Guest guest Posted February 13, 2008 Report Share Posted February 13, 2008 I need some advice about study design. I have a golden opportunity to be part of a grant to use an acupuncture intervention. I am providing the study design to a group of oncologists. Having never done this before I need a bit of help. First, how do I handle the point selection in the intervention group. Of course I would like to honor TCM theory by not doing standardized points for all patients. But I have to balance this with the desire of the Onco's to have a more controlled study. My idea is to have a group of " base points " and then have a few extras depending on pattern discrimination. Please advise. Second. I was going to use a cross-over study design but the onco's didn't like that sying it was not statistically valid and we would need a much larger group than what we can recruit for the study. I like it because each patient becomes their own control. So now that has been rejected what to do? it seems to my knowledge that sham studies in which points are used that are not on the main meridians gets about the same results as regular points. So that is out. My suggestion is to only recruit acupuncture naieve patients, blindfold all patients and for the placebo control polk with a guide tube and then tape on a needle. Then validate the placebo by asking questions after each treatment of whether the patient thought it was real or not. If anyone has participated in an acupuncture trial I would love to hear from you, and soon. I just want to make sure that I am honoring my medicine and setting up the right circumstances to get a good result while still keeping the Onco's happy not to mention getting the grant. I can be reached off the list at alex or on the list also. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted February 13, 2008 Report Share Posted February 13, 2008 After we talked over the weekend I realized a call up to Richard Hammerslag (?) at OCOM in Portland would be in line. Nice guy, lots of experience at the design level. Also Steve Given might be able to help at Bastyr. As you know, their DAOM focuses on oncology. Doug , " Alex Berks " <aberks wrote: > > I need some advice about study design. I have a golden opportunity to > be part of a grant to use an acupuncture intervention. I am providing > the study design to a group of oncologists. Having never done this > before I need a bit of help. > > First, how do I handle the point selection in the intervention group. > Of course I would like to honor TCM theory by not doing standardized > points for all patients. But I have to balance this with the desire > of the Onco's to have a more controlled study. My idea is to have a > group of " base points " and then have a few extras depending on pattern > discrimination. Please advise. > > Second. I was going to use a cross-over study design but the onco's > didn't like that sying it was not statistically valid and we would > need a much larger group than what we can recruit for the study. I > like it because each patient becomes their own control. So now that > has been rejected what to do? it seems to my knowledge that sham > studies in which points are used that are not on the main meridians > gets about the same results as regular points. So that is out. My > suggestion is to only recruit acupuncture naieve patients, blindfold > all patients and for the placebo control polk with a guide tube and > then tape on a needle. Then validate the placebo by asking questions > after each treatment of whether the patient thought it was real or not. > > If anyone has participated in an acupuncture trial I would love to > hear from you, and soon. I just want to make sure that I am honoring > my medicine and setting up the right circumstances to get a good > result while still keeping the Onco's happy not to mention getting the > grant. > > I can be reached off the list at alex > or on the list also. > Quote Link to comment Share on other sites More sharing options...
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