I can address your issue generally, but, unfortunately not specifically. Hopefully this general response is insightful and potentially helpful to you.

As an expert in plasmapheresis,  there was an article published years ago in NEJM by Fred Miller of NIH on the efficacy of plasmapheresis in refractory dermatomyositis. In the study , there was no difference between "sham apheresis" and plasmapheresis with improvement in 3/10 in each group (actually 2 treatment and sham groups).

Those of us with much larger , unpublished experience, would welcome in such "refractory" patients to use a Sham procedure with 30 % response rate would be welcome by docs and patients with such conditions that typically end in mortality. Some think that the "sham" apheresis procedure, as performed in that NEJM published study, may not actually represent a presumed placebo response, but may indeed be an active treatment.

In other words, if you see responses in your "sham" acupuncture control group, PLEASE, do not presume that this is entirely attributed to a "placebo" response. 

I hope this helps~

Thanks!

The work that I have seen in this space has used real acupuncture needles at sites that are not acupuncture points. So, the needles are real (not sham) but the approach is not real (it's sham).

Or, use needle stim to a depth that you would not normally use.

As you are probably aware, there are many different types of needling approaches, and you will need to understand exactly what approach you are using and what would be sham points.

Some have tried to develop sham needles with attendant problems.

Suggest that you read the following articles:

Sham acupuncture may be as efficacious as true acupuncture: a systematic review of clinical trials. Moffet HH (2009) J Altern Complement Med. 

http://cdn.intechopen.com/pdfs-wm/43391.pdf

Also, consider applying the STRICTA guidelines (Standards for Reporting

Interventions in Clinical Trials for Acupuncture) to your work.

Dear Arthur,

there is no such thing as sham acupuncture with needles. If you stick a needle anywhere in the body there will be an increase in e.g.stress hormones. And in western physiology so called Head's zones are well known since decades, surface areas connected to deeper lying organs. The only way to perform placebo stimulation of acupuncture points is with infrared laserlight which the patient can neither see nor feel.  If the laser is equipped with a randomizer, true double blind studies can be performed - the effect of the stimulation can be controlled by functional MRI in the brain.

Best regards : Andy Wirz-Ridolfi

Dear Arthur,

Investigators have used several strategies to achieve sham acupuncture. Recently acupuncture sham devices have been developed and used in several trials. You can find more information in this paper: http://www.ncbi.nlm.nih.gov/pubmed/26536619/?ncbi_mmode=std

Regards

Carles Fernádnez

Andy,

That's an interesting insight. I would suggest however, that laser acupuncture is not sham either, as it has been found to stimulate outcomes. Suggest reading:

J Acupunct Meridian Stud. 2008 Dec;1(2):65-82. doi: 10.1016/S2005-2901(09)60026-1.

Clinical effectiveness of laser acupuncture: a systematic review.

Baxter GD, Bleakley C, McDonough S.

Regards,

Liisa

Lisa,

Ithink Andy mean the laser can have a sham laser to test laser, but Acupuncture can not. I agree with him.

arthur

There are validated Sham Acupuncture techniques, one is to use the Park retractable needle and another is to use our technique of using a blunt needle that does not penetrate the skin through a foam pad.

1.            Goddard, G., Shen, Y. Steele, B., A controlled trial of placebo vs. real acupuncture, The Journal of Pain, 2005, Volume 6, Number 4, pages 237-242.

Hi!

In infants with colic, we got significantly reduced crying with one single needle inserted 2 mm deep for two seconds (!!) in LI4 (Landgren et al 2010). This result indicates that even minimal acupuncture has effect and should not be used as sham acupuncture!

Kajsa

Both the Park Sham needle and m our technique do not penetrate the skin and have been validated.

Greg

This is a real interesting discussion and a lot of things said by Liisa and Andreas i can support. But the sham-question is still more difficult!!!

 I have been trained in China and we always had to look for the adequate needling technique, means bufa or xiefa or neutral.

Besides you know Yi dai qi! So 1) the patient will realize he got the needling sensation and this is real acupuncture. 2) talented doctors with empathetic patients might even by concentrating their qi-energy to a specific point have results without needle.

So actually there is either no sham and / or no adequate needling?

There is a placebo(sham) technique, it is only good for acupuncture naive patients.

A controlled trial of placebo vs. real acupuncture

Greg Goddard · Yoshi Shen · Brian Steele · Nathan Springer ·

[Show abstract]

Journal of Pain 05/2005; 6(4):237-42. DOI:10.1016/j.jpain.2004.12.009 ·

When using sham acupuncture you need first to answer the question, what variable are you the using sham acupuncture to control. Are you using it to control the placebo effect or are you using it to control the the non-needling aspects of the practitioner interaction with the patient. As previously discussed, needling even minimally has a benefit as does the intention have an effect. It is called sham acupuncture not placebo acupuncture which in itself gives some insight into the issue.

The method to control for the non-needling aspects of the practicioner interaction with the patient is to have the same practicioner replicate the interaction exactly with both the verum and placebo groups.

I agree with both Andreas and Liisa. Ultimately there is no true placebo for acupuncture, other than laser. However, laser acupuncture is not generally accessible in most clinics, therefore any potential study results would not be directly related to clinical practice.

However, if the question is aimed at, does penetrative acupuncture yield a greater outcome than sham acupuncture? As Greg highlighted, sham acupuncture devices (Streitberger, Park, Takakura) have been validated, and if a study adheres to the STRICTA guidelines, I feel this would be the most robust method of comparing acupuncture to sham acupuncture. If that is the question you are trying to answer.

Berj

Berj,

Laser acupuncture with no laser is a good placebo control for laser acupuncture.

The sham/placebo devices(Streitberger, Park, Takakura) have been validated, and are good placebo controls for needle acupuncture.

Randomized placebo controlled study results are directly related to clinical practice; they give us our evidence based treatment.

Greg

My comment was directly related to the use of laser acupuncture as a placebo versus sham needle acupuncture. I do not believe the effects of laser acupuncture can be directly compared to needle acupuncture, therefore unless you have a laser acupuncture machine in a clinic, there is no direct comparison. In the UK the use of needle acupuncture is the most common form of acupuncture, therefore any study using laser would not be directly related to clinical practice.

I do not feel needle acupuncture/sham devices are not placebo, as already mentioned in the above comments and in numerous papers, as im sure you are aware.

I am also aware RCT's provide our evidence, hence my statement above regarding the STRICTA guidelines.

Berj