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The butterfly emblem is frequently chosen by carefree souls, which suits my care-less persona also! My attention has flitted to continued controversy over two chronic pain studies – PACE for chronic fatigue, and Auckland University’s Stroke and Applied Neurosciences report: ‘Daytime napping associated with increased symptom severity in fibromyalgia syndrome’. Blogs and commentaries frequently generate traffic by highlighting controversy (but not mine, of course). Digging out the truth is easier by discarding any opinionated article which doesn’t link the original study for scrutiny, since both were published in open publicly accessible forums. If it matters, it’s usually in PublicLibraryofScience or the like. If hidden behind the commercial barrier of a medical journal, then it was probably just an extension of Pfarma’s marketing (if the statement by past editor of the unimpeachable British Medical Journal is to be believed). The late, great Dr Dave Sackett tickled my humours with his Clinical Trial Organisation HARLOT (How to Achieve positive Results without actually Lying to Overcome the Truth).

Linked study PACE was of very high quality. UK govt sponsored and large enough to be powerfully conclusive, it randomised sufferers from chronic fatigue into four arms:- standard medical care alone, or in combination with either of Cognitive-Based Therapy (CBT), Graded Exercise Therapy (GET), or Adaptive Pacing Therapy (APT). The outcome published in The Lancet in 2011 showed improvements in fatigue and physical functioning scores for CBT and GET, but not APT. An outraged patient community expressed alarm that doctors would prescribe exercise to reverse lack of physical condition resulting from illness. A planned followup investigation this year re-ignited the furore, explaining that CBT and GET mediate changed belief and citing a Belgian study “…the role of beliefs in chronic fatigue syndrome and fibromyalgia, which suggested that fear and avoidance of movement were associated with poorer outcomes.” Criticisms include the PACE protocol’s broad inclusion criteria, that their participant’s syndrome wasn’t real CFS are quite ironic given the difficulties experienced by anyone seeking validation for their own sero-negative invisible illness. Emotive catastrophisation reflects the shame felt at being stricken to bed – when the reality uncovered by another Belgian team is that CFS suffferers were hitherto over-achievers. This study isn’t published for the public, but I’m grateful for someone breaching Elsevier© copyright. It also seems free from bias.

cat

All the evidence is clearly presented in the links, so I won’t insult by advising what you ought to think of it all. Complaints will have to be made to the 640 who presented their results. However, the failure of ABT bears editorialising. It was a program delivered by experienced Occupational Therapists per PaceTrial.org published manuals . ABT wisely directs diarising of activity and subsequent post-exertional malaise to establish baselines of safe achievement, thus the salient lesson of ‘you play, you pay’ is documented in order to inform self-management. Advice is given on the need to inform work, family or friends on limited capacity to give of oneself. Diaphragm breathing exercises are explained with the importance of control over fight/flight responses. How could this not improve wellbeing? The answer awaits further analysis, but clearly deficient is any strategy for activity which may increase the envelope of energy. The therapist manual requires joint devising with the client of goals and aims  in CBT and GET only, and instructs not to motivate for an improvement in function in ABT. Emphasis on self-compassion  without guidance for rehabilitation will leave patients stuck where they are. Mindfulness of the condition without movement to actively re-engage with the world, is analogous to theory without the practical.

Onto psychologist Alice Theadom and her survey. The implication is of causality between resting up and worsening symptoms, under the heading of Results: “Daytime napping was significantly associated with increased pain, depression, anxiety, fatigue, memory difficulties and sleep problems.” Worsened relationship with one’s boss too, I’d reckon. If the order of words was changed, one would presume that fibromites suffering worsened symptoms take more naps. But in each presentation of facts uncovered, the order is naps -> bad outcome. Briefly consider the impact to sleep, and the difference reported by nappers being an average of 17 minutes less each night. Mmm ‘kay. When strong pain hits, hit the couch and make up for that lost quarter hour. Incidentally, table 4 shows that the use of opioids is as strong a predictor of likelihood to nap as is gender. That one’s overlooked in the text, and close behind come gabapentin and pregabalin for sending you to sleep.

mackey

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7 Comments

  1. Prof Rob Bennett has devoted decades to fibromyalgia research, and his foundation has made available a similar study – except that this trial integrated breathing meditations and gentle movement. http://www.myalgia.com/PDF%20files/Yoga%20Carson%202010.pdf
    The followon report found another excellent outcome when the control arm participants undertook the Yoga of Awareness 8 week program. Posttreatment results in the wait-list group largely mirrored results seen at posttreatment in the immediate treatment
    group, with the FIQR Total Score improving by 31.9% across the 2 groups. Follow-up results showed that patients sustained most of their posttreatment gains, with the FIQR Total Score remaining 21.9% improved at 3 months.

    No medication benefit exceeds the Clinically Important Difference for the FIQR of 14% like exercise does.

  2. It’s interesting that you describe the PACE trial as being “of very high quality” and “powerfully conclusive”. It would seem that many who read this trial critically would disagree with your assessment.

    David Tuller, journalist, and coordinator of the Masters in Public Health and Journalism at the University of Berkeley, wrote this damning, in-depth 4-part piece on the PACE trial.

    http://www.virology.ws/2015/10/21/trial-by-error-i/

    This has led to a raft of other credible scientists weighing with criticism, including:

    – James Coyne, Clinical Health Psychologist, who described the recent follow-up study as “uninterpretable”:

    http://blogs.plos.org/mindthebrain/2015/10/29/uninterpretable-fatal-flaws-in-pace-chronic-fatigue-syndrome-follow-up-study/

    – An open letter to the Lancet from 6 eminent scientists (one a Nobel laureate), citing significant flaws in the original study, and seeking an independent analysis of the PACE trial data:

    http://www.virology.ws/2015/11/13/an-open-letter-to-dr-richard-horton-and-the-lancet/

    – A petition, led by people with ME/CFS, calling for the claims of the PACE trial to be retracted, and the data re-examined, currently has more than 11,000 signatures.

    Requests filed under FOI for release of the PACE trial data for re-analysis have been denied. The Independent Commissioner’s Office ordered the release of the data, but Queen Mary University of London (QMUL) has lodged an appeal against its release. Many FOI requests in regards to the PACE trial have been deemed vexatious, though it is not always clear why. Whilst not behind a paywall, the behaviour of the PACE trial authors has not been open and transparent, and leaves the impression of a group of people with something to hide.

    https://jcoynester.wordpress.com/2015/12/02/what-it-takes-for-queen-mary-to-declare-a-request-for-scientific-data-vexatious/

  3. This discussion was continued on the FB page, mostly due to my problem of web inadequacy in regional Bali. I noticed fibromite & Occupational Therapist blogger Bronnie revisited this issue yesterday, and her opinion of the protocol is a worthy one: healthskills.wordpress.com/2011/04/27/working-inside-the-envelope-or-pushing-the-boundaries

  4. The first question to resolve must be: What is remission? Is it acceptance in the absence of worsening symptoms, or recovery – and if so, of what….. fitness, Quality of Life? Pandora’s box of evils has been opened, and the disconnect between medicine and patient experience has revealed closed minds on both sides. Some are bold and claim ‘Cure’: http://www.theguardian.com/society/2016/feb/15/it-was-like-being-buried-alive-victim-of-chronic-fatigue-syndrome

  5. PACE will forever be controversial – so I’m getting in early re Goldin’s editorial in STATS. She’s strictly a mathematician, so we rely on Tuller’s expertise. He’s not medical, but his latest published article on health policy titled ‘Renewed Prescriptions For An Old Remedy: Physical Activity’ is abstracted…
    “An article published in 2014 in the British Journal of Sports Medicine summed up the data succinctly: “Physical inactivity is a leading cause of death worldwide.” Indeed, US and international public health and medical experts have converged on that view in the past decade, thanks to a large body of compelling research. According to the World Health Organization, physical inactivity is responsible for 3.2 million deaths annually and is the fourth-biggest risk for mortality, after high blood pressure, tobacco use, and elevated blood glucose. The goal: to stem the rising burden of noncommunicable diseases, such as diabetes, cardiovascular disease, and colon and breast cancer. The relationship between physical activity and good health has been recognized since at least the days of the ancient Greeks. Although the benefits of physical activity are undisputed, a recent Cochrane Review of communitywide interventions to increase it — including public education and awareness campaigns — found little evidence that they worked.” (Health Affairs, Sep 2015)

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