Friday, 23 June 2017

Mixed response to GETSET from Science Media Centre experts | 23 June 2017

From science media centre, 22 June 2017.

Expert reaction to study on guided self-help graded exercise therapy as a treatment for chronic fatigue syndrome (CFS)

Researchers publishing in The Lancet present their findings from a randomised controlled trial they conducted to test the efficacy and safety of graded exercise delivered as guided self-help, for the treatment of chronic fatigue syndrome.

Dr Jon Stone, Consultant Neurologist and Honorary Reader in Neurology, Western General Hospital, Edinburgh, said:

“The GETSET trial is a helpful addition to the evidence base for treatment of CFS which is a common and disabling condition.

“What this shows, for the first time, is that it is possible for relatively time-limited guided self-help based on a graded exercise model to make a modest positive difference overall to a group of patients with CFS over a short time window (12 weeks).

“Importantly, the trial addresses concerns that graded exercise may be harmful in CFS by showing that deterioration was no more common in the group allocated the intervention.

“In absolute terms, around 1 in 6 patients noticed a positive change overall compared to 1 in 20 patients not receiving the intervention and nearly all the secondary outcome measures were also positive.

“The trial has been well conducted but it is important to note that the long term outcome of this intervention is not yet known and that data at 12 months is yet to be published.

“This is likely to be a treatment option that is helpful for some but not all patients with CFS. Clinicians should not assume that just directing patients to a booklet is sufficient. These patient had up to 90 minutes of input from experienced physiotherapists over four sessions which is likely to have been an important part of the treatment effect.

“It’s encouraging that this effect was also achieved through technologies such as skype which help patients who find it difficult to travel to appointments.

“The study also offers encouragement for managing fatigue in a range of other conditions such as multiple sclerosis and Parkinson’s disease where this approach may also be useful for some patients

“Studies like this should encourage the NHS to invest in relatively low tech interventions which may have a significant impact on disability and distress.”

Dr David Henderson Slater, Consultant in Neurological Disability & Rehabilitation Medicine and Honorary Senior Clinical Lecturer, Nuffield Orthopaedic Centre NHS Trust, said:

“The results of this positive study will probably not be surprising to clinicians who have worked with patients suffering from CFS/ME.  It is encouraging that there is further evidence that graded exercise is an effective treatment leading to clinical improvements.  The evidence is that the participants who received the graded exercise self-help programme benefitted from the input of the physiotherapist advising on the graded exercise either face to face, by Skype, or by telephone.  Given the difficulty some patients with CFS/ME may have in getting to hospital appointments, and the limited nature of NHS resources, this suggests that future treatments involving consultation and discussion by Skype or telephone should extend the reach of limited therapy resources and enable more patients to benefit from this treatment approach.”

Prof. Allan House, Professor of Liaison Psychiatry, University of Leeds, said:

“It is well established that physical inactivity and sedentary behaviour are bad for you, and that physical activity can have health benefits in conditions as diverse as coronary heart disease, rheumatoid arthritis and prostate cancer. It is therefore reasonable to start with an assumption that in most health problems, a sensible gradual increase in physical activity is likely to beneficial unless there is evidence to the contrary.

“In chronic fatigue syndrome there is already evidence to support this supposition of the benefit of physical activity, from for example the PACE trial. In the present study, the researchers ask whether a version of graded activity could be effective if it is largely self-managed – based upon a self-help guide with light touch help in using it.

“The study was generally well-designed, with (importantly) its protocol published in advance of conduct of the trial itself. In a group of patients with chronic fatigue syndrome who were perhaps not as severely affected as some can be, about a third made important improvements compared with 1 in 7 of those in the comparison group. On its own this trial wouldn’t be definitive, but against the background of what we know more generally about the benefits of activity for physical and mental health, including the health of people with chronic fatigue syndrome, this is further evidence of the usefulness of carefully managed increase in activity.

“Perhaps more important were the trial’s findings about harm – because so many sufferers from chronic fatigue worry about harmful effects from doing too much. About a quarter of patients in the trial reported worsening of their physical health over the three months of the trial but there was no evidence of severe untoward events at all, and no evidence that those practising graded activity did worse than those in the comparison group.

“We can be confident that responsibly managed graded activity is safe in chronic fatigue syndrome, and that for some sufferers at least, it can lead to significant improvements in their health.”

Dr Simon Day, Statistician, Clinical Trials Consulting & Training Limited, said:

“This is an important question and a randomised controlled trial is probably the best way to try to answer it.  But any trial like this has limitations.

“The trial is described as ‘pragmatic’ – but it is not clear what the authors mean by that.  In particular, this is not a trial of all patients diagnosed with chronic fatigue syndrome; it is a trial of all such patients who are interested to take part in such a trial.  Note, in contrast, the results of trials of pharmaceutical interventions are generally assumed to apply to all patients who would meet the inclusion criteria, not just those with the enthusiasm to take part in a trial.  The results of this trial, therefore, might not be as positive if GES (Graded Exercise Self-help) +SMC (Specialist Medical Care) were introduced more routinely.

“The trial is not, and cannot be, blinded – but the obvious inability to blind the trial does not negate the possible biases that may be introduced in an unblinded study.  This is particularly so as the endpoints are self-reported by the patients (who knew which ‘treatment’ they were getting).  The authors state, ‘Primary outcomes were self-reported by participants, thus preventing observer bias’ and also ‘all outcomes were self-rated, which might lead to bias by expectation…’.

“The authors rightly identify some other limitations of their trial.  The lack of standardisation of SMC is an inevitable problem, but lack of recording and reporting of its content is unfortunate.  For me, the biggest unanswered question (which the authors do recognise) is the very limited number of health-care professionals involved and, hence, the extent to which the findings might apply more broadly if GES+SMC were administered by other healthcare professionals.  In trials of pharmaceutical interventions, it is usually assumed that the pharmacological effect will be independent of the treating physician, but in trials of this nature (and, for example, trials in surgery) the outcome is likely to be highly dependent on the skills of the health-care professionals delivering the intervention.”

Prof. Chris Ponting, Chair of Medical Bioinformatics and Principal Investigator at the MRC Human Genetics Unit, Institute of Genetics and Molecular Medicine, University of Edinburgh, said:

“The beneficial effect was for fewer than 1 in 5 individuals, for an unblinded trial, and there was no consideration of long-term benefit or otherwise. The study could also have exploited actometers that would have more accurately measured participant activity.”

Prof. Trudie Chalder, Professor of Cognitive Behavioural Psychotherapy, Institute of Psychiatry, Psychology & Neuroscience, Kings College London, said:

“This study contributes to a body of evidence that graded exercise can help to improve functioning and reduce fatigue in people with chronic fatigue syndrome.  It replicates the finding that graded exercise if tackled in a measured way is safe. This non pharmacological intervention for CFS can be delivered to patients in their own home which gives patients flexibility. Although it doesn’t help all patients it can undoubtedly help some.”

Guided graded exercise self-help plus specialist medical care versus specialist medical care alone for chronic fatigue syndrome (GETSET): a pragmatic randomised controlled trial’ by Clark et al. published in The Lancet on Thursday 22 June.

Declared interests

Dr Jon Stone: I am a neurologist with an interest in self-help, guided self-help and physiotherapy for a range of conditions seen in neurology, especially functional disorders.

I have published studies of physio interventions and have applied for funding for a multicentre trial of a physiotherapy intervention

I run a free website http://ift.tt/1qCSCvm for patients with functional disorders in neurology.

Dr Simon Day: Dr Day works as a paid consultant to the pharmaceutical industry.  He has also received research and/or travel grants from the Medical Research Council, the European Commission and the National Institutes of Health.

Prof. Chris Ponting: “I am funded by the MRC and by the Wellcome Trust.”

Prof. Trudie Chalder: TC has authored self-help books on fatigue and collaborates with Peter White on a number of research projects.

None others received.



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