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Acupuncture Study Design Questions

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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.

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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.

>

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