About 5 years ago, the UK government issued funding for a large scale study investigating the efficacy and safety of various treatments for ME/CFS, known as the PACE trial. This trial compared specialist medical care (SMC), SMC with cognitive behavior therapy (CBT), SMC with graded exercise therapy (GET), and SMC with adaptive pacing therapy (APT). Of the 641 participants recruited to the trial, each meeting the Oxford criteria for ME/CFS, 160 were randomly assigned to the APT group, the GET group, and the SMC group, with 161 assigned to the CBT group. The treatments lasted 12 months and the participants’ progress was monitored for 5 years. It was found that CBT and GET in combination with SMC were more effective at treating ME/CFS than SMC alone.1
Of the four treatments being tested, SMC is the more prevalent way to treat ME/CFS and involves simply seeing a doctor and being prescribed medicine to help with the symptoms of ME/CFS, such as pain and fatigue. APT involves matching activity levels to the amount of energy the patient has available. Participants assigned to CBT saw a therapist that examined how their thoughts, and behaviors, influenced the symptoms of ME/CFS and suggested different coping strategies. The fourth and final treatment, GED, works by gradually increasing physical activity to condition the body to higher levels of fitness through a basic activity routine.
Out of all of these therapies, the participants that were assigned to CBT showed the greatest improvement in their fatigue scores after the 12 month program, followed closely by GET. Participants assigned to APT did not improve any more than those assigned to the SMC group. In terms of physical function, individuals assigned to the GET group showed the greatest improvement, followed by the CBT group, when compared to the SMC group. Those in the APT group did not have any statistically significant improvements compared to those in the SMC group. Participants in the CBT and GET groups had less fatigue and better function than those in the other two groups. Thus, it was concluded that CBT and GET are safe and effective additions to SMC to improve CFS symptoms, whereas APT is not an effective addition.
More recent analyses of the PACE trial examined how many participants recovered from CFS following the 12 months of treatment. Recovery was defined as achieving the normal range for fatigue and physical function, and no longer meeting the criteria for CFS. It was found that both CBT and GET yielded the same recovery rate of 22% from CFS and participants who were assigned to GET and APT saw 8% and 7% recovery respectively. It was concluded that CBT and GET, in conjunction with SMC, are the therapies that are most likely to lead to recovery.2
After the release of these findings, several key criticisms came to light. First, the results of the PACE study used the Oxford selection criteria as opposed to the CDC criteria, meaning that some of the participants might not qualify as having ME/CFS according to internationally accepted CDC criteria. Second, the protocol was changed during the trial. Third, the Chandler Fatigue Scale, designed by one of the researchers, was used by participants to rate fatigue, but it has not yet been accepted as an objective and scientific method for measuring fatigue. All of these factors could confound the results.
In conclusion, despite yielding positive outcomes for around a quarter of the study population participating in CBT and GET, we would like to see higher recovery rates in patients with ME/CFS. More research needs to be done to understand this multifaceted condition in order to best predict what patients would succeed with which therapies. It is important to keep in mind that everyone is different and to consult your physician before starting any new treatments.
Meriem Mokhtech, BS
UF Center for Musculoskeletal Pain Research
- White PD, Goldsmith KA, Johnson AL, Potts L, Walwyn R, DeCesare JC, Baber HL, Burgess M, Clark LV, Cox DL, Bavinton J, Angus BJ, Murphy G, Murphy M, O’Dowd H, Wilks D, McCrone P, Chalder T, Sharpe M; PACE trial management group (2011). Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomized controlled trial. Lancet 379, 1412–1418.
- D. White, K. Goldsmith, A. L. Johnson, T. Chalder and M. Sharpe Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychological Medicine, Available on CJO 2013 doi:10.1017/S0033291713000020