miércoles, 27 de octubre de 2010

Placebo in clinical trials: are they justified and credible?

Placebo in clinical trials: are they justified and credible?

Ann Intern Med published online October 25, 2010
Disued and sacked by the French Dept. of Health (see HealthWatch Newsletter, issue 79, October 2010. Available Golomb et al rightly questioned the composition of the placebo in clinical trials.(1) I crave that they use their database for 2 major questions yet unanswered.
In what percentage of cases the Helsinki declaration (point 32) which clearly requires "that patients are not randomized to a clearly inferior treatment." is implemented? Indeed serious breaches exit, even for diseases with a high short term mortality where patients can receive a placebo despite that an effective treatment is recommended.(2)
In what percentage of cases the placebo composition can allow for a credible "double-blind" statement?
References
1 Golomb BA, Erickson LC, Koperski S, Sack D, Enkin M, Howick J. What's in placebos: who knows? Analysis of randomized, controlled trials. Ann Intern Med. 2010 19;153:532-5.
2 Braillon A. Sciensationalism. Am J Med. 2010 Sep 29. PMID: 20887967 In press, available on line

In what percentage of cases the Helsinki declaration (point 32) which clearly requires "that patients are not randomized to a clearly inferior treatment." is implemented? Indeed serious breaches exit, even for diseases with a high short term mortality where patients can receive a placebo despite that an effective treatment is

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