used to define the condition are not sufficiently good enough to exclude those whose primary problems are psychological.

This study was useless right from the start. No statistician could resurrect anything worthwhile from it. Who would dream of repeating its conclusions?

OK, it's been a long time, but a group of us have now completed a fuller analysis of the PACE trial. You can find it at
http://evaluatingpage.phoenixrising.me/home.html

There is also an introductory Youtube video at
http://www.youtube.com/watch?v=Sa3LyYxu49s

It may have taken a while, but last year's PACE publication was only meant to be the first part. There is still no word about when the rest of the analysis will be available, and the authors are resisting requests to release the data for others to analyse, despite the fact that we all paid for it. We still do not have any data on whether any of the patients managed to sustain a return to full or part-time work.

Last year, Richard Horton of The Lancet issued a challenge to patient groups to engage in a proper discussion of the PACE trial, but although we contacted him on 15th May this year, and the assistant editor on the 25th, neither has replied. I wonder what he had in mind when he invited us to engage in discussion? Perhaps we need to qualify as doctors first.

However, Janelle spoke at the CFSAC meeting last week, and introduced our analysis there. Phoenix Rising are hosting the site and members contributed greatly to its production, and we are continuing to try to have our findings recognised.

If you have any suggestions, or would like to spread the word, please feel free to contact me via the website.

The Pace Trial 2011 - can we GET any better?

On 18/12/10 a study was published in the Lancet that compared the effectiveness of different therapies on patients diagnosed with CFS. It concluded that Cognitive Behaviour Therapy and Graded Exercise Therapy can safely be added to specialist medical care to moderately improve outcomes for chronic fatigue syndrome. Headlines suggested that the use of GET and CBT for treating ME/CFS had been justified: the actual report makes it clear that the use of GET and CBT should be continued.

The PACE trial had 4 groups, each with around 160 patients: the members of one group had specialist medical care about 5 times over the year: the other three groups had specialist medical care 3 or 4 times as well, but also had an additional 12 to 15 sessions of Graded Exercise Therapy (GET), or of Cognitive Behaviour Therapy (CBT), or of Adaptive Pacing Therapy (APT). Their progress was tracked in a variety of ways, and was measured at the start, after 12 weeks, after 24 weeks and after 52 weeks.

It cost over £4 million: the report is complex and often unclear. I feel sorry for any medical practitioner trying to understand the whole picture: it takes hours.

We are just looking at two aspects of those results - they are typical of the general pattern of results, so they will give you a pretty clear idea of the whole balance of the study.

Part One

First let us look at the way that GET is claimed "to moderately improve" the fatigue levels of patients. We will focus on their assessment of fatigue using the "continuous" Chalder scale, which runs from 0 points to 33 points, where 33 points represents utter exhaustion (in the true sense of the term - not just feeling very tired). Patients were assessed at the start of the trial, after 12, after 24 and after 52 weeks. A drop in score therefore represents a drop in fatigue: an improvement in health.
(The animation below has a commentary.)


The GET line is actually flattening out: it is roughly taking twice as long for each drop of 0.8 points on the fatigue scale. It isn't sensible to try to predict very far, but it would suggest that it might take another year to drop another one point, then another 2 years to drop another point... That is a daft thing to speculate, but it does emphasise that, speaking realistically, the improvement is about as good as it gets. I would call this a very minimal improvement, and hardly cost-effective.

It leaves me with two questions. As most of us are lucky to get even one appointment with an M.E. specialist, and that is generally to confirm diagnosis, wouldn't it have been appropriate for the authors of this trial, if anything, to suggest that patients with M.E. should have more sessions with a specialist, since this gave the greatest improvement? (Although it is important to remember that the overall improvement was not great).

Also, I wonder how much of the initial overall improvement was due simply to "settling down" and getting used to the study (the biggest improvement in all groups came in the first interval between tests, after 12 weeks). I know myself how much it takes out of me to go somewhere new and participate in new activities. It isn't possible to guess this, because for some reason, the authors of the study chose not to allow for such initial stresses. It is my guess that if the study had been set up with a "settling down" period giving patients time to familiarise themselves with the location, situation and testing procedures, before actually embarking on the therapies, then this initial improvement would have been very much reduced.

We would have been able to estimate this, and any placebo effect, if there had been a proper control group, where the patients had not had the benefits of specialist medical care or therapies but did have an equal amount of support time, but the authors of the study chose not to do this.

Part Two

Now we would like to explain our concerns about the variability in these results. Again we are concentrating on the improvement in fatigue caused by GET alone. Obviously we do not have the raw data, so all we can do is to give you a sort of picture of what could be happening here, but we have tried hard to be realistic and fair to the information that we do have.  This is not intended to be an accurate graph: it is intended to illustrate how such a small average improvement has major implications on the mixture of recovery patterns that we could see.


Why haven't we been told how many patients did really well under GET? How many improved a little? How many made no change or actually got worse? We are often told by experts that many people with ME do recover and go on to enjoy a full and productive life. Did this trial support those claims? Are we now able to say what sort of patient will improve with GET? After all, giving absolutely everyone in a doctor's waiting room a course of antibiotics would improve the overall average health by a little, but who would advocate that? Just like the patients in the waiting room, we know that patients diagnosed with CFS represent a range of conditions. With each patient in the study having at least 4 hours of specialist medical care, surely there is enough information to distinguish between the different subsets, and to see which groups actually showed a worthwhile improvement.

We, as taxpayers, have paid for a lot of data. Isn't it about time that someone analysed it in a fair and useful manner?

Click on this link http://www.meetup.org.uk/pacedownload.html if you would like to dowload a pdf file that covers the content of this blog, but adds a little more depth and detail.

This analysis was a joint effort between Graham, Bob and Ian: click here to contact us by email.