Times article, by Tom Whipple, 28 September 2016: Exercise and therapy cure for ME is ‘seriously flawed’


A landmark study suggesting that ME could be treated with exercise and psychological intervention is seriously flawed, scientists have claimed.

If correct, it would mean that treatments recommended on the NHS, which have proved hugely controversial among Britain’s 250,000 sufferers of ME, are ineffective.

However, the study, which, since its publication in the Lancet, has been the focus of bitter dispute, has been defended by its authors and other scientists. The new analysis used the same data but a different definition for what constituted “recovery”. Philip Stark, professor of statistics at Berkeley, argued that this simple change converted a “finding into an unfinding” — showing that there was no benefit from exercise or cognitive behavioural therapy.

He conducted the re-analysis because he said the original authors had weakened the criteria used to judge the severity of symptoms.

“It was lax to the point where an individual who would have been deemed ill on entry could have been considered healthy at the end, even if they had deteriorated,” he said.

His paper is the latest salvo in a clash between the scientists behind the trial and patients, many of whom disagree that their condition can be treated with behavioural interventions. At times the dispute has become so bitter that scientists have complained of death threats.

ME, also known as chronic fatigue syndrome, is a mysterious condition in which people experience severe tiredness, often to the extent that they cannot work. Many mechanisms have been proposed for triggering it. Some have suggested it is a maladaptive reaction to viral infection, others that it is psychological.

While the causes are unknown, the disputed trial claimed that its symptoms could be alleviated with exercise and cognitive behavioural therapy. Some sufferers, who saw headlines such as “Got ME? Just get out and exercise, say scientists”, considered this offensive and have disputed both its methodology and conclusions.

Now, independent scientists say they have a point.

“It’s an unfortunately common practice to change criteria in trials,” said Professor Stark. “The consequence of this is you can’t really interpret if something is meaningful or not.”

Peter White, one of the original researchers, said he did not dispute Professor Stark’s methods, but added that the argument was about the definition of recovery.

“They’ve used more conservative criteria. We thought people who rated their health as ‘much better’ or ‘very much better’ should be included. They used ‘very much better’. We said in the paper one major limitation is it is very difficult to define recovery.”

He was defended by George Lewith, professor of primary care at Southampton University, who was not involved in the original research. He said the field was in danger of becoming politicised.

“I’ve worked in the area for ten years, and I’ve been appalled by what has happened. There’s a small group of people with fixed and opposing views, and they want to torture the data until it proves what they believe. I think there’s a great danger people will stop doing research because it’s so confrontational.”

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