Rituximab, etc:
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
"We now have two treatments that we can recommend with confidence to
our patients.
However, the story does not quite end there.
Patient groups rejected the trial out of hand, and the internet was
abuzz with abuse and allegations.
The main reason for this depressing reaction was the stigma that
attaches to disorders perceived (rightly or wrongly) to be psychiatric
in origin, whatever that means.
If one obtained identical results to the PACE trial, but this time
with anti-viral drugs, the reaction would have been totally different.
This is exactly what did happen when a very small trial of a drug that
modulates the immune system (and which has some nasty side effects)
was greeted with acclaim from the same sources that tried to discredit
the PACE trial, which tested interventions with an impeccable safety
record."
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
From:
http://bit.ly/uqelEi i.e.
http://www.foundation.org.uk/journal/pdf/fst_20_07.pdf (free)
The Journal of the Foundation for Science and Technology
Volume 20, Number 7, December 2011
Health in mind and body
Simon Wessely
-----------
Regarding:
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
"the PACE trial, which tested interventions with an impeccable safety recor=
d."
=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D=3D
- This is the sort of claim I've challenged in:
----------
Reporting of Harms Associated with Graded Exercise Therapy and
Cognitive Behavioural Therapy in Myalgic Encephalomyelitis/Chronic
Fatigue Syndrome
Tom Kindlon
ABSTRACT
Across different medical fields, authors have placed a greater
emphasis on the reporting of efficacy measures than harms in
randomised controlled trials (RCTs), particularly of nonpharmacologic
interventions.
To rectify this situation, the Consolidated Standards of Reporting
Trials (CONSORT) group and other researchers have issued guidance to
improve the reporting of harms.
Graded Exercise Therapy (GET) and Cognitive Behavioural Therapy (CBT)
based on increasing activity levels are often recommended for Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
However, exercise-related physiological abnormalities have been
documented in recent studies and high rates of adverse reactions to
exercise have been recorded in a number of patient surveys.
Fifty-one percent of survey respondents (range 28-82%, n=3D4338, 8
surveys) reported that GET worsened their health while 20% of
respondents (range 7-38%, n=3D1808, 5 surveys) reported similar results
for CBT.
Using the CONSORT guidelines as a starting point, this paper
identifies problems with the reporting of harms in previous RCTs and
suggests potential strategies for improvement in the future.
Issues involving the heterogeneity of subjects and interventions,
tracking of adverse events, trial participants=92 compliance to
therapies, and measurement of harms using patient-oriented and
objective outcome measures are discussed.
The recently published PACE (Pacing, graded activity, and cognitive
behaviour therapy: a randomised evaluation) trial which explicitly
aimed to assess =93safety=94, as well as effectiveness, is also analysed
in detail.
Healthcare professionals, researchers and patients need high quality
data on harms to appropriately assess the risks versus benefits of CBT
and GET.
Bulletin of the IACFS/ME. 2011;19(2):59-111.
Free full text at:
http://bit.ly/sUsWs3 i.e.
http://www.iacfsme.org/LinkClick.aspx?fileticket=3DRd2tIJ0oHqk%3D&tabid=3D5=
01
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