Acupuncture discussion

topic posted Thu, May 19, 2005 - 5:54 AM by 
I thought this deserves its own thread.

Richard, I have thought about this, and I think I have an answer for you. Not about the JAMA article (which, if I get my hands on, I'll send you a copy of), but how to do DBPCS for acupuncture.

"It's easy to do DBPCS's with pills. Just make somethat look like the real thing but aren't. You can even do it with food stuffs to some extent. Just stuff it in capsules. But with something like traditional acupuncture, where each treatment is different, and each patient would receive a treatment quite different from any other patient how could you blind the treatment? How can you really blind a treatment where it's acknowledged that the intention, energetic strength, and skill of the acupuncturist are at least as important as where the needles are stuck? "

OK, here goes:

The key elements in a double-blind, placebo controlled trial are a) the subject being treated does not know whether they are getting the real thing or the placebo and b) the person gathering data/evaluating outcomes does not know which treatment the patient got. There is no requirement that the person evaluating the outcome be the same as the one who delivered the treatment.

Therefore, here's the trial design:

The TREATMENT group is seen, evaluated, and treated by a Truly Skilled Acupuncturist (TSA) - someone like yourself or someone you would recognize as the real deal. The CONTROL group is seen, "evaluated", and "treated" by a Bull-$hit Artist (BSA) - someone like me, who has watched you do the evaluation and treatment and maybe gotten one or two lessons in sticking needles into someone with a convincing demeanor, but who knows only where to stick the needles (and the places where they are to be stuck are chosen to be bogus anyway). Then, after whatever treatment schedule is done, the patient is evaluated by an independent clinician who does not know which group the patient was in.

This way, we overcome your key objection - that the people delivering treatment aren't really delivering the real thing (because they are not TSAs). In such a setup, the treatment group is getting the best acupuncture that we can find, and the control group is getting stuck with needles by some guy who can talk the talk, but can't treat anything with needles. The patients are treated, the data are gathered by someone who doesn't know how they were treated, the statistical analysis is done, and we can tell whether TSA = BSA.

How's that?
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  • Re: Acupuncture discussion

    Thu, May 19, 2005 - 8:04 AM
    It's OK, but the way that you propose is a single blind. In a true double blind test, neither the person receiving the treatment, nor the person giving the treatment can know whether the treatment is real or sham. In a drug test (at least the ones I've seen) the bottles of pills are randomly coded, and no one involved with the testing procedure having any contact at all with the patients knows what the codes mean, nor has any idea which are real and which are sham. It's done this way so that there isn't the slightest bit of the slightest chance that any type of communication, conscious or unconscious will be transmitted to the test subject from the persons who actually interact with the subject.

    So again, here is the problem with acupuncture being double blinded: as soon as you have a trained acupuncturist putting the needles in, he'll (or she'll of course) know immediately whether it's a real or sham treatment. This will be communicated to the test subject and it will influence the objectivity of the study.

    The only way that I can see of doing this, and it's not really good enough, is to have each patient evaluated by a skilled acupuncturist, who makes a choice of points. Then a third person randomly chooses whether that particular patient gets real or sham points. The choice of points then goes to the technician who will insert either real points or sham points with either proper technique or improper technique, not knowing which is which. You can see that this creates a problem in that the needle tech would have to be fairly highly trained in order to do the treatment. There is a whole lot more to acupuncture than just sticking needles into a person. These variables include depth of insertion, direction of needle, intent and technique used to either tonify, sedate, or give a neutral effect for each needle inserted.

    You could of course have a real acupuncturist doing the insertion, but then you have the problem of the acupuncturist unconsciously evaluating the subject and thus ruining the double-blind aspect.
    • Re: Acupuncture discussion

      Thu, May 19, 2005 - 8:44 AM
      I've been following this topic and I wanted to throw in some stuff.

      Grisha said " I have many thoughtful clinician friends who regard homeopathic medicine as a golden opportunity to do just that - you tell the patient that you can recommend something to try in addition to their conventional therapy (thus "complementary" medicine), which has not been proven to work in any formal scientific sense, but which many people report does them some good. As long as you can do that with a straight face, you've added a treatment modality that might do some good and can't do any harm (since it's basically water). "

      I think it needs to be pointed out that there can be conflicts between homeopathic and western medicine. I've heard of a detrimental St Johns wart and Prozac conflict, not basically water all the time. :)

      About the energies, Grisha, as a fellow fire artist please tell me you have tapped into these energies before. Science is still struggling on how to measure chi and other related energies, but I do believe they exist and they can aid in healing. Nexxus, I see your pure scientific stance, but science isn't perfect hence theories. Once your a practicing nurse for a while you'll whiteness some miracles science cannot explain and maybe you can open up to some other un-scientifically explainable processes. Science isn't always right and it's proven wrong often. :)

      • Re: Acupuncture discussion

        Thu, May 19, 2005 - 12:02 PM
        I see here an error that I often encounter - the confusion of science as a process and science as a body of knowledge.

        Science as a body of knowledge is imperfect and has many gaps. There are many things it can't explain.

        Science as a process is something entirely different, and a full explanation is beyond the scope of this post. The process is one of observing the natural world, coming up with some ideas that might explain a set of data in some useful way, and then constructing an experiment in which the ideas are used to generate some predictions about the outcome which are testable. This process is science... and it has enabled us to generate the body of knowledge and the tools that we use in the process of what most people think of as "science". It is not "proven wrong"... ever. If something happens that is not accounted for by current hypotheses, that becomes grist for the mill... we modify our ideas, and then test those modified ones.


        Cody, "homeopathy" does not mean herbal meds. Medications are medications, whether they are made by a natural chemical process in a plant or a designed chemical process in a chemical plant. There is ample proof that naturally made chemicals have physiological effects (most medications were originally extracts of various plants).

        Homeopathy is a treatment approach that essentially takes a medieval sort of reasoning (like cures like) and involves administering to people substances diluted to 10 ^-200 molar or so (less than one molecule of something per tanker truck volume). This is just water... not medicine of any kind.
        • Re: Acupuncture discussion

          Thu, May 19, 2005 - 12:52 PM
          If you think homeopathy is just water, you might find the following studies interesting:

          Homeopathy for Menopausal Symptoms in Breast Cancer Survivors: A
          Preliminary Randomized Controlled Trial
          Journal of Alternative and Complementary Medicine Feb 2005, Vol. 11, No. 1: 21-27

          Jennifer Jacobs, M.D., M.P.H.
          Department of Epidemiology, University of Washington School of Public
          Health and Community Medicine, Seattle, WA.
          Patricia Herman, N.D., M.S.
          Program in Integrative Medicine, University of Arizona, Tucson, AZ.
          Krista Heron, N.D., D.H.A.N.P.
          Ravenna Homeopathic Clinic, Seattle, WA.
          Steven Olsen, N.D., D.H.A.N.P.
          Snohomish, WA.
          Lucy Vaughters, P.A.-C., C.C.H.
          Edmonds, WA.

          Objectives: To carry out a preliminary trial evaluating the
          effectiveness of two types of homeopathy for the treatment of menopausal symptoms in breast cancer survivors.

          Design: Randomized, double-blinded, placebo-controlled

          Settings/location: Private medical clinic, Seattle, WA.

          Subjects: Women with a history of breast cancer who had completed all
          surgery, chemotherapy, and radiation treatment and who had an average
          of at least three hot flashes per day for the previous month.

          Interventions: Subjects were randomized to receive either an
          individualized homeopathic single remedy, a homeopathic combination medicine, or placebo. Patients were seen by homeopathic providers every 2 months for 1 year.

          Outcome measures: Hot flash frequency and severity, Kupperman Menopausal Index (KMI), Short Form 36 (SF-36).

          Results: There was no significant difference found in the primary outcome
          measure, the hot flash severity score, although there was a positive trend
          in the single remedy group during the first 3 months of the study (p = 0.1).
          A statistically significant improvement in general health score in both
          homeopathy groups (p < 0.05) on the SF-36 after 1 year was found.
          Evidence of a homeopathic "drug proving" in the subjects receiving the
          homeopathic combination medicine who were not taking tamoxifen also was found.

          Conclusions: Small sample size precludes definitive answers, but results
          from this preliminary trial suggest that homeopathy may be of value
          in the treatment of menopausal symptoms and improving quality of life,
          especially in those women not on tamoxifen. Larger studies should be carried out that also include healthy women who want to avoid hormone replacement therapy.




          C. N. Shealy, MD, R.P. Thomlinson, V. Borgmeyer,
          Osteoarthritic Pain: A Comparison of Homeopathy and Acetaminophen
          American Journal of Pain Management, 1998;8:89-91
          A double-blinded study to document the relative efficacy of homeopathic remedies in comparison to acetaminophen for the treatment of pain associated with osteoarthritis (OA) among 65 patients. An IRB approved protocol. Results of the study documented better pain relief in the homeopathic group (55% achieved measured relief from homeopathy as compared to 38% from acetaminophen); however, the superiority of this treatment, in comparison with the acetaminophen group, did not reach statistical significance. The investigators conclude that homeopathic treatments for pain in OA patients appear to be safe and at least as effective as acetaminophen, and are without its potential adverse effects including compromise to both liver and kidney function. Many of the patients asked to continue with the homeopathic treatment.

          M. Weiser, W. Strosser, P. Klein,
          Homeopathic vs. Conventional Treatment of Vertigo: A Randomized Double-Blind Controlled Clinical Study
          Archives of Otolaryngology--Head and Neck Surgery, August, 1998, 124:879-885.
          This was a study with 119 subjects with various types of vertigo, half of whom were given a homeopathic medicine (a combination of four homeopathic medicines) and half were given a leading conventional drug in Europe for vertigo, betahistine hydrochloride. The homeopathic medicines were found to be similarly effective and significantly safer than the conventional control.

          D. Reilly, M. Taylor, N. Beattie, et al.,
          Is Evidence for Homoeopathy Reproducible?
          Lancet, December 10, 1994, 344:1601-6.
          This study successfully reproduced evidence from two previous double-blinded trials all of which used the same model of homeopathic immunotherapy in inhalant allergy. In this third study, 9 of 11 patients on homeopathic treatment improved compared to only 5 of 13 patients on placebo. The researchers concluded that either homeopathic medicines work or controlled studies don't. Their work has again be recently replicated and is submitted for publication. (See Is Homeopathy a Placebo Response? Lancet 1986, below.)

          J. Jacobs, L. Jimenez, S. Gloyd,
          Treatment of Acute Childhood Diarrhea with Homeopathic Medicine: A Randomized Clinical Trial in Nicaragua,
          Pediatrics, May 1994, 93,5:719-25.
          This study was the first on homeopathy to be published in an American medical journal. The study compared individualized high potency homeopathic preparations against a placebo in 81 children, between ages 6 mo. and 5 yrs., suffering with acute diarrhea. The treatment group benefited from a statistically significant 15% decrease in duration. The authors noted that the clinical significance would extend to decreasing dehydration and postdiarrheal malnutrition and a significant reduction in morbidity.

          E. Ernst, T. Saradeth, and K.L. Resch,
          Complementary Treatment of Varicose Veins: A Randomized Placebo-controlled, Double-Blind Trial,
          Phlebology, 1990, 5:157-163.
          This study of 61 patients showed a 44% improvement in venous filling time in the homeopathic treated group when compared with placebo.

          P. Fisher, A. Greenwood, E.C. Huskisson, et al.,
          Effect of Homoeopathic Treatment on Fibrositis
          British Medical Journal, August 5, 1989, 299:365-66.
          This trial was double-blind with a crossover design, comparing R toxicodendron to a placebo in 30 patients all suffering from an identical syndrome identified as the admission criteria. It showed a significant reduction in tender spots, by 25%, when patients were given the homeopathic medicine, as compared to when they were given the placebo.

          D. Reilly, M. Taylor, C. McSherry,
          Is Homeopathy a Placebo Response? Controlled Trial of Homeopathic Potency with Pollen in Hayfever as Model,
          Lancet, October 18, 1986, 881-86.
          The double-blind study compared a high dilution homeopathic preparation of grass pollens against a placebo in 144 patients with active hay fever. The study method considered pollen counts, aggravation in symptoms and use of antihistamines and concluded that patients using homeopathy showed greater improvement in symptoms than those on placebo, and that this difference was reflected in a significantly reduced need for antihistamines among the homeopathically treated group. The results confirmed those of the pilot study and demonstrate that homeopathic potencies show effects distinct from those of the placebo
          • Re: Acupuncture discussion

            Thu, May 19, 2005 - 1:44 PM
            I really cannot engage this in a full debate, as I have a very busy clinical schedule this afternoon and want to finish up and get out of here at some point, but I will summarize my thoughts by saying that:
            a) individual studies rarely add up to anything conclusive, and of the ones you cite either have clear methodological flaws visible even from the abstracts or have little statistical power.
            b) the theoretical principles underlying homeopathy run counter to some very well established precepts of biology and physics. Extraordinary claims, to be believed, must be supported by extraordinary evidence.
            c) while as an MD-PhD, the evaluation of clinical trials is part of my training, I have little or no specific expertise in the area of homeopathic treatment. However, there are intelligent and knowledgeable people whom I know and trust who are experts in this area, and who have told me that the evidence supporting the effectiveness of homeopathic medicine is beyond flimsy and well into the laughable.

            • Re: Acupuncture discussion

              Thu, May 19, 2005 - 1:54 PM
              I think we might be experiencing "if it doesn't fit in my belief system, it can't be happening", or to put it another way, what does a person do when reality may conflict with one's beliefs. Most people simply deny the possibility of the world being anything other than that which fits into their belief structure. I've seen this over and over and over again. Common human trait, btw.

              I also have quite a busy schedule today, so I'm calling it quits for now. I am curious however as to what methodological flaws you see in the above studies.
              • Re: Acupuncture discussion

                Thu, May 19, 2005 - 2:27 PM
                I'll go through them at some point and analyze them if I get to it. I am disappointed that you think I am rejecting the claims made by homeopathic medicine out of hand.

                Serious clinicians and scientists examine claims of new medical treatments of ANY kind with a very critical eye. This includes homeopathy and all non-orthodox treatments, as well as the latest thing from the Mayo or Pfizer. Many of us would love to find some real value to the other approaches. However, the science behind them is shoddy, and the standard of proof we require of new medical treatments has not been met by homeopathy. People are very good at fooling themselves into perceiving patterns that don't exist, and sick people who need some hope are especially vulnerable to this. The whole point of scientific testing of medical treatments is to eliminate that "I want to believe, so I'll make it true in my mind" tendency.

                In any case, this is one area where I don't think we'll be able to really convince each other of anything. Acupuncture is a field where I believe a lot of good work has been donw, but homeopathy is such clear quackery that unless some truly major breathrough occurs no responsible clinician will use it except as a form of placebo treatment.
              • Unsu...
                 

                Re: Acupuncture discussion

                Fri, May 20, 2005 - 12:01 PM
                Calling people closed-minded because they disagree with what you do for a living is somewhat childish, Richard. Don't you think there may be a valid reason we don't support this stuff?

                I swear, according to anyone I ever debate I'm either crazy, stupid, evil, or arrogantly closed-minded. Can't I just have a different point of view? Why demonize your opponent? Ad hominems do no one any good, Richard.

                Common human trait, btw. I've seen this over and over again. ;-)
          • Unsu...
             

            homeopathy articles

            Fri, May 20, 2005 - 11:51 AM
            Richard, the first article was published in the Journal for Alternative and Complementary Medicine. If you don't know their track record for publishing flawed studies... well, you should know that. I find it hard to take anything from that journal seriously.
            Jennifer Jacobs has a track record of producing flawed studies as well, especially her previous study on homeopathy regarding children with diarrhea, which was quickly thrown out because as pointed out in a published critique, the study showed no clinically significant benefits of homeopathic treatment, no benefits were demonstrated for most measured outcome variables, different homeopathic products were used on different subjects, and the subjects did not have diarrhea severe enough for treatment, rather than monitoring, to be indicated.
            She has not gotten much better. That's probably why this was only published in JACM.


            The second study you mentioned had results no better than placebo, actually. Acetaminophen produced similar results, in case you were curious. ;-) To quote straight from the abstract, "the superiority of this treatment, in comparison with the acetaminophen group, did not reach statistical significance."


            Your third article is unavailable, either pulled from the archives due to overwhelming evidence against it, or maybe it was retracted by the authors.


            Your fourth study quoted only used 28 subjects, only 20 of which did any follow-up. It shows a need for more research, but absolutely nothing conclusive by any stretch of the imagination.


            The 5th one you quoted I have already shown to be useless in my first paragraph.


            The 6th, on varicose veins, is also apparently unavailable.


            The 7th is from 1989, too old to pull up online (and too old to conscientiously use as a reference), and in a check at my school the library does not hold archives that long. Can't find it to read it.
            But I did find this: www.ucl.ac.uk/Pharmacolog...html#fisher1


            The foremost author of your last article is none other than David T. Reilly, homeopath to the Windsors of England, and staunch supporter of the debunked Benveniste. Although the study itself was done in 1986 and way too old to really be used as support of anything, the fact that it was done by none other than David Reilly makes it even worse.

        • Re: Acupuncture discussion

          Thu, May 19, 2005 - 12:58 PM
          Forgive my misuse of the rhetoric. :) I have a few questions. What are the substances your diluting in homeopathic treatments? Science process can be prooven wrong, right? Specifically it used to be common accepted fact that different parts of the tougue taste different things, but now we know that isn't true. So that piece of "Science Process" has been proven wrong?

          Just trying to understand your examples. :)
          • Re: Acupuncture discussion

            Thu, May 19, 2005 - 1:27 PM
            OK I don't have time to get into a very lengthy explanation, but right here is an example of what I mean. The specific factoid that "different parts of the tongue taste different things" is not science, nor is it the process of science. It's a hypothesis, or statement, which may be proven wrong (and do we really know that this is not the case? I thought that the distribution of taste receptors does vary from place to place on the tongue...). However, the process of testing an explanation or idea against other ideas in a way which allows you to distinguish which reflects the real world more accurately is in no way diminished by the fact that one hypothesis is overturned. Specific ideas get overturned all the time, but that's part of the process too.

            G
      • Unsu...
         

        Re: Acupuncture discussion

        Fri, May 20, 2005 - 11:04 AM
        Homeopathic does not mean herbal. St. John's wort is herbal, as is chamomile, rose hips, and garlic.

        Homeopathic "medicine" is so heavily diluted, many times well past Avogadro's number, that it's just dilutant and maybe, if you're lucky, one or two molecules of treatment.

        Of course we aren't perfect and don't know everything, Cody. But just because we can't explain something does not make it a "miracle." Just makes it currently unexplained.
        I prefer to side with science because at least it's tested and challenged vigourously. Acupuncture, homeopathy, etc. are not. Practioners of these fight real testing, fight challenges, and throw fallacious arguments around.
        I swear, these "alternative" practices are more religious than anything else -- at least, the followers and practitioners act like it's dogmatic religion. That's a Bad Sign™.
    • Re: Acupuncture discussion

      Thu, May 19, 2005 - 12:46 PM
      However, what I propose would be enough to demonstrate the effectiveness of real acupuncture, if the effectiveness exists. The setup I propose is testing real acupuncture done by real experts against sham acupuncture done by bull$shit artists. If there is a real benefit to acupuncture done properly, it should manifest itself in this test, right? The real treatment group should get much more benefit from the treatment than the sham group.

      If it does not, then we've shown that the best acupuncture is no better than people with a grave professional demeanor sticking needles into people at quasi-random points.

      Remember, the "double blind" part means that both the PATIENT and the EVALUATOR are blinded with respect to the treatment group. The person delivering the treatment need not be blinded. For instance, real surgical procedures are tested this way, with a real operation and a sham operation (where everything but one crucial step is done the same way). The surgeon knows whether they are doing a real or a sham operation, but the patient and the person who assesses the outcome do not.
      • Unsu...
         

        Re: Acupuncture discussion

        Fri, May 20, 2005 - 11:58 AM
        The best way to test treatments with a high risk of placebo effect in all groups of subjects is triple-blind, which is slowly phasing into use with studies on homeopathy, acupuncture etc, where it seems the matter of belief is highly plausible for explaining successful results.

        Triple-blinded studies blind the subject, the administrator of the drug or placebo, and the evaluator. The only person who knows the nature of the substances or techniques given is the head of the study, who remains entirely uninvolved with other paticipants until the end.

        So far, the few triple-blinded studies in existence show no apparent use for homeopathy, acupuncture, reiki, or prayer. Benveniste is among those.
        • Re: Acupuncture discussion

          Fri, May 20, 2005 - 12:51 PM
          Nexxus,

          It makes sense to me that the triple blind methodology would be the ideal way to go, but Richard seems to be raising the objection that the delivery of proper treatment is not possible to do in a truly blinded fashion because the sort of expert who can deliver true acupuncture will know the difference between the test treatment and the negative control. His statement is that anyone who can administer a treatment and not know whether it's the real thing or a negative control is unable to do whatever special thing it is that real practitioners do, and thus the ineffectiveness of the treatment in the study is not a true reflection of its value in the hands of a real expert. My thought was that we might be able to circumvent those objections at least for the purposes of establishing that there is some non-placebo effect taking place when a real expert delivers the best acupuncture care s/he can.

          Incidentally, thank you for taking on the task of addressing the homeopathy studies. In addition to the (rare) ability to write and think clearly, you appear to have knowledge of the field, and know some of the names (famous or infamous) within it. If you don't mind my asking, how does a nursing student come to have such detailed knowledge of a field which, AFAIK, is not part of the standard nursing curriculum? Is this a subject you have studied out of personal curiosity, or does your background include some formal training in this?

          G
          • Unsu...
             

            Re: Acupuncture discussion

            Fri, May 20, 2005 - 2:46 PM
            Grisha,

            The reason I know so much about CAM (complementary/alternative med) is that I used to be a practitioner. Herbalism was my specialty, but I followed homeopathy and acupuncture as well. To a lesser degree, reiki. I still keep up with it today as a personal interest. We do not study it in school, which I think is a shame, really.

            It's a long story, but I've since found most CAM to be not only placebo at its base, but in many instances it can be harmful, as in herbalism. I've also found that most practitioners and followers of CAMs adhere to more religious and dogmatic thinking than scientific or critical thinking regarding their particular treatment or technique. I find it frightening sometimes, the attitude that their way is The True Way™ which needs no testing, and all else be damned.

            I don't personally have anything against CAM, as long as it works. The sad thing is, so many doctors and researchers who support CAM have such shady research practices it makes all of CAM look bad. I wish they would be more honest, so we can get honest results and can trust them more freely as professional researchers. Sadly, as it stands right now, we just can't do that. The past has tainted the present, and I think it's important to regard all CAM studies as skeptically as possible, at least until they have proven to clean up their acts.


            My question regarding Richard's complaint: Why can't acupuncture work with a non-expert?
            If it's just about sticking the needles in the "right" places, anyone given a proper chart can do that.
            If it's about manipulating an unseen, unmeasurable "energy" that only experts can detect (by invisible means), how can we even test this? It goes from falsifiable to unfalsifiable in a heartbeat and makes all tests worthless.
            And then there's the question of how we decide what the "right" places are. I already stated that each acupuncturist does it differently. There are a million and one meridian charts and point charts, all slightly different from the next. Which one is right?
            And then there's regular Chinese acupuncture, Japanese acupuncture, Western acupuncture, combination acupuncture, etc etc etc. Which one of those is right?

            As for the objection to the study, a real acupuncturist can give "real" acupuncture, while a doctor posing as an acupuncturist can give the placebo acupuncture.
            The subjects were treated at 18 different centers in Germany, so I find it quite plausible that this would be the case. I do not know for sure, however.

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