research critique

[Guest guest]

, " alon marcus " <alonmarcus@w...>

wrote:

 

from

> Provisional PDF = http://www.biomedcentral.com/1472-6882/4/6/pdf

>

 

" Each of the three treatment arms are completed by physical therapy (six

physical therapy sessions,

e.g. isometric training of muscles, walking school, exercises with medical

equipment). "

 

Alon

 

You said that this type of active PT is a verified evidence based therapy.

Since all patients receive this type of PT in addition to either real or sham

acupuncture, I wonder how valid the comparison is (and thus the entire study).

 

1. any therapy will yield a 30% placebo rate

 

2. acupuncture, whether sham or real, has nonspecific effects such as

inducing the relaxation response, accounting for perhaps another 30% of the

action according to authorities like Kapchuk and Hammerschlag. This is not a

bad thing. It is probably also true of passive PT, chiropractic and much other

bodywork, I would suspect.

 

3. Active PT is a proven therapy for chronic pain that could account for

another 30% of the observed effects.

 

At this point, one can account for 90% of the observed success rates without

even considering the specific effects of acupuncture. It becomes very

difficult to achieve better success than 90% in any large pain study for a

variety of reasons, such as noncompliance, dropout and other random causes of

treatment failure. so any study that uses active PT in all the groups as an

equalizer creates a situation where success rates are going to be so high in

every group that it will be unlikely to show any signficant difference between

groups.

 

However, it is also well recognized by most pain specialists that exercise is

the best way to manage chronic pain and that all passive physical therapies

including chiropractic only support the necessary exercises, not vice-versa.

This is the position of every acupuncturist I know who specializes in pain

management. Because it would be essentially unethical to do a pain study that

did not allow for exercise therapy to perfomed simultaneously, it will

probably not be possible to ever show that real acupuncture is superior to

sham acupuncture. However it probably can be shown that real acupuncture is

as effective as standard therapy.

 

I think this approach makes the most strategic sense for study design. It will

also silence critics within the field who oppose single blind placebo research

on acupuncture altogether. So rather than having an arm of sham acupuncture

plus active PT, a better study would be to have an arm of passive PT plus

active PT and compare that to arm of real acupuncture plus active PT. In this

latter type of study, it is not necessary to show significant advantage, just

equivalent results. critics will respond that we have to contend with the

sham issue as such studies do not prove that traditional theory works better

than just putting points anywhere. But we should not be led down this

slippery slope. Instead we should devote our arguments to showing that sham

acupuncture is a bogus control due to the mathematical reasons enumerated

above (which I think can be demonstratd with more detailed statistics).

 

But we will probably also have to accept the fact similar types of studies

will also proably be able to show that medical or orthopedic acupuncture also

fares well against standard therapies, not just TCM or some other classical

method. It is losing battle to fight the use of acupuncture by other healthcare

professionals as evidence will probably justify medical acupuncture as safer

and more effective than standard therapies. Even if not as effective as

traditional acupuncture, it will still beat current therapy and thus be

considered a desirable option by many MDs and chiros. We should consolidate

our strength by showing what we do works and that will be our bulwark

against threats to the profession. It will be unlikely that we will be able to

show our traditional styles of acupuncture works better than any other, so

why spend time trying. Especially since many of us use modern approaches

such as orthopedics already.

 

An article from the skeptical inquirer by an MD psychiatrist is promoting a

needle free acupuncture done with transcutaneous patches, that gets the same

results as needles and can be learned in 1 hour (not 100, not 300, not 3000,

but 1 single hour). go to:

 

http://www.csicop.org/si/2003-03/acupuncture.html

 

Another way to show the validity of TCM methodology is show that bian zheng

dx makes a difference in outcomes. Studies like Bensousan's IBS study show

that long term followup in herbal treatment shows better effect when bian

zheng dx is performed. If this holds true in acupuncture as well, it would

mitigate the sham issue. Also showing that patterns have associations with

measurable biomedical parameters as preliminary chinse research has

indicated. And finally the use of MRI's to distinguish specific effects of

traditional acupuncture from the general effects of touching the body.

 

[Guest guest]

Todd

I agree we need to start writing up rebuttals and the study does have some

problems. At the same time is was well designed as far as acupuncture. By the

way exercise is not that effective for knee OA which i believe this study

studied. I did not get a chance to read it closely. There are some studies that

have actually shown strength quad exercise to increase the pain.

Alon

 

 

[Guest guest]

Hi Todd-

 

>Another way to show the validity of TCM methodology is show that bian zheng

>dx makes a difference in outcomes. Studies like Bensousan's IBS study show

>that long term followup in herbal treatment shows better effect when bian

>zheng dx is performed. If this holds true in acupuncture as well, it would

>mitigate the sham issue.

 

I think the results published by Bensousan were extremely important,

and if that work can be expanded, it would do much to advance the

case that TCM is logically coherent as a system, making it much less

likely that TCM therapies would be co-opted piecemeal by allopaths.

 

One of the problems with that study, however, is that it does not

speak to how the differentiations were made, or to what degree there

was inter-obeserver variability in the diagnoses. Even in WM

research, there is much research seeking to establish the rates

inter-observer reliability in fields with highly subjective tests

(i.e. making a diagnosis of pneumonia using chest radiographs) and to

figure out how to increase the likelihood that different clinicians

will make the same diagnosis. Since all of TCM relies on such highly

subjective tests, it seems that if we want to make the case for

pattern differentiation, we must first figure out how to reliably get

the same diagnosis from practitioner to practitioner. One solution,

as you have mentioned before, is to determine which biomedical

markers might coincide with TCM pattterns. Another, might be to

devise diagnostic schemas (checklists and such) that guide clinicians

to diagnoses using the four pillars.

 

If we also want to run clinical trials of TCM as TCM (meaning with

pattern differentiation), and not some allopathic version of it, then

we need to establish how to reliably get similar diagnoses during the

trial. It seems to me that any trial using pattern differentiation

is going to run up against that criticism until it is sorted out.

 

-Steve

--

Stephen Bonzak

<smb021169

[Guest guest]

, Stephen Bonzak <

smb021169@e...> wrote:

One solution,

> as you have mentioned before, is to determine which biomedical

> markers might coincide with TCM pattterns. Another, might be to

> devise diagnostic schemas (checklists and such) that guide clinicians

> to diagnoses using the four pillars.

>

 

I think the latter solution is the only one we can use right now, but we can use

early studies to try and determine biomed markers for later studies. The

inter-rater reliability issue is another factor we have discussed here before

and another issue that will draw increasing scrutiny to our field. Inter-rater

reliability in CM is typically low for several reasons:

 

1. lack of calibration - if the observers are not trained in the same method of

dx, they will arrive at different results, however if they are trained

similarly, calibration is high.

 

2. lack of standards - the PRC publishes diagnostic standards that can and

should be used to design research. Without diagnostic standards in our field,

any research designed to demonstrate the validity of bian zheng will be

worthless.

 

3. over-reliance of subjectivity - calibration is much easier when the

emphasis is on tongue and questioning. Tongues can be photographed and

interviews recorded in order to maintain a precise record of these variables.

 

with established standards of pattern diagnosis and calibration of tongue dx

through a brief orientation can address much of this. but we are left with the

matter of pulse. It would be impossible to calibrate the practitioners in a

study for pulse dx without at least a full day of orientation, but this may be

worth it. Since herbal texts rarely get into extremely nuanced pulsetaking,

herbal studies should be similarly structured in this regard. Give researchers

a few set variables to define in the pulse rather making a freeform pulse dx.

It is easier to calibrate for things like superficial vs. deep, forceful vs.

forceless, fast vs. slow, irregular vs, regular than it is for things like wiry,

slippery and choppy.

 

And how reliable is the pulse anyway when making multipattern dx. If a

patient has spleen yang xu, damp, blood stasis and kidney yin xu, the pulse

cannot show all of these at once - cannot be both fast and slow or choppy and

slippery, for example. I find reliance on questioning and tongue to lead much

more accurate dx and effective tx. Any studies I did would not emphasize

complex pulse dx as a major factor and I think this is in line with much

modern PRC practice and research, even if sounds heretical to many of the

faithful. The more subjective the inclusion criteria for studies, the more they

will be critiqued as invalid. Especially studies that attempt to prove TCM

works according to its own logic. If pulse is a major rule in/rule out criteria

for a study, I cannot see how such a study could produce reproducible results.

 

I have no experience with pulsetaking machines. While it is hard to imagine

that such machines can feel much nuance, I suspect they can generate some

relatively objective, reproducible pulsewave data. Just like an audiotape can

back up an interview and a photo the tongue, perhaps such a machine could

back up the subjective pulsetaking. While a study could be designed that

relied on subjective pulse nuances as primary diagnostic indicators, I would

submit that the subtlety of this method would be likely to yield results that

will reflect poorly on the field.

 

[Guest guest]

, Stephen Bonzak <

smb021169@e...> wrote:

One solution,

> as you have mentioned before, is to determine which biomedical

> markers might coincide with TCM pattterns. Another, might be to

> devise diagnostic schemas (checklists and such) that guide clinicians

> to diagnoses using the four pillars.

>

 

I think the latter solution is the only one we can use right now, but we can use

early studies to try and determine biomed markers for later studies. The

inter-rater reliability issue is another factor we have discussed here before

and another issue that will draw increasing scrutiny to our field. Inter-rater

reliability in CM is typically low for several reasons:

 

1. lack of calibration - if the observers are not trained in the same method of

dx, they will arrive at different results, however if they are trained

similarly, calibration is high.

 

2. lack of standards - the PRC publishes diagnostic standards that can and

should be used to design research. Without diagnostic standards in our field,

any research designed to demonstrate the validity of bian zheng will be

worthless.

 

3. over-reliance of subjectivity - calibration is much easier when the

emphasis is on tongue and questioning. Tongues can be photographed and

interviews recorded in order to maintain a precise record of these variables.

 

with established standards of pattern diagnosis and calibration of tongue dx

through a brief orientation can address much of this. but we are left with the

matter of pulse. It would be impossible to calibrate the practitioners in a

study for pulse dx without at least a full day of orientation, but this may be

worth it. Since herbal texts rarely get into extremely nuanced pulsetaking,

herbal studies should be similarly structured in this regard. Give researchers

a few set variables to define in the pulse rather making a freeform pulse dx.

It is easier to calibrate for things like superficial vs. deep, forceful vs.

forceless, fast vs. slow, irregular vs, regular than it is for things like wiry,

slippery and choppy.

 

And how reliable is the pulse anyway when making multipattern dx. If a

patient has spleen yang xu, damp, blood stasis and kidney yin xu, the pulse

cannot show all of these at once - cannot be both fast and slow or choppy and

slippery, for example. I find reliance on questioning and tongue to lead much

more accurate dx and effective tx. Any studies I did would not emphasize

complex pulse dx as a major factor and I think this is in line with much

modern PRC practice and research, even if sounds heretical to many of the

faithful. The more subjective the inclusion criteria for studies, the more they

will be critiqued as invalid. Especially studies that attempt to prove TCM

works according to its own logic. If pulse is a major rule in/rule out criteria

for a study, I cannot see how such a study could produce reproducible results.

 

I have no experience with pulsetaking machines. While it is hard to imagine

that such machines can feel much nuance, I suspect they can generate some

relatively objective, reproducible pulsewave data. Just like an audiotape can

back up an interview and a photo the tongue, perhaps such a machine could

back up the subjective pulsetaking. While a study could be designed that

relied on subjective pulse nuances as primary diagnostic indicators, I would

submit that the subtlety of this method would be likely to yield results that

will reflect poorly on the field.

 

[Guest guest]

It would be impossible to calibrate the practitioners in a

study for pulse dx without at least a full day of orientation, but this may be

worth it.

>>>A study of those that claim to be able of getting interrater reliability in

pulse taking is highly needed. This must be done correctly and follow good

statistical methods.It is very unlikely that such a study will be positive

especially if more than just basic qualities such as quick slow, large small,

and deep superficial are incorporated.I know that in class environments it seems

that people can calibrate, i do not believe this will also be true in a

controlled study.Anyway before we state that TCM studies must utilize the pulse

to do good research. We need to demonstrate that pulse taking can have

significant agreement and that it would change pattern diagnosis clinically.

Alon

 

 

[Guest guest]

, " "

wrote:

 

 

>

> And how reliable is the pulse anyway when making

multipattern dx. If a

> patient has spleen yang xu, damp, blood stasis and kidney yin

xu, the pulse

> cannot show all of these at once - cannot be both fast and slow

or choppy and

> slippery, for example. I find reliance on questioning and

tongue to lead much

> more accurate dx and effective tx.

 

 

 

 

This may be true of the pulse as taught and practiced according

to the TCM model. It is demonstrably incorrect when applied to

the pulse method taught by Leon Hammer, or the late Jim

Ramholz. It is precisely the ability to identify multiple patterns,

even very early in their development, that renders the pulse so

important. But it should also be noted that even Dr. Hammer,

with his consummate skill, never suggests that the pulse be

divorced from a searching questioning and the other pillars of

diagnosis. (In fact, second-year students at Dragon Rises

College in Gainesville have the benefit of studying the " Asking

Diagnosis " with Leon right now). Thus one can find qualities on

the pulse which are borne out in the questioning and it only

enhances one's understanding of the case. The pulse can be

used reliably to understand much more than simple patterns.

 

Sincerely,

 

Brandt

[Guest guest]

Todd-

 

>1. lack of calibration - if the observers are not trained in the

>same method of

>dx, they will arrive at different results, however if they are trained

>similarly, calibration is high.

 

How about if they are trained to look at a patient using only a

definable set of parameters set by the trial? For instance, only

give pulse readings as fast/slow, strong/weak, deep/superficial,

regular/irregular, and thin/wide.

 

>2. lack of standards - the PRC publishes diagnostic standards that can and

>should be used to design research. Without diagnostic standards in our field,

>any research designed to demonstrate the validity of bian zheng will be

>worthless.

 

What are the diagnostic standards published by the PRC or do you know

where I can get that kind of information?

 

>3. over-reliance of subjectivity - calibration is much easier when the

>emphasis is on tongue and questioning. Tongues can be photographed and

>interviews recorded in order to maintain a precise record of these variables.

>

>Since herbal texts rarely get into extremely nuanced pulsetaking,

>herbal studies should be similarly structured in this regard. Give

>researchers

>a few set variables to define in the pulse rather making a freeform pulse dx.

>It is easier to calibrate for things like superficial vs. deep, forceful vs.

>forceless, fast vs. slow, irregular vs, regular than it is for

>things like wiry,

>slippery and choppy.

 

Right. I think in the WM literature they discuss the need to limit

the numbers of variables described in order to increase the

inter-rater reliability. It makes sense that is should be the same

in TCM.

 

Thanks for your ideas.

 

-Steve

--

Stephen Bonzak

<smb021169

[Guest guest]

How about if they are trained to look at a patient using only a

definable set of parameters set by the trial? For instance, only

give pulse readings as fast/slow, strong/weak, deep/superficial,

regular/irregular, and thin/wide.

>>>>We need to focus of parameters that can actually be used clinically and we

believe change outcome. No need to get bogged down in esoteric

Alon

 

 

[Guest guest]

On Apr 5, 2004, at 11:04 AM, alon marcus wrote:

 

> How about if they are trained to look at a patient using only a

> definable set of parameters set by the trial? For instance, only

> give pulse readings as fast/slow, strong/weak, deep/superficial,

> regular/irregular, and thin/wide.

>>>>> We need to focus of parameters that can actually be used

>>>>> clinically and we believe change outcome. No need to get bogged

>>>>> down in esoteric

 

These pairs of pulse dimensions are really the only way that I've found

any inter rater reliability. That's one reason that I stress this

approach when teaching pulses.

 

My students, after just three weeks, have a very clear concept of 90%

of the pulses simply because they've mastered

 

thin / wide

long / short

superficial / deep

fast / slow

forceful / forceless

regular / irregular

 

Then, I add " taut / slack " . The taut pulse is the wiry pulse. I really

would like to teach it as " hard / soft " but soft is one of the

translations of the " ru mai " which is thin, forceless, and superficial

and also called " soggy " by some books. So, I stick with " taut / slack "

which doesn't have any particular pulse associated with it, but I like

to avoid " wiry " as a quality which isn't very intuitively defined.

" Hard " however, people can get as soon as they feel it.

 

Slippery and Choppy is the final pair which does need to be felt to

understand. Choppy presents an additional problem in that it doesn't

show up that frequently and that it has something like three different

definitions which vary somewhat from teacher to teacher.

 

Among the 28 usual pulse characteristics there are only 2 more terms

that aren't described with the terms provided above. They are " stable "

which applies only to the Lao Mai (firm - confined) pulse which is

described as deep, forceful, wide, long, hard, and stable. The other

term is " vibrating " which applies only to the Jin Mai (tight - tense)

pulse which is described as hard, forceful and vibrating (vibrating is

sometimes described as uneven in its left/right location, though I

don't claim to really understand this term, not being sure I've ever

felt it).

 

Still, the first six parameters should show a high inter rater

reliability.

 

Shucks, when I was in China, I had little trouble agreeing with the TCM

practitioners there on pulse characteristics, not because I'm good at

what I do, but because I was trained by TCM practitioners who were

trained in China. We were all on the same page.

 

--

 

Pain is inevitable, suffering is optional.

-Adlai Stevenson

[Guest guest]

, " kbstickley " <kbstickley>

wrote:

> , " "

> wrote:

>

>

> >

> > And how reliable is the pulse anyway when making

> multipattern dx.

 

 

>

> This may be true of the pulse as taught and practiced according

> to the TCM model. It is demonstrably incorrect when applied to

> the pulse method taught by Leon Hammer, or the late Jim

> Ramholz.

 

 

Depends what you mean by demonstrably. I have certainly never seen such a

demonstration despite waiting my whole career to see one. Perhaps I just

have not met the right folks or our criteria for evidence differs. But be that

as it may, the type of pulsetaking you describe is not at all the standard of

pratice either here or in the PRC, so it would not make sense to study it. It

will be hard enough to calibrate around the much more simplistic TCM style.

It would make the study results even less applicable to the general population

of practitioners.

 

But if you feel strongly about this and it appears you do, I would be very

interested to see the results of a pilot study that somehow demonstrated the

subtlety of the systems you describe. It would be fairly easy to set up such a

study. Have expert hammer style pulsetakers predict the development of

patterns and then followup to verify if they ever manifest. You could have a

treatment group and a no treatment group; and the assessors could be blinded

to everything. But merely claiming to detect something in the pulse, then

treating before it manifests and claiming success when symptoms never arise

would not be satisfactory to me.

 

[Guest guest]

, " "

wrote:

> , " kbstickley "

<kbstickley>

> wrote:

> > , " Todd

Luger "

> > wrote:

> >

> >

> > >

> > > And how reliable is the pulse anyway when making

> > multipattern dx.

>

>

> >

> > This may be true of the pulse as taught and practiced

according

> > to the TCM model. It is demonstrably incorrect when applied

to

> > the pulse method taught by Leon Hammer, or the late Jim

> > Ramholz.

>

>

> Depends what you mean by demonstrably. I have certainly

never seen such a

> demonstration despite waiting my whole career to see one.

Perhaps I just

> have not met the right folks or our criteria for evidence differs.

But be that

> as it may, the type of pulsetaking you describe is not at all the

standard of

> pratice either here or in the PRC, so it would not make sense

to study it. It

> will be hard enough to calibrate around the much more

simplistic TCM style.

> It would make the study results even less applicable to the

general population

> of practitioners.

>

> But if you feel strongly about this and it appears you do, I would

be very

> interested to see the results of a pilot study that somehow

demonstrated the

> subtlety of the systems you describe. It would be fairly easy to

set up such a

> study. Have expert hammer style pulsetakers predict the

development of

> patterns and then followup to verify if they ever manifest. You

could have a

> treatment group and a no treatment group; and the assessors

could be blinded

> to everything.

 

 

We hope to develop the work through research projects which

track these types of information and more.

 

 

 

But merely claiming to detect something in the pulse, then

> treating before it manifests and claiming success when

symptoms never arise

> would not be satisfactory to me.

 

Yes, you are right, and I follow your logic, but that is not exactly

what i was saying. I said demonstrably as in: there are reliable

indicators on the pulse that suggest multiple patterns, provide

understanding of the etiology of those patterns, and become

especially useful tools when they demonstrate that the indicators

match up with history. This provides a fairly complete picture of

the reality of the condition. I have evidence of the predictability of

patterns based on the pulse from my own experience as well,

but these would still be considered anecdotal.

 

When we take a pulse in a teaching situation, we do " blind "

ourselves to the history. Then we examine the pulse findings

and interpret them. When we examine the history it is often

stunning how accurately the pulse findings reflect the history.

This is roughly analogous to the study of the ear as a diagnostic

indicator at UCLA, where the patient was shrouded with just the

ear showing.

 

I appreciate your pragmatism. With that in mind, if you'd like to

experience this approach to the pulse for yourself, we could

arrange it.

 

Sincerely,

 

Brandt

[Guest guest]

Choppy pulses I've found very frequently in clinical practice, both in

my own clinic and as a supervisor.

 

What are the three definitions you are talking about? How do they vary

from teacher to teacher, in your experience?

 

 

On Apr 5, 2004, at 11:58 AM, Al Stone wrote:

 

> Slippery and Choppy is the final pair which does need to be felt to

> understand. Choppy presents an additional problem in that it doesn't

> show up that frequently and that it has something like three different

> definitions which vary somewhat from teacher to teacher.

[Guest guest]

On Apr 5, 2004, at 6:13 PM, wrote:

 

> What are the three definitions (of the choppy pulse) you are talking

> about?

 

1) inconsistent in amplitude and/or strength.

 

2) pulse shape has rough steps to it. Imagine the smooth up and down of

the slippery pulse, then add stair steps. That's the second type of

choppy and the one that I'm most familiar with.

 

3) The so-called " three - five " pulse which is inconsistent in speed

(three beats per breath, then five beats per breath...)

 

> How do they vary

> from teacher to teacher, in your experience?

 

Simply this: Bob Flaws teaches the three-five pulse as one of the many

expressions of the se mai (choppy, hestitant, etc.) while Ma, Xiu-ling

has never heard of this definition.

 

I'll bet that if you asked around your PCOM teaching clinic you would

find even more than these three definitions.

 

I've made it a point to get as clear as possible on the pulses and this

se mai never ceases to give rise to a wide variety of perspectives.

 

-al.

 

--

 

Pain is inevitable, suffering is optional.

-Adlai Stevenson

[Guest guest]

, " kbstickley "

<kbstickley> wrote:

se would still be considered anecdotal.

 

> This is roughly analogous to the study of the ear as a diagnostic

> indicator at UCLA, where the patient was shrouded with just the

> ear showing.

 

Were can I read about this? Can you elaborate...

 

-Jason

[Guest guest]

, " "

<@h...> wrote:

> , " kbstickley "

> <kbstickley> wrote:

> se would still be considered anecdotal.

>

> > This is roughly analogous to the study of the ear as a

diagnostic

> > indicator at UCLA, where the patient was shrouded with just

the

> > ear showing.

>

> Were can I read about this? Can you elaborate...

>

> -Jason

 

 

I am referring to a passage I encountered in the Terry Oleson

book. I do not have it at hand, but the book discusses the study.

I found it an amusing image. The gist of it is that points located

on the ear (through measuring electrical conductivity, and/or

color change, skin change, etc.) were demonstrated to

correspond to diagnosed musculo-skeletal problems. The

particular problem was identified independently, and the the

patient was covered with a sheet with only the ear showing, and

all canes, crutches, wheelchairs were removed from the area.

Sorry I can't be more specific presently.

 

Brandt

[Guest guest]

Jason this was a study were they measured electrical ear points and were able to

tell what orthopedic problems the patients had in about 80-90% of patients (if i

remember the numbers correctly). This study, however, must be repeated.

Alon