“ME can be beaten by positive thinking and taking more exercise,” is the rather simplistic message from the Daily Mail following the results of a long-term study involving 481 people.
The study compared four types of treatment for chronic fatigue syndrome (CFS), a condition where people feel so persistently exhausted they cannot function, also called myalgic encephalomyelitis (ME). Researchers found positive results for two types of treatment lasted for at least two years.
A 2011 study comparing four commonly used treatments seemed to show two types of treatment worked better: cognitive behavioural therapy (CBT), a type of talking therapy that aims to help people challenge unhelpful thinking patterns, and graded exercise therapy (GET), where people are helped to gradually increase the amount of exercise they do each day.
The other treatments were specialist medical care (SMC) or adaptive pacing therapy (APT), where people are helped to pace their activities to avoid getting fatigued.
The researchers went back to the patients two years after the study began to see what happened next. They found those who had CBT and GET kept their initial levels of improvement, while those who had APT and SMC had improved since the end of the study year.
But, as the researchers themselves concluded, “Better treatments are still needed for patients with this chronically disabling disorder”.
Controversy over the PACE studies
It’s fair to say this study’s lead author, Professor Michael Sharpe, has attracted a great deal of controversy. His work – the PACE study – has been criticised by one of the leading patient associations for people with CFS/ME, the ME Association.
This latest study prompted a press release from the ME Association, claiming its methodology and that of previous studies was flawed and lacked “objective measures of outcome”.
In turn, the ME Association has been criticised by some as pursuing a specific agenda that aims to shut down any research that suggests CFS/ME may have psychiatric, as well as physical, factors.
One thing is for certain – it’s unlikely this debate will be settled any time soon.
Where did the story come from?
The study was carried out by researchers from the University of Oxford, King’s College London, University College London, and Queen Mary University of London, and was funded by the UK Medical Research Council, the Department of Health for England, the Scottish Chief Scientist Office, the Department for Work and Pensions, and the National Institute for Health Research.
One of the researchers declared a potential conflict of interest, as they have worked as a consultant for an insurance company. Two other authors declared they had written books that promote cognitive-based approaches to treating CFS/ME, which they continue to receive royalties for.
Although they did report the overall study results, The Daily Telegraph and the Daily Mail focused on questions about whether CFS is a physical or mental illness, as well as the disagreements between the study author and the ME Association. They did not look closely at the study results. The study itself was a comparison of four types of treatment, so cannot answer questions about the nature of the illness.
The papers’ headlines were also somewhat simplistic, suggesting the condition had been “beaten” or “overcome”. While there was a reported improvement in symptoms, this certainly didn’t amount to a cure.
What kind of research was this?
This follow-up of a randomised controlled trial looked at what happened to the people who took part in the original trial after the study had finished.
Randomised controlled trials are the best way to compare different treatments. Follow-up after a study has finished can show us whether any benefits are lasting.
However, as the study had ended, we can be less sure about whether differences between treatment groups are the result of the treatment participants originally had, or if it was anything that happened since the study ended.
What did the research involve?
In the original study, people with chronic fatigue syndrome were split into four groups. All were offered specialist medical care. In addition, one group had cognitive behavioural therapy (CBT), one group had graded exercise therapy (GET), and one group had adaptive pacing therapy (APT).
At the end of one year, each group was assessed to see whether their symptoms had improved. In this new research, the same groups were followed up at least two years after the original study started and answered the same questions about their symptoms.
Between the end of the one-year study and the follow-up questionnaires, people had been able to have additional treatment, choosing which therapies to try with input from their doctor. This means some people will have tried additional therapies, while others only received their original treatment.
The researchers carried out different analyses to see whether their results could have been changed by numbers of people not returning questionnaires, how long people took to return the questionnaires, how ill they were at the start of the study, and so on.
What were the basic results?
The results of the original study found people who had CBT or GET had, on average, lower levels of fatigue and were able to function better physically at the end of the study year. The follow-up study showed these results persisted, so people in these groups either stayed the same or improved slightly after the first year.
People who had specialised medical care alone, or with APT, had less positive results at the end of the study year, although everyone improved somewhat. By the end of the follow-up, these groups had further improved for fatigue and physical functioning. The final results at the end of two or more years were about the same for people in each of the four groups.
More than half (63%) of those who received specialised medical care alone went on to have more treatment after the study finished, as did 50% of those who had APT. In the other two groups, 31% of people who had CBT and 32% of those who had GET went on to have more treatment. Most of the additional treatment received was CBT or GET.
How did the researchers interpret the results?
The researchers say the most important result was that, “The beneficial effects of CBT and GET seen at one year were maintained at long-term follow-up” two or more years after the trial started. They say the improvements seen by people who originally had specialist medical care alone or with APT could have a number of causes.
It could simply mean these people got better with time, or their symptoms settled down from being very bad at the start of the study to average after two years. However, the researchers say the improvements could also be because by this time many of these people had now received CBT or GET.
This study gives us the long-term results of the only randomised controlled trial to directly compare four commonly used treatments for chronic fatigue syndrome. It is encouraging that people who seemed to benefit from CBT and GET in the first year of the study were still seeing those benefits after another year.
The finding that people who had the other types of treatment – specialist medical care alone or with APT – improved during the year after the study had finished is interesting and difficult to interpret.
It could simply be the case that these people got better over time, although previous studies have shown people with chronic fatigue syndrome tend not to get better without treatment. It could also be because some of them had CBT or GET in the year following the study. But we simply don’t know if this is the case.
The researchers say they carried out an analysis that did not show additional treatment was linked to higher chances of getting better. They warn this analysis was not reliable because it could not take account of other factors that might have affected the results. This is one of the study’s main limitations.
Another limitation is that only 75% of people who took part in the original study returned their follow-up questionnaire, and the length of time between people finishing the study and sending back the questionnaire varied.
This study doesn’t tell us anything about the cause of chronic fatigue syndrome, a much-debated cause for controversy. Some people think it is a physical illness caused by infection, while others think it may be more of a mental health condition or reaction, and could be an umbrella term for a number of different conditions. As the study mentions, there are around 20 different published case definitions of what chronic fatigue syndrome is.
What is not in doubt is chronic fatigue syndrome causes much suffering. At present, we don’t know what causes it and there are no cures, though some people do fully recover. In the meantime, researchers, doctors and patients have to seek out the treatments that have the best evidence for effectiveness.
As the researchers themselves say, some people in this study didn’t get any better, regardless of which treatment they had. We know CBT and GET don’t help everyone, even if they seem to help more people than other currently available treatments. We still need better treatments for this complicated and disabling condition.