Chronic Fatigue Syndrome: The Pace Trial Debunked

Yesterday David Tuller published his highly critical investigation into the UK’s £5 million PACE trial in 2011. The trial which was funded by the UK government supposedly proved that sufferers of CFS/ME improve with two non-pharmacological therapies, these being graded exercise therapy (GET) and cognitive behavioral therapy (CBT). These two therapies are the cornerstone of treatment in the UK NHS for treatment of CFS/ME.

David Tuller, DrPH, is academic coordinator of UC Berkeley's joint masters program in public health and journalism. He was a reporter and editor for 10 years at the San Francisco Chronicle, served as health editor at Salon.com and frequently writes about health for The New York Times.

David Tuller's findings

*The study included a bizarre paradox: participants’ baseline scores for the two primary outcomes of physical function and fatigue could qualify them simultaneously as disabled enough to get into the trial but already “recovered” on those indicators–even before any treatment. In fact, 13 percent of the study sample was already “recovered” on one of these two measures at the start of the study.

*In the middle of the study, the PACE team published a newsletter for participants that included glowing testimonials from earlier trial subjects about how much the “therapy” and “treatment” helped them. The newsletter also included an article informing participants that the two interventions pioneered by the investigators and being tested for efficacy in the trial, graded exercise therapy and cognitive behavior therapy, had been recommended as treatments by a U.K. government committee “based on the best available evidence.” The newsletter article did not mention that a key PACE investigator was also serving on the U.K. government committee that endorsed the PACE therapies.

*The PACE team changed all the methods outlined in its protocol for assessing the primary outcomes of physical function and fatigue, but did not take necessary steps to demonstrate that the revised methods and findings were robust, such as including sensitivity analyses. The researchers also relaxed all four of the criteria outlined in the protocol for defining “recovery.” They have rejected requests from patients for the findings as originally promised in the protocol as “vexatious.”

*The PACE claims of successful treatment and “recovery” were based solely on subjective outcomes. All the objective measures from the trial—a walking test, a step test, and data on employment and the receipt of financial information—failed to provide any evidence to support such claims. Afterwards, the PACE authors dismissed their own main objective measures as non-objective, irrelevant, or unreliable.

*In seeking informed consent, the PACE authors violated their own protocol, which included an explicit commitment to tell prospective participants about any possible conflicts of interest. The main investigators have had longstanding financial and consulting ties with disability insurance companies, having advised them for years that cognitive behavior therapy and graded exercise therapy could get claimants off benefits and back to work. Yet prospective participants were not told about any insurance industry links and the information was not included on consent forms. The authors did include the information in the “conflicts of interest” sections of the published papers.

Top researchers who reviewed the study had these comments.

Dr. Bruce Levin, Columbia University: “To let participants know that interventions have been selected by a government committee ‘based on the best available evidence’ strikes me as the height of clinical trial amateurism.”

Dr. Ronald Davis, Stanford University: “I’m shocked that the Lancet published it…The PACE study has so many flaws and there are so many questions you’d want to ask about it that I don’t understand how it got through any kind of peer review.”

Dr. Arthur Reingold, University of California, Berkeley: “Under the circumstances, an independent review of the trial conducted by experts not involved in the design or conduct of the study would seem to be very much in order.”

Dr. Jonathan Edwards, University College London: “It’s a mass of un-interpretability to me…All the issues with the trial are extremely worrying, making interpretation of the clinical significance of the findings more or less impossible.”

Dr. Leonard Jason, DePaul University: “The PACE authors should have reduced the kind of blatant methodological lapses that can impugn the credibility of the research, such as having overlapping recovery and entry/disability criteria.”

Source

Another Link

off benefits and back to work

Thats their only objective!
They dont give a crap about the patients themselves.

a reply to: VoidHawk

It's NHS. If you are off benefits and back to work, you are a net positive in their bean-counting system, not a negative. Same goes for the NHS itself. If they use a therapy that includes no drugs, it costs less.

this PACE trial was bought and paid for by the insurance industry.

The trial has been organized by what we have called "psychobabblers" psychiatrists of the Wessely School, most of whom work for the medical and permanent health insurance industry, including UNUMProvident.
This allowed the psychobabblers to go forward and explains the title of the 442 page report: "Magical Medicine, how to make a disease disappear." The report states in chilling detail how the UK (and, yes, the United States) is ignoring all the science and has committed themselves to turn ME into a psychosomatic and behavioral illness. This has resulted in the patients having to endure cruel actions including but not limited to parents of young patients being accused of having Munchausens Syndrome by Proxie (MSBP). Patients have been refused payments by their insurance companies and have often endured lengthy and expensive legal bills to have their insurance reinstated.
www.ncf-net.org...

Add to this the errors of mis-diagnosis made by psychiatrists in the past (Parkinson’s Disease, multiple sclerosis, epilepsy, diabetes, thyrotoxicosis and many other disorders with a physical causation have all been asserted by psychiatrists to be “mental” disorders until medical science revealed their true aetiology) and one has a right to despair at the current situation facing ME/CFS patients.


These same doctors tried this with fibromyalgia.

Its now been found that around 50% of people DXed with fibromyalgia have Small Fiber Polyneuropathy.

Small Fiber Polyneuropathy can be tested for with a simple test and is treatable.

I agree with all the posts. Thanks


Published in the DM today, another psychiatrist (who specialises in psychiatric aspects of medical illness) claiming it is all in the mind.

DM Link

It is really annoying that these idiots get into the MSM and yet science is never mentioned.

The Aerobic Energy Production and the Lactic Acid Excretion are both Impeded in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome

Mark Vink, Family Physician/GPwSI, Soerabaja Research Center, The Netherlands
E-mail: [email protected]

Abstract
Background: In this study the muscle bioenergetic function in response to exercise in severe ME was explored to see if the underlying metabolic problem in ME, responsible for the severe difficulties with trivial exercise, and the severe loss of muscle power, could be discovered.

Methods: Inorganic phosphate, creatine kinase and lactate were measured in a former Dutch National Field Hockey Champion, who is now a patient bedridden with severe ME, before and 5 minutes after very trivial “exercise”, from which his muscles needed 12 hours to recover.

Results: Inorganic phosphate and creatine kinase were both normal, however, lactate after this trivial exercise was very high, and further testing showed that a second batch of lactic acid was excreted after the same exercise with a 6-fold delay, showing that the lactic acid excretion was impaired and split into two. And this was delayed up to 11- fold by eating closer to the exercise.

Conclusion: This study found that in severe ME, both the oxidative phosphorylation and the lactic acid excretion are impaired, and the combination of these two is responsible for the main characteristic of ME, the abnormally delayed muscle recovery after doing trivial things. The muscle recovery is further delayed by immune changes, including intracellular immune dysfunctions, and by lengthened and accentuated oxidative stress, but also by exercise metabolites, which work on the sensitive receptors in the dorsal root ganglions, which in severe ME are chronically inflamed, and are therefore much more sensitive to these metabolites, which are produced in high quantities in response to trivial exercise, which for ME patients, due to the underlining metabolic problem, is strenuous exercise. And a similar problem is most likely responsible for the abnormally delayed brain recovery after doing trivial things.

This study also shows that the two metabolic problems are the result of an impaired oxygen uptake into the muscle cells or their mitochondria and in combination with the Norwegian Rituximab studies, which suggest that ME is an autoimmune disease, it is suggestive that antibodies are directly or indirectly blocking the oxygen uptake into the muscle cells or their mitochondria.

Thanks, this is of particular interest to me since my mum has been given a working DX of M.E (relapse) and is due to see an NHS M.E specilist in a couple of weeks so it will be interesting to see what he recommends.

I did take her to a support group recently where the whole group agreed that CBT and graded excercise had not helped them. She does suffer from anxiety though so I guess the CBT could at least help with that aspect.

For anyone interested the author has a follow-up article, published on his blog two days ago.

Trial By Error, Continued: Why has the PACE Study’s “Sister Trial” been “Disappeared” and Forgotten?

"This Fatigue Intervention by Nurses Evaluation,” or FINE was published in 2010 by the BMJ. Because the PACE trial was targeting patients well enough to attend sessions at a medical clinic, the complementary FINE study was designed to test treatments for more severely ill patients.."

The PACE Trial was published a year later with no mention of the FINE trial. It seems there was a gross manipulation of data by researchers in FINE study as well.

Sorry for the dumb question but.. what is ME? Thanks in advance!

Lil

they probably figure most people have this now, and it's due to all the pollutants in the system, but they figure everyone would qualify for disability if they admit it, it'd be a slippery slope, they'd get sued, forced to improve environmental laws going forward, which will cost corporations money and power . . .

a reply to: Lilroanie

A good explanation here

Link

a reply to: deliberator

Thanks.. I tried to Google it but wasn't sure what I was looking at.

Lil

Are these people so stupid that they don't realize they're effectively looking at the car analogy? Try talking to your already low mileage car on an empty tank of gas, and while you're at it, try to make it think it can eek out more MPG and see how far down the driveway it gets you. Same goddamn idea with CFS/ME people. Blind jackasses, Jesus Christ