Treating Chronic Fatigue Syndrome

A new study published online in the Lancet presents the results of a comprehensive research project examing the benefits of cognitive behaviour therapy and graded exercise therapy in the treatment of chronic fatigue syndrome.  Despite ongoing controversy over its nature, cause and treatment, chronic fatigue syndrome (CFS) is believed to affect millions of people worldwide.  Generally defined by a persistent fatigue unrelated to exertion, not substantially relieved by rest and accompanied by the presence of other specific symptoms for a minimum of six months, the disease (or diseases) appears multi-systemic in  nature and is classified by the World Health Organization as a disorder of the nervous system.   There is currently no reliable diagnostic test or biomarker. 

To examine the comparative benefits of four different treatments in treating CFS patients, a prospective research project was launched by a team of researchers from the University of  London and the University of Edinburgh.  Known as the PACE study (Pacing, Graded Activity, Cognitive Behaviour Therapy: a Randomized Evaluation), the project was designed as a parallel-group randomized trial comparing the relative benefits of cognitive behaviour therapy (CBT),  graded exercise  therapy (GET),  adaptive pacing therapy (APT),  and standardised specialist medical care (SSMC).   SSMC  typically involves providing patients with information on their condition and advice on coping strategies.  APT focuses on helping patients structure their activities to match their reduced energy levels.

Using a sample of 640 patients meeting Oxford criteria for CFS,  the study participants were randomly assigned to treatment groups receiving SSMC alone or SSMC in conjunction with one of the other three treatments.    Patients in the parallel treatment groups received monthly individual therapy sessions as well as group therapy sessions every three months.  Approximately 75 per cent of the study participants were women with a mean age of 38 years.  Average duration of CFS symptoms was 32 months.  Results after one year have shown that  those  participants who received CBT and GET in conjunction with conventional medical care showed  moderate  improvement over the participants in the other two groups.  Over 60 per cent of patients reported reduced fatigue and improved functioning while 30 per cent reported no change.  Despite the preliminary nature of the results, the study authors emphasize that it provides robust evidence of the  value of CBT and GET in  treating chronic fatigue patients.  The results also show that adaptive pacing strategies, often advocated by patient groups, have no apparent benefit in treating CFS.

In an accompanying Lancet editorial, Dr. Gijs Bleijenberg and Dr. Hans Knoop of Radboud University Nijmegen (Netherlands) Medical Centre stated that, "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)"    They also emphasize that CBT and GET provide symptom relief only but do not address the underlying cause of CFS. 

For the study

Comments

[Kelly Latta]

I believe what the PACE authors meant was the adaptive pacing was not as effective for the subgroup they studied.

The cohort may have been large, but they used a very rarely used and broader definition for which one of this study's authors, Michael Sharpe was the lead researcher and another, Peter White, funded.

Essentially the PACE trial folded in a significant number of
subjects who do not have CFS according to standard criteria or who may possibly have affective disorders only.

Unlike the definition used by most researchers (original 1994 Fukuda definition), and the one used by researchers showing the effectiveness of pacing as well as researchers researching exercise induced abnormalities in CFS patients, post exertional malaise lasting 24-hours or longer and unrelieved by rest was not included in the definition for this cohort.

According to psychologist Dr. Fred Friedberg who is the president of the professional IACFS organization, studies show that the stricter criteria for CFS are linked to poor prognosis and conversely, subjects who don’t meet strict criteria for CFS have better outcomes.

Extrapolation of study results to such patients meeting the strictest criteria is limited by this variable.

As well, an examination of the endpoints between the protocol originally registered showed that ‘recovery’ as defined originally required an SF-36 PF score of 85 or over, however the final endpoints published were measured as: ‘back to normal’ – which only needed a SF-36 PF score of 60. Inclusion criteria for the trial required that patients have “severe and disabling fatigue” – this included SF-36 PF scores of up to 65.

The take away message? While CBT and GET may be helpful in some subgroups they do not meet the level of significance for "curative" results according to Friedberg, Activity and exercise recommendations must be based on a thorough evaluation and a sensitive individualized approach. Similar conclusions were reached by researchers publishing an RCT trial of GET and CBT in January.

Future studies comparing not only treatment modalities, but patients cohorts drawn from the various definitions in use should be the next step.

Many of the authors are consultants for disability insurers and litigators used by employers. This needs to be considered as well since both employers and insurers stand to benefit significantly financially if their consultants can point to treatments purported to "reverse" this disease.

[Romeo Vitelli]

I don't think they made any claim that the treatments represented a way of "reversing" CFS, just that it was beneficial in relieving symptoms.