About Research..

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About Research..

Postby Tim Cleary » Tue May 02, 2006 6:13 am

Hi Y'all- in this, my first topic, I would like to get some feedback from people on acupuncture/CHM research in general, but particularly acupuncture trials.

We know that the 'Gold standard' for research into pharmaceuticals is the Randomised Controlled Trial (Double-Blind, if possible) (RCT)- but what is missing from the general knowledge pool (of the public as well as those like us, with a vested interest in acupuncture) is that this standard and type of research is, according to it's design, suited to chemical trials and NOT to procedural ones. As an analogy- drugs get RCT'ed, but surgery doesn't.

Surgery, as far as my reading suggests, is subject primarily to peer review- if a lot of surgeons think that a new procedure is sensible, it is adopted into mainstream practice. It is very difficult if not impossible to perform an RCT with any procedure at all- so why is it that the RCT is still set up as the standard to which acupuncture research is subject? Would it not make more sense to treat acupuncture as a procedure, rather than like a chemical?

Also- why is it that 'sham acupuncture' so often resembles "Japanese acupuncture"? (which I know is not a term that should be used- acupuncture in Japan has an enormously wide variety of techniques, particularly in regard to depth of needling...) and doesn't the consistent positive results of sham technique in trials suggest more that humans respond favourably to even crappy acupuncture, not that there's no significant difference between 'real' and 'fake' acupuncture?

Please, those of you who like research (you sick freaks :lol: ), can you help to enlighten me?

As an alternative model- I wonder if it would be possible to set up a battery of general health tests that could tell us whether the patient's health status is improving over the course of treatment. Flexibility, Strength, Cardiovascular/Liver/Lung/Kidney function and blood-work (haematocrit, O2 saturation, RBC/WBC counts, etc)are all easy enough to test, without even needing to look at symptoms..

Do we think that we would see positive results from these tests? Or would others be better?

What I'm concerned about is that as a profession (and I'm definitely guilty of this) we aren't making enough noise to promote CM as a genuine, primary health-care system in ways that affect established medical and public opinion. Telling our patients and potential patients how good the system is is just not enough.

There is a mounting backlog of shoddy or biased research, articles from quackwatch.com and others slagging acupuncture and CHM off as being useless or dangerous, and a distinct lack of positive, worthwhile research and reporting of verifiable clinical results- especially in the phenomenology of acupuncture.

Maybe I could make more sense here- and please, let me know if you need any further information (or if Japanese syntax I've slipped into - or something). I'd like to see some discussion here of what we should be doing in research, not just how useless this trial or that one was..

Thanks for reading..
Tim.
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Same old chestnuts...

Postby markaird » Wed May 03, 2006 12:46 am

Hi Tim,

A good email, covering several issues that have been discussed regularly for the 11 years I’ve been studying acupuncture, and I’m sure many years before that too. I’m sure Sean and Carole will have comments too if they have the time. Speaking of time, this is kind of long, so you might want to make yourself a hot drink now before you start.

It’s probably easiest to go through these issues in the order you presented them, so let’s start with the double-blind randomised controlled trial. RCTs (albeit obviously not double-blind) have been conducted for surgical techniques, although I’m only aware of a couple, and only one in the last 10-20 years. There are good reasons for the paucity of surgical RCTs.

Placing an arbitrary division between “procedural� and “chemical� interventions might be overly simplistic. Chiropractic, physiotherapeutic, and massage interventions are all procedural, but do lend themselves to RCTs if properly designed. Surgery is in itself an established and well-understood procedure, as far as it is measured. On one level you might consider surgery a fairly simple intervention – provide access to damaged tissue and repair it mechanically. Progress in the field of surgery is linked more strongly to technological advancement in the tools used, rather than in discovering a new surgical procedure. As the tools improve, access can be made to deeper and smaller structures, to which the basic surgical techniques are then applied. So in this sense, surgery should not in itself need to be re-evaluated every time a tool is improved.

The second consideration with surgery is an ethical one. If a patient needs surgery, can it ethically be denied while a study is conducted? In other words, can a group of patients receive either a placebo or no treatment at all? If a patient does not need the surgery, how ethical is it to expose that patient to the inherent dangers and stresses of surgery? In the very small number of cases where a technique is minor enough so that a patient can undergo the procedure twice (once while receiving the placebo or null treatment, and then once properly after the study), there is still the ethical issue of the value of conducting that study. Very, very few surgical interventions are going to get to this point and continue on to trial. One that recently did involved a very simple surgical technique on the knee (one enabled by technological advancements which drastically reduced the invasiveness of the technique).

Acupuncture, on the other hand, is relatively non-invasive (note I said “relatively� – having a metal needle stuck into you is not non-invasive – just far less so than having surgery!). Also, acupuncture is not, in 21st century Western society, an emergency therapy. The conditions practitioners treat are relatively benign. So the ethical consideration of delaying treatment is drastically lessened. Further, an ethical consideration is introduced by NOT conducting a RCT. Is the patient receiving the most appropriate treatment available for the condition being treated? How can we tell? By conducting, publishing, and reading research. Patients today have no shortage of choices for treatment. Why do they choose to have a dozen metal spiked inserted into their bodies instead taking medicine prescribed by their GP, or instead of another alternative or complementary therapy? Because acupuncture therapists assert that acupuncture is the answer. How do acupuncture therapists know this is true? Well, it gets a bit confronting for some acupuncturists here, so those with blinkers and short fuses might like to change channels now.

We assert that acupuncture works for their therapy because (a) we have read good quality research that found significant effects, or (b) we have read garbage research that claimed positive effects, or (c) we read in a book or heard in class that it works for the condition, so it must be so, or (d) acupuncture advertising is crucial to success as an acupuncturist, so it follows that I must be positive about its effects.

More often than not acupuncturists will be motivated by a number of these drivers at once. The critical point is that patients have choices, and it is in their interests for them to receive a treatment that has been proven to work. How ethical is it for us to promote a treatment which is unproven when in reality the patient will likely then forgo other treatments? Further, if the research is available and a practitioner hasn’t bothered to read it because “research is boring�, how can that person consider himself or herself a holistic therapist? All they’re doing is putting their own business interests before the health interests of the patient. Derryn Hinch would have a field day. Shame, shame, shame.

Okay, I’m getting a bit excited. Back to the point. The point is that acupuncture is researched and reported. Therapists have an ethical and professional duty to embrace it. RCTs are appropriate for acupuncture because they are a superior model and they work for acupuncture. Just look at the literature. Unfortunately, those practitioners who don’t like studying research methods, don’t like reading research, and/or have a chip on their shoulders are those most likely to cry foul on the issue of RCTs for acupuncture. True, double-blind studies are hard to design for acupuncture. I do think they are achievable. The question is whether there is value in going that far, but that’s an argument for another day…

Okay, your second point was why is it that sham acupuncture so often resembles Japanese acupuncture? I think the core of this issue is a clash of cultures – traditional medicine versus orthodox contemporary medicine. Traditional medicine, in this case the minimal stimulation school of Japanese acupuncture, does not relate the strength of stimulation to the strength of effect. Orthodox contemporary medicine does make this relationship. Therefore, in one school, minimal stimulation is correct for maximising therapeutic effect, in the other, it is appropriate to minimise therapeutic effect. How can we tell which is correct? How does conducting a number of RCTs sound? Research is the answer.

Your third question related to conducting a battery of general health tests that could tell us whether the patient's health status is improving over the course of treatment. There are a couple of issues to consider here. Firstly, such a raft of tests is resource-intensive (time, personnel, money, equipment, etc.) Secondly, why would these tests work? Acupuncture is supposedly a subtle medicine. The classics tell us that disease should be found before signs are evident. The tests you propose are relatively gross when compared to taking the pulse, palpating the body and reading the tongue. And what would they tell us? Where in the classics are blood-work results discussed? I think when we try to combine two disparate theories of medicine, we tread where monsters be. It’s akin to prescribing acupoints according to an orthodox contemporary medicine diagnosis. Acupuncture wasn’t designed that way. HOWEVER, if it can be established that certain physiological effects are caused by research, then yes, appropriate measurements, perhaps including blood-works may be useful. How would we find this out? Guess. RCTs.

And your final point is one close to my heart, and I think I’ve touched on it a couple of times already. No, the profession of acupuncture is not doing enough to be, well, professional. Individuals are doing a great deal. Kath Berry and her colleagues deserve kudos for establishing this forum and maintaining it. Meaghan Coyle has spent years working in the Australian hospital environment demonstrating how acupuncture can be researched and applied as a complement to orthodox contemporary medicine. Sean Walsh and Emma King both researched fundamental issues regarding the practice of acupuncture. Deirdre Cobbin, Carole Rogers and Chris Zaslawski paved the way for these people, and have done a tremendous amount to increase the professionalism in Australia and internationally. Many other people have made similar contributions, but the sad fact is that the majority of practitioners are pointed in the opposite direction, and spend more time disparaging research methods and acupuncture research, and ultimately, consciously or not, often making false claims about the efficacy of acupuncture. It is unrealistic to expect acupuncture is appropriate for all or even most diseases. No form of medicine is ever going to achieve that title. Better to invest our efforts in discovering what acupuncture can do better than other therapies, and promote that. And the road to that end is paved with many research studies which must be properly design and run, written and published, read and understood. Evaluating them and determining “how useless this trial or that one was� is how we as a profession learn what works and what is better left alone.

If you read this far, you probably need a Panadol. Or perhaps LR3. Check Medline and see which works better… ;-)

Mark
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Postby Carole Rogers » Wed May 03, 2006 5:32 am

Both great posts guys. Thanks Tim for raising these important questions. Mark has answered for me, but Sean may have something to say.

Just one item. My 'about to graduate' PhD student, Victor Vickland, who posts here when he has the time, has just finished writing up his thesis and I hope he will share his results with the forum.

His work is of great interest and provides some evidence to support Mark's view that: "...if it can be established that certain physiological effects are caused...". Victor has used some interesting research tools to establish that subtle physiological changes do occur when needles are inserted. in specific points. As he used healthy patients in an RCT these changes are only slight, but the trend is toward normalisation.

This is of course only the first step in what will have to be a prolonged and exhaustive series of trials, that eventually move on to using patients with specific conditions. Such results have to be replicated and a number of different points tested. This will require ongoing funding and the maintenance of a highly specialised research lab - plus the skilled personnel to operate it.

The point is that research generally moves forward at a snails pace and it is still just over 10 years since university based research has been possible in this country. It should also not be forgotten that many assumptions are made when we look at CM research - particularly in acupuncture. These need to be looked at before we go further. Mark has done some excellent work in accurate point location and Sean's research into pulse diagnosis is equally important.
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Postby dragonmonk » Wed May 03, 2006 5:55 am

Here is an interesting article written by Chris Zaslawski.....
Also there is a lot of amazing information on this topic in the start of "Chasing the Dragons Tail, by Manaka....
It is curious to note the old sea-margins of human thought! Each subsiding century reveals some new mystery; we build where monsters used to hide themselves.
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Postby Tim Cleary » Wed May 03, 2006 7:35 am

Thanks for your responses- particularly Mark..
I want to discuss a few aspects of the posts (and this is off the top of my head, so if I'm unclear- sing out and let me know)


I guess I'll do this backwards- Dargonmonk, I too have read Manaka's work (cover to cover, many times)- the problem is that for his major procedures, his research methodology (find pressure pain, palpate the channels - checking particular points, re-check pressure pain) is not 'scientific' enough. Yes, apparently observing nature is no longer scientific.


One criticism that I have heard levelled at him for this was: why didn't he use any instruments to measure changes in the pressure pain threshold? Another might be: This is all placebo effect- if you press on enough points, the patient will eventually tell you the pressure pain is less. I've even been informed that the entire procedure of cross-checking in this manner (which I use for each and every [generally quite successful in relieving symptoms] treatment that I do) is entirely fruitless, due to idiomotor activity, either on the part of the therapist (changing the pressure) or the patient (squirming to get out of the way or unintentionally changing their muscle tension, thereby changing their pressure pain response- which I think is actually a significant factor- if the muscles release their (idiopathic or habitual) tension, the pain disappears. This effect is what sets up conditions for healing in the patient's body, as far as I'm concerned- I know there are other models that also work.)

The problem here is that when instruments are used to detect changes in the pressure pain threshold, it's pretty unreliable anyway, due to the fact that it's almost impossible when using them to assert the same pressure at the same angle on the same point more than once. Another is that they don't feel the same as hands do, or give the same feedback to the practitioner. I've been a patient in one research trial and I can tell you that this makes a huge difference to the results- when the pressure was exerted directly into the muscle being tested, the practitioner could almost stand on it- but when it was off to the side, it was very painful straight away. There are similar 'operator error' or technical problems in just about every trial I have ever seen.

Manaka does include some interesting speculations on the origin of pressure pain, as well as a couple of vasomotor studies on rabbit ears that show some nice phenomena occuring over the time before, during and after needle retention. Also some snippets of Japanese studies into the effects of moxa burns (on rabbit ears again, I think) on blood chemistry. This is the type of research that I think is useful- and I know it's being done in Japan (in Japanese) but I don't see much coming from the West.

Carol and Mark- I'd love to see anything on more accurate point location- is there any chance of posting anything here- or providing a link? I'm also awaiting the outcome of Viktor's research, as I thought it sounded interesting when I heard what he was doing.

Mark- I've been given to believe from my reading (another 'appeal to authority') that there were almost as many studies showing poor results massage, chiropractic (osteopathic) and physiotherapeutic interventions as there are for acupuncture ones- but that could be because I'm looking at quackwatch and it's ilk more than medline or similar. I also can't quite figure out why these other methods are more readily amenable for RCT's- is it because they're (largely) based on gross anatomy rather than our 'hippy model'? I was under the impression that the main problem with doing RCT's in acupuncture was the customised nature of the diagnoses and treatments- which would surely also be a problem in any other manual therapy.

I feel that one of the problems of acupuncture research in general is that people want to research acupuncture to ascertain it's effectiveness, but they then design treatments that don't much resemble what happens in an actual treatment. Or that the trial itself is just so poorly designed it is as though the researchers wanted it to fail. It's unfortunate, but it happens all the time.

For example-
http://www.webmd.com/content/article/87/99574.htm
Here's a study in which 'acupuncture failed to reduce hypertension' - in eleven people, when electroacupuncture was applied 'to all the blood pressure acupuncture points identified in traditional chinese medicine'. I don't have access to the online databases here, so I can't get any further info- but I find it difficult to believe that any points were identified in the classics as being good for 'high blood pressure'... Which makes me think that they selected points that are currently popular- which to me could have included SP2, 3, 6 and 9, ST36 and 40, KD6, 9, 10 and 27, TE8 or 9, several ear points, points around Bl10 and PC6 to name just the ones I remember from the top of my head as being a little unusual- used depending on the presentation of the patient. There is no way I would use all of these at the same time- and I hope no-one else would either. Especially with electroacupuncture.. Those machines give me the heebie-jeebies...

What concerns me is that this is the type of research that is readily available to anyone who looks, but to find well-designed studies supporting the use of acupuncture in just about any condition is almost impossible. I also have concerns about the fact that people will read this stuff, decide acupuncture is no use and tell everyone they know. And some of them will be doctors.

I'd like to add another driver to Mark's list of those motivating acupuncturists- we recommend acupuncture because many currently accepted medical practices regularly do more harm than good (the examples that spring to mind are the laminectomy, the 'precautionary' cholecystectomy and a large proportion of hyserectomies)- we feel that our interventions are at least less likely to cause permanent, life-changing damage on the patient, and may actually help.

Lastly, I have often wondered about which conditions indvidual practitioners consider to be outside the scope of acupuncture (emergency conditions aside). Maybe it's a topic for a different discussion.

Anyway, thanks again for the input (so far) and I look forward to climbing onto this particular soapbox in the near future...

Tim.


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Postby Sean Walsh » Tue May 16, 2006 8:50 am

Tim Cleary wrote:The problem here is that when instruments are used to detect changes in the pressure pain threshold, it's pretty unreliable anyway, due to the fact that it's almost impossible when using them to assert the same pressure at the same angle on the same point more than once.


Yes it is unreliable. That is why a number of subjects representative of the population are used to average out such variations in a research context. Additionally, blinding the people taking the measurements also assists in this. In this sense, there are a range of rules and assumptions that need to be met to ensure that the testing method is reliable.


Tim Cleary wrote:Another is that they don't feel the same as hands do, or give the same feedback to the practitioner. I've been a patient in one research trial and I can tell you that this makes a huge difference to the results- when the pressure was exerted directly into the muscle being tested, the practitioner could almost stand on it- but when it was off to the side, it was very painful straight away. There are similar 'operator error' or technical problems in just about every trial I have ever seen.


As you identified Tim this is an operational error: well conducted trials should operationally define the angle and how the pressure should be applied, to exclude such an obvious extraneous variable. This is a reflection of the study design, not of the use of research.

Tim Cleary wrote:Manaka does include some interesting speculations on the origin of pressure pain, as well as a couple of vasomotor studies on rabbit ears that show some nice phenomena occuring over the time before, during and after needle retention. Also some snippets of Japanese studies into the effects of moxa burns (on rabbit ears again, I think) on blood chemistry. This is the type of research that I think is useful- and I know it's being done in Japan (in Japanese) but I don't see much coming from the West.


And that Tim is the crux of the problem - we're all keen to identify problems and deficits but too few have the passion to do something about it. I believe enrolments for post-graduate research are now open at all universities - have you considered a research Masters or PhD? You certainly have the inquiring mind to do very well in such an undertaking and address some of the problems you've identified in the literature.

Tim Cleary wrote:Mark- I've been given to believe from my reading (another 'appeal to authority') that there were almost as many studies showing poor results massage, chiropractic (osteopathic) and physiotherapeutic interventions as there are for acupuncture ones- but that could be because I'm looking at quackwatch and it's ilk more than medline or similar. I also can't quite figure out why these other methods are more readily amenable for RCT's- is it because they're (largely) based on gross anatomy rather than our 'hippy model'? I was under the impression that the main problem with doing RCT's in acupuncture was the customised nature of the diagnoses and treatments- which would surely also be a problem in any other manual therapy.


There are a number of studies available that have used individual diagnosis and treatment in addition to a standard treatment. Was there a difference in outcomes? Yes. Was this significant? No. The difference related to a range of qualitative factors such as sleep, mood, energy but with regards to the primary problem being treated, there was no significant difference between individual versus standard treatments.

In addition, it might be worth your while to track down a copy of STRICTA - these are guidelines developed by the international CM profession in direct response to the same concerns you have. However, as Mark can tell you, there are still some deficits with these that need addressing, but they are a start.

Tim Cleary wrote:I feel that one of the problems of acupuncture research in general is that people want to research acupuncture to ascertain it's effectiveness, but they then design treatments that don't much resemble what happens in an actual treatment. Or that the trial itself is just so poorly designed it is as though the researchers wanted it to fail. It's unfortunate, but it happens all the time.

For example-
http://www.webmd.com/content/article/87/99574.htm
Here's a study in which 'acupuncture failed to reduce hypertension' - in eleven people, when electroacupuncture was applied 'to all the blood pressure acupuncture points identified in traditional chinese medicine'. I don't have access to the online databases here, so I can't get any further info- but I find it difficult to believe that any points were identified in the classics as being good for 'high blood pressure'... Which makes me think that they selected points that are currently popular- which to me could have included SP2, 3, 6 and 9, ST36 and 40, KD6, 9, 10 and 27, TE8 or 9, several ear points, points around Bl10 and PC6 to name just the ones I remember from the top of my head as being a little unusual- used depending on the presentation of the patient. There is no way I would use all of these at the same time- and I hope no-one else would either.


Yep - and once more this comes down to either CM practitioners untrained in research/study design or researchers untrained in CM undertaking these studies. The study above likely speaks more about unqualified people doing the research - not about the non-efficacy of acupuncture, or, to be correct, the points they were using and the context the points were being used. (Did I mention that you should consider enrolling into a research degree?).

Tim Cleary wrote:I'd like to add another driver to Mark's list of those motivating acupuncturists- we recommend acupuncture because many currently accepted medical practices regularly do more harm than good (the examples that spring to mind are the laminectomy, the 'precautionary' cholecystectomy and a large proportion of hyserectomies)- we feel that our interventions are at least less likely to cause permanent, life-changing damage on the patient, and may actually help.



Just like when acupuncture or herbal medicine goes wrong? We all hear about the really nasty side effects and bad stories; good stories are rarely spread as widely as the bad ones. It’s easy to pick on the bad examples and forget about the good. In this case, biomedicine also has alot of amazing and wonderful treatments as well. The problem is that no medicine can claim to treat everything - CM and Biomedicine included. Each has its strengths and weaknesses and it is recognising these that leads to the appropriate use of the related medicine. In the case of laminectomy, the conditions that are treated using this procedure are likely better dealt with by another health professional group. Hence the necessity of recognising limitations of the related health/medical practice.

Tim Cleary wrote:Lastly, I have often wondered about which conditions individual practitioners consider to be outside the scope of acupuncture (emergency conditions aside). Maybe it's a topic for a different discussion.


Yes, please do - put it on the main forum discussion though - it should be very interesting to read the responses!!
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