Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 , " Bob Flaws " < pemachophel2001> wrote: > > > I don't know anything about grant-writing. However, let me make a counter proposal. I would be willing to donate enough Ultimate > Immortals to do a comparison study on dose-based efficacy. do you think we would need NIH funding to make this fly or could it be done with volunteers and a school clinic? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 > do you think we would need NIH funding to make this fly or could it be done > with volunteers and a school clinic? Depends on how big the study and where you hope to publish the eventual paper describing the study and its outcomes. First of all, I would suggest that you consider what you want to accomplish: A) to determine the importance of dose in the use of ready-made Chinese herbal medicines, or B) to determine if a particular Chinese herbal formula is clinically effective in the treatment of perimenopausal night sweats. I would donate product to either of these two studies, but I would suggest that they are two separate, though both interesting, studies. If you did a " pilot " study at a school clinic that proved successful, then you could more easily get grant money from a larger institution, such as the NIH. A smaller successful study would make it easier to also involve the necessary MDs to do the diagnosis, pharmacists to dispense the placebo and meds while blinding the practitioners, and statiticians to crunch the numbers. A small initial is always a good way to interest third parties in a larger, more elaborate, and more conclusive study. If you were to use Ultimate Immortals, I could not be part of the grant-writing since I am a principle in the company which would be providing the meds for such the study. But I'd be happy to advise you. I have been a co-author for an NIH-funded study. So I have been through the process from beginning to end, including co-authoring the resultant article published in JAMA.. Blue Poppy Herbs is willing to donate the necessary product to ANY SCHOOL CLINIC willing to conduct such an RCT on one of our formulas. Any takers should contact me at: bob Bob Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 , " Bob Flaws " < pemachophel2001> wrote: A) to determine the importance of dose in the use of ready-made > Chinese herbal medicines, or B) to determine if a particular Chinese herbal formula is clinically effective in the treatment of > perimenopausal night sweats. I would donate product to either of these two studies, but I would suggest that they are two separate, > though both interesting, studies. how does one determine whether dose affects efficacy w/o demonstrating efficacy simultaneously. I would assume one has to show that one form of herbs or both or neither were clinically effective for perimenopause in order to decide if one form was better or not. right? Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 " how does one determine whether dose affects efficacy w/o demonstrating > efficacy simultaneously. I would assume one has to show that one form of > herbs or both or neither were clinically effective for perimenopause in order > to decide if one form was better or not. right? The study itself would demonstrate efficacy. Part of the design of an RCT is the definition of outcomes. We would simply adopt criteria already established in either Chinese or Western medicine. Maybe criteria from both. Then we would see if both groups met that criteria and if one group met that criteria better than the other. As a for instance, cure might be defined as disappearance of all night sweats with no recurrence within three months of stopping taking the meds. Marked effect might be defined as complete cessation of night sweats but relapse within three months. However, the night sweats went away again when treated was reinitiated. Some effect might mean that, although the night sweats never completely stopped, their incidence and severity decreased by 50%. No effect might then be defined as a decrease in night sweats of less than 50% after X-courses of treatment. This would demonstrate efficacy. Then any differences in these mean outcomes would demonstrate differences in efficacy that were dose-dependent. This is a simple, straight-forward two wing comparative study. All patients would meet the inclusion criteria which would be of two kinds: 1. Western medical diagnosis (perimenopausal night sweats) 2. Chinese medical pattern discrimination (the pattern described in the BPH product literature for Ultimate Immortals) The patients would be randomly assigned and the Chinese medical practitioners and patients would both be blinded in terms of who was getting what doses of the same formula. If you want to have a third, placebo wing to conclusively demonstrate efficacy beyond a shadow of a doubt, as Alon has suggested, that would also be great if A) enough patients could be enrolled and B) you could get patients willing to receive a placebo. One way around this is to offer them free 'real " treatment after the study is concluded if it turns out they were assigned to the placebo group. Bob Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 , " " wrote: > do you think we would need NIH funding to make this fly or could it be done > with volunteers and a school clinic? > I realize that this was a reply to Bob, but I thought I would put this out there. PCOM campus in San Diego has about 400 students. Full-time tuition is about $10,000 per year. If every student was full-time, that would be $4 million in tuition, but not every student is full-time. There is probably $2.5 - $3 million in tuition payments each year. This is just for the San Diego campus. We have 2 other campuses: New York and Chicago. There are also money generating clinics at all three of those campuses, collecting payment for patient visits and for herb sales. I have no idea how much money that would amount to. I realize that there is overhead for PCOM, sust as rent, utilities, employee wages, etc., but it would seem that there is enough money left over to fund the type of study that you mentioned - especially if students and / or faculty donated their time. This would not only produce a significant study, but it would also serve to increase the reputation and future patient load of PCOM's clinics. Bob Flaws already mentioned the possibility of donating patient medicine. If the people involved donated time, the expensess should not be so much: mostly advertising for recruitment. Brian C. Allen Quote Link to comment Share on other sites More sharing options...
Guest guest Posted November 25, 2003 Report Share Posted November 25, 2003 If you design it as a pilot study, then you do not need the funding. A pilot study is often the basis for applying to the NIH or another organization for real money. As someone said however, you need to double blind the study so that neither the person dispensing the herbs, the person getting the herbs or the person doing intakes etc. has any idea who is getting what. Marnae At 05:43 PM 11/25/2003 +0000, you wrote: > , " Bob Flaws " < >pemachophel2001> wrote: > > > > > > I don't know anything about grant-writing. However, let me make a counter >proposal. I would be willing to donate enough Ultimate > > Immortals to do a comparison study on dose-based efficacy. > >do you think we would need NIH funding to make this fly or could it be done >with volunteers and a school clinic? > >Todd > > > >Chinese Herbal Medicine, a voluntary organization of licensed healthcare >practitioners, matriculated students and postgraduate academics >specializing in Chinese Herbal Medicine, provides a variety of >professional services, including board approved online continuing education. > > > > Quote Link to comment Share on other sites More sharing options...
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