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The Lancet responds to criticism of its publication of the PACE Trial results
Thursday 19 May 2011
Once every few years, we publish a paper that elicits an outpouring of consternation and condemnation from individuals or groups outside our usual reach. The latest topic to have caused such a reaction is chronic fatigue syndrome (CFS), and—more specifically—Peter White and colleagues' randomised PACE trial published on March 5, this year.
In the PACE trial, White and colleagues set out to answer a question that has long troubled the CFS community: are the treatments recommended by clinical guidelines—ie, cognitive behaviour therapy and graded exercise therapy—really the best option for patients with CFS? The trial's findings showed that, compared with specialist medical care alone, both treatments were associated with significant improvements in self-rated fatigue and physical function (the primary outcomes) after 52 weeks.
The response to the trial's publication was swift and damning. “When is the Lancet going to retract this fraudulent study?” demanded a Facebook group. A 43-page complaint (now available via Wikipedia) branded the trial “unethical and unscientific”. There were 44 formal letter submissions, eight of which we publish today, together with a response from White and colleagues.
Many of the letters critique the definitions of secondary outcomes, question protocol changes, and express concern over generalisability. But one cannot help but wonder whether the sheer anger and coordination of the response to this trial has been born not only from the frustration many feel about a disabling condition, but also from an active campaign to discredit the research. White and colleagues have been accused of having “formed their opinion about the intended outcome” before the trial began. This view is unjustified and unfair. The researchers should be praised for their willingness to test competing ideas and interventions in a randomised trial. The evidence might even suggest that it is the critics of the PACE trial who have formed their opinions first, ignoring the findings of this rigorously conducted work.
The above originally appeared here.
We could have told the Lancet it would get a lot of blowback on a study it recently published suggesting that chronic fatigue syndrome can be helped by cognitive behavioral therapy and a slowly ramped-up exercise program — we got 53 comments on our original post about the research, many of them critical.
Sure enough, the medical journal said today that the paper was one of those that, every few years, “elicits an outpouring of consternation and condemnation from individuals or groups outside our usual reach.”
Many patients have long been told that their problems are psychological in nature, while they report symptoms that are similar to those seen in viral diseases. Suggesting that the condition can be significantly improved by psychotherapy and exercise didn’t sit well with many people. (The WSJ’s Amy Dockser Marcus has written about the search for a biological cause of CFS, also known as myalgic encephalomyelitis.)
The Lancet says it received 44 formally submitted letters to the editor, and published eight, along with a response from the paper’s authors. (You can read them all here, on the lower right.)
Critics focused on whether or not the exercise and cognitive behavioral therapy programs actually produced a clinically useful difference and, as the Lancet summarizes, “critique the definitions of secondary outcomes, question protocol changes and express concern over generalizability.”
In their reply, the authors go over their methods and say that “however we compared the results and however we defined CFS and myalgic encephalomyelitis,” exercise and cognitive behavioral therapy programs combined with specialist care showed a “significant and clinically useful advantage of moderate size” over specialist care alone, as well as over that care combined with therapy teaching patients how to recognize symptoms and ratchet down their activity as needed.
The Wall Street Journal article originally appeared here.
Out of many letters submitted, the journal has published correspondence by (1) Bart Stouten, Ellen M Goudsmit and ME Association Chair Neil Riley; (2) CFS patient Andrew James Kewley; (3) CFS patient John T Mitchell; (4) Mieko Shinohara (Japan Chronic Fatigue Syndrome Association); (5) Johan WS Vlaeyen, Petra Karsdorp, Rena Gatzounis, Saskia Ranson, Martien Schrooten (researchers from University of Leuven and Maastricht University); (6) Sarah M Feehan (Liverpool ME Support Group); (7) Tom Kindlon (Irish ME/CFS Association); and (8) Jane Giakoumakis (Lanarkshire ME Support Group).
Action for M.E.’s letter, expressing its disappointment at the PACE trial results, was among the many other letters not published in what the Lancet describes as an “outpouring of consternation and condemnation from individuals or groups” which followed its publication of the initial results of the PACE trial.
The authors of the PACE trial say: “The commonest concern of correspondents was our conclusion that these differences indicated moderate clinical usefulness. We based this conclusion on standard recommendations.” They go on to describe their methods and discuss changes made to protocols to “improve either recruitment or interpretability.”
In conclusion they say, “However we compared the results and however we defined CFS and myalgic encephalomyelitis, we found that cognitive behaviour therapy and graded exercise therapy provided a significant and clinically useful advantage of moderate size over adaptive pacing therapy and specialist medical care, but were no less safe. We suggest that the issue is not whether these treatments work and are safe, but how to make them available to those who might benefit from them.”
Sir Peter Spencer CEO of Action for M.E. says, "I can only reiterate what has already been said by our Vice Chair, Tony Golding – that the findings of the PACE trial are completely at odds with the patient voice, illustrated by some of the letters which appear in the Lancet and by the considerable evidence of our own surveys and those of other patient groups.”
The charity’s stance and strategy on PACE and pacing – together with discussion by Professor Derek Pheby and a number of clinicians – was published in the latest issue of Action for M.E.’s membership magazine, InterAction.
The statement made by the charity in February, when the initial paper was published, still stands:
"Of the 2,763 people with M.E. who took part in our 2008 survey, 82% found pacing helpful, compared with 50% for CBT and 45% for GET. Worryingly, 34% reported that GET made them worse.
"A smaller, more recent survey of 273 people with M.E. confirms that, inappropriately applied, graded exercise is still causing harm.
"Whilst these figures are not directly comparable with the PACE results, they cannot be ignored.
"Nor can the fact that, at best, PACE is telling us that the two main therapies currently recommended by the National Institute for Health and Clinical Excellence (NICE) are only moderately effective.
"It’s important to remember that safety outcomes under trial conditions are not representative of what is still happening in some parts of the NHS.
"And to focus on modest improvements in fatigue and physical functioning, which researchers can measure – rather than on how much better patients themselves say they feel overall – overstates the benefits and of these therapies."
Action for M.E. supported the PACE trial because we wanted pacing to be assessed and legitimised by the NHS. We have already expressed our reservations about the current over-emphasis on CBT and GET in the NICE guideline.
As Vice Chair, Nadia Conway, has said, "The trustees and staff of Action for M.E. are unequivocal in their view that M.E. is neurological and may well have a viral cause.
"Currently, there are no effective treatments for M.E. This research shows that none of the therapies currently available results in a complete recovery. The need for more biomedical research is more paramount than ever before.”
The Action for ME article originally appeared here.
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