Frenchay takes part in UK’s largest research trial into treatment for chronic fatigue

Friday, 18 February 2011

Two effective treatments benefit up to 60 percent 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.

Around 70 patients at Frenchay Hospital were among 640 people across the country who took part in the trial.

The trial’s 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.

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.

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 was published online in The Lancet on February 18, was funded by the MRC, National Institute for Health Research, Chief Scientist Office, Scotland, and Department for Work and Pensions.

North Bristol NHS Trust was selected as one of 14 specialist centres in the UK for the development of services for people diagnosed with Chronic Fatigue Syndrome/ME.

The centre is based within the Pain Management Centre on Ward 22 at Frenchay Hospital and is led by Dr Hazel O’Dowd.

The specialist centre (known as a Clinical Network and Co-ordinating Centre) has a role to support and improve the NHS services provided within the Avon, Wiltshire and Gloucestershire region.

There is also a Local Multidisciplinary Team (LMDT) based here, and this clinical team includes Occupational Therapists, Physiotherapists, Clinical Psychologists, a Counsellor, and a Specialist General Practitioner. The LMDT offers an outpatient service to people living in Bristol, North Somerset, and Gloucestershire.