Too Big to Fail
Commentary on the PACE Trial
By K. Kimberly McCleary
A paper published Feb. 18, 2011 in the Lancet, "Comparison of adaptive pacing therapy, cognitive behavior therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial" compares four treatment approaches in a population of 641 patients in the United Kingdom (U.K.). The study reported modest benefits following a six-month course of cognitive behavioral therapy (CBT) or graded exercise therapy (GET) compared to specialized medical care alone or adaptive pacing therapy, based on improvement in self-reported symptom scores. There were no biological measures taken during the study to correlate with the results. Read our detailed analysis of the study, "Falling Off the PACE."
News stories have touted more conclusive results than the data support. The authors conclude in the paper, "Our finding that studied treatments were only moderately effective also suggests research into more effective treatments is needed." However, the public will likely only read headlines like this one, "Talking and exercise could cure M.E. - study." Such tidy conclusions are dangerous. They contribute to dismissive attitudes about CFS and undermine understanding of its severe and life-altering impact. They vastly oversimplify the individual patient's ability to recover his or her health. As a result of reading quips like this, patients may attempt more aggressive regimens than their bodies can withstand and professionals may recommend and/or deliver services that are not tailored to the restrictions imposed by CFS, especially post-exertional relapse. It is understandable that this study, the publication and the resulting media coverage have provoked deep concerns and strong negative reactions from the patient community worldwide and many professionals.
Structured programs that seek to expand function and reduce symptoms may provide modest benefits when added to standard medical care, but they do not offer complete resolution of symptoms or cure, and the benefits are equivalent to those seen in other studies of chronic illness. Younger, less severely ill and more recently ill individuals may benefit more, according to the effects seen in this select study population and other trials of CBT and GET. But there are risks to these therapies, especially when employed outside the standardized setting of research studies.
The PACE Trial was guided by hundreds of pages of manuals with heavy scripting for provider-patient interactions and close supervision of all services. Validating the past and present experiences of participants was a core feature of the training provided to those who conducted the services. To compare the outcomes of this trial to what one might find in the real marketplace is a little bit like comparing a visit to Disney's EPCOT Center to a bona fide trip around the world. Even if the services in the trial weren't delivered perfectly, participants were somewhat buffeted against the types of negative encounters in health care settings that are routinely experienced by CFS patients due to persisting myths and misinformation about CFS. That fact alone may have contributed to the modestly positive outcomes, but there was no direct "untreated" comparison group included in the study.
While the authors state that the funding agencies had no role in the study design or conduct, it is difficult to ignore the U.K. government's strong stake in a good outcome. The study was funded by the country's Medical Research Council, Department of Health and Department for Work and Pensions. It was conducted for the benefit of making or revising health policy for the treatment of CFS by the National Health Service. It came at a cost of some 5 million pounds (British) or $8 million (U.S.). In essence, it was too big to fail to reinforce existing U.K. policy that favors provision of psychological approaches over medical ones.
The size and scope of this study make it the biggest clinical trial of any kind for CFS, even if you weed out the participants who didn't meet the standard research criteria for CFS and evaluate it on the basis of the 400 subjects who did. It is bound to be cited as the gold standard for years to come, even with its many weaknesses. Subgroup and cost-effectiveness analyses are yet to come. Even so, it's hard to imagine that it was worth $8 million to obtain the data on slim gains achieved in such an artificially constructed setting.
The CFIDS Association of America is committed to advancing research that leads to the early detection, objective diagnosis and effective treatment of CFS. The scientific and medical communities are obligated to understand the biological roots of CFS so that targeted and effective treatments can be made available to the millions of people around the world whose lives have been derailed by CFS.