Onlangs verschenen in de Lancet 8 lezersbrieven met inhoudelijke kritiek op de PACE-trial, alsmede een "onbevooroordeelde" editorial van de redaktie van Lancet "samenspanning etc.)

en de reaktie van White en kollega's die uiteraard geen konkrete antwoorden verschaffen op de kritiek m.b.t. patiëntenselektie, berekening van het "succes", de "prestatie" na afloop etc.

Uiteraard betreft het bijna allemaal brieven van patiënten (en niet van wetenschappers),

zodat de redaktie van de Lancet haar "gelijk" weer bevestigt:

die zeurpieten/patiënten spannen samen en zijn niet voor wetenschappelijke rede vatbaar!

Over de te verwachten "kontroverse" (feiten versus verdachtmakingen/algemeenheden)

verscheen een artikel op de website van de Wall Street Journal. Klik op onderstaand logo.

Relevante citaten uit een paar van de hierboven vermelde brieven:

The PACE trial in chronic fatigue syndrome.

Sarah M Feehan.

Peter White and colleagues 1 say that normal fatigue is represented by a figure of 18 or less on the Chalder fatigue questionnaire (Likert scoring), rather than the validated definition of fatigue caseness (4 or more, bimodal scoring) used in the trials protocol. 2,3

.....

Furthermore, 17,6% of chronic fatigue syndrome patients diagnosed at the Chronic Fatigue Unit (South London and Maudsley NHS Trust) had a score of 18 or less before they were treated. 4 This suggests either that the Chronic Fatigue Unit diagnoses and treats fatigue problems in patients with normal levels of fatigue or, alternatively, that the threshold of18 to represent normal fatigue is not suitable.

The PACE trial in chronic fatigue syndrome

Tom Kindlon

.....

Given many patients reports of adverse reactions from such interventions, the biological reasons why they might be problematic (e.g. abnormalities in muscle and immunological response to exercise), and the fact that adverse reactions are often only noted outside of trials, the assumption that cognitive behaviour therapy and graded exercise therapy are safe is premature.2,4,5

The PACE trial in chronic fatigue syndrome

Bart Stouten, Ellen M Goudsmit, Neil Riley

The findings of the PACE trial 1 seem impressive, but the discrepancy between the definitions of improvement in the protocol 2 and paper requires an explanation.

However, the criteria for improvement published in the trial protocol were much more demanding (table). 2 Use of a cut-off score of 75 on the short-form 36 physical functioning subscale, as originally proposed, would halve the number of recovered patients.

.....

The PACE trial in chronic fatigue syndrome

Andrew James Kewley

.....

The lack of objective data, such as hours employed or actometer results, is problematic, since Wiborg and colleagues 4 showed that improvements on questionnaires are not reflected in an increase in activity, as would be expected if the patients had more energy. 4

The only significant difference between treatments for the 6-min walking test was for graded exercise therapy. But the increase in walking distance is small when compared to the distance walked by healthy elderly people (mean age 65 years), which was shown to be 631 m (SD 93). 5

Meters gelopen in zes minuten (uit PACE-studie, FT)

Unfortunately, the overall results of the PACE treatments were unimpressive, and with only 41% of patients reporting positive change after cognitive behavioural therapy or graded exercise therapy, further biomedical research is imperative.

De "onbevooroordeelde kijk" van de redaktie van de Lancet....

Editorial

http://download.thelancet.com/pdfs/journals/lancet/PIIS014067361160696X.pdf

.....

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 Lancet

Met dank aan Rob.