Guardian opinion piece, by Peter White, 20 September 2016: ‘If my team’s research on ME is rejected, the patients will suffer’

Sufferers of chronic fatigue syndrome have been neglected too long. But our Pace trials show the right talking and exercise therapies can make a real difference

Chronic fatigue syndrome – sometimes called ME (myalgic encephalomyelitis) – is a sad tale for everyone involved. It is a debilitating illness that affects about 250,000 children and adults in the UK alone, wrecking lives as people are unable to hold down a job and are sometimes left bed-bound for years on end.

Unfortunately these patients have not been treated well – their illness is often dismissed or belittled, leading to much anger, misinformation and argument. There are claims of foul play, with issues over freedom of information and sharing of trial data; this week it was claimed that sexism is part of the reason those with ME struggle to get the proper treatment. My colleagues, Professors Trudie Chalder and Michael Sharpe, and I have spent our careers trying to improve care for patients with CFS/ME. At the heart of this story is the Pace trial we have been conducting since 2005.

For many years Nice (the National Institute for Health and Care Excellence, which oversees healthcare evidence) recommended just two treatments – graded exercise therapy (GET) and cognitive behavioural therapy (CBT) – because it had the best evidence that these therapies worked. However, many patients were not using them, following instead a self-guided treatment called “pacing”: listening to the messages from their bodies and pacing themselves – trying not to do too much, wary of pushing themselves to a point where they might make the illness worse. The idea of doing exercise therapy was scary for some patients, worried that over-exertion would exacerbate their ill-health. The idea that CBT, a talking treatment, might help, raised fears that the illness was regarded as “merely psychological”, or even “all in the mind”.

With so much uncertainty and fear among patients, we wanted to find out which of these treatments worked best and whether they were safe. So we ran a large trial with 640 patients that would seek to replicate earlier studies, but on a much bigger scale. All those who took part were given specialist care and randomly allocated to also receive either pacing therapy, CBT, GET, or nothing extra. We had involvement from CFS/ME community, and the research was overseen by independent committees looking at data, safety and how the trial was run.

The results of our study, published in The Lancet in 2011, were clear – those patients given CBT or GET experienced significantly greater improvements in both symptoms and ability to do things, compared with either pacing therapy or specialist medical care alone. Not only were CBT and GET more effective: crucially, they were just as safe as the other treatments when done correctly.

Our results confirmed the earlier smaller trials, and strengthened the evidence upon which the recommendations of Nice were based. Added to this, a recent Cochrane review (a summary of all the evidence, and considered the gold standard in medical research) also concluded that exercise is a safe and effective treatment. In short, CBT and GET are safe, can definitely help some people and are more effective than other treatments: but, as with all treatments in medicine, they cannot help everyone.

From here on this should have become a happier story. However, some of the ensuing newspaper headlines – such as “Got ME? Just get out and exercise, say scientists” – gave the misleading impression that patients just needed to pull themselves together, or even that they were making it all up. In our clinics we had seen far too much suffering to ever think this illness could be dismissed in this way.

Our research, and that of our colleagues in this field, has attracted its fair share of criticism. Some campaigners have even called for the research to be stopped, the findings retracted, and CBT and GET abandoned completely as they cause harm. One recent focus of criticism has been whether CBT and GET can actually bring about recovery or remission from the illness, not just reduce the symptoms. And by recovery we mean recovery from a patient’s present episode of illness – which is not necessarily the same as being cured, as someone might fall ill again.

To address this we did another test on the data, and found that 22% of people could be considered as recovered with either CBT or GET. Though not a large proportion it was about three times more than the recovery rates achieved by the other two treatments. Other studies showed similar proportions recovering after CBT.

In the latest step in this saga, a blog that hasn’t gone through the rigours of scientific peer-review, or being published in a journal claims that CBT and GET are not as effective as we reported. The authors got their figures by tweaks such as increasing the pass-grade for what counted as recovery, and excluding patients who had reported themselves as “much better”.

Whichever way the data is viewed, patients get better results from CBT and GET – both confirmed as safe – than they do from pacing or medical care alone.

This whole affair is perhaps saddest for the patients themselves, whose suffering has been neglected for far too long. However, there is hope. First, the important message for patients is that it is possible to get treatment that will help them improve and for some to recover. Second, we agree with campaigners that we need more research into the causes and treatments of CFS/ME. However, if their campaign puts people off trying CBT and GET, it will be the patients themselves who will suffer the most.

This post is followed by 156 comments (by 9am 3 Oct 2016). This is the first:

Unfortunately, this is a totally misleading analysis of the situation. Independent scientists are now more or less unanimous that the PACE trial is worthless because of basic design flaws. The recent reanalysis by an independent group was based on the PACE authors’ original endpoints and it shows no significant evidence for recovery due to specific therapies. The independent review in the recent Freedom of Information tribunal confirmed that the PACE authors’ claims that criticism of their trial was an attack on science were groundless. I have become involved in this as an independent outside academic and I am very clear that the criticism are entirely justified and often too lenient.

Jonathan Edwards
Professor Emeritus
Department of Medicine University College London