There is something very satisfying about reading a well-designed and beautifully written research paper. Not only can it produce some helpful answers (and usually pose multiple questions!), but the process that is followed means it’s pretty easy to see how the researchers arrive at their conclusions. This paper by White, Goldsmith, Johnson, Potts, Wolwyn, DeCesare, et al., is just one of those papers.
Why am I writing about research into four treatments for chronic fatigue syndrome? Well, the treatment options used in this trial are exactly the same treatments used in chronic pain management (cognitive behavioural therapy, graded exercise therapy, adaptive pacing therapy and specialist medical care). And it poses the question: does ‘working inside the envelope’ of energy help people achieve better mood status and better functional status than challenging the assumption that ‘this is as good as it gets’?
On with the method. This study examines four different treatments carried out in parallel, it’s an unblinded/masked randomised trial designed to establish the effectiveness of these treatments as well as the adverse events associated with each treatment, and reviews the outcomes up to one year after treatment ended.
Participants were carefully selected to meet the criteria for a diagnosis of chronic fatigue syndrome, and it’s interesting to see that only 28% of the people initially recruited actually met these criteria, and of this group, only 71% or 641 people actually progressed through to treatment. Thankfully the CONSORT trial profile included in the paper shows very clearly who was ‘in’ and who was ‘out’ – and why!
Clinicians were carefully trained, supervised regularly, and treatments were monitored for adherence to the treatment type, the manual used, and that sufficient number of sessions were carried out.
A number of outcome measures were used – primary outcome measures of fatigue and the SF-36 physical subscale, with secondary outcome measures covering a range of variables including the ‘I think you look better’ clinical global impression scale, the six minute walk test, and the number of chronic fatigue symptoms remaining, along with a couple of others.
So what exactly were they testing in this study?
Adaptive pacing therapy is based on the idea that people with chronic fatigue have a limited amount of energy available, and that this is fairly static with limited potential for improvement. People are asked to monitor their fatigue, and plan their days according to their energy levels, avoid ‘overdoing’ things, prioritise and therefore achieve what is important, and set the scene for natural recovery, if that occurs. The strategies include looking at daily activities to identify links between activity and fatigue, becoming aware of ‘early warning signs’ of fatigue, regularly using rest and relaxation and generally attempting to ensure that no single activity exceeded ‘70% of the energy envelope’. Participants could participate in more activities provided they felt they could and as long as their symptoms didn’t get worse.
Cognitive behavioural therapy is based on the idea that chronic fatigue is reversible, and that fear of activity (cognitions) and avoidance of activity (behaviours) influence physiology and perpetuate the problem. By changing the appraisals of symptoms and introducing approach behaviour rather than avoidance within ‘behavioural experiments’, participants can test the usefulness of their beliefs and gradually, in a planned way, increase their activity level. This is delivered within the context of identifying important activities and problem solving through obstacles that could get in the way of engaging in these activities.
Graded exercise therapy is based on the idea that people with chronic fatigue are, at least in part, deconditioned and intolerant of activity. By gently extending the level of activity, participants can reverse the physiological changes that perpetuate chronic fatigue, and gradually return to participate in everyday activities. Participants develop a baseline level of activity, then in planned increments of time rather than symptoms, start to increase the amount of time they spent in exercise. Target heart rates and time exercising were set collaboratively, and most participants started with walking.
Specialist medical care consisted of education about chronic fatigue, prescription of symptom-alleviating medications (mainly for sleep, pain and mood), and general ‘self help’ advice.
Well, surprisingly, both the specialist medical care and the adaptive pacing therapy achieved similar results across the outcome domains. And both CBT and graded exercise therapy achieved similar results over the domains, with CBT improving mood slightly more than GET, and GET improving physical activity slightly more than CBT. What was incredibly surprising is that both of these therapies were more effective than pacing and specialist medical advice. And even more surprising was that the rate of adverse events was pretty similar – with CBT having the least number of events than those in adaptive pacing or graded exercise therapy. None of these adverse events was considered, according to predetermined criteria, to be a ‘serious’ event, and adverse events generally were quite common.
How does this study finding apply to chronic pain management?
I think the underlying hypotheses of the treatments used in this study are pretty much the same as those used in chronic pain management. The question is – do we help people ‘live within their limits’, or do we help people extend beyond those current restrictions and progress towards doing things they think they can’t? It’s a question that some clinicians don’t even consider because the focus in chronic pain management has so often been on curing or fixing the pain. And then there are clinicians like myself who want to help people live well despite still experiencing pain.
But in a large number of support groups, the whole idea of learning to do more seems invalidating. To want to change from being seriously disabled to living pretty much normal lives means giving up some of the ‘being disabled’ identity. It can mean no longer being given special consideration, or having the limitations of choosing what to do and when to do it acknowledged by others.
I’m not sure that I give enough time and attention to helping people mourn these losses as we try to push the boundaries. At the same time as making space for mourning though, I want to give hope that life can be good, and better, than what is current. Time to push the boundaries – but gently does it.
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 randomised trial. Lancet, 377 (9768), 823-36 PMID: 21334061