MD, PhD, FMedSci, FRSB, FRCP, FRCPEd.

Can I tempt you to run a little (hopefully instructive) thought-experiment with you? It is quite simple: I will tell you about the design of a clinical trial, and you will tell me what the likely outcome of this study would be.

Are you game?

Here we go:

_____________________________________________________________________________

Imagine we conduct a trial of acupuncture for persistent pain (any type of pain really). We want to find out whether acupuncture is more than a placebo when it comes to pain-control. Of course, we want our trial to look as rigorous as possible. So, we design it as a randomised, sham-controlled, partially-blinded study. To be really ‘cutting edge’, our study will not have two but three parallel groups:

1. Standard needle acupuncture administered according to a protocol recommended by a team of expert acupuncturists.

2. Minimally invasive sham-acupuncture employing shallow needle insertion using short needles at non-acupuncture points. Patients in groups 1 and 2 are blinded, i. e. they are not supposed to know whether they receive the sham or real acupuncture.

3. No treatment at all.

We apply the treatments for a sufficiently long time, say 12 weeks. Before we start, after 6 and 12 weeks, we measure our patients’ pain with a validated method. We use sound statistical methods to compare the outcomes between the three groups.

WHAT DO YOU THINK THE RESULT WOULD BE?

You are not sure?

Well, let me give you some hints:

Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.

Group 2 will be pleased to receive some treatment. However, during the course of the 6 weeks, they will get more and more suspicious. As they were told during the process of obtaining informed consent that the trial entails treating some patients with a sham/placebo, they are bound to ask themselves whether they ended up in this group. They will see the short needles and the shallow needling, and a percentage of patients from this group will doubtlessly suspect that they are getting the sham treatment. The doubters will not show a powerful placebo response. Therefore, the average pain scores in this group will decrease – but only a little.

Group 1 will also be pleased to receive some treatment. As the therapists cannot be blinded, they will do their best to meet the high expectations of their patients. Consequently, they will benefit fully from the placebo effect of the intervention and the pain score of this group will decrease significantly.

So, now we can surely predict the most likely result of this trial without even conducting it. Assuming that acupuncture is a placebo-therapy, as many people do, we now see that group 3 will suffer the most pain. In comparison, groups 1 and 2 will show better outcomes.

Of course, the main question is, how do groups 1 and 2 compare to each other? After all, we designed our sham-controlled trial in order to answer exactly this issue: is acupuncture more than a placebo? As pointed out above, some patients in group 2 would have become suspicious and therefore would not have experienced the full placebo-response. This means that, provided the sample sizes are sufficiently large, there should be a significant difference between these two groups favouring real acupuncture over sham. In other words, our trial will conclude that acupuncture is better than placebo, even if acupuncture is a placebo.

THANK YOU FOR DOING THIS THOUGHT EXPERIMENT WITH ME.

Now I can tell you that it has a very real basis. The leading medical journal, JAMA, just published such a study and, to make matters worse, the trial was even sponsored by one of the most prestigious funding agencies: the NIH.

Here is the abstract:

___________________________________________________________________________

Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors and often result in therapy discontinuation. Small studies suggest that acupuncture may decrease aromatase inhibitor-related joint symptoms.

Objective:

To determine the effect of acupuncture in reducing aromatase inhibitor-related joint pain.

Design, Setting, and Patients:

Randomized clinical trial conducted at 11 academic centers and clinical sites in the United States from March 2012 to February 2017 (final date of follow-up, September 5, 2017). Eligible patients were postmenopausal women with early-stage breast cancer who were taking an aromatase inhibitor and scored at least 3 on the Brief Pain Inventory Worst Pain (BPI-WP) item (score range, 0-10; higher scores indicate greater pain).

Interventions:

Patients were randomized 2:1:1 to the true acupuncture (n = 110), sham acupuncture (n = 59), or waitlist control (n = 57) group. True acupuncture and sham acupuncture protocols consisted of 12 acupuncture sessions over 6 weeks (2 sessions per week), followed by 1 session per week for 6 weeks. The waitlist control group did not receive any intervention. All participants were offered 10 acupuncture sessions to be used between weeks 24 and 52.

Main Outcomes and Measures:

The primary end point was the 6-week BPI-WP score. Mean 6-week BPI-WP scores were compared by study group using linear regression, adjusted for baseline pain and stratification factors (clinically meaningful difference specified as 2 points).

Results:

Among 226 randomized patients (mean [SD] age, 60.7 [8.6] years; 88% white; mean [SD] baseline BPI-WP score, 6.6 [1.5]), 206 (91.1%) completed the trial. From baseline to 6 weeks, the mean observed BPI-WP score decreased by 2.05 points (reduced pain) in the true acupuncture group, by 1.07 points in the sham acupuncture group, and by 0.99 points in the waitlist control group. The adjusted difference for true acupuncture vs sham acupuncture was 0.92 points (95% CI, 0.20-1.65; P = .01) and for true acupuncture vs waitlist control was 0.96 points (95% CI, 0.24-1.67; P = .01). Patients in the true acupuncture group experienced more grade 1 bruising compared with patients in the sham acupuncture group (47% vs 25%; P = .01).

Conclusions and Relevance:

Among postmenopausal women with early-stage breast cancer and aromatase inhibitor-related arthralgias, true acupuncture compared with sham acupuncture or with waitlist control resulted in a statistically significant reduction in joint pain at 6 weeks, although the observed improvement was of uncertain clinical importance.

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Do you see how easy it is to deceive (almost) everyone with a trial that looks rigorous to (almost) everyone?

My lesson from all this is as follows: whether consciously or unconsciously, SCAM-researchers often build into their trials more or less well-hidden little loopholes that ensure they generate a positive outcome. Thus even a placebo can appear to be effective. They are true masters of producing false-positive findings which later become part of a meta-analysis which is, of course, equally false-positive. It is a great shame, in my view, that even top journals (in the above case JAMA) and prestigious funders (in the above case the NIH) cannot (or want not to?) see behind this type of trickery.

98 Responses to PLEASE JOIN ME IN A FUN EXPERIMENT: Let’s design a study that might deceive (almost) everyone

  • That is extremely informative. Thank you. I learned a lot from this and from similar detailed explanations of scam experiments in your latest book “SCAM” (so called alternative medicine)

  • Agreed. But how would you suggest improving the study design for acupuncture trials in terms of the placebo control arm? Double blind studies will not be possible for obvious reasons. Is the only alternative to include further treatment arms (e.g. here: physiotherapy)?

  • Unfortunately since retiring I have lost the access to many academic journals that I used to have through my place of work. I was therefore unable to read the original paper to see how the trial was conducted. Could you confirm that the sham acupuncture was minimally-invasive using short needles?

    • yes, that section of my post is copied directly from the JAMA paper

      • Thank-you for clarifying that.

        I can certainly see the difficulty with managing adequate controls in an acupuncture trial, though I would have thought the problem would not be so much that the sham treatment itself is unconvincing (unless the subjects already have enough experience of receiving acupunture that they can tell the difference, which would be simple to manage by making previous acupuncture an exclusion), as that the person performing sham acupuncture will know that he is not doing it properly, and somehow convey his doubt to the patient. Perhaps the answer would be to train a skeptical investigator in acupuncture technique.

        Certainly the similarity in results between the untreated control arm and the sham arm strongly suggests that the sham treatment was not a very effective placebo, whatever the reasons might be.

        I still think it is unwise to dismiss all trials of this type, however. We still know so little of the mechanisms of the body’s response to injury, and it seems plausible to me that the trauma of putting needles into skin or muscle has some physiological effect. That this is confined to acupuncture meridians seems less plausible, and that the treatment is unblocking the flow of qi, heat or any other mystical fluid seems very implausible indeed.

        I think it would be interesting to investigate whether acupuncture, however performed, has any consistent, measurable effect on inflammatory markers, or up-regulation / down-regulation of genes involved in inflammatory processes. Finding that it did would not necessarily validate it as a useful treatment, however.

        • ” Perhaps the answer would be to train a skeptical investigator in acupuncture technique.”
          that’s a good idea; I have proposed it often but do not know more than 1 study where it has been done.

          • I’m not sure how many skeptical investigators would be willing to undertake the 3 years + full-time study and clinical exposure it would take to gain beginner-level acupuncture proficiency? Anything less than that, and arguably anything that uses a protocol-based treatment, wouldn’t be a measure of real-world treatment by an acupuncturist, which is surely what should be under examination? I’m well aware of the problems that poses for trial design, but trials that don’t insist on this seem pretty pointless (excuse the pun).

          • you don’t need 3 years to stick in some needles.
            so, a fully trained acupuncturist could mark the ‘right’ points in black and some ‘wrong’ ones in red.
            then the patient sees a competent needler who looks up the random code and needles accordingly either the red or the black points.
            NOT ROCKET SCIENCE, IS IT?
            but in my experience, acupuncturists are not truly interested in falsifying their beliefs; to me, THAT is the main problem in alt med research [as I have stated ad nauseam].

        • Fully agree with your arguments. Thank you for this!

  • Of course, a lot of questions and remarks in the margin arise. For instance, what is your source / what are you thoughts for stating re. Group 3, “but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.” Perhaps all of them are ardent readers of your blog and are happy to not object, understanding the aims of the study? Who can tell?

  • Excellent! My question has always been: I have been alive, at least rudimentarily for many decades and can recall no time nor any condition where I experienced a placebo-response. I’m still trying to give “it” some sort of practical-parameter(s) to which I could understand it personally. Perhaps like faith and pornography you ‘know it when you see’….but for me I’m still outside looking in. I just don’t think I ever “got better” or better “faster” due to some outside-agent substantially altering my inside-workings.

  • Thank you so much for this, it pretty much blew my mind! I knew from reading your blog about the non-penetrating sham needles, and how the efficacy of acupuncture vanishes in trials using them, but I have to admit I thought these single-blinded trials had at least a little bit of methodological legitimacy.

    I’m wondering: how come these needles are not the gold standard by now?

    Obviously trials by acupuncturists won’t be using them, but the NIH should. Ethical committees approving trial design should know about them. Peer reviewers too. So what’s going on?

    • because the do not deliver the results acupuncturists want, they were quick at trying to discredit these sham devices.

  • ‘You don’t need 3 years to stick in some needles. so, a fully trained acupuncturist could mark the ‘right’ points in black and some ‘wrong’ ones in red.’

    I (and most other acupuncturists) would disagree entirely. Learning to correctly needle a point for the given situation takes a lot of skill and practice, it’s really not just ‘sticking in some needles’. And, although there are many specific point locations that are more-or-less agreed upon, almost anywhere can be a ‘right’ point, regardless of whether it is in a text book. Visual inspection, careful palpation, and feedback from the patient are all crucial in determining point locations. I’m amazed after all your years in the field that you haven’t picked up on some of these basic principles.

    Of course, if you assume acupuncture is nothing but placebo, none of the above is of any interest.

    • Likewise, shallow needling is not a sham technique – Japanese acupuncture uses shallow needling almost exclusively. Surely you know that?

      • you don’t need to sound like a patronising git each time you comment. [BTW, I did know that}

        • Coming from someone who responded to my first message with ‘NOT ROCKET SCIENCE, IS IT?’ – amazing.

          • “not rocket science” is a correct statement of fact.
            “I’m amazed after all your years in the field that you haven’t picked up on some of these basic principles.” sounds patronising, particularly when it is based on the wrong assumption that I am unaware of the basic principles of acupuncture.

    • “Learning to correctly needle a point for the given situation takes a lot of skill and practice”
      but not 3 years; it’s a technique that can be learnt in a much shorter time.
      “Visual inspection, careful palpation, and feedback from the patient are all crucial in determining point locations.”
      this would all be possible in my set-up.
      “. I’m amazed after all your years in the field that you haven’t picked up on some of these basic principles. ”
      thank you for this disclosure of your failure to understand what I suggested.

    • The problem with that line of thought is that no trial or “skeptical investigation” of acupuncture will ever satisfy these requirements. Even with the best possible methodology, many will still say : “It’s not real acupuncture, real acupuncture has to be individualized and improvised according to patient feedback, etc.”. In other words, moving the goalposts.

      Out of curiosity: from what I understand, using the non-penetrating sham needles allows fully-trained – and fully-blinded – acupuncturists to take part in the trial. Would you accept findings of such a trial then?

      • @Oliver I don’t see it as goalposts being moved. Most acupuncturists would simply expect a fair test of their craft to involve experienced practitioners doing something closely resembling what they do in their clinics – that’s the original position of our goalposts. Is it more important to control for every possible extraneous variable, and therefore potentially water down the skill involved in the procedure? Or is it more important to test the real-world technique in question? I agree that it’s a problem, and the ‘best possible methodology’ is very much a matter of opinion.

        • @Olivier

          ‘Out of curiosity: from what I understand, using the non-penetrating sham needles allows fully-trained – and fully-blinded – acupuncturists to take part in the trial. Would you accept findings of such a trial then?’

          I imagine that the ‘real’ group in such trials have to use needles that look the same as the sham needles – i.e. with a plastic base and an insertion tube. I can’t see how it would be possible to use standard needle techniques with that type of needle. And you definitely can’t fully blind the practitioner – sensitively feeling the response of the tip of the needle to the underlying tissue is fundamental.

          I also assume (having never used one) that the needle housing needs to be stuck cleanly onto the patient’s skin, which would make their use on hairy areas such as the occiput (a key area for headaches, for example) difficult or impossible without shaving the patient first.

          So, whilst I acknowledge the ingenuity of these needles, and can see how they could be used to gain certain useful insights, I don’t see how they can accurately mimic real-world acupuncture.

          • one could run a trial of the active devices versus ‘real-world acupuncture’ to test whether your assumption that their effects on health differ. until we have such data, your assumption is speculative, in my view.

  • But it isn’t a single technique – there are multiple needling techniques, depending on the given situation, the patient’s constitution, the point being needled etc. Yes, anyone can learn to put a needle in someone’s skin fairly easily, but to act on it in a way most likely to bring about a beneficial change is another story. I’ve been an acupuncturists for more than 10 years, and I’m certainly still learning about needling techniques.

    • and in what way would this be a hindrance to the trial I suggested?

      • You were talking about training skeptical investigators to perform acupuncture – I’m suggesting that would be inadequate unless they undertook full training, which presumably they wouldn’t be willing to do.

        • exactly!
          and you are mistaken; the sceptical investigator would need to learn the hand-on technique, but nothing about point selection, meridians, yin/yang-woo etc.

          • But they aren’t separate things, at least not to acupuncturists – in order to needle a point correctly, you need a framework of theoretical understanding, as well as many hours of guidance and experience. You can perhaps test one type of beginner’s pin-sticking against another type, but neither will be real acupuncture.

          • now, if that isn’t moving the goal post….
            either that, or you really take yourself so frightfully seriously.
            there is absolutely no evidence that beginners are worst than experienced acupuncturists; on the contrary, there was one comparison that showed that there is no difference [Melchart/Linde … if you want to look it up].
            now can we please discuss the topic at hand?

          • It seems to me that this discussion about how to test the effectiveness of acupuncture is really a discussion about what hypothesis should be tested.

            1. Deep vs. superficial needling

            2. Skin penetration vs. non-penetration

            3. Treatment delivery by experienced vs. inexperienced practitioner (on the basis that the experienced acupunturist will be able to sense the precise position of the acupuncture points in that specific patient rather than approximating them from a chart, or have honed some other skill)

            4. Chinese vs. Western acupunture (bearing in mind the different belief systems and the widespread superstition among Chinese people)

            5. The whole package (assessment of the patient, choice of treatment, delivery and duration) vs. a conventional medical approach

            Clearly each of these questions would require a different study design and would have its own difficulties.

          • true – but the real null-hypothesis has to be ACUPUNCTURE IS NO DIFFERENT FROM A PLACEBO; and to test it, we do not necessarily need all the hypotheses you listed.

  • ‘“not rocket science” is a correct statement of fact.’

    I think most people would agree that ‘NOT ROCKET SCIENCE, IS IT?’ in shouty capital letters could be construed as patronising. I took it that way at least, and responded sarcastically because of the tone you’d set. You’ll note I didn’t respond in that tone to Olivier, because of the way he put his point across.

    • I noticed that you often seem to prefer to distract from the subject of the post instead of relating to it.
      perhaps you read it again and, if you have something meaningful to say about the topic, please do so.
      your contributions so far have been mere distractions, in my view.

  • Edzard, if you are looking for someone to help devise a study that deceives people , I nominate James Randi!!

  • “Group 3 is not going to do very well; not only do they receive no therapy at all, but they are also disappointed to have ended up in this group as they joined the study in the hope to get acupuncture. Therefore, they will (claim to) feel a lot of pain.”

    They used a wait list which was an attempt to minimize any effect of “disappointment”

    Also the natural progression of a condition can be towards resolution and may be observed in an inactive control group. Therefore, the inactive control group serves as a more natural baseline.

  • ‘one could run a trial of the active devices versus ‘real-world acupuncture’ to test whether your assumption that their effects on health differ. until we have such data, your assumption is speculative, in my view.’

    I agree, that would be interesting to see. And yes, I agree that my assumptions have to be classed as speculative because they’re based on my personal experiences.

    But they are also based on fundamental principles of traditional acupuncture (and more modern styles), and it seems reasonable that any study ought to allow for these principles if they purport to draw broad conclusions.

    • And what are the ‘fundamental principles of traditional acupuncture’ based on?
      Assumptions!

      • I would say ‘observations’, if I had to pick a single word.

        • Dear Mr. Kennedy,
          I have read your posts with interest and if I summarize your statements correctly (please correct me if I´m wrong), your basic claims are:
          • Acupuncture is effective for treating several health issues.
          • Acupuncture is difficult to learn and practice correctly.
          • Acupuncture is more than just sticking the correct number of needles into the correct positons (acupoints) for the correct frequency and time period; therefore simple, reliable protocols do not exist and never will. Quote: “(…)almost anywhere can be a ‘right’ point, regardless of whether it is in a text book.”
          You describe acupuncture as more like an “art of healing”, since even the best methodology is a matter of the opinion of the acupuncturist.
          • “Fair” testing of acupuncture cannot be achieved via Randomized controlled trials (RCTs), as modern medicine requires.

          IF you would be correct, the only logic conclusion in my opinion would be to currently BY NO MEANS GET ANY TREATMENT FROM AN ACUPUNCTURIST!
          My reasoning is mainly based on these two issues:
          1. Acupuncture can have severe side effects (evens deaths have been reported) and the benefits are not proven beyond placebo via RCTs for the reasons you mentioned, therefore it is not possible to state that the risk vs. benefit balance is positive.
          2. In Germany alone, many THOUSANDS of persons (some are doctors, some are not) offer acupuncture. I have checked the numbers of a webpage that lists German doctors (“jameda”). More than eleven thousand (!) persons are listed offering acupuncture. The real number must even be higher, since this list will not be complete.
          If you are correct and the “real art” of acupuncture is so difficult to learn, the MAJORITY of these persons must be CHARLATANS. Even if an effective acupuncture treatment beyond placebo WOULD exist (which I doubt), there is no way for me to know if the acupuncturist that I picked is one of the few that does it correctly. Even worse, even the acupuncturist cannot know it (see point #1), since positive feedback from the clients is not evidence that the method works, as has been pointed out numerous times before in this blog.

          From my point of view, acupuncturists must FIRST establish reliable, reproducible treatment methods/protocols that are verified to be more effective than placebo. Next, those protocols (and only those!) must be taught to all acupuncturists and legislation must make sure that education of acupuncturists is of high quality. ONLY THEN, any treatment should be offered and ONLY THEN I would consider seeing an acupuncturists.
          Unfortunately, TCM has been made up a very long time ago, where the inventors where ignorant of all knowledge that modern science has brought us since then. So if TCM or acupuncture would have been dreamt up today, it would not pass the any modern test for logic or efficacy.
          I assume that you will disagree, please indicate why my approach is wrong.

          • @Jashak Thanks for your interesting questions. I more or less agree with your summary of my basic understanding of acupuncture. However, I do think there’s a place for protocol treatments – I just doubt that they’re optimal. I think a group of recognised points chosen by a panel of experienced practitioners is a better bet than a group chosen from the index of a textbook by a scientist, for example. But the accepted norm in traditional practice involves individualised point prescriptions based on many factors, including specific symptoms (not just disease category), observation of the patient, careful palpation of the points etc. And the needling angle/depth/manipulation technique will vary considerably too depending on the situation.

            But I hold out hope that better and ‘fairer’ ways of evaluating the various styles of acupuncture will emerge. I can’t see at the moment how we’ll ever develop something that will satisfy all parties, but I hope we do.

            ‘IF you would be correct, the only logic conclusion in my opinion would be to currently BY NO MEANS GET ANY TREATMENT FROM AN ACUPUNCTURIST!’

            I understand that reaction, but it is based on a fairly extreme standpoint that I don’t think most people share. If we only ever considered trying things that were proven beyond any doubt with placebo-controlled RCTs, our options would be pretty limited. What about exercise therapy for example? And should we only consider surgical procedures that have been proven to work consistently over placebo? How many other conventional medical approaches would have to be discarded?

            I’m not suggesting acupuncture shouldn’t be tested as robustly as possible – I’d love to know for sure whether the approaches I’ve learned really are as effective as they seem to be, and whether there are techniques I’m missing out on that would further improve my results. But for now at least I feel I have to keep doing my best to evaluate all the evidence available to me, including the feedback I get from patients.

            I share your desire for tighter regulation, but in this country for example people can find a register of practitioners with degree-level training via the British Acupuncture Council website, which helps to ensure safe practice. The studies that I’m aware of suggest that adverse events are minor and extremely rare when treatment is carried out by fully trained practitioners.

          • @ Mr. Kennedy,
            Quote#1:“ I understand that reaction, but it is based on a fairly extreme standpoint that I don’t think most people share. “
            I consider it not extreme, but rational and logical. Why would I want to be a guinea pig for unproven treatments? The only exception would be a participation in a RCT trial. And why would I prefer acupuncture over less invasive options like e.g. exercise therapy? Or even prefer it over rubbish like homeopathy, for that matter?

            Quote#2:“ If we only ever considered trying things that were proven beyond any doubt with placebo-controlled RCTs, our options would be pretty limited. “
            I strongly disagree. Maybe YOUR options as an acupuncturists are limited (more precisely, you would not have any options left), but fortunately we live in a time where for many health issues, evidence-based treatments are available in developed countries like Germany.

            Quote#3:“What about exercise therapy for example? And should we only consider surgical procedures that have been proven to work consistently over placebo? How many other conventional medical approaches would have to be discarded?”
            I have and I will ONLY use treatments that have proven efficacy in RCTs or AT LEAST treatment/remedies where the specific mode of action is based on the best of modern scientific evidence. Both are not true for acupuncture and the TCM ideology behind it.
            I indeed have very strong opinions on this, partly because I was diagnosed with cancer three years ago, so also on a personal level , these issues are more than just thought experiments to me.

  • @Edzard I’d be interested in your thoughts on this study:

    https://academic.oup.com/brain/article/140/4/914/3058778

    I hope you don’t think it’s a distraction from the topic. The topic is acupuncture trial design, and this seems to be an intriguing example of trial design that seeks to measure objective outcomes and therefore bypasses the placebo problem. It’s a shame they used electro-stimulation, because I agree this muddies the waters. But what are your thoughts on the trial design, and do you agree with the conclusions?

    • seems interesting; much of the methodology is way outside my expertise. to provide an informed opinion would need more time than I currently have.

    • @ Tom
      Reading the introduction I could ascertain that this study does not test acupuncture. The title should say ‘electrostimulation’ not ‘acupuncture’ Why did this paper get published with such a grossly misleading message?

      • @Bjorn, as I said, it’s a shame they used electro-stimulation. I hope there are follow-up studies that look at the same thing minus the electro.

        • Yes you said that and I expected this to be a comparison of “electroacupuncture” with AP. But this trial has NO relevance at all to AP. NONE of the arms involve AP. In my view, saying that this is a trial of acupuncture is completely wrong, might even be called misconduct. Someone needs to complain to the journal. Electrostimulation is not remotely a test of the efficacy of AP. That is the problem with a large proportion of papers purporting to test AP.

  • So we have a study which has a methodological loophole and produced results that have uncertain clinical importance with a treatment that has no identifiable * basis of action. In my view this study confirms that acupuncture does not work.

    * okay, stick a needle in me and my brain will recognise it and you might temporarily take my mind off other things. I can self treat by banging my head against a wall or more productively listen to a spot of Mozart. The wall prefers Mozart.

      • No. Because I agree with a previous post – this is not a trial of acupuncture but rather a trial of applying electric stimulation. Furthermore, because the symptomatic impacts are similar until unblinding takes place, which as the authors state is a possible confounding reason for the increase in symptoms of sham acupuncture post unblinding.

        I can accept that electric stimulation of the body can result in physiological changes. I don’t think on the basis of this study I can accept that needling alone can produce these changes. Furthermore given that prior to unblinding all of the arms of the trial had similar improvements in symptom scores, my interpretation would be that the improvements seen in symptom scores from all arms are down to patient’s perceptions having been changed by taking part in the trial. The physiological changes as measured may have no relevance to the symptom scores.

  • @Jashak – I’m sorry to hear about your diagnosis, and I wish you all the very best.

    I agree, yours is a rational and logical approach, but to my mind it’s a fairly extreme form of rational logic. I consider myself to be rational and logical too, but perhaps in a less fundamental way. My own approach – and that of many other people – would be to cast the net beyond the mainstream in the (I think) rational expectation that not everything that could help me has yet been deemed ‘proven’, and perhaps never will be. Certainly, in my experience treating cancer patients at the Penny Brohn Cancer Care Centre, I’ve been moved by how helpful many of them have found complementary approaches including acupuncture, and I feel honoured to have had the opportunity to offer them the chance to try it. Incidentally, these therapies are offered as support to conventional medicine rather than alternatives.

    RE quote 2, perhaps things are different in Germany, but many people come to me because they feel they aren’t being offered adequate options by conventional medicine. Of course, that doesn’t mean everyone has that experience, but apparently many do.

    I understand and respect your approach, but my own experiences and outlook lead me to different conclusions.

    • @Mr. Kennedy,
      Thank you for your wishes.
      You say that you consider yourself as being a rational and logical person; however, the very next sentence indicates that you are not. Logic cannot be separated into “extreme” or “fundamental” forms and less “extreme/fundamental” forms. Either something is logical or it is not.
      But you are correct that once I have arrived at a logical conclusion, I tend to follow this route, until new evidence/information causes me to change my view. Especially if my life or well being depends on it.

      We both agree that OF COURSE, “not everything that could help me has yet been deemed ‘proven’, and perhaps never will be”. But this does not explain why one should BELIEVE in acupuncture. You have not addressed why one should prefer acupuncture over e.g. homeopathy. So where´s the logic behind the choice for acupuncture, if solid scientific evidence is missing and, as I have pointed out, you cannot trust the qualification of the acupuncturists?!

      In the last sentence you mention that you rely on your own experience. I had a long dispute with one of your colleagues, Mr. M. Bauer, about this topic in a recent blog article of Prof. Ernst.
      https://edzardernst.com/2018/06/why-do-insurance-companies-pay-for-ineffective-treatments/

      Since I don´t want to go through this again, let me summarize my position: The best (if not only) way today to find out if a medical treatment/remedy is effective or not is via RCTs. Personal experience is not a valid path to the truth, as discussed in detail in the blog comments.

      • @Jashak – It seems as though we’ll have to agree to disagree. To my mind, Mr Spock is ‘extremely logical’, and the idea behind his character is that he behaves that way because he’s only half human! Approaching everything as if there were a binary ‘logical’ or ‘illogical’ answer seems to me a robotic approach to life, and one at odds with the way nature works. Although I suspect you wouldn’t enjoy it immensely, you might do well to read the Dao De Jing if you want to understand some of the ideas behind Chinese medicine, which embrace uncertainty: https://www.amazon.co.uk/Dao-Jing-Roger-T-Ames/dp/0345444191

        There are plenty of people who try acupuncture for logical reasons – someone they know and trust has benefited from it, for example. And without doubt, much of the scientific evidence is open to interpretation – many look at it and reason, quite logically, that there is at least ‘something going on’ that can’t be brushed aside. Add to this the existence of regulatory bodies such as the British Acupuncture Council. which give assurances about training and safety, and trying acupuncture for let’s say migraine is, I would argue, a perfectly rational option.

        The fact is that life is full of shades of grey, and although the scientific method clearly has its place and has lead to all manner of amazing developments, it’s not a perfect system. I can’t quite imagine what life would be like without such things as instinct, and without at least a reasonable degree of trust in ones own experiences. I certainly wouldn’t want to have surgery, for example, from someone who relied only on the letter of the evidence-based manual, and shut themselves off from their experience and judgement. Any endeavour that involves experience and skill (and I believe acupuncture very much falls into that category) will always be mediated by personal experience, however closely the evidence base is adhered to.

        • @Mr Kennedy,
          • First, I think it is quite funny (and revealing), that -during a discussion about the scientific value of acupuncture- you choose your example from SCIENCE FICTION. But ok, if you like Star Trek so much: When it comes to decisions about heath related issues, I would indeed always apply Spock’s approach and choose the evidence based treatment (derived from many successive logical conclusions).

          • You seem to confuse logical behavior with the reality of human nature. Despite the fact that I try to base my health decisions on logic and reason, I have of course human instincts and emotions like everybody else. For example, while trying to assess your comments, my emotion is an increasing level of frustration, because you repeatedly avoid this question:
          *On what logical basis should a person prefer acupuncture over homeopathy, since reliable scientific evidence for efficacy is lacking for both?
          For me, both methods are worthless, until they prove to have a positive risk/benefit balance.
          I assume that you cannot give a logical answer to my question, so you avoid it. Instead, you praise the fact that humans unfortunately have a strong tendency to irrational, believe in their own (extremely limited) experience and, as a consequence, make wrong health decisions (e.g. seek help from an acupuncturist). In my opinion, you should base your decision about health issues on the best available scientific evidence even if this goes against your own experience, instincts, or any “ancient wisdom”. As long as the evidence that acupuncture has a specific benefit (BEYOND placebo, regression to the mean, natural progression, etc.) is not reliable (or present at all) and as long as there is no possibility that you can trust the qualification of the person that´s sticking needles into your body, my conclusion is that acupuncture cannot be recommended for any health issue. Instead, less invasive therapies should be chosen without the potential risks that acupuncture involves.

          • You are now the second acupuncturist on this blog who tries to lecture me. May I ask you WHY you think that you are qualified to give lectures about “how nature works”? As a biologist, I am always open to learning something new about nature, but it should please be based on evidence and reality, not on >2.000 year old scriptures like the Dao De Jing, the Bible, the Talmud, etc., written at a time when people didn´t even know that molecules, cells or microbes exist or how neurons transmit signals, etc. etc. etc..
          So if your qualification is the study of >2.000 year old TCM philosophy, I would like to ask you to refrain from patronizing comments on “how nature works”.
          Instead, I recommend that you read scientific literature that is more up to date.

          • @Jashak ‘On what logical basis should a person prefer acupuncture over homeopathy, since reliable scientific evidence for efficacy is lacking for both?’

            Sorry, time is short and I haven’t had time to respond to every point. My knowledge of homeopathy is very limited, and I haven’t studied the evidence base. However, let me suggest a decision matrix that to me is a logical and reasonable one.

            1) If you have condition or symptom X, first go to your doctor to see what they have to say. They are likely to be well trained in spotting serious or life-threatening conditions that Google or a non-medically trained practitioner are more likely to miss. And despite the known shortfalls in the conventional medical model (the financial influence of drug companies, the unreliability of many clinical trials etc.) they will hopefully be able to explain some of the evidence-based options to you.

            2) If the condition is serious or life-threatening, follow your doctor’s advice, but also consider the following steps if you want to explore complementary avenues.

            3) If the condition isn’t serious or life-threatening, research the potential side-effects of the treatment options offered by your doctor. If they are serious or unpleasant, and if you can afford it consider looking into CAM options. Start with those that have the most promising scientific backing where possible. Bear in mind that there is a range of opinion about how best to test complementary approaches and how the results of these trials should be interpreted. If you look into both sides of this argument and conclude that you only want to try approaches that are solidly backed by placebo controlled trials, avoid those that aren’t. If you conclude however that other forms of evidence, including pragmatic trials, physiological markers, and even the anecdotal experience of others is worth taking into account too, weigh up both the skeptics’ and advocates’ assessment of this data. If you don’t find anything that meets your criteria, weigh up the potential side-effects of your doctor’s offering against your current symptoms and make a decision accordingly.

            3) If step 2 leads you to believe treatment Y is worth trying, find out all you can about its safety record and potential side effects. Talk to your doctor about treatment Y to get their opinion. Ask friends and family whether they’ve tried treatment Y and consider their experiences too.

            4) If you still believe that treatment Y is worth trying, find a governing body that insists on high training and safety standards, find a registered practitioner and contact them to ask any questions you might have. If they can answer your questions satisfactorily, book an initial appointment.

            5) Judge the results of the treatment/s for yourself, and if they aren’t satisfactory, weigh up your options again.

            This is basically what I did many years ago for my own health problems, and it led me to acupuncture, not homeopathy. I was extremely happy with the results I got, I became interested in the field, and the rest is history.

            So it seems we have a different way of going about things, and that’s fine by me. I don’t think that makes me irrational.

            As for your final point, I do not mean to lecture you at all. I suggested that nature doesn’t work in a predictable, binary way. Of course, there are predictable aspect of nature, especially at the microscopic level, but I’m referring to nature in the broadest sense, as in the Dao De Jing. My suggestion of reading material was to offer a different perspective – as I said ‘if you want to understand some of the ideas behind Chinese medicine, which embrace uncertainty’. I didn’t say ‘if you want to understand biochemistry’, which no doubt you understand well. If you don’t want to understand Chinese medicine better, that’s fine too! Personally I find it both interesting and informative to consider various perspectives, philosophical and scientific, old and new.

          • @Mr. Kennedy,
            I only agree with #1 of your matrix. The rest reads like a recipe for ill persons to end up in the hands of charlatans of all kind of trades. If someone would really consider following your advice, the reiterative nature of your matrix would actually pretty much guarantee that this would happen.

            Regarding your quote “I suggested that nature doesn’t work in a predictable, binary way. Of course, there are predictable aspect of nature, especially at the microscopic level, but I’m referring to nature in the broadest sense, as in the Dao De Jing.”
            I have no clue what you mean with the term “nature in the broadest sense”. Sounds like a made-up, nonsense term to me.
            You seem to have a fundamental ignorance of natural sciences and the scientific method, because this is exactly what we try to do: find out how different aspects of nature work. And once we have discovered a generalizable rule, then we indeed are able to make predictions, which can sometimes be very precise. The great thing and important difference between belief (e.g. in CAM) and science is that these predictions can then be TESTED via experiments.
            In contrast to CAM proponents, scientists try to DISPROVE their hypothesis and only accept that they are true as long as this was not possible. CAM proponents desperately cling to their belief, even if this contradicts very basic laws of nature.
            In this context, let me ask you a question: Is there any evidence in the world that would lead you to accept that acupuncture is indeed only a placebo and has no method specific benefit at all? You seem to be very much invested in your belief, so I suspect that NOTHING would ever convince you.
            In contrast, I have made clear what would change my mind, since I apply the same rules for EVERY treatment option: reproducible scientific evidence that the treatment works beyond placebo and the risk/side effects are lower than the expected benefit.

  • I wouldn’t say it has ‘NO relevance’ to acupuncture. Of course the arms of this trial ‘involved’ acupuncture, but they also ‘involved’ electro-stimulation. Putting needles in the skin is only one part of what a typical acupuncturist does, and these days, many practitioners use electroacupuncture at least some of the time, even though it isn’t part of the traditional approach. The aim of Chinese medicine has always been to bring about a positive change in a person in whatever way is appropriate for them. Acupuncturists typically use needles (in various ways), acupressure/tuina massage, lifestyle and dietary counselling, moxabustion, cupping, guasha, and now electro-stimulation.

    I would love to see a similar trial that compared:

    The Park Sham device (‘real’ and sham versions)
    Japanese-style shallow needling
    Chinese style deeper needling
    Acupressure/tuina massage
    Electroacupuncture

    And all of the above with experienced practitioners using points they select themselves vs. beginner practitioners using protocols (and combinations of these), in large numbers and with frequent treatments. This is unlikely to happen of course! But I hope we get more trials like this that use other styles of acupuncture.

    • @Bjorn I contacted one of the contributors to the ‘Brain’ trial, and he kindly pointed me to a precursor trial from 2005: https://www.ncbi.nlm.nih.gov/pubmed/15499576

      This seems to suggest what I would expect – manual acupuncture and electro-acupuncture both lead to objective physiological changes in ways that sham procedures don’t, but the effects are different. Hopefully there will be many more of this type of trial looking at different styles of acupuncture, and we’ll gain insights into best practice as well as mechanisms of action.

      • There certainly is a major difference between the purported mode of action of AP on one hand and electrostimulation using needle electrodes on the other. Of course they both affect the brain, so does a blow on your thumb with a hammer.
        Before we start adding electric current (or a hammer) to the equation we need to establish that a needle in the skin has an inherent, specific action. You simply cannot call electric stimulation acupuncture and pretend it corroborates the efficacy of the latter.

        I did not mention it before but there is another big problem with this research and it has to do with the use of fMRI.
        This technology is wide open for wishful interpretation as can be understood from the story of the dead fish that seemed to have brain actitvity despite having laid on ice for an extended time, and from recent research showing how unreliable this technology has turned out to be. See e.g. here: https://ideas.ted.com/much-of-what-we-know-about-the-brain-may-be-wrong-the-problem-with-fmri/

        I read your second reference as far as the term “fMRI”. Is there any need for me to read further? I think I will check my mail instead before turning off the iPad and trying to get some rest.

        After reading on this matter for years I am convinced that thescholars are right who say that we now have enough research on AP to conclude with certainty that it is nothing more than theatrical placebo, or make-believe medicine as I like to call it.

        • @Bjorn My reading of the article you link to is that fMRI faces challenges, especially when it comes to software analysis of data, but that it can still offer valuable insights. I don’t know how the data was analysed in the trials I linked to. I expect these challenges are being addressed by the neuroscience community, and I hope we’ll see many more robust trials over time.

          ‘I am convinced that the scholars are right who say that we now have enough research on AP to conclude with certainty that it is nothing more than theatrical placebo’

          How you can conclude that ‘with certainty’ seems strange to me. I am fairly sure (‘convinced’ seems too finite a word to use for any contested subject to me) the scholars are right who say that we now have enough research on AP to conclude that it has beneficial effects beyond placebo. I also expect further evidence to emerge over time as research methods improve.

    • Tom.

      “This is unlikely to happen of course! But I hope we get more trials like this that use other styles of acupuncture.”

      Instead of hoping, why don’t you apply to a funding source (e.g. MRC, Wellcome Trust, CRUK) for a grant to fund a study of this type? I’m sure they would receive with interest an application for research that seeks to provide actual evidence for the efficacy or otherwise of acupuncture and its myriad variants. But it would have to describe a protocol that was realistic and made good scientific sense. I’m sure you could do it.

  • Perhaps Tomtheacupuncturist may blame at least some of his logical glitches and fallacious thinking skills to an overly tight hairpiece interfering with his 3rd eye chakra. In my experience this is often the case.

  • @Jashak ‘I have no clue what you mean with the term “nature in the broadest sense”’.

    That’s precisely why I suggested you read the Dao De Jing (and the commentary).

    ‘Is there any evidence in the world that would lead you to accept that acupuncture is indeed only a placebo and has no method specific benefit at all?’

    For various reasons I don’t see how a true and fair placebo controlled trial is possible for acupuncture. I actually wish that weren’t the case, but to me it’s trying to fit a square peg in a round hole. So unfortunately I’m left weighing up all the various strands of evidence there are, including my own experience, and ultimately wrestling with a degree of uncertainty over the extent of acupuncture’s effectiveness in various situations.

    Now let me ask you, how different really is my situation to that of a surgeon? Placebo controlled trials are very rare for surgical procedures (https://jme.bmj.com/content/42/12/776). An article in the Indian Journal of Surgery summarises it this way:

    ‘The surgical community as a whole has been negligent in implementing the best evidence practices for therapeutic interventions. This is not entirely purposeful. There are various constraints that make it difficult and sometimes impossible to conduct RCTs to validate many surgical treatments.’ (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3144342/)

    There are of course big differences between these groups – the acupuncture community is far more nebulous and doesn’t have the same resources available to it as the surgical community for a start. But some of the challenges are remarkably similar, for example:

    ‘While a pharmaceutical intervention requires no physician skill, and the intervention i.e. the drug administration is easy and the same every time, no two surgical procedures are the same.’ (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3144342/)

    This is exactly the argument I make about acupuncture.

    • “There are of course big differences between these groups”…
      you forgot a few differences like, for instance:
      1) surgery is biologically plausible,
      2) there are currently 274237 clinical trials in Medline of which most suggest effectiveness,
      3) often, the effectiveness of surgery is so obvious that it is even unethical to run a clinical trial,
      4) many controlled clinical trials of surgery compare a current approach to an innovation.
      I feel that your mention of surgery displays an alarming degree of delusion.

      • ‘you forgot a few differences’

        I didn’t forget them, I merely gave one example.

        ‘1) surgery is biologically plausible’

        Various biological mechanisms have been observed in acupuncture – here’s a summary of some of them: https://www.evidencebasedacupuncture.org/mechanisms/signal-transmission/

        ‘2) there are currently 274237 clinical trials in Medline of which most suggest effectiveness’

        Aren’t these the types of trial that don’t satisfy you when it comes to acupuncture? I.e. no placebo control? Despite the relative lack of funding, there are plenty of clinical trials that suggest effectiveness for acupuncture too.

        ‘3) often, the effectiveness of surgery is so obvious that it is even unethical to run a clinical trial’

        But there are many procedures where that isn’t true.

        ‘I feel that your mention of surgery displays an alarming degree of delusion’

        If I’d said ‘the evidence for acupuncture and surgery are basically the same’ that might be delusional, but I didn’t. I raised it as a valid comparison in response to Jashak’s notion that all medical procedures must be proven to be beyond placebo before they’re used.

        • 1) largely based on wishful thinking, in my view.
          2) no, I advocate as much rigour in clinical trials as possible; there are modalities where it is not possible or not necessary to use placebos (there is not a single placebo-controlled trial of parachutes, for instance).
          3) that’s why I used the word ‘often’ in that sentence.

    • @ Mr. Kennedy,
      • Scriptures which are > 2.000 years old might contain interesting bed-time stories and maybe even are interesting from a historic point of view, but I consider them of absolutely NO value for getting closer to understanding the reality of nature. Natural science books and research journals are the adequate literature for this purpose. If you would be involved in science, you would be aware how fast (objective, independently reproducible) knowledge about nature has grown over the last century.
      Recent achievements like genetic engineering of plant and animal cells via CRISPR/Cas9 or CRISPR/CPF1, development of new antibiotics for multiresistant bacteria or monoclonal antibodies & checkpoint inhibitors for cancer treatment are only a few of many extremely exciting developments. Scriptures that have not changed for centuries or even millennia are of no value in this context.

      • Since Prof. Ernst has already addressed your flawed comparison with surgery, I will not further comment on this.

      • You have indirectly admitted that nothing can change your mind about acupuncture. Ok, that´s your choice. But I have to say that I find it weak that you do not clearly and honestly stand behind this fact. Instead, you say things like:
      “So unfortunately I’m left weighing up all the various strands of evidence there are, including my own experience, and ultimately wrestling with a degree of uncertainty over the extent of acupuncture’s effectiveness in various situations”.

      As in your previous comments, you portray yourself as a considerate, rational, maybe even skeptical person on this blog who “wrestles” with the uncertainty of the efficacy of acupuncture and who is honestly trying to find the truth. But in reality, you do not even shy away from using your own infant daughter to promote your belief, as I had to observe in this dreadful YouTube video.

      https://www.youtube.com/watch?v=AbiWtpbJK8I&list=PL2WPeCcUIXQX1-bf45UtbMaPTZlgkACOy&index=3

      Not much wrestling with the truth going on in this clip. I think it is despicable when children get exploited by their parents or from other adults, no matter if it is because of belief or for financial interest (political, religious, CAM). From this discrepancy between your statements and your actions, I have to conclude that you are either an extraordinarily self-delusional person, or you are actively trying to deceive readers of this blog. For this reason, I have lost interest in continuing this exchange.

      • what a coincidence!
        my blog post of tomorrow will deal with acupuncture for infant colic.

      • @Jashak OK, happy to leave it there – I have a lot of people to deceive after all. As for the video, I’d almost forgotten about that as I made it almost a decade ago. I do cringe slightly watching it now, and would present the subject quite differently if I were to re-do it. But I stand by the essence of the video, i.e. that acupuncture is worth considering for colic, so I’ll leave it up in case anyone finds it useful, or in case it stimulates debate. You’ll be delighted to know that my daughter survived the experience, and now asks me for acupuncture from time to time.

        • in this case, you can now call her a ‘willing volunteer’ – not a decade ago though!

          • Some call it willing volunteer, others might call it child abuse. I wonder where one ends and the other begins.
            She might be ten or eleven years now. Not sure about the laws in the UK, but can you give willing consent at that early age?
            I am looking forward to reading about your take on this subject tomorrow, Prof. Ernst.

  • ‘Some call it willing volunteer, others might call it child abuse‘

    Wow.

    • not wow!
      imagine every crank is allowed to do his/her little experiments on his/her child.
      you do acupuncture and you think it is evidence based.
      a spiritual healer also thinks he has some evidence behind him.
      you treat colic.
      someone else might treat a condition that does not resolve itself anyway.
      some infants might be in great danger.
      there are plenty of published cases of that.
      where would you draw the line?
      I would use the evidence to draw it.
      sadly, the evidence does not back you up – see my post tomorrow.

      • @Edzard/Jashak It’s one thing debating the evidence base for acupuncture; quite another to imply child abuse. I’m not sure if you’re parents, but in case you’re not, let me tell you that when you watch your child screaming and writhing in pain for hours on end, and nothing else brings them comfort, it is a natural instinct to do all you can to help them. That’s what happened to my wife and me. Acupuncture wasn’t my first option, but on a particularly bad night of colic we carefully weighed up the options, and decided together that I would try a single ultra-fine needle on a very safe point. Our daughter stopped crying instantly, and went to sleep within moments. This is purely anecdotal, and I make no claims that anything magical happened, but we were extremely grateful at the time. As you can see from my video, there is no sign of any discomfort whatsoever (and nothing was edited out!), so even if you feel the evidence doesn’t stack up, conflating this with ‘abuse’ is ridiculous. Where do I draw the line? Beyond a trained practitioner using painless, minimal acupuncture techniques when nothing else works, certainly.

        • In the General Medical Council publication “Good Medical Practice”, which details the duties and responsibilities of a doctor, it states that:
          “You must… wherever possible, avoid providing medical care to yourself or anyone with whom you have a close personal relationship”

          Elsewhere it clarifies the meaning of the specific wording used:
          ” ‘You must’ is used for an overriding duty or principle”

          With regard to consent:
          “You must be satisfied that you have consent or other valid authority before you carry out any examination or investigation, provide treatment or involve patients or volunteers in teaching or research”

          Quite separate from GMC guidelines, consent is also a legal matter. A small child is unable to give consent, and the parent or guardian would normally be expected to give consent on their behalf, though I don’t think the Courts would necessarily be sympathetic in cases where the person giving consent is the same as the person giving treatment. An older child may in some circumstances be deemed capable of giving consent, to the extent to which they understand the treatment, what is involved and what it is supposed to achieve. Nobody can give consent on behalf of an adult who is unable to consent to treatment themselves, unless they hold the appropriate Power of Attorney – I have several times found myself in the position of having to treat an incapacitated adult without their consent in the hope that I would be supported by my professional bodies should they subsequently decide to press charges.

          Treating anybody without their consent is criminal assault.

          For those doctors thinking of using alternative approaches for their patients, the GMC also says:
          “You must… provide effective treatments based on the best available evidence”

          Clearly where you have chosen to draw the line is in a different place from the General Medical Council, and indeed the Law.

          • thanks for clarifying this so well and understandably.

          • “I don’t think the Courts would necessarily be sympathetic in cases where the person giving consent is the same as the person giving treatment.” That’s a bit worrisome: it suggests that, technically, a parent can’t give their baby e.g. Calpol, or bandage a small wound. How would the law define the cut-off between acceptable management of trivial lesions in an infant and, say subjecting them to acupuncture?

          • As far as I know, Tom isn’t a doctor. So the line drawn by the GMC (and indeed the law) isn’t applicable.

            If he has the same training as acupuncturists that I know, he is ethically bound to ease the suffering of his child. Which it seems that he did.

          • I did not know that the law does not apply to acupuncturists.

          • You should probably find out before traveling down the child abuse accusation route. And find out what the British Acupuncture Council has to say about acupuncture being child abuse.

          • In answer to Frank Odds:
            I am a doctor, not a lawyer, so I can’t give a legal opinion. However, I would regard the appropriate administration of Calpol (in accordance with the manufacturer’s instructions or following advice from a pharmacist or other healthcare professional) as part of normal parenting, along with treatment of minor wounds, insect bites etc. However, where the parent is a doctor, they are in dangerous territory prescribing drugs or initiating other more specialist treatment for their own children. There is a strong risk that the personal relationship would override professional objectivity leading to wrong decisions regarding diagnosis and treatment.

            An extreme case comes to mind (I’m sorry, I can’t remember the names but it is in the public domain and occurred in the 1970’s) of a GP whose schizophrenic wife had paranoid delusions that she had a brain tumour. When none of her own doctors were able to confirm this, it appears that the husband continued to believe his wife, in a way entering her delusions (this is a recognised phenomenon, “folie a deux”). One theory as to what happened next was that in desperation he took it upon himself to try to treat the non-existent tumour by prescribing and administering chemotherapy. He actually wrote the prescriptions in the names of his own patients who were already deceased. He was not oncology trained and didn’t know what he was doing, and sadly his wife died from toxic effects of the treatment. He was found guilty of murder and went to prison for it, but while the jury clearly thought his intent was to kill her, I am not so sure. Either way, his judgement was severely impaired by the relationship between them.

            Another less extreme case concerned a friend of mine whose wife noticed that he was driving erratically when they went to visit friends in Wales, one of whom was a radiologist. The radiologist, acting with the best of intentions, arranged a CT brain scan there and then which sadly appeared to show a brain tumour. This resulted in a very messy situation where the poor man wasn’t in any official system for dealing with this disasterous news or taking it any further. What he did at that point was to return home to London and ask me to meet him urgently in a local pub. When I got there I heard the story and saw the scans. At least at that point I was able to phone a neurosurgeon who kindly agreed to see him and arrange treatment through the proper channels. But everything would have gone much more smoothly if the radiologist had simply advised him to see his GP.

            Coming back to the earlier point, I don’t think many people would regard administering acupuncture as a normal part of parenting.

            JM’s point about an acupuncturist being ethically bound to ease the suffering of his child (by acupuncture) suggests that the ethical code of the profession is in urgent need of review. And while no SCAM practitioner is regulated by the General Medical Council, nevertheless if they seriously purport to be treating vulnerable patients it is disappointing that they are happy to hold themselves to a lower standard.

        • Mr. Kennedy does not seem to be aware that having children is not the same as owning them. Children have their own rights as human beings.
          Quote: Article 19 of the Convention on the Rights of the Child enjoins parties to “take all appropriate legislative, administrative, social and educational measures to protect the child from all forms of physical or mental violence, injury or abuse, neglect or negligent treatment, maltreatment or exploitation” (source: Wikipedia)

          So indeed: where do you draw the line when you are confronted with your screaming baby? Parents have found different answers to this question. Most try talking calmly to the baby, lullabies, gentle cradling, and so on. Some might try a soft slap on the behind. Few (I sincerely hope) obviously try piercing the skin with needles. And unfortunately sometimes, parents even try vigorous shaking until the baby is dead.
          https://en.wikipedia.org/wiki/Abusive_head_trauma#
          Child abuse can take different forms and the degree seems to be on a sliding scale.
          For me the answer is: you can try anything that does not harm the child but may help. Like it or not, the skin is a protective barrier and for this reason, piercing it per se poses an inherent risk. Furthermore, as Dr. Money-Kyrle pointed out, performing acupuncture on babies is a violation of GMC guidelines and, at least in my view, should be illegal.

          But apart from treatment of infant colic:
          Calling a baby a “willing volunteer” borders cynicism and the baby in the video did not seem to be sick at all. So why perform any invasive and therefore potentially harmful treatment? Was it to get good video PR material?
          Since Mr. Kennedy is a rational and considerate person, this notion must be wrong, and acupuncture was only done to help his (imperceptibly) suffering baby with this shady, non-evidence based treatment.

          • @Jashak – I thought you didn’t want to talk any more? Anyway, I’ll keep this as brief as possible.

            I agree entirely with the Article 19 quote.

            ‘Most try talking calmly to the baby, lullabies, gentle cradling, and so on’ – obviously, I and presumably any parent who ends up trying other measures, tried this first extensively.

            If minimal needling and ‘vigorous shaking until the baby is dead’ are indeed on a sliding scale (and obviously I don’t think they are), it’s a rather large sliding scale.

            ‘you can try anything that does not harm the child but may help’ – my reading of the data leads to me believe acupuncture falls into this category. I’ll expand on this when I have time, probably on my site.

            ‘Calling a baby a “willing volunteer” borders cynicism’ – this was a tongue-in-cheek comment, meant to acknowledge that, quite obviously, consent is not possible with a baby. I think the video illustrates how gentle the technique is.

            ‘the baby in the video did not seem to be sick at all’ – colic is episodic in nature, and babies can be quite happy in between bouts.

          • Jashak,

            On a comment thread recently, you wrote: “You accuse me of committing personal attacks… This I don´t appreciate.”

            Hard to take you seriously when you make a comment like “Mr. Kennedy does not seem to be aware that having children is not the same as owning them.”. That’s pretty pathetic.

          • Call me crazy, but if a healthy baby appears to be happy, I would assume that it actually IS happy and certainly does not need any invasive treatment.
            But well, I am not a pediatrician. However my brother is, so I will ask him for his professional opinion.

            I feel silly for asking, because the answer is so obvious: does any scientific evidence PROVE that acupuncture is effective for preventing colic episodes in infants?
            If you think the answer is “yes”, then please show the peer reviewed articles published in trustworthy journals. If you have no evidence, stop putting needles into babies, may they appear happy or unhappy.

          • I have asked my brother (the pediatrician) via text messenger about Mr. Kennedy´s video.
            To my surprise, he told me that during his studies, he voluntarily took a (one or two semester) course in acupuncture, has even himself treated a couple of persons and got some good feedback from them.
            Since later, he was not convinced about the evidence for efficacy, he doesn´t practice it and certainly wouldn´t recommend it for infants (he also took umbrage at the fact that Mr. Kennedy used the phrase willing volunteer for the baby).

            He told me that the etiology for infant colic is often unknown, potential factors could be the developing microbiome, diet, hemoglobin adjustment, swallowing air, etc. Although highly efficiant treatments are not available, he would recommend paying attention to the baby, gentle massage of the belly, adaptation of the drinking behavior and potentially dimeticon (anti-flatulent) drops.

            His answer was interesting of me for two notable reasons:
            1. I was surprised that a renowned German University such as the MHH (Medizinische Hochschule Hannover) offers courses in TCM to regular students of medicine. I wonder how this is justified.
            2. Once again, it became apparent that practicing doctors like my brother (whom I consider to be quite a reasonable person in general), more often than not seem to have a rather relaxed attitude towards the question if a specific treatment is evidence-based or not.
            It seems that, in order to get their work-load done, even evidence-oriented doctors shy away from long discussions with their patient (or parents) about treatment efficacy and rely on the placebo effect in case of minor ailments. In a previous discussion he told me that although he does not recommend non-evidence-based treatments (like e.g. acupuncture or osteopathy), patients often put a lot of pressure on the doctors to get the treatment that they want, even if this may not efficient.
            For me as a scientist, this attitude is very regrettable. However, I am aware that doctors working at German hospitals have an extremely high work-load, therefore it´s hard for me to put too much blame on them.
            However, I will continue discussions about this with my brother and, where possible, with other practicing doctors to bolster their reliance on scientific evidence.
            As a first step, I introduced my brother to this blog and to the recent article about infant colic.

        • may I ask: did you ever learn anything about medical ethics; if not, can I recommend this book to you
          https://www.amazon.co.uk/More-Harm-than-Good-Complementary/dp/3319699407/ref=tmm_pap_swatch_0?_encoding=UTF8&qid=&sr=

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