Professor Michael Sharpe of Oxford University, UK, and colleagues followed up 481 of the original 641 participants in a 2011 study. In addition to cognitive-behavioral therapy (CBT) or graded (gradually increasing) exercise therapy, another group of participants was given adaptive pacing therapy, in which the individual is encouraged to schedule in periods of rest in their day-to-day activities. All three groups also received standard medical care, and a further group received standard medical care alone.
Participants were contacted two-and-a-half years after having one of the four treatments. Initial results showed improvements in fatigue and physical functioning after CBT and graded exercise therapy. The later set of results indicated that these improvements were sustained for at least two years, regardless of whether they had any further treatment.
Participants in these groups of the study were also less likely to have sought additional therapy afterward. Despite the improvements in fatigue and physical functioning, the four treatment groups had roughly equal numbers that experienced a long-term deterioration in their general health, about 10 percent in each. Full results were published in the Lancet Psychiatry.
“The finding that participants who had CBT and graded exercise therapy had maintained their improvement over two years after entering the trial, tells us that these treatment can improve the long-term health of people with chronic fatigue syndrome,” said Professor Sharpe.
Professor Peter White from Queen Mary University of London, UK, said, “Finding no significant differences in the proportions getting worse over time is a reassurance for those who worry that some of these treatments might make things worse. But it is also a reminder that these treatments do not help everybody, and more research is needed into finding other treatments that help.”
However, the ME Association has concerns over the reliability of the study, which it says “means that people with ME will recover if only they start exercising and develop a positive mental attitude.”
The charity’s own research has found that over 70 percent of patients say exercise therapy worsens their symptoms. “The conclusion that people with ME will respond to graded exercise therapy because they are simply inactive and deconditioned is no longer tenable,” the charity says.
Dr. Steven Moylan and colleagues at Deakin University, Australia, explain in the same journal, “Dozens of names have been used to describe illnesses resembling chronic fatigue syndrome. The diverse nomenclature reflects heterogeneity in the disorder’s conceptualization, spawning terms as divergent as chronic Epstein–Barr virus, epidemic neuromyasthenia, systemic exertion intolerance disease, post-viral fatigue syndrome, myalgic encephalomyelitis, and chronic fatigue immune dysfunction syndrome.
They add that this wide range of labels parallels the diversity in therapies used to try to treat these symptoms, which include drugs such as fluoxetine (Prozac), rintatolimod (Ampligen), or galantamine (Razadyne), psychological approaches such as CBT, and lifestyle interventions.
The Deakin University team interprets this study’s findings as suggesting that structured CBT and graded exercise therapy “seem to accelerate improvement of self-rated symptoms of chronic fatigue syndrome compared with standard medical care or adaptive pacing therapy, an important finding in an illness with few treatment options and substantial morbidity.”
However, the conclusions reached by the study’s authors have been criticized because long-term improvements were similar over the four groups, perhaps because a large proportion of participants in the adaptive pacing therapy and standard medical care went on to seek CBT or graded exercise therapy.
An ME patient subsequently responded to the trial findings. In the Lancet Psychiatry, Charles Shepherd, Medical Adviser of the UK’s ME Association writes, “The long-term follow-up of the PACE trial, which originally reported that CBT and graded exercise therapy produced a significant and sustained improvement, even recovery, for some people with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) should, in theory, have been greeted positively by patients.”
However, he adds, there was very little difference in outcomes at long-term followup between any of the four interventions, and the patient community has expressed anger “because the media, along with many health professionals, has concluded that people can recover from ME/CFS through a simplistic approach to management involving exercise and positive thinking.”
Mr. Shepherd quotes a recent survey of 1,428 patients in which 73 percent of respondents reported that CBT had no effect on their symptoms and 74 percent that their symptoms were made worse by graded exercise therapy.
“Without robust objective evidence relating to improvement and recovery, the ME patient community will continue to regard the PACE trial as a tremendous waste of research funding money,” he concludes.
Sharpe, M. et al. Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial. The Lancet Psychiatry, 27 October 2015 doi: 10.1016/S2215-0366(15)00317-X
Moylan, S. et al. Chronic fatigue syndrome: what is it and how to treat? The Lancet Psychiatry, 27 October 2015 doi: 10.1016/S2215-0366(15)00475-7
Shepherd, C. Patient reaction to the PACE trial. The Lancet Psychiatry, 27 October 2015 doi: 10.1016/S2215-0366(15)00546-5