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Safe treatments for CFS/ME

18 February 2011 

Two effective treatments benefit up to 60 per cent of patients with Chronic Fatigue Syndrome or Myalgic Encephalomyelitis (CFS/ME), according to a collaborative trial by King’s College London and colleagues from Queen Mary, University London, and the University of Edinburgh, published in the Lancet today. 

The largest ever study of CFS/ME treatments, the trial was funded by the Medical Research Council and supported by the UK Clinical Research Collaboration (UKCRC) Registered Mental Health and Neurosciences Clinical Trials Unit (MH&N CTU) at the Institute of Psychiatry. The PACE trial (Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation), assessed the safety and effectiveness of four separate treatments and found that graded exercise therapy (GET) and cognitive behavioural therapy (CBT) were the most effective. The findings suggest these two treatments should be offered to all patients who are able to attend hospital if they are suffering from fatigue caused by CFS/ME. The findings support current guidance from the National Institute for Health and Clinical Excellence (NICE).  

Professor Trudie Chalder from King’s College London and a co-author, said: ‘We have found that both CBT and GET can safely help a significant number of patients. While there is still room for improvement, this is a real step forward in informing patients with CFS/ME which treatments can help to improve their health and ability to lead a more normal life.’

CFS/ME is a long-term, complex and debilitating condition which causes fatigue and other symptoms such as poor concentration and memory, disturbed sleep and muscle and joint pain. The cause is not known. CFS/ME affects around 250,000 people in the UK.

The PACE trial included 640 patients with CFS from England and Scotland who were able to attend hospital clinics for treatment. All patients in the trial received specialist medical care which included general advice about managing the illness and prescribed medicines for symptoms such as insomnia and pain.

Patients were divided into four trial groups and three of the groups were also given one of the following therapies over six months: 

• Cognitive behavioural therapy (CBT) - A clinical psychologist or specially trained nurse helps the patient to understand how their symptoms are affected by the way that they think about and cope with them, and encourages them to try out increasing their activity. 

• Graded exercise therapy (GET) – A physiotherapist helps the patient to try a gradually increasing tailored exercise programme which takes into account the individual patient’s symptoms, fitness, and current level of activity. 

• Adaptive pacing therapy (APT) – An occupational therapist helps the patient to match their activity level to the amount of energy they have, aiming to help the patient adapt to the illness rather than assuming they can gradually do more.

CBT and GET are used for a wide range of conditions including rheumatoid arthritis, heart disease, diabetes and chronic pain.

Professor Chalder continues: ‘Patients can suffer for years with debilitating symptoms which affect their ability to lead a normal life. Although previous small trials had suggested that CBT and GET help some patients, concerns had been raised about the safety of these treatments. An alternative approach called pacing was widely advocated but had not been scientifically tested. The PACE trial was designed to find out the relative benefits and harms of all of these treatments when combined with specialist medical care.’

Patients were recruited from six secondary care clinics including South London and Maudsley NHS Foundation Trust. Adverse reactions to treatment were monitored closely by experts independent of the trial - serious adverse reactions to treatment were rare and no different in frequency between treatments. The trial was designed with input from the charity, Action for M.E. and the research proposals were subject to extensive review and scrutiny by independent experts and trial committees.

Professor Chalder concludes: ‘It is very encouraging that we have found not one but two treatments that are similarly helpful to patients, which provides them with a choice. We now need to find out what the common essential ingredient is that makes these treatments work, and which particular types of patients will respond best to which therapy.’

The PACE trial was funded by the MRC, National Institute for Health Research, Chief Scientist Office, Scotland, and Department for Work and Pensions. 

White et al., 'Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial', can be accessed here:

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