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The study made the first definitive comparison of various treatments for CFS/ME to deduce the most effective treatments.
Dr Alastair Miller, Consultant Physician at Royal Liverpool University Hospital, Clinical lead for CFS services in Liverpool, Independent assessor of trial safety data for PACE trial and Principal Medical Advisor, Action for ME, said:
“Although NICE have previously recommended graded exercise and CBT as treatments for ME/CFS, this was on the basis of somewhat limited evidence in the form of fairly small clinical trials. This trial represents the highest grade of clinical evidence – a large randomized clinical trial, carefully designed, rigorously conducted and scrupulously analysed and reported. It provides convincing evidence that GET and CBT are safe and effective and should be widely available for our patients with CFS/ME.
“It is clearly vital to continue our research into biological mechanisms for ME/CFS but recent ‘false dawns’ for example, over the role of retroviruses (XMRV) have shown how difficult this can be. In the current absence of a biomedical model for the causation and the absence of any pharmacological intervention, we have a pragmatic approach to therapy that works and we should use it.”
Dr Derick Wade, Consultant and Professor in Neurological Rehabilitation and Clinical Director, Enablement Directorate, Oxford Centre for Enablement, said:
“CFS is common, and it is vital to know whether treatments proposed and/or used are safe and are effective. Randomised controlled trials provide the best and only reliable evidence on safety and effectiveness of any intervention in any condition. The trial design in this study was very good, and means that the conclusions drawn can be drawn with confidence.
“This is a very significant finding. It identifies that one commonly used intervention is not effective (and therefore should not be used), and it confirms the effectiveness of two treatments, and their safety. The study suggests that everyone with the condition should be offered the treatment, and every patient who wishes to be helped should be willing to try one or both of the treatments. It also means that we can allocate resources to treatments that will benefit patients and, more importantly, stop allocating treatments that do not have proven efficiency. Further research should identify ways that treatments derived from these may deliver greater benefits.
“Research needs to investigate both treatments and factors that increase the risk of developing CFS. However, it is probably more effective to research treatments, and proving a treatment is effective starts to give clues about causative factors.”
Dr Fergus Macbeth, Director of the Centre for Clinical Practice at NICE, said:
“We welcome the findings of the PACE trial, which further support cognitive behavioural therapy and graded exercise therapy as safe and effective treatment options for people who have mild or moderate CFS/ME. These findings are in line with our current recommendations on the management of this condition.
“We will now analyse the results of this important trial in more detail before making a final decision on whether there is a clinical need to update our guideline. Until then, healthcare professionals should continue to follow our existing recommendations, especially as this latest research appears to endorse them as best practice for the NHS.”
Dr Esther Crawley, Consultant Paediatrician and Clinical Lead for the Bath Specialist Paediatrics Chronic Fatigue Syndrome/ME Service, said:
“All children with chronic fatigue syndrome and their parents are desperate for new research to understand how to treat this condition. The next step is to do a study like this for children to find out if these treatments work.”
Prof Willie Hamilton, GP in Exeter and Professor of Primary Care Diagnostics, Peninsula College of Medicine and Dentistry, said:
“At least half of patients improved with CBT or GET. The study also allays fears that CBT or GET may be harmful. There are a minority of patients who didn’t see improvement so the next step must try and find treatments to help them.
“This study matters: it matters a lot. CFS/ME is common, and causes a lot of suffering. Up until now we have known only that CBT and GET work for some people. We didn’t know if pacing worked. This caused a real dilemma – especially for those in primary care. We didn’t know whether to recommend pacing, or to refer for CBT or GET. Worse still, not all GPs have access to CBT or GET, so ended up suggesting pacing almost by default. This study should solve that dilemma.
“At a patient level, I now know what to suggest to my patients. Almost as important, it sends a powerful message to PCTs – and the soon-to-be-formed GP consortia – that they must fund CBT or GET. NICE proposed that before this study came out – the evidence is even stronger now.”
Dr Brian John Angus, Clinical Tutor in Medicine and Honorary Consultant Physician, University of Oxford and Centre Leader for the PACE Trial in Oxford, said:
“This study is the largest ever done in CFS/ME and as such is critically important. The study should reassure patients that there is an evidence based treatment that can help them to get better and there is no need to worry about harm from the treatment. The other significant result is that looking at different ways of classifying the condition through different diagnostic criteria do not make any difference to the effect of treatments.
“We do not know what the underlying cause of CFS/ME is. There is ongoing research to find the cause, and I have been involved with this, but none of these studies has shown any consistent evidence of cause never mind any rationale for treatment. However in the meantime I see many patients in my clinic who need help with their fatigue. This was a pragmatic trial to help patients while there is no other treatment available.
“It was extremely rigorous. It was large and it was randomised. The study was carefully conducted in the manner of a drug intervention study to not only establish the superiority of one treatment over the other but also to carefully report any side effects or harm from those treatments. Since the treatments were therapies and not drugs stringent efforts were made to ensure the ‘purity’ of each treatment and to rapidly report any adverse effects. As a trial this involved a huge amount of checking and cross checking.
“This should mean that GET and CBT should be widely available throughout the country. Despite NICE recommendations I still see patients who are unable to access any treatment for their CFS/ME in their local GP area. Travelling is obviously difficult for patients with CFS/ME. The increase in the availability of CBT therapists for other conditions should be mirrored for CFS/ME.
“The trial was conducted to a high ethical standard. Patients were fully informed and randomised to the different treatments. It was rigorously performed. The study has definitively shown that there is no harm associated with GET.”
Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial, by Peter White et al, published in the Lancet at 00.01hr UK time Friday 18 February 2011.