protocol, Trial Identifier, etc. and the published results, as well as
the justifications given for these changes. I haven't had time to go
through all of the docs, so if anyone notices any changes that were
made to the trial but were not requested from and/or approved by the
ethics committee, such as the changing of reporting adverse events
from a drop of 20 points in one interview to a 20 point drop in two
consecutive interviews (I didn't see this one mentioned or explained
by the authors in the paper), please let me know. Also, from the file
'Appendix5_UMC_Guidance'-
"Treatments to be avoided
Whilst no treatment is prohibited from medical care we would ask those
providing this to restrict their care to that usually given and not to
either seek to provide or refer patients for treatment which is being
evaluated in another arm of the trial. As part of the trial we would
ask you not to prescribe any medicine that is regarded as a putative
specific treatment for CFS. Excluded medicines would involve hormones,
such as hydrocortisone, but would not include indicated endocrine
treatments, such as thyroxine in a patient with corroborated and
compensated hypothyroidism. Putative immune treatments for CFS (e.g.
Ampligen, immunoglobulin, inosine pranobex) would be excluded.
Putative energy enhancing treatments (e.g. NADH) would be excluded."
How nice! 'Specialist treatment' minus the treatment! Brilliant!
zip file of changes made to the PACE trial-
http://www.mediafire.com/?uihi8zzfzihviux
---------------------------------------------
Send posts to CO-CURE@listserv.nodak.edu
Unsubscribe at http://www.co-cure.org/unsub.htm
Co-Cure Archives: http://listserv.nodak.edu/archives/co-cure.html
---------------------------------------------
Co-Cure's purpose is to provide information from across the spectrum of
opinion concerning medical, research and political aspects of ME/CFS and/or
FMS. We take no position on the validity of any specific scientific or
political opinion expressed in Co-Cure posts, and we urge readers to
research the various opinions available before assuming any one
interpretation is definitive. The Co-Cure website <www.co-cure.org> has a
link to our complete archive of posts as well as articles of central
importance to the issues of our community.
---------------------------------------------
