Hi Carlos,
I am a pediatrician and methodologist in Portugal; you might check a paper we wrote a few years ago in Journal of Pediatrics, before the Plos Med review; topic: placebo response in migraine trials, also almost twice as that in adult trials.
http://www.ncbi.nlm.nih.gov/pubmed/18346509
The placebo literature and discussion, be it methodological, ethical, clinical, has been going on for decades now. Goetzsche's NEJM/cochrane review revived it in the late 90s. Fascinating stuff, with a lot of neuroscience backing it up. Neonatal placebo is obviously a provocative question...:)
My thoughts are with the previous replies; placebo response is NOT the same as effect, and most of it is probably methodological issues and measurement bias.
Cheers, Ricardo.
On Fri, Jan 21, 2011 at 4:31 PM, Dr. Carlos Cuello
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Thank you all for your kind responses.
and thanks to my patient´s mother who initiated my request. More than explaining her clinical studies, I was explaining to her the placebo effect as in homeopathy and other alternative therapies. She was reluctant to believe that homeopathy could get a kid better only by the placebo effect. That´s when I mentioned the examples previously mentioned, like the placebo effect of
pacemakers, or the better results with four pills over two pills, etc. When she mentioned children I cited the "proxy effect" but I decided to go a little further, as sometimes the "proxy effect" might not be the only factor, as in double blind studies of neonates with sucrose or placebo (water) for pain relief.
Undoubtedly the placebo effect as we know it requires higher cognitive process to take place as in the examples previously cited. The reason or explanation on how it works in children and even in neonates is speculative and most likely explained by the "proxy effect" when parents or caretakers perceive and report an improvement.
I would like to hear more about studies and examples in babies (like the pacemaker example). In my searches I haven´t found much examples, but I´ll keep trying and I ´ll let you know.
...on other question (same topic)
Citing the first systematic review by Rheims:
Placebo effect is twice in children as in adults & I quote "Such a difference, if ignored, could well result in an underestimation of the placebo response and type II errors in paediatric RCTs."
Should we as "Evidologists" consider this effect when appraising pediatric trials? evenmore, when conducting one?
Have a nice weekend!
--
Carlos A. Cuello-García, MD
--
_________________________________
Ricardo M. Fernandes, MD
Department of Pediatrics, Santa Maria Hospital
Laboratório de Farmacologia Clínica e Terapêutica, Faculdade de Medicina
Lisboa, Portugal
Gulbenkian Foundation Advanced Medical Education phD Program
Institute of Molecular Medicine (
www.imm.ul.pt)
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"Croyez ceux qui cherchent la vérité, doutez de ceux qui la trouvent" André Gide