Thursday, September 8, 2011

PACE trial deemed "unsatisfactory" by

September 06, 2011
Read The Story
There are too many "somes" and not enough sums in this story about a study on cognitive behavior therapy for chronic fatigue syndrome. Our 3 reviewers (two journalists & one MD) yearned for more. 
Our Review Summary
It starts out with some good framing around the problem of diagnosing and treating chronic fatigue, but then, in a story that demands specifics, it provides only one number, noting that the study examined "over 600 patients." The rest of the story contains statements such as, "Doctors say some treatments can help." Which ones? It also says that "a form of talk therapy, as well as exercise, offered relief for some patients." How many? We like that the story tapped some outside expertise to put the study's findings in context, but the story was too short in other areas.

Why This Matters:
Chronic fatigue syndrome, as the story notes, is one of the most elusive disorders in modern medicine. Is it truly a single syndrome? Is it several disorders that are ill defined and difficult to pinpoint and so end up being tossed under the same umbrella? Is it all in the patient's mind? it can be a devastating condition - affecting physical, emotional function and financial well-being. Because science has yielded few clues to the origin and true nature of the syndrome, it is all the more important for journalists to write with precision when addressing a new scientific attempt to address chronic fatigue. This was particularly important for a controversial study like the one here because many people interpreted the study to mean that chronic fatigue is a psychological disorder.
Click on Criteria for definitions.
The story mentions "a form of talk therapy" but never makes it clear how exactly the therapy works and whether any psychiatrist could provide it. This is one of many places in the story where additional detail would help. Cognitive behavior therapy (CBT) was offered for up to 14 sessions over 23 weeks. A booster session was offered at 36 weeks. CBT is a widely available and standard psychological treatment used for many conditions. Similar to CBT, details on the duration, frequency and availability of the competing interventions would be useful. Helping readers understand what might be involved in the intervention would improve understanding.
Discuss costs? - NOT SATISFACTORY
This was a significant hole in the story. Any sort of behavioral therapy usually requires multiple visits that can add up to thousands of dollars per month. If you add an exercise program that could require a gym membership or even a personal trainer, this could prove to be far too expensive for the typical chronic fatigue patient.
Avoid "disease-mongering"? - SATISFACTORY
The story is quite careful to avoid disease-mongering. At the top of the story, it quickly takes readers through the last three decades of work around chronic fatigue and attempts to describe what it feels like for the typical patient. Actually, the story says "some patients," but we'll give it a pass here.
Evaluate the quality of evidence? - NOT SATISFACTORY
The story makes a fundamental error. As written, it sounds like a three-group design, but it was a four-group design. Specialty medical care (SMC) alone versus SMC and CBT versus two other combinations of SMC and therapy. So, the critical issue is - how much additional benefit is there from these therapies compared to SMC. The fact that there was benefit is important. In addition, this appears to be a well done study with a large sample size, yet there is no sense in the story that this study was different from any of the others before.
Quantify the potential harms? - NOT SATISFACTORY
The story makes no attempt to quantify harms, even though harm rates were mentioned in the study. It does talk about the potential harms, though, in quoting a physician who treats chronic fatigue patients in Salt Lake City.
The story never tells us enough about the type of therapy involved to decide whether it is novel. CBT is not novel and has been tested before for chronic fatigue, but only in small trials. It is a recommended therapy in some guidelines. This trial is a large head-to-head comparison of viable treatment options, so, in this respect, the findings are novel and quite important.
Quantify the potential benefits? - NOT SATISFACTORY
The story does not quantify the potential benefits. Instead it says that the therapy "offered relief for some patients," and it later says that those who received therapy and exercise, "improved the most, reporting less fatigue, insomnia and anxiety." Everyone knows that exercise can make a person feel healthier and more alert, but this study was looking at a more difficult question than that. Hard numbers quantifying the actual benefits of this approach would have helped readers understand the value to place on this research.
The story did not rely on a news release.
The story only quoted two people, but we like that it at least attempted to bring in a different view on how to treat chronic fatigue. In talking with Lucinda Bateman at Fatigue Consultation Clinic in Salt Lake City, the story brought out some of the limitations of the study.
The story did not compare this approach to any alternatives; other options include antidepressant medications (in fact about 1/3 of patients were on an antidepressant). 
Total Score: 3 of 10 Satisfactory

See also: PACE trial results are out: ME is caused by an oncogenic virus or The putative agent of ME/CFS can be transferred to monkeys or Professor of Psychology, Rhona Johnston shows that ME/CFS is NOT a psychological condition (on a UK Government website !!!) … a MUST READ See also: The main characteristic of ME is an abnormally delayed muscle recovery after doing trivial things, if you don't have that, you don't have ME 
  See also: Dr. Hilary Jones, When you say, "ME is controversial", did you check that with Alison, Annabel and Sophia? Now, I'm sure you didn't, because all three died of ME. Yes you read that right, …
See also: Cerebrospinal fluid profiles can differentiate between Lyme disease, ME/CFS and healthy controls
See also: Metabolic dysfunction causes Post-Exertional malaise in ME/CFS
See also: Almost 5% of ME/CFS patients contracted ME/CFS from a blood transfusion
See also: Harvard Medical School: EEG spectral coherence data distinguish chronic fatigue syndrome patients from healthy controls and depressed patients

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