PACE study results – Medical Research Council (UK) news report, 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 funded by the Medical Research Council (MRC) and UK government departments. The largest ever study of CFS/ME treatments, called the PACE trial, assessed the safety and effectiveness of four separate treatments and found that graded exercise therapy and cognitive behavioural therapy 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).

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 Michael Sharpe, from the University of Edinburgh and co-author on the PACE trial, said:

“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.”

All patients saw a specialist doctor approximately three times over the 12 month period. Those receiving an additional treatment had 14 further one hour treatment sessions over the first six months. The success of the treatments was measured by patient ratings of fatigue, physical function, overall health and the ability to lead a normal life, plus assessments of how far the patient could walk in six minutes, and of sleep, mood and specific symptoms such as fatigue after exertion.

Professor Peter White, from Barts and The London School of Medicine and Dentistry, Queen Mary, University of 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.”

Professor Trudie Chalder from King’s College London and a co-author, said:

“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.”

Dr Declan Mulkeen, director of Research Programmes at the MRC, said:

“There is an urgent need to find ways of improving the healthcare and quality of life for patients with CFS/ME, and the PACE trial is a great example of how MRC-funded research can evaluate treatments and help to bring them to patients as quickly as possible.

“The MRC’s next step is to support further high quality research proposals in this area and we are committing £1.5m to encourage research that looks at the root causes of the illness.”

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 carried out by a team of experts and led by researchers from Queen Mary, University London, King’s College London and the University of Edinburgh and was designed with input from the charity, Action for M.E. The research proposals were subject to extensive review and scrutiny by independent experts and trial committees.

The PACE trial, which is published online in The Lancet today, was funded by the MRC, National Institute for Health Research, Chief Scientist Office, Scotland, and Department for Work and Pensions.

Ends

For more information or to speak with one of the scientists please contact the MRC Press Office on 0207 395 2345 or email press.office@headoffice.mrc.ac.uk

Notes to editors

1. 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, http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(11)60172-4/abstract

2. The MRC uses the term CFS/ME when referring to CFS and/or ME, to cover the breadth of the condition. Some people consider CFS and ME as separate illnesses while others regard them to be the same. CFS and ME have similar, but different diagnostic criteria. The PACE trial classified patients using the diagnostic criteria for both CFS and ME to test whether the results applied to both groups of patients. NICE guidance on CFS/ME is found at:” http://guidance.nice.org.uk/CG53″> http://guidance.nice.org.uk/CG53.

3. PACE stands for Pacing, graded Activity and Cognitive behaviour therapy: a randomised Evaluation

4. Patients were recruited from six secondary care clinics: St Bartholomew’s Hospital, Frenchay Hospital, Bristol, Royal Free Hospital, London, South London and Maudsley NHS Foundation Trust, The John Radcliffe Hospital at the University of Oxford and Western General Hospital, Edinburgh.

5. For almost 100 years the Medical Research Council has improved the health of people in the UK and around the world by supporting the highest quality science. The MRC invests in world-class scientists. It has produced 29 Nobel Prize winners and sustains a flourishing environment for internationally recognised research. The MRC focuses on making an impact and provides the financial muscle and scientific expertise behind medical breakthroughs, including one of the first antibiotics penicillin, the structure of DNA and the lethal link between smoking and cancer. Today MRC funded scientists tackle research into the major health challenges of the 21st century. www.mrc.ac.uk. The MRC’s recent CFS/ME funding call can be found at: www.mrc.ac.uk/Newspublications/News/MRC007675.

6. Barts and The London School of Medicine and Dentistry offers international levels of excellence in research and teaching while serving a population of unrivalled diversity amongst which cases of diabetes, hypertension, heart disease, TB, oral disease and cancers are prevalent. At the heart of the School’s mission lies world class research, the result of a focused programme of recruitment of leading research groups from the UK and abroad and a £100 million investment in state-of-the-art facilities. Research is focused on translational research, cancer, cardiology, clinical pharmacology, inflammation, infectious diseases, stem cells, dermatology, gastroenterology, haematology, diabetes, neuroscience, surgery and dentistry. The School is nationally and internationally recognised attracting £40 million annually in research income.

7. King’s College London is one of the top 25 universities in the world (2010 QS international world rankings), The Sunday Times ‘University of the Year 2010/11′ and the fourth oldest in England. A research-led university based in the heart of London, King’s has nearly 23,000 students (of whom more than 8,600 are graduate students) from nearly 140 countries, and some 5,500 employees. King’s College London and Guy’s and St Thomas’, King’s College Hospital and South London and Maudsley NHS Foundation Trusts are part of King’s Health Partners. King’s Health Partners Academic Health Sciences Centre (AHSC) is a pioneering global collaboration between one of the world’s leading research-led universities and three of London’s most successful NHS Foundation Trusts, including leading teaching hospitals and comprehensive mental health services. www.kingshealthpartners.org

8. The National Institute for Health Research provides the framework through which the research staff and research infrastructure of the NHS in England is positioned, maintained and managed as a national research facility. The NIHR provides the NHS with the support and infrastructure it needs to conduct first-class research funded by the Government and its partners alongside high-quality patient care, education and training. Its aim is to support outstanding individuals (both leaders and collaborators), working in world class facilities (both NHS and university), conducting leading edge research focused on the needs of patients. www.nihr.ac.uk

9. The Chief Scientist Office (CSO) is the division of the Scottish Government Health Directorates which supports and promotes high quality research aimed at improving the health of the people of Scotland and the quality and effectiveness of health services.