Study casts doubt on Random Controlled Trials in China

[Guest guest]

Study casts doubt on authenticity of outcomes for both TCM and standard medical

studies. Notes positive bias towards treatment investigated and that issue is

not unique to China. Always the grain of salt.

 

http://www.sciencedaily.com/releases/2009/07/090702184146.htm

 

For those in the States happy 4th.

Cheers,

Michael

[Guest guest]

Posted by: " mpplac " inquiry mpplac

Fri Jul 3, 2009 9:51 am (PDT)

 

Study casts doubt on authenticity of outcomes for both TCM and standard medical

studies. Notes positive bias towards treatment investigated and that issue is

not unique to China. Always the grain of salt.

 

http://www.sciencedaily.com/releases/2009/07/090702184146.htm

 

For those in the States happy 4th.

Cheers,

Michael

----------------------

Hi Michael

Thank goodness no one imagines that " off the shelf " standardized formulas will

be the " gold standard " of Chinese medicine for your patient. Hopefully the well

designed and highly tailored formula for the presentation of patient diagnostic

signs and symptoms will continue to be the " gold standard " of Chinese medical

efficacy.

 

Just like the patient, who finally gets a bit of deep sleep on your acupuncture

table, they might also finally cook a soup (herb formula) for the first time in

their lives under your guidance. Who knows, they might actually embrace the

slow cooking trend and give up the packaged food.

 

Gratefully " independent " in the fast food nation to celebrate so many " gold

standards " ,

 

Emmanuel Segmen

 

 

[Guest guest]

Dear group,

 

I have a few 'doubt's about this post.

 

1. I am curious about the motive or objective of this post.What is the message

and why it is posted in this forum?

 

2. The post itself is not 'objective'. According to the title

 

<<<<Doubts Cast On Credibility Of Some Published Clinical Trials

ScienceDaily (July 3, 2009) ¡X Randomised Controlled Trials (RCTs) are

considered the 'gold standard' research method for assessing new medical

treatments. But research published in BioMed Central's open access journal

Trials shows that the design of a remarkable 93 percent of 2235 so-called RCTs

published in some Chinese medical journals during 1994 to 2005 was flawed,

casting doubt on the reliability of research that is likely to influence medical

decision-makers.>>>>>>

 

If 93% out of 2235 cases are questionable, the title should be 'majority'

instead of 'some' trials.

 

3. I wonder how they find these 2235 cases? Out of how many?

 

4. I wonder how they draw the conclusion: the medical dicision-makers are

'influenced' by these misrepresented methods. I guess it will take a whole lot

more efforts to 'influence' those in driving seats-western medicine profession.

 

5. 'Golden standard' is the only standard? I doubt that. I believe that (a

concensus among all tcm professors I study with) TCM is unique in itself that

the contemporary research methodology cannot genuinely include and fit in

there). Acupuncture alone is an sound example. Sham acupuncture group is hardly

regarded as a controlled group no matter how many blind-folded,double-blinded,

triple-blinded methods are used.

 

SUNG, Yuk-ming

[Guest guest]

this is not the first study to question chinese studies. I have

witnessed fraudulent publications when i was in china in 1985. That

said i think it was very encouraging that the study fount university

based publications to be more reliable. SUNG while sham acup in

definitely not an inactive intervention as long as a real group does

not do better than sham we are not showing any specific effects and

cannot support acupuncture as a profession. We must do studies were

real group shows better outcomes than sham. Why should a healthcare

system pay 65=120$ per acup visit if anyone can just stick a needle

and get same results?

 

 

400 29th St. Suite 419

Oakland Ca 94609

 

 

 

alonmarcus

 

 

 

 

 

 

 

 

[Guest guest]

Hi Sung Yuk-Ming and Michael,

 

Thank you. Your point was my point, Sung. An investigator can not have a " large

sample size " if each patient presentation is unique. This statistical scenario

requires a defined domain or " disease state " . Also the treatment protocols of

CM are tailored, so you can't statistically test a unique presentation treated

by a unique protocol.

 

The two paradigms WM and CM have gone through an entirely different development

pathway as regards tests of efficacy. Looking through the lens of WM at CM, one

only sees the parts of CM that show up coincidentally through the filter. Your

point, Sung, is well taken as regards numbers and as regards what is a

" controlled variable " and what is a " tested variable " . The controlled variable

of correct point selection with sham acupuncture turns out to have efficacy in

Chinese medicine. We do this very thing in both tui na and liu he ba fa

practices for the sake of its efficacy.

 

The intention of the report is the intention of WM to define, authorize and

regulate the domain of " disease states. " However, WM can " see " very little of

the intention of CM through it's paradigm filters. By the way, try reading the

actual paper's results and conclusions at

http://www.trialsjournal.com/content/pdf/1745-6215-10-46.pdf. What Michael has

cited here is a basic tabloid news media selling online " spectacle " . In

philosophy we would say that this entire exercise " begs the question. " The

actual paper is above at the open access site in pdf form. That's a better

place to start since no news agency is an actually " source " . Right?

 

Respectfully and gratefully,

 

Emmanuel Segmen

 

Regarding: http://www.sciencedaily.com/releases/2009/07/090702184146.htm

--------------

 

 

Dear group,

 

I have a few 'doubt's about this post.

 

1. I am curious about the motive or objective of this post.What is the message

and why it is posted in this forum?

 

2. The post itself is not 'objective'. According to the title

 

<<<<Doubts Cast On Credibility Of Some Published Clinical Trials

ScienceDaily (July 3, 2009) ¡X Randomised Controlled Trials (RCTs) are

considered the 'gold standard' research method for assessing new medical

treatments. But research published in BioMed Central's open access journal

Trials shows that the design of a remarkable 93 percent of 2235 so-called RCTs

published in some Chinese medical journals during 1994 to 2005 was flawed,

casting doubt on the reliability of research that is likely to influence medical

decision-makers.>>>>>>

 

If 93% out of 2235 cases are questionable, the title should be 'majority'

instead of 'some' trials.

 

3. I wonder how they find these 2235 cases? Out of how many?

 

4. I wonder how they draw the conclusion: the medical dicision-makers are

'influenced' by these misrepresented methods. I guess it will take a whole lot

more efforts to 'influence' those in driving seats-western medicine profession.

 

5. 'Golden standard' is the only standard? I doubt that. I believe that (a

concensus among all tcm professors I study with) TCM is unique in itself that

the contemporary research methodology cannot genuinely include and fit in

there). Acupuncture alone is an sound example. Sham acupuncture group is hardly

regarded as a controlled group no matter how many blind-folded,double-blinded,

triple-blinded methods are used.

 

SUNG, Yuk-ming

 

 

[Guest guest]

Chinese Medicine , " Emmauel Segmen "

<mrsegmen wrote:

 

Hello everyone

 

It's the same-old-same-old...

The structure of the RCT - blinded or not, simply doesn't 'fit' TCM or

homeopathy.

I still wonder why TCM practitioners - herbal & /or acupuncture - continue to

participate in RCTs.

We all know it's an inappropriate tool to assess TCM; in fact the RCT in itself

is a flawed and ultimately very strange way to assess the efficacy of

interventions delivered to individuals.

Note I say 'individuals'.

TCM practitioners treat individuals, not population groups.

Don't we?

 

I dream of the day when outcomes-based study tools become the 'gold standard' of

assessing TCM health interventions in individuals.

'Outcomes' being the objective and subjective information fed back to us by our

patients, one-by-one.

 

'Health interventions'... ERRK ... even the wretched language of clinical

research and 'modern' medicine is contaminating my mind

 

And to put this into a very personal perspective, my mother was recently denied

a CT scan of her brain after knocking herself unconscious. The hospital used a

particular assessment tool - instead of another - to assess who gets a CT, and

who doesn't - and her presenting condition didn't tick any of the boxes. Those

assessment tools are designed after years of looking at statistical

probabilities.

She walked out of that hospital with an undiagnosed sub-arachnoid haemorrhage,

just a couple of hours after presenting to the ER.

 

Allopathy practices medicine in the bell-curve of statistical probability, and

medical doctors are taught to think this way.

 

We are not.

 

Let's not forget it.

 

To see how dangerous bell-curve medicine, and assumptive thinking can be, the

account of my Mother's experience at the hands of the allopathic system is here:

 

http://margihealing.wordpress.com/2009/05/20/medical-negligence-and-the-meaning-\

of-life/

 

Margi

Happy 4th July to all in the US... and a sweet day for the rest of us.

[Guest guest]

Hi Alon and all:

 

--Alon-

We must do studies were real group shows better outcomes than sham. Why should

a healthcare system pay 65=120$ per acup visit if anyone can just stick a needle

and get same results?

---

 

 

Yes and no - RCTs are not the right research method for acupuncture, and yet

that is the standard we are being held to. And I know for a fact that no one who

is just sticking needles in (or toothpicks) is getting the same results as me.

Now how do we get _that_ information out in terms of rigorous numbers? Good

question. The answer will not be found in RCTs or similar research, I believe,

but rather in qualitative research. I am not sure if you think that we should be

creating RCTs to support our profession.

 

I, for one, will not be lying down, belly up, just because an RCT (or one

thousand RCTs) say I should.

 

Many medical interventions (and the majority of human activities) rely on case

series (and similar methods) rather than RCTs. Heart surgery is the example

usually brought up.

 

Again, I refer everyone to:

Parachute use to prevent death and major trauma related to gravitational

challenge

BMJ 2003

 

A google search will take you to the paper which can be accessed after a free

sign-up to the BMJ site.

 

It's an important and humorous look at the assumption that RCTs are the gold

standard. They obviously aren't when they ask that a parachute trial crossover

its particpants (parachute group and non-parachute group, after their jumps,

have to switch groups and go again. haha.).

 

Hugo

 

________________________________

Hugo Ramiro

http://middlemedicine.wordpress.com

http://www.chinesemedicaltherapies.org

 

 

 

 

 

[Guest guest]

It's come into question why I posted the news item about RCT's in China. I

think the colloquial phrase at the end of my post says it best, " grain of salt " .

For those not familiar with the phrase it is simply a reminder to remain a bit

skeptical. It is not uncommon for some in the community to latch onto positive

results of some of these RCT's while dismissing outcomes that show our medicine

in a less than ideal light. It is an inconsistency that lends itself to

criticism. Understanding that reporting has bias and studies are

inappropriately designed allows one to more effectively respond to one's critics

and more importantly point out to that critic that their own house may not be in

order.

 

Is it important to consider that products marketed to the community, be they

informational or herbal use some of these studies to lend credibility to

engender sales? Drug companies do this in the U.S. all the time. Is it

important to understand basic statistics and experimental design so one can

critically read reporting to the benefit of oneself and patients? After all we

are some of the " medical decision makers " as portrayed in the article who may be

influenced by the reporting. I'm not a practitioner who eschews modern

techniques and information as being of slight benefit, perhaps because I have

western medical training also. I'm interested in the intersection of what the

modern can tell us about the classical, and how the classical can inform the

modern to the benefit of my clients.

 

It was not my intent to cast dispersions on the Chinese studies, but rather to

remind myself and others that what we read in all journals is subject to the

biggest foible which is we are all human. We have our biases and they can

influence design and reporting of studies and patient care. So I'll end with

" grain of salt " and wish you well.

Cheers,

Michael

[Guest guest]

Hi Michael, thank you for both your posts, and I hope you keep posting; they

were both useful to me.

 

As Alon has pointed out many times, we need to be excruciatingly careful about

our biases. That said, I personally have a bias and will stand on my side of

" it " . Those who pretend to not have a bias, to be neutral, are *also* picking a

bias and standing on their marked ground.

 

To be without bias is summed up by the saying: the only fish who go completely

with the flow of water are dead fish.

 

Thanks,

Hugo

 

 

________________________________

Hugo Ramiro

http://middlemedicine.wordpress.com

http://www.chinesemedicaltherapies.org

 

 

 

 

 

________________________________

mpplac <inquiry

Chinese Medicine

Sunday, 5 July, 2009 22:36:22

Re: Study casts doubt on Random Controlled Trials in China

 

 

 

 

 

It's come into question why I posted the news item about RCT's in China. I

think the colloquial phrase at the end of my post says it best, " grain of salt " .

For those not familiar with the phrase it is simply a reminder to remain a bit

skeptical. It is not uncommon for some in the community to latch onto positive

results of some of these RCT's while dismissing outcomes that show our medicine

in a less than ideal light. It is an inconsistency that lends itself to

criticism. Understanding that reporting has bias and studies are

inappropriately designed allows one to more effectively respond to one's critics

and more importantly point out to that critic that their own house may not be in

order.

 

Is it important to consider that products marketed to the community, be they

informational or herbal use some of these studies to lend credibility to

engender sales? Drug companies do this in the U.S. all the time. Is it

important to understand basic statistics and experimental design so one can

critically read reporting to the benefit of oneself and patients? After all we

are some of the " medical decision makers " as portrayed in the article who may be

influenced by the reporting. I'm not a practitioner who eschews modern

techniques and information as being of slight benefit, perhaps because I have

western medical training also. I'm interested in the intersection of what the

modern can tell us about the classical, and how the classical can inform the

modern to the benefit of my clients.

 

It was not my intent to cast dispersions on the Chinese studies, but rather to

remind myself and others that what we read in all journals is subject to the

biggest foible which is we are all human. We have our biases and they can

influence design and reporting of studies and patient care. So I'll end with

" grain of salt " and wish you well.

Cheers,

Michael

 

 

 

 

 

 

 

 

[Guest guest]

Emmanuel

The problem is that studies that used " individualized " acup did do any better.

At some point we have to show in a large study that we can do better than sham.

Its all excuses otherwise.

 

 

 

 

 

 

 

 

 

 

[Guest guest]

Hugo

If you cannot show better outcome in randomly assigned patients compared to

someone just sticking needles than you cant show acup to work. There is nothing

wrong with this kind of study as long as you can do individualized therapy in

the study group. Unfortunately we have not seen positive results in even these

kind of studies done in west. RCTs have no conflict at all with CM when designed

to accommodate CM. I ask again why cant we have a single school in US design and

execute such as study? All an RCT requires is randomization of patients to sham

compared to treatment group. A blind assessment of outcome...please let me know

were this have any conflict with CM principles? All i am hearing is a bunch of

excuses..

 

 

 

 

 

 

 

 

 

 

[Guest guest]

Alon-

 

There are not any inherent problems with CM and randomized trials per

se, as long as people can agree about the diagnosis. I worked for a

while with a hospital here in Chicago, and we worked on designing some

smaller studies ( they are expensive to run!). One of the problems we

ran into was how to devise criteria by which we could separate

patients into treatment groups according to pattern. There exist in

English no agreed upon, objective, and reliable way to distinguish

patterns for such a trial. I think the work needs to be done on that

end before you will see atrial that reflects TCM treatment according

to pattern differentiation.

 

-Steve

 

Sent from my iPhone

 

On Jul 6, 2009, at 10:14 AM, " Alon Marcus " <alonmarcus wrote:

 

>

>

> Hugo

> If you cannot show better outcome in randomly assigned patients

> compared to someone just sticking needles than you cant show acup to

> work. There is nothing wrong with this kind of study as long as you

> can do individualized therapy in the study group. Unfortunately we

> have not seen positive results in even these kind of studies done in

> west. RCTs have no conflict at all with CM when designed to

> accommodate CM. I ask again why cant we have a single school in US

> design and execute such as study? All an RCT requires is

> randomization of patients to sham compared to treatment group. A

> blind assessment of outcome...please let me know were this have any

> conflict with CM principles? All i am hearing is a bunch of excuses..

>

>

>

>

>

>

>

>

>

>

[Guest guest]

It might be better to look at acupuncture channel/merridian diagnostics instead

of herbalized TCM diagnostics for acupuncture. It is also interesting to note

that using channel based acupuncture theory such as Master Tong's and much of

Japanese style acupuncture there is no such thing as " sham " acupuncture due to

the fact that much of acupuncture is based on the halographic and microsytem

theory of acupuncture. That being the case, any point on the body can be an

acupuncture point.

 

 

 

The problems with RCTs and acupuncture are the same as that experience with RCTs

and surgery. Can there really be a " sham " surgery?

 

 

 

Just my opinion.

 

 

 

Donald J. Snow, Jr., DAOM, MPH, L.Ac.

 

 

 

Chinese Medicine

stephenbonzak

Mon, 6 Jul 2009 10:36:47 -0600

Re: Re: Study casts doubt on Random Controlled Trials in China

 

 

 

 

 

 

 

Alon-

 

There are not any inherent problems with CM and randomized trials per

se, as long as people can agree about the diagnosis. I worked for a

while with a hospital here in Chicago, and we worked on designing some

smaller studies ( they are expensive to run!). One of the problems we

ran into was how to devise criteria by which we could separate

patients into treatment groups according to pattern. There exist in

English no agreed upon, objective, and reliable way to distinguish

patterns for such a trial. I think the work needs to be done on that

end before you will see atrial that reflects TCM treatment according

to pattern differentiation.

 

-Steve

 

Sent from my iPhone

 

On Jul 6, 2009, at 10:14 AM, " Alon Marcus " <alonmarcus wrote:

 

>

>

> Hugo

> If you cannot show better outcome in randomly assigned patients

> compared to someone just sticking needles than you cant show acup to

> work. There is nothing wrong with this kind of study as long as you

> can do individualized therapy in the study group. Unfortunately we

> have not seen positive results in even these kind of studies done in

> west. RCTs have no conflict at all with CM when designed to

> accommodate CM. I ask again why cant we have a single school in US

> design and execute such as study? All an RCT requires is

> randomization of patients to sham compared to treatment group. A

> blind assessment of outcome...please let me know were this have any

> conflict with CM principles? All i am hearing is a bunch of excuses..

>

>

>

>

>

>

>

>

>

>

[Guest guest]

Hi Steve;

 

Emmanuel brought up a similar point as yours, I think.

 

An individual, unique, patient cannot be separated into a " group " . This is

non-sense.

 

I am thinking to myself about a common diagnosis I make: Spleen Qi deficiency.

We could assume that this would be one of the bigger " groups " in my practice.

And yet these people all present so differently that I would be fearful of

grouping them and treating them as a group. I think it can be done, but, as you

say, there are certain obstacles. You mention that agreeing upon a diagnosis and

treatment groups was very difficult. I have a solution, but it involves changing

our attitude toward CM and research:

 

Each study has to come from 1 " lab " that is headed by *one* person (a chief

scientist). *This* person makes all the final decisions. This way we don't have

to aim to achieve homogeny (which is impossible) across the profession, but

rather consistency within one lab. Then different labs will produce their

results and we can work from there. If modern science can't take having more

than one chief scientist in a lab, all splitting hairs with each other (because

they DO), then why would we feel it is acceptable for us, especially considering

our tradition is composed of separate *schools*? We don't all have to be same,

and we all have to have our particular flavour and individuality while having

fidelity to foundational principles and methods in CM.

 

Thoughts?

 

Hugo

 

________________________________

Hugo Ramiro

http://middlemedicine.wordpress.com

http://www.chinesemedicaltherapies.org

 

 

 

 

 

________________________________

Stephen Bonzak <stephenbonzak

" Chinese Medicine "

<Chinese Medicine >

Monday, 6 July, 2009 12:36:47

Re: Re: Study casts doubt on Random Controlled Trials in China

 

 

 

 

 

Alon-

 

There are not any inherent problems with CM and randomized trials per

se, as long as people can agree about the diagnosis. I worked for a

while with a hospital here in Chicago, and we worked on designing some

smaller studies ( they are expensive to run!). One of the problems we

ran into was how to devise criteria by which we could separate

patients into treatment groups according to pattern. There exist in

English no agreed upon, objective, and reliable way to distinguish

patterns for such a trial. I think the work needs to be done on that

end before you will see atrial that reflects TCM treatment according

to pattern differentiation.

 

-Steve

 

Sent from my iPhone

 

On Jul 6, 2009, at 10:14 AM, " Alon Marcus " <alonmarcus (AT) wans (DOT) net> wrote:

 

>

>

> Hugo

> If you cannot show better outcome in randomly assigned patients

> compared to someone just sticking needles than you cant show acup to

> work. There is nothing wrong with this kind of study as long as you

> can do individualized therapy in the study group. Unfortunately we

> have not seen positive results in even these kind of studies done in

> west. RCTs have no conflict at all with CM when designed to

> accommodate CM. I ask again why cant we have a single school in US

> design and execute such as study? All an RCT requires is

> randomization of patients to sham compared to treatment group. A

> blind assessment of outcome...please let me know were this have any

> conflict with CM principles? All i am hearing is a bunch of excuses..

>

>

>

>

>

>

>

> www.integrativeheal thmedicine. com

>

>

[Guest guest]

But as Alon says: when the researchers have complete freedom over their

treatment and need not even rationalize their choice (e.g. spleen vacuity so

we use BL20, SP3,.) I see no conflict at all with a large, randomized study.

 

 

 

 

Possible problems would be disease categorization (term choices: is a

western medical diagnosis like 'allergic rhinitis' acceptable or only

Chinese medical disease terms) and an accepted questionnaire that evaluates

the diagnosed condition.

 

I don't think there are any accepted questionnaires within the Chinese

medical framework, so that is perhaps one reason we would need to accept a

western medical disease term like allergic rhinitis, psoriasis or lumbago

should we want to evaluate the clinical work in a statistically relevant

way.

 

However, I think we would need someone experienced in statistics to develop

a study that stands up to critique. Sample size and the chosen mathematical

model are extremely important if we want to prove anything at all. Perhaps

Roger Wicke can chime in here, since I believe he knows a thing or two about

these matters?

 

Another problem with the studies is the level of the acupuncturists

involved- there clearly is a difference. Sometimes studies mention that the

acupuncturists have such-or-such years of experience, but I don't think

there is an accepted guideline about this. Not that years of experience mean

everything, of course.

 

 

 

But I agree with Alon, I see no big problems with an RCT if there is

agreement on disease diagnosis, individualized treatments by well-known

acupuncturists, and peer-accepted evaluation questionnaires. We should be

able to find, at least in some diseases, statistically significant changes

as compared to random superficial needle insertion, no? I realize that

Chinese medicine cannot be completely rationalized, but shouldn't it stand

up to at least some scientific scrutiny?

 

 

 

Tom Verhaeghe

 

Stationsplein 59

 

8770 Ingelmunster

 

www.chinese-geneeskunde.be

 

_____

 

Chinese Medicine

Chinese Medicine On Behalf Of Hugo

Ramiro

maandag 6 juli 2009 19:42

Chinese Medicine

Re: Re: Study casts doubt on Random Controlled Trials in

China

 

 

 

 

 

 

 

 

Hi Steve;

 

Emmanuel brought up a similar point as yours, I think.

 

An individual, unique, patient cannot be separated into a " group " . This is

non-sense.

 

I am thinking to myself about a common diagnosis I make: Spleen Qi

deficiency. We could assume that this would be one of the bigger " groups " in

my practice. And yet these people all present so differently that I would be

fearful of grouping them and treating them as a group. I think it can be

done, but, as you say, there are certain obstacles. You mention that

agreeing upon a diagnosis and treatment groups was very difficult. I have a

solution, but it involves changing our attitude toward CM and research:

 

Each study has to come from 1 " lab " that is headed by *one* person (a chief

scientist). *This* person makes all the final decisions. This way we don't

have to aim to achieve homogeny (which is impossible) across the profession,

but rather consistency within one lab. Then different labs will produce

their results and we can work from there. If modern science can't take

having more than one chief scientist in a lab, all splitting hairs with each

other (because they DO), then why would we feel it is acceptable for us,

especially considering our tradition is composed of separate *schools*? We

don't all have to be same, and we all have to have our particular flavour

and individuality while having fidelity to foundational principles and

methods in CM.

 

Thoughts?

 

Hugo

 

________________________________

Hugo Ramiro

http://middlemedici <http://middlemedicine.wordpress.com> ne.wordpress.com

http://www.chinesem <http://www.chinesemedicaltherapies.org>

edicaltherapies.org

 

________________________________

Stephen Bonzak <stephenbonzak@ <stephenbonzak%40comcast.net>

comcast.net>

" Traditional_ <Chinese Medicine%40>

Chinese_Medicine " <Traditional_

<Chinese Medicine%40>

Chinese_Medicine >

Monday, 6 July, 2009 12:36:47

Re: Re: Study casts doubt on Random Controlled Trials in

China

 

Alon-

 

There are not any inherent problems with CM and randomized trials per

se, as long as people can agree about the diagnosis. I worked for a

while with a hospital here in Chicago, and we worked on designing some

smaller studies ( they are expensive to run!). One of the problems we

ran into was how to devise criteria by which we could separate

patients into treatment groups according to pattern. There exist in

English no agreed upon, objective, and reliable way to distinguish

patterns for such a trial. I think the work needs to be done on that

end before you will see atrial that reflects TCM treatment according

to pattern differentiation.

 

-Steve

 

Sent from my iPhone

 

On Jul 6, 2009, at 10:14 AM, " Alon Marcus " <alonmarcus (AT) wans (DOT) net> wrote:

 

>

>

> Hugo

> If you cannot show better outcome in randomly assigned patients

> compared to someone just sticking needles than you cant show acup to

> work. There is nothing wrong with this kind of study as long as you

> can do individualized therapy in the study group. Unfortunately we

> have not seen positive results in even these kind of studies done in

> west. RCTs have no conflict at all with CM when designed to

> accommodate CM. I ask again why cant we have a single school in US

> design and execute such as study? All an RCT requires is

> randomization of patients to sham compared to treatment group. A

> blind assessment of outcome...please let me know were this have any

> conflict with CM principles? All i am hearing is a bunch of excuses..

>

>

>

>

>

>

>

> www.integrativeheal thmedicine. com

>

>

[Guest guest]

I agree and so did Dr. Harris Coulter about the Clinical Trial even for western

medicine. He stated so long ago that the individuals genome was too different

for a Clinical Trial to be of much use. I laughed when he told me medicine was

more about politics than science. Also, I noted that it took a Political Science

Doctor to show to western medicine

what they could not recognize right in front of their face.

Sincerely, Patricia Jordan DVM,CVA,CTCVM & Herbology

 

 

 

 

 

Chinese Medicine

margi.macdonald

Mon, 6 Jul 2009 00:00:20 +0000

Re: Study casts doubt on Random Controlled Trials in China

 

 

 

 

 

 

 

Chinese Medicine , " Emmauel Segmen "

<mrsegmen wrote:

 

Hello everyone

 

It's the same-old-same-old...

The structure of the RCT - blinded or not, simply doesn't 'fit' TCM or

homeopathy.

I still wonder why TCM practitioners - herbal & /or acupuncture - continue to

participate in RCTs.

We all know it's an inappropriate tool to assess TCM; in fact the RCT in itself

is a flawed and ultimately very strange way to assess the efficacy of

interventions delivered to individuals.

Note I say 'individuals'.

TCM practitioners treat individuals, not population groups.

Don't we?

 

I dream of the day when outcomes-based study tools become the 'gold standard' of

assessing TCM health interventions in individuals.

'Outcomes' being the objective and subjective information fed back to us by our

patients, one-by-one.

 

'Health interventions'... ERRK ... even the wretched language of clinical

research and 'modern' medicine is contaminating my mind

 

And to put this into a very personal perspective, my mother was recently denied

a CT scan of her brain after knocking herself unconscious. The hospital used a

particular assessment tool - instead of another - to assess who gets a CT, and

who doesn't - and her presenting condition didn't tick any of the boxes. Those

assessment tools are designed after years of looking at statistical

probabilities.

She walked out of that hospital with an undiagnosed sub-arachnoid haemorrhage,

just a couple of hours after presenting to the ER.

 

Allopathy practices medicine in the bell-curve of statistical probability, and

medical doctors are taught to think this way.

 

We are not.

 

Let's not forget it.

 

To see how dangerous bell-curve medicine, and assumptive thinking can be, the

account of my Mother's experience at the hands of the allopathic system is here:

 

http://margihealing.wordpress.com/2009/05/20/medical-negligence-and-the-meaning-\

of-life/

 

Margi

Happy 4th July to all in the US... and a sweet day for the rest of us.

 

 

 

 

 

 

 

 

 

_______________

Lauren found her dream laptop. Find the PC that’s right for you.

http://www.microsoft.com/windows/choosepc/?ocid=ftp_val_wl_290

 

 

[Guest guest]

Hi Tom!

 

 

--Tom-

when the researchers have complete freedom over their

treatment and need not even rationalize their choice (e.g. spleen vacuity so

we use BL20, SP3,.) I see no conflict at all with a large, randomized study.

---

 

That sounds great, but in my experience with study design, the process is one

of whittling down until there is almost nothing left. Remember that it is

insufficient to simply show that treatment is superior to sham *because if

treatment is not heavily controlled and isolated* then the charge will simply be

it was something else other than the acupuncture which gave results above sham -

i.e. lifestyle changes, dietary changes, herbs, placebo, the list goes on. And

we're back at square one: " Is the acupuncture intervention at all superior to

sham (random pricking)? "

 

I just don't see the simplicity that Alon is talking about.

 

--Tom-

I don't think there are any accepted questionnaires within the Chinese

medical framework, so that is perhaps one reason we would need to accept a

western medical disease term like allergic rhinitis, psoriasis or lumbago

should we want to evaluate the clinical work in a statistically relevant

way.

---

 

As far as " Accepted " . the skeptics don't accept anything they don't desire to,

but there is a relatively recnt offering out of Hong Kong regarding a Chinese

Quality of Life and Health survey (all Chinese Medical theory). I've got it on

my HD somewhere, I can't find it right now, these desktop search engines are not

all they're cracked up to be, but if I have time I'll look for it.

 

As far as statistics, we cannot acept western terms because they will mess up

our results. I can treat acute wind-heat well, but not necessarily allergic

rhinitis (complicated by damp, deficiency etc). This is a huge stumbling block -

we cannot use western terminology to describe CM patterns or diseases.

 

--Tom-

I realize that Chinese medicine cannot be completely rationalized, but shouldn't

it stand

up to at least some scientific scrutiny?

---

 

Your comment above is representative of the misconceptions that plague our

profession. CM can be FULLY rationalised, but not in the way *western*

rationalism divides, analyzes and ignores data-sets which do not parse easily

via reduction.

CM can stand up to *full* scientific scrutiny.

The problem is that *so-called* scientific scrutiny is asking the wrong

questions for the wrong reasons, setting the bar way too high way too early and

changing bar height at its whim.

 

Thanks, Tom,

Hugo

 

 

________________________________

Hugo Ramiro

http://middlemedicine.wordpress.com

http://www.chinesemedicaltherapies.org

 

 

 

 

 

[Guest guest]

Chinese Medicine , " Tom Verhaeghe "

<tom.verhaeghe wrote:

 

 

" ...should we want to evaluate the clinical work in a statistically relevant

way. "

 

" ...Sample size and the chosen mathematical model are extremely important if we

want to prove anything at all... "

 

" Another problem with the studies is the level of the acupuncturists

involved- there clearly is a difference....Not that years of experience mean

everything, of course. "

 

" But I agree with Alon, I see no big problems with an RCT if there is

agreement on disease diagnosis, individualized treatments by well-known

acupuncturists, and peer-accepted evaluation questionnaires. ... "

 

 

Tom, and All

little of this artifice provides for meaningful results with external validity

in the 'real world' of clinical practice.

 

And what is it we'd all be trying to 'prove' if we go down the path of using

RCTs as the most useful or credible model of studying TCM?

 

Let's review the model of Evidence Based Medicine - EBM - of which the RCT is

but ONE component. The model is a pyramid. At the pointy end is the

meta-analysis of RCTs - in the TCM context, this is usually an exercise in

comparing apples with oranges, or at best, green apples with red ones and

stripey ones.

At the base of the pyramid - the foundation - are individual case studies.

Every one of us in practice is contributing to EBM with the work we do each day,

with individuals who come to us for assistance.

Between this foundational base, and the pointy end, much good work is done, most

of it never seeing the light of day, or making it to the pages of a journal.

 

Let's walk before we start running... let's examine our foundation, what holds

it together, and what makes it work. Once we've done that, we are better able to

design meaningful models of studying, researching and collating TCM outcomes.

 

Allopathy has its own nomenclature, cultures, and methodologies. EBM evolved in

this paradigm.

 

TCM has its own nomenclature, cultures and methodologies.

 

In which paradigm can TCM best be examined?

 

I'm not sure I want to be seduced into the allopathic EBM model, if it means I'm

going to start thinking like this medical student and his teacher:

" ...A professor, in the first few weeks of Med, lecturing our class said

'Medicine is about the odds, the chances. If you know the odds, if you know

what's likely, what's common, most of the time, you'll be right'

He continues:

" ...few things are absolute. It's a brave physician who'll respond to a clinical

question with a jovial Absolutely! Sure, some diagnoses reveal themselves

incontrovertibly, but not all. For the rest, the physician might diagnose an

disease, or recommend a specific treatment, but remember, they're playing the

odds. They have a list in their head (or on paper) of Differential Diagnoses,

and one or two is most likely...

http://www.captainatopic.com/2009/06/absolutely.html

Though I do like that he acknowledges there are few absolutes...

Think about it...

Margi

[Guest guest]

I second all Margi's viewpoints. Thanks, Margi. What I wondering is the original

poster's profession. Is the gentleman a L Ac or someone who shows causal

interests in our profession but doesn't make a living of it.

 

I understand there is authenticity issue of researches done in China and lack

of decent funding is a cruicial factor. What I question is the logics of the

conclusion the study drew.

 

SUNG, Yuk-ming

..

[Guest guest]

I published some articles a few years ago covering a number of issues germane to

research design and acupuncture. It is obviously a very complex area. It is my

opinion that research protocols need to be completely redesigned to render them

appropriate to what we do every day in clinic (first and foremost, we don't even

treat diseases - although people come to us with a main complaint, we usually

reframe that complaint into a much bigger context and after a few treatments,

many of their symptoms are improving) . . .

 

Schulman D. The Unexpected Outcomes of Acupuncture. Case Reports in Support of

Refocused Research Designs. Journal of Alternative and Complementary Medicine;

November, 2004: Volume 10 (5); Pages 785-789.

 

Schulman D. Gold Standard or Fool's Gold. Staking Our Own Claim on the

Evidence-Based Medicine Map. North American Journal of Oriental Medicine.

November, 2004: Volume 11(32); Pages 26-28.

 

Schulman D. Acupuncture Research and the Pursuit of Equal Partner Status:

Plausibility, Safety and Effectiveness Examined. The Journal of Chinese

Medicine. June, 2005: Volume 78; Pages 25-32.

[Guest guest]

A welcome viewpoint Pat, thnx.

 

--- On Mon, 7/6/09, Patricia Jordan <coastalcatclinic wrote:

 

Patricia Jordan <coastalcatclinic

RE: Re: Study casts doubt on Random Controlled Trials in China

" traditional chinese med " <Chinese Traditional Medicine >

Monday, July 6, 2009, 3:04 PM

 

 

I agree and so did Dr. Harris Coulter about the Clinical Trial even for western

medicine. He stated so long ago that the individuals genome was too different

for a Clinical Trial to be of much use. I laughed when he told me medicine was

more about politics than science. Also, I noted that it took a Political Science

Doctor to show to  western medicine

what they could not recognize right in front of their face.

Sincerely, Patricia Jordan DVM,CVA,CTCVM & Herbology

 

 

 

 

 

Chinese Medicine

margi.macdonald

Mon, 6 Jul 2009 00:00:20 +0000

Re: Study casts doubt on Random Controlled Trials in China

 

 

 

 

 

 

 

Chinese Medicine , " Emmauel Segmen "

<mrsegmen wrote:

 

Hello everyone

 

It's the same-old-same-old...

The structure of the RCT - blinded or not, simply doesn't 'fit' TCM or

homeopathy.

I still wonder why TCM practitioners - herbal & /or acupuncture - continue to

participate in RCTs.

We all know it's an inappropriate tool to assess TCM; in fact the RCT in itself

is a flawed and ultimately very strange way to assess the efficacy of

interventions delivered to individuals.

Note I say 'individuals'.

TCM practitioners treat individuals, not population groups.

Don't we?

 

I dream of the day when outcomes-based study tools become the 'gold standard' of

assessing TCM health interventions in individuals.

'Outcomes' being the objective and subjective information fed back to us by our

patients, one-by-one.

 

'Health interventions'... ERRK ... even the wretched language of clinical

research and 'modern' medicine is contaminating my mind

 

And to put this into a very personal perspective, my mother was recently denied

a CT scan of her brain after knocking herself unconscious. The hospital used a

particular assessment tool - instead of another - to assess who gets a CT, and

who doesn't - and her presenting condition didn't tick any of the boxes. Those

assessment tools are designed after years of looking at statistical

probabilities.

She walked out of that hospital with an undiagnosed sub-arachnoid haemorrhage,

just a couple of hours after presenting to the ER.

 

Allopathy practices medicine in the bell-curve of statistical probability, and

medical doctors are taught to think this way.

 

We are not.

 

Let's not forget it.

 

To see how dangerous bell-curve medicine, and assumptive thinking can be, the

account of my Mother's experience at the hands of the allopathic system is here:

 

http://margihealing.wordpress.com/2009/05/20/medical-negligence-and-the-meaning-\

of-life/

 

Margi

Happy 4th July to all in the US... and a sweet day for the rest of us.

 

 

 

 

 

 

 

 

 

_______________

Lauren found her dream laptop. Find the PC that’s right for you.

http://www.microsoft.com/windows/choosepc/?ocid=ftp_val_wl_290

 

 

[Guest guest]

>

Is the gentleman a L Ac or someone who shows causal interests in our profession

but doesn't make a living of it.

>

 

Sung Yuk-ming,

I am moving into my 17th year as a solo provider in a single practice and it has

been my sole source of income. I have undergraduate training in botany and plant

pathology, I graduated from Bastyr University where I trained in acupuncture,

Chinese herbal medicine, and Naturopathic medicine. My major professors were

from Chengdu, Shanghai, Harbin, Nanjing and Hong Kong. I continued my education

in Shanghai and Chengdu at the TCM universities and community hospitals. Later

in my career I was a board member of the Washington Acupuncture Society. I

returned to Bastyr university to teach as a clinical supervisor and became a

trustee of the university for a number of years functioning as vice chair of the

board and chair of the academics and research committee. I belief I have enough

time in practice to have a reasonable understanding of the profession, education

and research issues facing practitioners in the U.S. Perhaps if you refer to my

follow up post it may clarify my reason for posting the news item.

Best Regards,

Michael

[Guest guest]

Alon, you make a good point, but i would suggest that the problem isn't that so

called " sham " points demonstrate possible function, but that the profession as a

whole is not focused on research. This, of course, begins with the schools that

have no interest in bringing TCM to a more rigorous standard, it just simply is

not in their interest and the expense of devising programs and protocols too

daunting.

The most disconcerting aspect of all this is not that the so called " sham "

points are showing effect, but that the illusion that points contain some

mystical property is being questioned. One only needs to read the ancient texts

to know that frequently it is stated that a monkey can shove a needle into

someone and get basic results, it is the true physician who sees and feels the

imbalance of the meridians and seeks then to bring the body into balance.

As long as we as a profession allow these antiquated and overly simplistic ideas

of the function of acupuncture to be furthered by research without a consensus

of what proper research is in the first place, we will continue to operate

without a solid foundation of why our medicine works at all.

Regards, Tymothy

 

 

 

 

>

> this is not the first study to question chinese studies. I have

> witnessed fraudulent publications when i was in china in 1985. That

> said i think it was very encouraging that the study fount university

> based publications to be more reliable. SUNG while sham acup in

> definitely not an inactive intervention as long as a real group does

> not do better than sham we are not showing any specific effects and

> cannot support acupuncture as a profession. We must do studies were

> real group shows better outcomes than sham. Why should a healthcare

> system pay 65=120$ per acup visit if anyone can just stick a needle

> and get same results?

>

>

> 400 29th St. Suite 419

> Oakland Ca 94609

>

>

>

> alonmarcus

>

 

[Guest guest]

Excellent point, Tymothy. . .

 

 

On Jul 6, 2009, at 10:41 PM, miracles28 wrote:

 

> As long as we as a profession allow these antiquated and overly

> simplistic ideas of the function of acupuncture to be furthered by

> research without a consensus of what proper research is in the first

> place, we will continue to operate without a solid foundation of why

> our medicine works at all.

> Regards, Tymothy

 

 

Chair, Department of Herbal Medicine

Pacific College of Oriental Medicine

San Diego, Ca. 92122

 

 

 

 

 

 

 

[Guest guest]

Michael: Nothing personal and the only background information about you in your

post is

 

<<<perhaps because I have western medical training also>>>>.

 

It suggests that you are a MD and it is logical to come up with the conclusion

that you may not be a L Ac. Besides, I missed the last word in the sentence.

 

My truly apologies if you feel offended. I respect all group members here as we

all share the same goal to better Chinese medicine as a profession.

 

SUNG, Yuk-ming