LONDON – Cognitive behavioral therapy and graded exercise therapy are both safe and effective to use in combination with specialist medical care for chronic fatigue syndrome, according to the results of a large randomized, controlled trial.
In contrast, adapted pacing therapy (APT), which several patient organizations have advocated as the preferred treatment choice together with specialist medical care, offers no real benefit – leading some experts to suggest that perhaps APT should no longer be used.
The findings were reported online Feb. 17 in the Lancet.
Dr. Trudie Chalder
Cognitive behavioral therapy (CBT) and graded exercise therapy (GET) – but not APT – significantly lowered fatigue and raised physical function scores when compared with specialist medical care (SMC) alone.
At 1-year follow-up, the respective changes in fatigue and physical function scores versus SMC alone were –3.4 and +7.1 for CBT, and –3.2 and +9.4 for GET, all of which were statistically significant differences. In contrast, the changes in those scores for APT were –0.7 and –3.4, respectively, differences that weren’t statistically significant.
Although the effects of CBT and GET on chronic fatigue syndrome (CFS) are still rather moderate, "the bottom line is that patients given CBT and GET showed more improvement than the other two groups," said Trudie Chalder, Ph.D., one of the study’s authors and a professor of cognitive behavioral psychotherapy at King’s College London (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60096-2]).
CFS affects around a quarter of a million people in the United Kingdom. Symptoms include severe fatigue, poor concentration and memory, disturbed sleep, and muscle and joint pain. Effective treatments for the condition are limited, with debate over the use of CBT and GET versus the more frequently used APT.
CBT and GET offer a more hopeful approach to CFS treatment than APT, because they focus on patients’ abilities rather than their disabilities, the investigators noted. APT is based on a more nihilistic premise, focusing on coming to terms with the illness and optimizing activities accordingly, they added.
The Pacing, Graded Activity, and Cognitive Behaviour Therapy: a Randomised Evaluation (PACE) trial was a prospective, multicenter, randomized trial of 640 outpatients with CFS comparing four parallel treatment arms: SMC alone, SMC plus APT, SMC plus CBT, and SMC plus GET. Patients were given individual therapy sessions once a month and group interventions every 3 months. Interventions were given for up to 24 weeks, with follow-up assessments at 1 year.
More than 3,100 patients were originally screened for the trial, but only those who met the Oxford criteria for CFS were enrolled. Those criteria require fatigue to be the predominant symptom, accompanied by significant physical disability in the absence of any other psychiatric or organic brain disorder.
Approximately 75% of the study participants were women, and the majority (93%) of patients was white. The mean age was 38 years, and the mean duration of illness was 32 months. The coprimary end points of fatigue and physical functioning were measured using the patient-reported Chalder fatigue questionnaire and the Short Form-36 physical function subscale.
"The take-home message is that we now have robust evidence of the effectiveness, and importantly for patients, the safety of CBT and GET, as long as they are given by properly trained people," said Dr. Michael Sharp, a study coauthor who is a professor of psychological medicine and director of psychological medicine research at the University of Edinburgh, Scotland.
Funding for the PACE trial was provided by the U.K. Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, and Department for Work and Pensions. Dr. Chalder and Dr. Sharp reported no relevant conflicts of interest.
"Although the PACE trial shows that recovery from chronic fatigue syndrome is possible, there is clearly room for improvement with both interventions (cognitive behaviour therapy and graded exercise therapy)," noted Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre in an accompanying editorial (Lancet 2011 Feb. 17 [doi:10.1016/S0140-6736(11)60172-4]).
"Both interventions could be improved if more was known about the mechanisms of change," they added. "Future studies into mechanisms of change are urgently needed and could help to improve the efficacy of the interventions, by focusing on the elements that are crucial for change."
Other independent experts welcomed the findings of the PACE study, commending the trial for finally answering a long-held dilemma.
"This study matters – it matters a lot," said Dr. Willie Hamilton, a primary care practitioner and professor of primary care diagnostics at the Peninsula College of Medicine and Dentistry in Exeter, England.