Trial information

Please note that the PACE trial closed to recruitment on 28 November 2008.

Latest news:
Government support for the PACE trial (50KB PDF)

21 September 2012 update:
Health economics paper, including cost-effectiveness comparisons, has now been published in PLOS ONE, and is available for free download at this link.

11 March 2011 update:
Full PACE paper and web appendix now available to download free of charge, after registering with The Lancet

18 February 2011 update:
Results now available at The Lancet

Participants' newsletter issue 4 now available on the Trial information page

17 February 2011 update: PACE treatment manuals available

The treatment manuals are available, free of charge, on the Trial Information page for downloading, so long as no changes are made to the manuals. Any use of these manuals should acknowledge the PACE trial (www.pacetrial.org). These manuals were used in the PACE trial by healthcare professionals and participants to support PACE trial treatments, which are described in the manuals. The results regarding efficacy and safety of these treatments are not yet published, but will be reported in the main paper of the PACE trial.

These treatments should only be delivered by appropriately qualified healthcare professionals, who have received appropriate training and continued supervision in their use. The treatments described were not designed to be stand-alone self-help approaches. No responsibility is accepted by the authors for the application of treatments described in these manuals outside of the PACE trial. The PACE trial team are unable to respond to queries or comments regarding the use of these manuals or the treatments described.

March 2010 update: Data collection for the one year follow up has now been completed. The trial data is currently being analysed in preparation for publication of the findings. Further information regarding publication will be posted here when available.

What is the PACE trial?
This large-scale trial is the first in the world to test and compare the effectiveness of four of the main treatments currently available for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME). These are adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and standardised specialist medical care (see below). All of the treatments offer ways for patients to deal with and improve the symptoms of CFS/ME and its effects on disability. The participants in the trial are randomly allocated to one of the treatments and then given a 12-month programme involving appointments with specialised doctors and, for three of the four treatment groups, therapists. Participants' progress is closely monitored by specially-trained research nurses or assistants. The five-year trial will involve 600 participants, aged 18 and over, in Scotland and England. All have to be referred from the specialist hospital CFS/ME clinics involved in the trial and these are based in Edinburgh, Oxford and three London hospitals.

What is CFS/ME?
CFS/ME is a common disorder. Estimates vary, but it is believed that between one in 40 and one in 250 of the population will suffer from the illness at any one time. CFS/ME causes disability as a result of persistent, abnormal tiredness which is made worse by activity. Other symptoms can include disturbed or unrefreshing sleep, or sleeping for longer, problems concentrating or remembering, pain in the muscles and/or joints, headaches, sore throats and tenderness in the neck. The diagnosis of CFS/ME sometimes can be difficult because it requires that a large number of other possible causes of the symptoms, such as thyroid gland disease and severe depression, are excluded.

What are the treatments being tested?
The four treatments are standardised specialist medical care (SSMC) alone, SSMC plus adaptive pacing therapy, SSMC plus cognitive behaviour therapy and SSMC plus graded exercise therapy. The therapies are delivered, as appropriate, by occupational therapists, physiotherapists, clinical psychologists or by other healthcare staff with specialist training.
  • Standardised specialist medical care. This is the most common treatment for CFS/ME. Specialist doctors can give an explanation of why participants are ill and general advice about managing the illness. They may also prescribe medicines to help with troublesome symptoms such as insomnia and pain, or advise GPs on what medicine is appropriate. If a participant is randomised to this treatment alone, they are encouraged to use specific self-help management that make most sense to them.   .
  • Adaptive pacing therapy. This therapy is about carefully matching activity levels to the amount of energy available. Therapists work with participants in this treatment group to help monitor activity and symptoms, aiming to improve quality of life and create the best conditions for a natural recovery.
  • Cognitive behaviour therapy. This therapy is about examining how thoughts, behaviour and CFS/ME symptoms interact with each other. Between therapy sessions, participants in this treatment group are encouraged to try out new ways of coping with their illness.
  • Graded exercise therapy. This is about gradually increasing physical activity to improve fitness and get the body used to activity again. A therapist helps participants in this treatment group to work out a basic activity routine and slowly build up the amount of exercise as fitness increases.