In a large UK trial, chronic fatigue syndrome (CFS) patients who received cognitive behaviour therapy (CBT) or graded exercise therapy (GET), combined with specialist medical care, were three times more likely to recover than those who received other treatments.

Researchers from King’s College London, Queen Mary University of London, the University of Oxford and the Medical Research Council , write about the results of the PACE trial in a paper published in the January online first view issue of Psychological Medicine.

Co-author Trudie Chalder, a professor in the Department of Psychological Medicine at King’s College London’s Institute of Psychiatry, says in a statement:

“The fact that people can recover from chronic fatigue syndrome is excellent news.”

“Healthcare professionals can now be more confident in sharing this possibility with patients, many of whom are understandably concerned about their future,” she adds.

Chronic fatigue syndrome (CFS), also referred to as ME or myalgic encephalomyelitis, affects some 250,000 people in the UK. It is a long-term, debilitating condition that causes profound physical and mental fatigue (often made worse by exertion), accompanied by muscle and joint pain, disturbed sleep, and problems with concentration and memory.

The affected person feels exhausted and not able to carry on with normal everyday life. It doesn’t go away with sleep or rest, but for most people, the symptoms gradually go away over time.

There is currently no cure for CFS/ME, although some treatments can ease symptoms. Trials like PACE are evaluating which treatments work best.

The causes of CFS/ME are unknown. In 2009 a study suggested the XMRV mouse virus plays a role in the development of CFS, but two reports published in June 2011 refuted the claim, saying the more likely explanation for the finding was lab contamination.

There is some controversy surrounding CFS/ME, as reflected in the two names. CFS is the term mostly used by the medical profession, because the main symptom is usually chronic fatigue, and many argue there is not enough evidence that the condition is accompanied by brain and spinal cord inflammation, as the name ME suggests.

ME is the term most patients prefer because they see fatigue as too general a way to describe their symptoms; it insufficiently describes the severity and types of fatigue, and does not convey the fact fatigue, despite being the most common, is only one of several symptoms.

For this reason, there are several ways to diagnose CFS/ME, each with its own set of criteria.

The PACE trial started in 2005 and compared four of the main treatments available for CFS.

640 participants, recruited from six secondary care CFS clinics in England and Scotland, were randomly allocated to one of four treatment groups, with a final follow-up 52 weeks later.

The researchers used a range of criteria to define CFS/ME. These included the Oxford Criteria for CFS (all patients met these) and the London Criteria for ME (51% of patients met these).

The four treatment groups were:

  • Specialist medical care (SMC) alone. In SMC, specialist doctors give the patient an explanation of CFS, and general advice about how to manage it. They also prescribe medicines for symptoms such as insomnia and pain, or they advise the patient’s GP (general practitioner) as to which medication is most appropriate. In the SMC only group, patients are also encouraged to use the self-help methods that make most sense to them.

  • Cognitive behavioural therapy (CBT) with SMC. In CBT, a trained clinical psychologist or nurse helps the patient understand how the way they think affects their symptoms and how they cope with them, and gradually encourages them to increase activity.

  • Graded exercise therapy (GET) with SMC. In GET, a trained physiotherapist helps the patient adopt a gradually increasing tailored exercise programme that is designed around their individual symptoms and current level of activity and fitness.

  • Adaptive pacing therapy (APT) with SMC. In APT, a trained occupational therapist helps the patient to match their activity level to the amount of energy they have. The idea is to help them adapt to the illness rather than assuming they can gradually do more.

Many patients treated via the NHS in the UK are offered CBT and GET for treating conditions ranging from rheumatoid arthritis to heart disease, diabetes, depression and chronic pain.

Previously published results from PACE showed that many patients improved with CBT and GET but did not answer the question about how many patients recovered.

Funds from the Medical Research Council, Department of Health, Chief Scientist Office, Scotland, and Department for Work and Pensions paid for the PACE trial, which is thought to be the largest ever randomized controlled trial of treatments for CFS.

The researchers examined the evidence for recovery after the one year follow-up.

Previously published results from PACE showed that both CBT and GET with SMC led to bigger reductions in symptoms and disability than either APT with SMC, or SMC alone.

In this latest analysis, the researchers went a step further and looked at how many patients had recovered.

They classed recovery as no longer meeting several diagnostic criteria for CFS, including no longer suffering from significant fatigue or physical disability. These were the same criteria that were used to select the patients for the trial in the first place.

Patients also had to rate their overall health as being “much” or “very much” better.

The results showed that patients who received CBT or GET in addition to SMC, were three times more likely to meet the criteria for recovery than patients who only received SMC on its own, or APT with SMC.

The findings show that overall, 22% of patients receiving CBT or GET with SMC recovered, compared to 8% who received APT with SMC, and 7% who received only SMC.

Even when measured against different criteria for CFS, the patterns were similar, including when the diagnostic criteria were confined to myalgic encephalomyelitis (ME), which some people consider to be different to CFS.

Co-principal investigator of PACE, Peter White, is Professor of Psychological Medicine at Barts and the London School of Medicine and Dentistry, part of Queen Mary, and lead author of the latest paper. He says:

“This is good news and shows that recovery from this debilitating condition is possible for some patients.”

“We now need to go further to understand why only a relatively small proportion of patients recover, which shows how much this condition varies between individuals; one treatment is unlikely to work for everyone.”

White touched on the issue of how to define “recovery” and accepts some people reading about this study may question their use of the term. He says this was a key issue in the design of the study, and they chose to focus on “recovery from the current episode of the illness”, so they “used several measures of both symptoms and disability to give … the most complete picture possible.”

However, he concedes that “further analysis is needed to see if recovery is sustained in the long-term.”

Co-author Michael Sharpe, a professor at the University of Oxford and the other co-principal investigator of the PACE trial, says:

“The rehabilitative treatments of CBT and GET for CFS have been controversial. This analysis of the PACE trial data shows that not only do they achieve improvements in the majority, but that they can also lead to recovery in a substantial minority.”

Written by Catharine Paddock PhD