“Many ME-patients suffer from tremendous exhaustion for days after exercise, the so-called post-exertional malaise, or PEM. There were doubts as to whether the large British PACE trial was correct,” said professor of Internal Medicine and Immunology Jan Willem Cohen Tervaert, a couple of weeks ago in the Myth Busters- series of Observant. The professors Trudie Chalder, Michael Sharpe and Peter White, who led this PACE trail on the chronic fatigue syndrome, are convinced that cognitive behaviour therapy and graded exercise therapy “are moderately effective and safe for patients with CFS/ME. To suggest that this is not the case is to propagate a myth”.
Professor Cohen Tervaert states in his interview with Observant in “Myth: ME is a mental illness” that chronic fatigue syndrome (CFS), regarded as another name for ME, is a disabling and much misunderstood illness. Feeling worse after activity is a central feature, along with poor concentration, sleep problems and pain. We agree with these statements. But, in his keenness to debunk the myth that such a serious illness can be readily dismissed as unreal or unimportant, he risks creating a new myth – that behavioural treatments do not help people with CFS.
We led the PACE trial, which was criticised by Professor Cohen Tervaert, and which found that such treatments are effective. The PACE trial was the largest trial of any treatments of the illness, in which 641 patients with CFS were randomly allocated to one of four treatments: specialist medical care or specialist medical care in addition to one of three therapies: adaptive pacing therapy (pacing activity to stay within the limits of the illness), cognitive behaviour therapy (CBT) or graded exercise therapy (GET). The results clearly showed that CBT and GET improved both symptoms and disability more than the other two treatments. Equally importantly, the trial showed that all four treatments were safe. This trial added to the evidence from many previous trials showing the same thing; that CBT and GET safely helps people with CFS. At the same time, we emphasise what we said in our main paper: “The effectiveness of behavioural treatments does not imply that the condition is psychological in nature.” CBT and GET are useful treatments for many chronic and disabling physical conditions.
In a secondary analysis, we found that 22% of patients who had CBT or GET, met criteria for recovery, compared to 7% and 8% after the other two treatments. Our criteria for assessing recovery (all of which had to be met) included: being within the normal range for fatigue and physical function, no longer having CFS sufficiently badly to be eligible for the trial, and patients rating their own overall health as either “much better” or “very much better”.
As Professor Cohen Tervaert said, some data from the PACE trial were released last year under the UK Freedom of Information Act. Some patient activists, aided by two statisticians, re-analysed just the recovery data – not the main outcome results. They used more stringent thresholds for defining recovery, such as only counting people who were “very much better”. Unsurprisingly, they found that smaller numbers of patients met their criteria for recovery. Using different thresholds to assess recovery will clearly result in different recovery rates. There is no universally agreed definition of recovery, so we cannot be sure which figures are most accurate, but previous trials and studies of patients found similar figures to ours.
However one chooses to define recovery, the main findings of the trial stand - that CBT and GET are both safe and effective in reducing fatigue and improving functioning. In such a chronic and disabling illness, it is good to have a hopeful message for patients that, like previous researchers, we found not one but two treatments that are moderately effective and safe for patients with CFS/ME. To suggest that this is not the case is to propagate a myth.
Professors Trudie Chalder, Michael Sharpe and Peter White, Kings College London, University of Oxford, Queen Mary University of London, UK
Read here the opinion article of Mark Vink, in Dutch
Read here the reaction of Mark Vink in English
Read here the reaction of David Tuller in English
Read here the reaction of Caroline Wilshire in English