Confessions of a Quackbuster

This blog deals with healthcare consumer protection, and is therefore about quackery, healthfraud, chiropractic, and other forms of so-Called "Alternative" Medicine (sCAM).

Thursday, December 23, 2004

Breaking News: Acupuncture Relieves Pain and Improves Function in Knee Osteoarthritis

Dr. Imrie does a good job of debunking this so-called research:

Re: Breaking News: Acupuncture Relieves Pain and Improves Function in Knee Osteoarthritis From: Robert Imrie, DVM

Late last week, I received a phone call from Rob Stein, of the Washington
Post, asking me for my views with regard to the upcoming Berman /
osteoarthritis and "acupuncture" paper (and other such papers) scheduled
to appear in the upcoming issue of Annals of Internal Medicine -- which he
forwarded to me as PDF files. Mr. Stein chose not to include any of my
thoughts or material in his Monday piece. That is, of course, "more than
okay with me," but I thought some of you might like to at least see,
verbatim, the information I originally afforded him -- and that he
subsequently chose to ignore. Here it is:

XXXXXXXXXXXXXXXXXXXXXXXXXXXx

12/16/04

Hi, Rob,

First things first. With regard to the message [press release] from
Berman, et al, cited below, according to the best available scholarship,
the statement that "[a]cupuncture -- the practice of inserting thin needles
into specific body points to improve health and well-being -- originated in
China more than 2,000 years ago," is not only false but also absurd. In
the first place, so far as I'm aware the technology required to produce
such "thin needles" for "twiddling" didn't exist anywhere in the world
prior to the 17th Century CE at the earliest, and it's unlikely that the
requisite fine (steel) needles would have been available or used,
clinically, in China prior to the 18th Century CE. Nothing even remotely
resembling "modern acupuncture" shows up unequivocally in the literature
prior to the 11th Century CE. Secondly, traditional Chinese medicine
never recognized a diagnosis of "osteoarthritis of the knee." Thirdly,
running electrical current through tissues -- which is what was done in the
trial in question -- is NOT acupuncture. Regardless of what modern
proponents have arbitrarily decided to call it, acupuncture is "the
manipulation of 'qi' in 'channels' by means of 'needling' (the latter
referring to any intervention by means of any 'sharp or hot thing' --
including knives and branding irons as well as what we would construe as
'needles')." The ancient Chinese had no clue what electricity was, much
less how it might be used therapeutically. Defining the running of
electrical current through tissues as "acupuncture" is like defining
sneakers as "canvas and rubber automobiles." Unfortunately, you may be
certain that proponents of mere needle twiddling will falsely claim the
study in question justifies their modality as a treatment for
osteoarthritis and just about everything else. It does not.
The clinical trial in question, itself, seems to display a similar lack of
rigor.

XXXXXXXXXXXXXXXXXXXXXXXXXXXXX

[The following constitute the "first blush" notes I sent to Mr. Stein
regarding the "Berman and acupuncture for osteoarthritis of the knee" late
last week.]

12/16/2004

The trial design readily allowed unblinding and virtually guaranteed
positive results by, among other things, "mixing apples and oranges and
then comparing them to no fruit at all." You can't apply both acupuncture
and electrical stimulation to "true acupuncture" subjects in a clinical
trial, only acupuncture to the "sham acupuncture" subjects, and no
"hands-on" treatment at all to an "education-only" control arm, and
reasonably expect that subjects won't be able to figure out which group
they're in. (I suspect patients can easily tell whether they are getting
current run through them, no current run through them, or no hands-on
treatment at all. It's well-established that virtually ANY "hands-on"
intervention will end up being more "effective" for ANY physical condition
than is ANY "non-hands-on" intervention.)

The trial was based on a false premise: that there are "true" and/or
"false" acupuncture points and meridia. The original Chinese medical
literature describes wildly varying points and conduit vessels (meridia)
over the centuries. The term meridian was, in fact, first coined by the
Frenchman Georges SouliƩt de Morant in 1939, the same man who first equated
qi with energy. Despite proponent claims to the contrary, all objective,
scientific attempts to physically identify and characterize such points and
lines have ultimately met with failure. As Dr. Felix Mann, founder of the
Medical Acupuncture Society and First President of the British Medical
Acupuncture Society has stated: "...acupuncture points are no more real
than the black spots that a drunkard sees in front of his eyes." (Mann
F. Reinventing Acupuncture: A New Concept of Ancient
Medicine. Butterworth Heinemann, London, 1996,14.)

Electrical stimulation is NOT acupuncture -- even when it's applied at
points modern acupuncturists arbitrarily deem to be "true"
acupoints. Defining the running of electrical current through tissues as
"acupuncture" is like defining sneakers as "canvas and rubber automobiles."

Since the sham group didn't have electrical current run through them, the
trial was effectively unblinded. Berman, et al, could easily have run
electrical current through sham group members at "sham" acupuncture points,
but they chose not to. I wonder why not. It's hard to believe that, over
the years that the trial was planned and during which patients were
recruited, this obvious problem/solution never occurred to any of the
investigators involved. Maybe it was because they felt they wouldn't get
the "right" results if they employed such an effective control.

Why didn't they use "placebo acupuncture needles" -- which, while not
without their own shortcomings, have at least been scientifically evaluated
over the last few
years? (See:
http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list uids=11799305&dopt=Abstract)

Why all the nonsense about "tapping needle guides" and "taping uninserted
needles to the patients"?

The authors claim that they were using a sham acupuncture technique they
had previously developed, but I suspect they never established that
patients couldn't easily distinguish between sham needling and the running
of electrical current run through needles that HAD been stuck through the
skin! (I admit, however, that I haven't yet read the publications dealing
with their "previously developed techniques.")

Now we have some trials showing effectiveness for this intervention and
some showing no effectiveness. That's exactly what one would expect from
poorly designed and controlled trials for a procedure that provides only
placebo, counter-irritation, and non-specific noxious stimulus effects.

e "OMERACT-OARSI responder index" portion of the paper reports only a 5%
difference between sham and true "responders." As I recall that's actually
less than the difference between those that could and could not distinguish
"real acupuncture" from "sham" in previous trials. I suspect that it's
actually less than the difference between those who can distinguish
acupuncture from having electrical current run through them.

The "masking effectiveness" portion of the paper makes it clear that by the
end of the trial, the trial was effectively unblinded. At least 75% of the
"true" group had figured out they were getting the "real" treatment, and
only 58% of the "sham" group still believed they were getting the "real"
treatment. That's almost a 30% difference! Note, also, that by the end of
the study "unsure" respondents were substantially fewer in the "true" arm
(by a factor of roughly 30%) than in the "sham" arm of the trial. In other
words, a whole lot of subjects who were in the "true acupuncture" arm were
able to figure that out, or were at least suspicious that they were in said
arm.

Were patients prohibited from, or at least admonished against, "comparing
notes" after the trial began? The paper doesn't tell us. They should have
been. It wouldn't take long for a patient to figure out that he/she was
not getting the electrical therapy if they were to discuss their treatment
experiences with someone who was getting such therapy.

Were the acupuncturists prohibited from speaking or communicating with the
patients during or after treatments? They should not have been, but this
was not mentioned in the paper. Why weren't they immediately ushered into
and out of the treatment area with observers making sure there was no overt
communication between patient and acupuncturist? They should have been in
order to at least minimize the possibility that they might provide an
additional potential source of unblinding. The medical and scientific
literature are both rife with examples of intentional and unintentional
communication between investigators and subjects that ended up defeating
the blinding of clinical trials and experiments, and therefore ended up
invalidating the results of same.

For anyone dependent on grant money from U.S. taxpayers, surely the most
important line in the paper is the one that begins: "Additional research is
needed..." I have no idea how much taxpayer money was spent on this
clinical trial by the NIH (or anyone else), but I'll bet a competent
reporter could readily come up with a figure. :-) My best guess would be
"at least several hundred thousands of dollars."

XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX

12/16/2004

Hi, Rob,

What follows is an excerpt from a paper Paul Buell, PhD, Dave Ramey, DVM
and I published in the Scientific Review of Alternative Medicine in
2002. I thought you might find it of interest. As you can see,
determining where "true" acupuncture "meridians" and points lie is more
than a little problematic, since these alleged structures seem to have
moved and changed in number, direction and character over the years. (You
may have noticed that few "non-imaginary" human anatomical structures have
changed in such manner over the last two millennia.) The Chinese seem to
have only recently "decided" where "true" points and "meridia"
lie. Despite proponent claims to the contrary, all objective, scientific
attempts to physically identify and characterize such points and lines have
ultimately met with failure. I wonder how Berman, et al, decided that
their "true" points and "meridia" were "truer" than those described in
previous centuries?

[...]

In human acupuncture, meridians have changed in number, name, character and
even position through history. The Mawangdui texts describe eleven
mai (vessels) which were described as containing both blood and qi.[i] No
distinction is made between vessels containing blood and those containing
qi, however, the vessels did not appear to connect with each other. "Blood
vessels are the obvious original referent of mai. The earliest attestation
of the word is fourth century B.C., in a Zuozhuan description of a horse:
'chaotic vapor, untamed, erupts; dark blood springs forth, coursing; ridges
of swollen vessels (mai) bulge.' (Zouzhuan, Xi 15,14.3a)"[ii]

By the late first century B.C. (in the Huangdi neijing suwen) the number of
vessels had grown to twelve, and they comprised a connected and more
complex system. Moreover, blood and qi sometimes seem to flow in separate
vessels, while at others they seem to flow in a mix.[iii] Vessels carrying
qi are by this time referred to as 'conduits' (ching) or "conduit vessels"
(ching-mai.) In later texts, the qi vessels and blood vessels are
separate. "The transition from the old idea of blood vessels to
physiological theory whose main purpose was to explain the movement of
vapor in the body directed attention away from the blood vessels per se and
towards an idealized system which meshed with correlative cosmology."[iv]

Perhaps most significantly, the twelve vessels described in the Huangdi
neijing follow substantially different courses than the eleven described in
the earlier Mawangdui texts. The "true" original location of human
acupuncture meridians was further obscured when, in 1993, a lacquer
conduit-figurine was recovered from a Western Han tomb depicting only nine
mai, even though it ostensibly dates from after the Mawangdui treatises
describing eleven mai. Moreover, two of the mai etched on the figurine are
ones that the Mawangdui treatises fail to discuss.[v],[vi] Later, Chinese
medical philosophers overtly lamented the "loss" of the original
conduits.[vii] Wherever the meridians may be, they are clearly not where
they started.

[i] Harper D, Early Chinese Medical Literature: The Mawangdui Medical
Manuscripts, Kegan Paul International, London, 1997, 5
[ii] Harper D, ibid, 82
[iii] Paul Unschuld. Personal correspondence.
[iv] Harper D, op. cit., 83-84
[v] Kuriyama, S. The Expressiveness of the Body and the Divergence of
Chinese Medicine. New York, Zone Books, 1999, 43
[vi] Unschuld P. Chinese Medicine, op. cit., 35
[vii] Unschuld P. Forgotten Traditions of Ancient Chinese
Medicine. Paradigm Publications, Brookline, MA, 1998, 244



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