Acupuncture Study Design Questions: AVOID sham Tx!

[Guest guest]

Hi All, & Alex,

 

Alex Berks 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.

 

> (1) How do I handle the point selection in the intervention group. 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 Oncos to

> have a more controlled study.

 

Most conventional researchers (and most scientific journals) insist on

standardised treatments. We are stuck with that in most cases.

 

> My idea is to have a group of " base points " and then have a few extras

> depending on pattern discrimination. Please advise.

 

I agree.

 

You need to be clear at the outset if you want to use TCM methods (as

below), or Are Thoresen's " One Needle Technique " , using the Ko Cycle.

Email: " Are Thoresen " <arethore if you want to discuss that.

 

As " base points " from TCM Theory, consider:

 

(a) Immunostimulant points: LI04, LI11, ST36, SP06, GV14

 

(b) Mu + Shu Pts for specific organs, if the Dx indicates primary cancer of

one specific organ, for example:

 

BL21 + CV12 for primary cancer of ST

BL18 + LV14 for primary cancer of LV

etc

 

© 1-2 points for the most important (severe) symptom(s)

 

The Oncos may not accept TCM Pattern Dx as a determinant of point

selection, because most conventional doctors have no understanding or

respect for that approach.

 

> (2) I was going to use a cross-over study design but the onco's didn't

> like that saying 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.

 

I agree on two issues:

 

(a) I agree with the Oncos, not on the basis of stats, but because I shudder

at the thought of cross-over design and sham-treatment in life-threatening

disease.

 

(b) Sham-treatment may have some effect; if so, it tends to detract from the

value of real acupuncture at the conclusion stage of the paper.

 

> My suggestion is to only recruit acupuncture naive patients, blindfold

> all patients and for the placebo control; poke 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.

 

I urge you most strongly NOT to include sham needling (see above).

 

Instead, have just two treatments:

 

(a) State-of-the-art conventional cancer Tx

and

(b) State-of-the-art conventional cancer Tx + the best acupuncture protocol

that you can design.

 

In today's high-tech society - western or eastern - it it most unlikely that

acupuncture ALONE will be accepted as the primary Tx of cancer. For the

TCM profession AND the patient, the best that we can expect is the

inclusion of acupuncture (and / or herbal medicine) to SUPPORT

conventional Tx (and reduce its adverse side-effects).

 

Therefore, IMO, it is imperative that well designed research demonstrate a

statistically significant benefit of COMBINING TCM and conventional cancer

Tx in extensive trials that compare those two groups, i.e.:

 

(a) State-of-the-art conventional cancer Tx

and

(b) State-of-the-art conventional cancer Tx + the best acupuncture protocol

that you can design.

 

Alex, I wish you the best of luck in this project,

 

 

 

 

 

 

 

[Guest guest]

Now that is really interesting! I mean that. A part of me resonates with

what you are saying. MT

 

_____

 

 

On Behalf Of Are Thoresen

Thursday, February 14, 2008 11:04 AM

 

SV: Acupuncture Study Design Questions: AVOID sham Tx!

 

 

 

Alex,

 

If you tell me what kind of cancer will be treated in this project, I will

tell you what point to use.

 

The importance of the immune-system in cancer is highly overestimated.

 

Are

 

Are Thoresen

 

Tinghaugveien 435

 

Gisleröd Gård

 

N-3175 Ramnes

 

telefon 33397930

 

arethore (AT) online (DOT) <arethore%40online.no> no

 

are <are%40sanare.no>

 

http://www.sanare. <http://www.sanare.no> no

 

http://www.sanare. <http://www.sanare.no/naturmedisin> no/naturmedisin

 

_____