Can exercise and positivity overcome M.E. / CFS? A look at the evidence

This week, the Telegraph had a front page article claiming a new study showed that exercise and positivity can cure M.E. This was a very misleading article. So amidst the flurry of responses, and the confusion surrounding Graded Exercise Therapy for ME/CFS, here’s some FAQs and the most helpful articles dealing with the question of whether exercise and positivity can overcome Myalgic Encephalomyelitis (sometimes referred to under the umbrella term Chronic Fatigue Syndrome).

• Was the study new?

In fact, this was not quite a new study. It was a follow-up study of the previously-published PACE trial, looking at whether the improvements in patients were sustained after c. 30 months.

• What did the ‘new’ study actually say?

The Telegraph article gave the impression that Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT) offer the best chance of recovery for M.E. patients. Actually, the study found something quite different – that those in the GET and CBT groups had no greater improvements, long-term, than those in the Pacing group (APT) and those who did nothing at all (Standard Medical Care). The authors hypothesised that it could be that those in the APT and SMC group went out and did Graded Exercise after the study, but they have absolutely no evidence or data to back that up.

In other words, their new follow-up study showed that there is no advantage in Graded Exercise Therapy over other therapies. 

“There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.” – from the abstract of the new study, published in the Lancet Psychiatry, 27 October 2015. 

• What was the original study?

Back in 2011, there was a controversial study called the PACE trial, which aimed to discover which treatment was best for M.E./CFS. It looked at four non-pharmacological treatments:

1. Graded Exercise Therapy (GET) – where you increase your exercise slowly, regardless of how ill you feel,
2. Cognitive Behavioural Therapy (CBT) – where you are encouraged to deal with your ‘false illness beliefs’,
3. Pacing (APT) – where you aim to stay within your energy envelope, and
4. Standard Medical Care (SMC) – which was used as a control group.

The study concluded that Graded Exercise Therapy and CBT were the most effective treatments for M.E. though these findings were challenged from several quarters (see below). The study advised that CBT, followed by GET would be the most ‘cost-effective’. The £5million study was part-funded by the UK government’s Department of Work and Pensions (DWP). (Find the abstract of the PACE trial here).

• What were some of the problems of the PACE trial?

 – Entry criteria. The PACE trial probably had a mix of ME patients and other people – rather than use a more rigorous definition of M.E. (such as the Fukuda, Canadian Consensus Criteria or International Consensus Criteria), they used the ‘Oxford criteria’ for Chronic Fatigue Syndrome, which just requires people who have been fatigued for six months or longer. There is no way of knowing which of the subjects had M.E., and which subjects had a different condition.

 – Subjective, not objective measurements. They had an objective measure of success, the six-minute walk test. However, these results showed that the patients made little progress, and the average subject, by the end of the trial, was walking shorter distances in that time than those suffering from congestive heart failure, cystic fibrosis, disabled with pacemakers fitted etc. This, in most people’s understanding, would not represent ‘recovery’. Neither did they measure how many, if any, had returned to full-time work, which is what most would define as recovery. Instead, they relied on a questionnaire system for the patients to self-evaluate how much better they felt.

 – Definition of recovery. Probably the biggest problem is that they changed their measurements halfway through, to redefine ‘recovery’. Originally, you had to score 85 out of 100 on the questionnaire for it to be called recovery. They changed this, halfway through the trial, to define recovery as a score of 60 out of 100. In order to be disabled/ill enough to enter the study itself, you had to score 65 or less. This meant that, on their scoring system, you could start at 65, deteriorate to 60, but be declared ‘recovered’ at the end of it.

Emeritus Professor Jonathan Edwards found it “a mass of un-interpretability.” Bruce Levin, a Columbia University epidemiologist called the study “the height of clinical trial amateurism.” Stanford geneticist Ron Davis questioned how it even got through peer review, given its deep methodological flaws.

Investigative reporter David Tuller recently wrote an exposé of the scandalous flaws of the PACE trial, and his extensive four-part piece is here.

To read a summary of what David Tuller’s piece and why the PACE trial is widely discredited,  check out #MEAction Network, The Faculty Lounge. 

• What exactly is Graded Exercise Therapy, and why is it unpopular among M.E. patients?

Graded Exercise Therapy means doing gradual exercise, every day, whether you experience symptoms or not. If you experience a relapse, you can rest for a few days, but you are expected to return to the exercise as soon as possible. The theory behind this therapy is that ME is not an organic disease, but a psychiatric one, a behavioural disorder or functional somatisation disorder, with the symptoms caused by a mixture of deconditioning and exercise phobia.

“Participants are encouraged to see symptoms as temporary and reversible, as a result of their current physical weakness, and not as signs of progressive pathology…Planned physical activity and not symptoms are used to determine what the participant does.” – quote from PACE trial manual, about Graded Exercise Therapy

Unfortunately, as ME is really an organic disease, M.E. patients have an abnormal physiological response to exercise, which means it takes them much longer to recover than most people. It is unpopular among ME patients because it makes them worse rather than better.

Here were some of the patients’ stories about Graded Exercise therapy (GET), compiled  by the ME Association:

From a child with ME – “During GET course I began to have episodes of paralysis below the waist, because of this my paediatrician stopped the GET. I have never been able to return to my level of health prior to GET. GET rendered me housebound and triggered off a number of new symptoms as well as worsening the severity of my old symptoms…I went from mild/moderate ME to severe ME following GET.” – page 135-6, ME Association CBT/GET/Pacing 2015 Survey

“Before the course I was able to complete a 40 minute walk with no physical side effects. After doing GET I could no longer walk for even 5 minutes without extreme breathlessness which lasted for up to three hours at its worst. I deteriorated so rapidly that my GP gave me an attendant wheelchair as I could no longer walk. Seven years later I still need the wheelchair. GET took away my independence and destroyed my life.” –   page 129-130, ME Association CBT/GET/Pacing 2015 Survey

• What is Pacing Therapy, and why do patients prefer it? 

Pacing Therapy means that you stay within your ‘energy envelope’ and allow your body space to heal itself. The important thing is to avoid overexertion, whether physically or cognitively, so that you protect the patient from an ME relapse, where the symptoms are worsened, sometimes with permanent effect. Patients are encouraged to listen to their body, and rest if they experience symptoms. Patients prefer it because it is low-risk – in the largest survey of ME patients (by the ME Association), Pacing was found to be the therapy least likely to harm, and most likely to help.

• Is there any proof that exercise/ Graded Exercise Therapy affects ME patients badly?

A recent study by Dr Snell, Van Ness et al, using VO2 Max testing, demonstrated that in a 2 day test, ME patients were shown to be able to exercise less the following day than they were the day before. This is the opposite of what happens to patients who are deconditioned – they can do more the following day. Because it measures chemical changes in the body, there is no way of ‘faking’ this physiological exhaustion. (For a summary of the study, click here; for the paper itself, click here.)

Another recent study by Dr Julia Newton et al in the UK has shown abnormal amounts of lactic acid produced in the muscles of patients with ME – twenty times more than the normal person. This could account for some of the pain experienced by ME patients. Her team took a biopsy of muscles from ME patients and ‘exercised’ them by running an electrical current through them. They showed significant physiological abnormalities when compared to the control subjects. This is an objective, rather than subjective measure. (For a summary of the study, click here or here; for the paper itself, click here).

There is also the evidence of the patients themselves. Though some say they have been helped by Graded Exercise Therapy, the majority of those who completed a Graded Exercise Therapy course surveyed in a recent study (2015) by the ME Association said they had been made worse. (For a more academic detailed analysis of the harms of Graded Exercise Therapy for ME/CFS patients, see Tom Kindlon’s paper here.)

• Could it just be because their Graded Exercise Therapy was done by non-experts? 

No. Almost all of the patients in the ME Association survey reporting harm had had NHS Graded Exercise Therapy delivered by NHS professionals who were specialists, delivering it in accordance with the PACE Trial manual.

• What evidence is there that ME is an organic disease? 

The most comprehensive independent review of all the research on M.E. and CFS was undertaken by the US’ Institute of Medicine this year. They concluded that because of the huge wealth of evidence showing physiological abnormalities, link with viruses, and the progression of the illness, it was a disease, not just a ‘condition’ or ‘syndrome’, and that it was physical, not psychiatric in origin. As a precaution, ME patients are forbidden from donating blood in the UK.

• If Graded Exercise Therapy is so harmful, why does it seem to work for some?

The psychiatrists involved in the PACE trial have suggested that the reason that some improved is that they truly ‘believed’ that the therapy would work. This lays the blame of the failure of the therapy squarely at the foot of the subject, rather than the researcher. This is something of a specious argument: if you find yourself doing Graded Exercise Therapy and deteriorating, you’re not going to believe it’s going to work when the evidence of your own body shows you it’s not. Association does not equate to causation.

There are now studies showing the damaging physiological effects of over-exertion; it is medically impossible to attribute those to a patients’ belief system.

There are several explanations for why some improve, while others deteriorate:

–  It should be noted that even with the bias of the PACE trial, which sought to prove that Graded Exercise was the most effective therapy for ME, the improvements in walking were minimal overall.

 – Furthermore, there could be a minority in the larger CFS category who don’t have classic ME, but instead truly have stress-related exhaustion, deconditioning and exercise-phobia, who improve with Graded Exercise Therapy. Until tighter diagnostic criteria are used or a biomarker is found, there will be a heterogenous group being diagnosed with Chronic Fatigue Syndrome, some of whom will not have ME, but will have been misdiagnosed.

 – A certain percentage of people with ME will improve, even without intervention. At the point of recovery, physical rehabilitation like Graded Exercise Therapy will help increase their fitness. In that case, it is not that the Graded Exercise Therapy has helped them to improve, but that once improved, the Graded Exercise Therapy has helped them to get fit and rehabilitated.

– It is possible that a small subset of people within the ME/CFS umbrella could respond physiologically well to exercise, while the majority of patients are damaged. Dr Julia Newton’s work suggests there may be a small phenotype of patients with M.E. who respond well to exercise.

Graded Exercise Therapy for M.E. is like running on a broken leg – if you start running when the bones have knit together and healed, you will improve your fitness and recover. If you run on a broken leg before the bones have fused, you will do permanent damage.

• What about CBT? Isn’t it a good thing to have CBT for ME, like counselling services for those who have cancer?

It would be wonderful if that’s what CBT for ME meant. Unfortunately, CBT for ME is based on the assumption that the condition is caused by ‘false illness beliefs’, and the therapy revolves around trying to persuade ME patients that they are not ill, and they need to stop listening to their body and ignore their symptoms.

Perversely, this means that ME patients have less access to counselling, rather than more. As a housebound ME patient, I asked for counselling in coming to terms with the limitations of the illness. I was refused telephone counselling or an NHS counsellor to visit me at home, on the grounds that ME patients should be ‘encouraged’ to ‘get out and about’.

• Is this about wanting to avoid the stigma of a mental illness?

No. This is about getting the right treatment for the right illness. We would think it absurd if a cancer patient were referred to a psychiatrist rather than an oncologist. The World Heath Organisation International Classification of Diseases (ICD-10) lists Myalgic Encephalomyelitis under neurological (not psychological) disorders under Ref 93.3, and has done since 1969 (see this article for more details). Thousands of patients testify to being harmed by Graded Exercise Therapy, even made permanently disabled by it. If this were a drug that were having this effect, it would have been recalled years ago.

• What do the NHS Nice guidelines advise in the way of treatment? 

Unfortunately, the Nice guidelines advise Graded Exercise Therapy and Cognitive Behavioural Therapy as the best ‘evidence-based treatments’. This includes children. In practice, this is almost universally the only thing offered to ME patients. If they are made worse by these therapies, there is nowhere else for them to go.

For children who refuse these therapies, their parents may be suspected of withholding treatment wrongly, and social services may become involved. The TYMES Trust have assisted more than 100 families wrongly accused of child abuse, simply because their child has ME.

• When are the NHS Nice guidelines going to be reviewed in light of the new evidence?

At the moment, the ME Nice guidelines have been placed on the ‘static list’, which means that they won’t be reviewed any time soon. The ME Association and others are calling for the NHS to review these guidelines much sooner – but as yet, they have refused. As it stands, the Nice guidelines advising Graded Exercise Therapy and Cognitive Behavioural Therapy as treatments for Myalgic Encephalomyelitis are as dangerous as advising sugar for diabetics.

The two faces of ME: the one you don’t see

• Just how serious is ME, anyway? Is it like being tired all the time?

It’s not like being tired all the time. Everyone’s tired all the time. It’s more like being too tired to brush your hair. Though fatigue is a factor in the illness (as it is with many other autoimmune/neurological illnesses), M.E. is a multi-system illness, with a wide variety of debilitating symptoms.

25% of people with ME are housebound or bed-bound. Roughly the same percentage don’t improve. Though not many doctors realise this, it is possible, though rare, to die of ME, and autopsies of patients with ME have found dorsal root ganglionitis in their spinal cord and other physiological abnormalities. For very severe patients, they are so ill that they cannot talk, cannot feed themselves, cannot walk or stand, and need to be in a darkened room, lying down, all the time, whilst experiencing agonising pain.

Read very severe ME sufferer Whitney Dafoe’s Story, or see it here.

Read the story of Sophia Mirza, who was locked in a psychiatric hospital because doctors believed her illness was psychiatric. She died in 2005 at the age of 32, and was the first person in the UK to be given ME/CFS as an official cause of death, or see her story here and here.

Read severe ME sufferer Tom Kindlon’s story here.

For further reading:

• Response to the Telegraph article – Guardian, ME Association Press Release, ME blogger Utting-Wolff Spouts, ME Action Net
• See this mini-documentary (35 minutes) of different ME patients telling their story – The Last Great Medical Cover-up.

Take action: 

• ME Action Net – Sign a petition calling on The Lancet to retract the PACE Trial claims of recovery 
• Change.org – Sign a petition asking the NHS to reform the NICE guidelines
• Better yet: Write to your MP, asking for the NICE Guidelines to be revisited in the light of the new study showing the ineffectiveness of Graded Exercise Therapy, and the potential harms caused to ME patients.