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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 <[log in to unmask]>wrote: > 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 <http://www.ncbi.nlm.nih.gov/pubmed/10190407>, 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) [log in to unmask], [log in to unmask] "Croyez ceux qui cherchent la vérité, doutez de ceux qui la trouvent" André Gide