Placebo Needle - follow up

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All,

 

In response to a couple of off-list discussions of my post on the " placebo

needle " (thanks to you both), I want to be more specific.

 

The first thing to keep in mind is that a placebo can not be active in any

way, thus the whole idea of a placebo needle is a contradiction. It's cute but

confused, and sadly newsworthy.

 

Second, the Kaptchuk protocol gives a physiological stimulation. This

makes sense, it can't be otherwise the way the " placebo insertion " is

performed. While this stimulation is less than that of actually inserting a

needle, it exits and this means that it is not a placebo. Because any

stimulation effects some bodily system or it must be considered in the trial

design. Furthermore, any placebo effect that could be measured using this

device depends upon external factors. For example: How was the study

promoted? How was the study described to potential participants? What

was the specific wording of the consent form? If the people in the study are

expecting acupuncture, they must be extremely naïve about acupuncture to

believe they have received treatment. If they can guess that they were not

really treated then the study was not blind -- the participants knew they

were controls -- and is basically invalid.

 

In terms of even being able to say that a placebo-controlled trial of

acupuncture was attempted according to the best-available science of this

time it must include at the very least:

 

-- assessment and comparison of base-line expectations, experiences with

acupuncture, etc.

 

-- ongoing assessment of the credibility of the the needling procedures.

 

-- ongoing assessment of all other relevant non-specific effects so that they

are not confused with any placebo effects, this includes a variety of

physiological assessments, as well as assessment of the pain experienced with

the treatment.

 

This last factor, assessment of pains or discomforts associated with the

administration of the treatment, is probably the most critical factor

invalidating this device as a tool for placebo controlled studies of

acupuncture. Since acupuncture treatment includes at least three major

treatment components, it needs to produce data concerning:

 

1. the specific effects of the treatment,

2. the placebo components of treatment,

3. the physiological effects that are not placebo related and not specific to

the actual treatment.

 

Any study of acupuncture that attempts to control for the placebo effect

must also control for the non-specific effects of the procedure itself. This is

the reason why the usual two group drug study approach - control and

treatment group - doesn't work The use of a non-invasive control needle

(their so-called " placebo needle " ) necessarily produces a different stimulus

than the actual acupuncture treatment, thus one cannot control for placebo

with such a device.

 

As you can see, this gets extremely complicated very quickly and my

explanation was incomplete.

 

I also failed to mention that if what the TV show reported is the carpal

tunnel study that was announced a couple of years ago, it says nothing about

the effects of acupuncture. That study uses acupuncture to study the effects

of placebo (and technically even that is questionable in relative to the best

available science). Of course, that will be unlikely to be clear in the news

reports and the " acupuncture is a placebo " tag line will be hard for the

media to resist.

 

Bob

 

 

bob Paradigm Publications

www.paradigm-pubs.com 44 Linden Street

Robert L. Felt Brookline MA 02445

617-738-4664

 

 

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