Deze informatie wordt u aangeboden door de Wake-Up Call Beweging vzw
Wetenschappelijke beweringen dat Cognitieve Gedragstherapie(CGT) en Graduele oefentherapie(GOT) effectief zijn bij de behandeling van het Chronisch Vermoeidheidssyndroom (CVS) liggen opnieuw onder vuur wegens frauduleuze praktijken die werden vastgesteld bij de PACE trial (UK). De oorspronkelijke doelstellingen bij aanvang van de studie voor wat betreft het bepalen van de mate van herstel bij de deelnemers werden halverwege de studie dermate afgezwakt om alsnog tot gunstige onderzoeksresultaten te komen.
Ook in België worden CGT en GOT door de overheid erkend als evidence based therapie voor mensen met CVS. De resultaten uit de PACE trial worden hierbij aangehaald voor het staven van het bewezen effect van deze therapieën maar opnieuw blijkt het om een studie te gaan waarbij de onderzoekers banden hadden met de private zorgverzekeraars en er geknoeid werd met de resultaten van de studie.
Dat de wetenschappelijke beweringen over het effect van deze therapieën onder bedenkelijke omstandigheden tot stand komen is wellicht dan ook de meest voor de hand liggende verklaring waarom heel veel CVS patiënten - bij de praktische toepassing ervan - beweren geen baat te hebben bij CGT en GOT.
Het huidige CVS beleid is nog steeds volledig gebaseerd op wat we niet weten over CVS, terwijl de zorg en opvang voor deze patiënten net zou moeten gebaseerd zijn op wat de wetenschap wel reeds weet over de ziektemechanismen achter deze slopende aandoening.
Volgens een recente Deense studie hebben CVS patiënten de laagste levenskwaliteit in vergelijking tot 17 andere ernstige aandoeningen/ziekten waaronder meerdere vormen van kanker, hartaandoeningen, reuma, depressie, diabetes type 2, ...
Gunther De Bock - WUCB vzw
An open letter to Dr. Richard Horton and The Lancet
13 NOVEMBER 2015 Dr. Richard Horton The Lancet 125 London Wall London, EC2Y 5AS, UK
Dear Dr. Horton:
In February, 2011, The Lancet published an article
called “Comparison of adaptive pacing therapy,
cognitive behaviour therapy, graded exercise
therapy, and specialist medical care for chronic
fatigue syndrome (PACE): a randomized trial.”
The article reported that two “rehabilitative”
approaches, cognitive behavior therapy and graded
exercise therapy, were effective in treating chronic
fatigue syndrome, also known as myalgic
encephalomyelitis, ME/CFS and CFS/ME.
The study received international attention and has
had widespread influence on research, treatment
options and public attitudes.
The PACE study was an unblinded clinical trial with
subjective primary outcomes, a design that requires
strict vigilance in order to prevent the possibility of
bias.
Yet the study suffered from major flaws that have
raised serious concerns about the validity, reliability
and integrity of the findings.
The patient and advocacy communities have known
this for years, but a recent in-depth report on this
site, which included statements from five of us, has
brought the extent of the problems to the
attention of a broader public.
The PACE investigators have replied to many of the
criticisms, but their responses have not addressed
or answered key concerns.
The major flaws documented at length in the
recent report include, but are not limited to, the
following:
*The Lancet paper included an analysis in which
the outcome thresholds for being “within the normal
range” on the two primary measures of fatigue and
physical function demonstrated worse health than
the criteria for entry, which already indicated serious disability.
In fact, 13 percent of the study participants were
already “within the normal range” on one or both
outcome measures at baseline, but the
investigators did not disclose this salient fact in the
Lancet paper.
In an accompanying Lancet commentary,
colleagues of the PACE team defined participants
who met these expansive “normal ranges” as
having achieved a “strict criterion for recovery.”
The PACE authors reviewed this commentary before
publication.
*During the trial, the authors published a
newsletter for participants that included positive
testimonials from earlier participants about the
benefits of the “therapy” and “treatment.”
The same newsletter included an article that cited
the two rehabilitative interventions pioneered by
the researchers and being tested in the PACE trial
as having been recommended by a U.K. clinical
guidelines committee “based on the best available
evidence.”
The newsletter did not mention that a key PACE
investigator also served on the clinical guidelines
committee.
At the time of the newsletter, two hundred or more
participants—about a third of the total
sample–were still undergoing assessments.
*Mid-trial, the PACE investigators changed their
protocol methods of assessing their primary
outcome measures of fatigue and physical function.
This is of particular concern in an unblinded trial like
PACE, in which outcome trends are often apparent
long before outcome data are seen.
The investigators provided no sensitivity analyses
to assess the impact of the changes and have
refused requests to provide the results per the
methods outlined in their protocol.
*The PACE investigators based their claims of
treatment success solely on their subjective
outcomes.
In the Lancet paper, the results of a six-minute
walking test—described in the protocol as “an
objective measure of physical capacity”–did not
support such claims, notwithstanding the minimal
gains in one arm.
In subsequent comments in another journal, the
investigators dismissed the walking-test results as
irrelevant, non-objective and fraught with
limitations.
All the other objective measures in PACE,
presented in other journals, also failed.
The results of one objective measure, the fitness
step-test, were provided in a 2015 paper in The
Lancet Psychiatry, but only in the form of a tiny
graph.
A request for the step-test data used to create
the graph was rejected as “vexatious.”
*The investigators violated their promise in the
PACE protocol to adhere to the Declaration of
Helsinki, which mandates that prospective
participants be “adequately informed” about
researchers’ “possible conflicts of interest.”
The main investigators have had financial and
consulting relationships with disability insurance
companies, advising them that rehabilitative
therapies like those tested in PACE could help
ME/CFS claimants get off benefits and back to
work.
They disclosed these insurance industry links in The
Lancet but did not inform trial participants,
contrary to their protocol commitment.
This serious ethical breach raises concerns about
whether the consent obtained from the 641 trial
participants is legitimate.
Such flaws have no place in published research.
This is of particular concern in the case of the
PACE trial because of its significant impact on
government policy, public health practice, clinical
care, and decisions about disability insurance and
other social benefits.
Under the circumstances, it is incumbent upon The
Lancet to address this matter as soon as possible.
We therefore urge The Lancet to seek an
independent re-analysis of the individual-level PACE
trial data, with appropriate sensitivity analyses,
from highly respected reviewers with extensive
expertise in statistics and study design.
The reviewers should be from outside the U.K. and
outside the domains of psychiatry and
psychological medicine.
They should also be completely independent of,
and have no conflicts of interests involving, the
PACE investigators and the funders of the trial.
Thank you very much for your quick attention to
this matter.
Sincerely,
Ronald W. Davis, PhD
Professor of Biochemistry and Genetics
Stanford University
Jonathan C.W. Edwards, MD
Emeritus Professor of Medicine
University College London
Leonard A. Jason, PhD
Professor of Psychology
DePaul University
Bruce Levin, PhD
Professor of Biostatistics
Columbia University
Vincent R. Racaniello, PhD
Professor of Microbiology and Immunology
Columbia University
Arthur L. Reingold, MD
Professor of Epidemiology
University of California, Berkeley
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