From Fatigue: Biomedicine, Health & Behavior, 14 December 2016
Can patients with chronic fatigue syndrome really recover after graded exercise or cognitive behavioural therapy? A critical commentary and preliminary re-analysis of the PACE trial
Carolyn Wilshire(1), Tom Kindlon(2), Alem Mathees(3), Simon McGrath (4)
1) School of Psychology, Victoria University of Wellington, Wellington, New Zealand
2) Irish ME/CFS Association, Dublin, Republic of Ireland
3) Perth, Western Australia
4) Monmouth, UK
Publications from the PACE trial reported that 22% of chronic fatigue syndrome patients recovered following graded exercise therapy (GET), and 22% following a specialised form of CBT. Only 7% recovered in a control, no-therapy group. These figures were based on a definition of recovery that differed markedly from that specified in the trial protocol.
To evaluate whether these recovery claims are justified by the evidence.
Drawing on relevant normative data and other research, we critically examine the researchers’ definition of recovery, and whether the late changes they made to this definition were justified. Finally, we calculate recovery rates based on the original protocol-specified definition.
None of the changes made to PACE recovery criteria were adequately justified. Further, the final definition was so lax that on some criteria, it was possible to score below the level required for trial entry, yet still be counted as ‘recovered’. When recovery was defined according to the original protocol, recovery rates in the GET and CBT groups were low and not significantly higher than in the control group (4%, 7% and 3%, respectively).
The claim that patients can recover as a result of CBT and GET is not justified by the data, and is highly misleading to clinicians and patients considering these treatments.
From the Journal of Psychosomatic Research, 8 December 2016.
Telephone-administered versus live group cognitive behavioral stress management for adults with CFS
Daniel L. Hall(1) Emily G. Lattie(1), Sara F. Milrad(1), Sara Czaja(2), Mary Ann Fletcher(3), Nancy Klimas(3), Dolores Perdomo(2), Michael H. Antoni(1)
1) Department of Psychology, University of Miami, Coral Gables, FL, USA
2) Department of Psychiatry and Behavioral Sciences, University of Miami, Miami, FL, USA
3) Institute for Neuro Immune Medicine, Nova Southeastern University, Davie, FL, USA
• L-CBSM and T-CBSM both yielded modest effects on perceived stress (PSS)
• L-CBSM, but not T-CBSM, also demonstrated modest effects on Symptom Severity and Symptom Frequency.
• Future studies should continue to explore ways to offer benefits of L-CBSM to CFS patients via other remote technologies.
Chronic Fatigue Syndrome (CFS) symptoms have been shown to be exacerbated by stress and ameliorated by group-based psychosocial interventions such as cognitive behavioral stress management (CBSM). Still, patients may have difficulty attending face-to-face groups. This study compared the effects of a telephone-delivered (T-CBSM) vs a live (L-CBSM) group on perceived stress and symptomology in adults with CFS.
Intervention data from 100 patients with CFS (mean age 50 years; 90% female) participating in T-CBSM (N = 56) or L-CBSM (N = 44) in previously conducted randomized clinical trials were obtained. Perceived Stress Scale (PSS) and the Centers for Disease Control and Prevention symptom checklist scores were compared with repeated measures analyses of variance in adjusted and unadjusted analyses.
Participants across groups showed no differences in most demographic and illness variables at study entry and had similar session attendance. Both conditions showed significant reductions in PSS scores, with L-CBSM showing a large effect (partial ε2 = 0 .16) and T-CBSM a medium effect (partial ε2 = 0 .095). For CFS symptom frequency and severity scores, L-CBSM reported large effect size improvements (partial ε2 = 0 .19 – 0 .23), while T-CBSM showed no significant changes over time.
Two different formats for delivering group-based CBSM—live and telephone—showed reductions in perceived stress among patients with CFS. However, only the live format was associated with physical symptom improvements, with specific effects on post-exertional malaise, chills, fever, and restful sleep. The added value of the live group format is discussed, along with implications for future technology-facilitated group interventions in this population.
From the Journal of Psychosomatic Research, 3 December 2016.
Heart rate variability biofeedback therapy and graded exercise training in management of chronic fatigue syndrome: An exploratory pilot study
Petra Windthorst(1), Nazar Mazurak1(1), Marvin Kuske(1), Arno Hipp(2), Katrin E. Giele(1), Paul Enck(1), Andreas Nieß(2), Stephan Zipfel(1), Martin Teufel(1).
1) Department of Psychosomatic Medicine and Psychotherapy, University Hospital, University of Tuebingen, Germany
2) Department of Sports Medicine, University Hospital, University of Tuebingen, Germany
• Heart rate biofeedback and graded exercise training improve fatigue as core symptom of CFS.
• Heart rate biofeedback improves quality of life and depression in patients with CFS.
• Graded exercise training reduces physical fatigue and betters physical functioning in patients with CFS.
Chronic fatigue syndrome (CFS) is characterised by persistent fatigue, exhaustion, and several physical complaints. Research has shown cognitive behavioural therapy (CBT) and graded exercise training (GET) to be the most effective treatments. In a first step we aimed to assess the efficacy of heart rate variability biofeedback therapy (HRV-BF) as a treatment method comprising cognitive and behavioural strategies and GET in the pilot trial. In a second step we aimed to compare both interventions with regard to specific parameters.
The study was conducted in an outpatient treatment setting. A total of 28 women with CFS (50.3 ± 9.3 years) were randomly assigned to receive either eight sessions of HRV-BF or GET. The primary outcome was fatigue severity. Secondary outcomes were mental and physical quality of life and depression. Data were collected before and after the intervention as well as at a 5-month follow-up.
General fatigue improved significantly after both HRV-BF and GET. Specific cognitive components of fatigue, mental quality of life, and depression improved significantly after HRV-BF only. Physical quality of life improved significantly after GET. There were significant differences between groups regarding mental quality of life and depression favouring HRV-BF.
Both interventions reduce fatigue. HRV-BF seems to have additional effects on components of mental health, including depression, whereas GET seems to emphasise components of physical health. These data offer implications for further research on combining HRV-BF and GET in patients with CFS.
The described trial has been registered at the International Clinical Trials Registry Platform following the number DRKS00005445.