MD, PhD, FMedSci, FSB, FRCP, FRCPEd

acupuncture

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What a silly question! At least this is what most sceptics would say: if we are not sure that it works, we do not need to spend any thoughts on a potential mechanism!

However, in the realm of acupuncture, the potential mode of action remains a hotly debated and fundamentally relevant issue.

The TCM folks, of course, ‘knew’ all along how acupuncture works: it re-balances the life-forces yin and yang. This is a nice theory – it has but one disadvantage: it has no bearing whatsoever on reality. Vitalistic ideas such as this one have long been proven to be nothing but fantasy.

Meanwhile, several more plausible hypotheses have been developed, and hundreds of papers have been published on the subject. One recent article, for instance, suggests a range of mechanisms including microinjury, increased local blood flow, facilitated healing, and analgesia. Acupuncture may trigger a somatic autonomic reflex, thereby affecting the gastric and cardiovascular functions. Acupuncture may also change the levels of neurotransmitters such as serotonin and dopamine, thereby affecting the emotional state and craving… By affecting other pain-modulating neurotransmitters such as met-enkephalin and substance P along the nociceptive pathway, acupuncture may relieve headache. Acupuncture may affect the hypothalamus pituitary axis and reduce the release of the luteinizing hormone…

Another article states that the Western explanation for acupuncture effectiveness is based upon more than half a century of basic and clinical research, which identified the activation of sensory system and the subsequent activity-dependent regulation of neurotransmitters, neurohormones, and several classes of neuromodulators as plausible mechanism for the acupuncture‘s therapeutic properties. The regulation of neurotrophins’ expression and activity is one of the possible neurophysiological mechanisms underlying acupuncture‘s effects on neuropathic pain, nerve injury, neurodegeneration, and even in the regulation of gonadal functions…

Recently Burnstock proposed that mechanical deformation of the skin by needles and application of heat or electrical current leads to release of large amounts of ATP from keratinocytes, fibroblasts and other cells in skin; the ATP then occupies specific receptor subtypes expressed on sensory nerve endings in the skin and tongue; the sensory nerves send impulses through ganglia to the spinal cord, the brain stem, hypothalamus and higher centres; the brain stem and hypothalamus contain neurons that control autonomic functions, including cardiovascular, gastrointestinal, respiratory, urinogenital and musculo-skeletal activity. Impulses generated in sensory fibres in the skin connect with interneurons to modulate (either inhibition or facilitation) the activities of the motoneurons in the brain stem and hypothalamus to change autonomic functions; specifically activated sensory nerves, via interneurons, also inhibit the neural pathways to the pain centres in the cortex.

A brand-new article in the journal SCIENTIFIC AMERICAN puts the hypothesis in perspective:

…scientists have been studying a roster of potential biological pathways by which needling might relieve pain. The most successful of these efforts has centered on adenosine, a chemical believed to ease pain by reducing inflammation. A 2010 mouse study found that acupuncture needles triggered a release of adenosine from the surrounding cells into the extracellular fluid that diminished the amount of pain the rodents experienced. The mice had been injected with a chemical that made them especially sensitive to heat and touch. The researchers reported a 24-fold increase in adenosine concentration in the blood of the animals after acupuncture, which corresponded to a two-thirds reduction in discomfort, as revealed by how quickly they recoiled from heat and touch. Injecting the mice with compounds similar to adenosine had the same effect as acupuncture needling. And injecting compounds that slowed the removal of adenosine from the body boosted the effects of acupuncture by making more adenosine available to the surrounding tissue for longer periods. Two years later a different group of researchers went on to show that an injection of PAP, an enzyme that breaks other compounds in the body down into adenosine, could relieve pain for an extended chunk of time by increasing the amount of adenosine in the surrounding tissue. They dubbed that experimental procedure “PAPupuncture.”

Both sets of findings have excited researchers—and for good reason. The current options for treating pain are limited and rely mostly on manipulating the body’s natural pain-management system, known as the opioid system. Opioid-based painkillers are problematic for several reasons. Not only does their efficacy tend to wane over time, but they have been linked to an epidemic of addiction and overdose deaths across the U.S.—so much so that the Centers for Disease Control and Prevention has recently advised doctors to seriously restrict their use. The available nonopioid pain treatments are few; many of them require multiple injections or catheterization to work; and they often come with side effects, such as impaired movement. Adenosine offers an entirely new mechanism to exploit for potential treatments—one that may come with fewer side effects and less potential for addiction. What is more, adenosine can be made to circulate in the body for prolonged stretches. Pharmaceutical companies are actively investigating adenosine-related compounds as potential drugs.

But however promising adenosine may be as a treatment, the findings from this research do not prove that acupuncture itself “works.” For one thing, the researchers did not show that the release of adenosine was specific to acupuncture. Acupuncture needles might cause adenosine to flood the surrounding tissue, but so might a hard pinch, or applied pressure, or any number of other physical insults. In fact, both of the studies found that when adenosine was turned on in mouse tissue by other mechanisms, the pain response was equal to or better than the response generated by acupuncture. For another thing, the study results offered no support for the use of acupuncture to treat any of the other conditions for which the procedure is often advertised. A localized adenosine response may mitigate localized pain. That does not mean it can also cure insomnia or infertility.

It may well be that the reams of research scientists have done on acupuncture have lit the path toward improved understanding of—and eventually better treatments for—intractable pain. But it may also be time to take whatever bread crumbs have been laid out by that work and move on.

END OF QUOTE

As we see, there is no shortage of potential explanations as to HOW acupuncture works. The most plausible theory still is that it works largely or even exclusively via a placebo effect.

Due to this type of mechanistic research, acupuncture has gained much credibility. The question is, does it deserve it? In my view, it would be much more fruitful to first make sure THAT acupuncture works (beyond a placebo response) and, if so, for what conditions. The question HOW it works is unquestionably interesting but in the final analysis it probably is secondary.

I am editor in chief of a journal called FACT. It has a large editorial board, and I am always on the look-out for people who might be a good, productive and colourful addition to it. On 3 June, I sent an invitation to Mel Koppelman, who is by now well known to regular readers of this blog. Here is a copy:

Hi Mel,

can I ask you a question?

would you consider joining the ed-board of FACT [as you mentioned it in one of your comments, I assume you know this journal – but you are wrong in implying that it has anything to do with the pharmaceutical or any other industry]? if you agree, we would expect you to write 2-3 ‘summaries/commentaries’ per year. in return you get a free subscription and, of course, can submit other articles.

no, this is not a joke or a set-up. I like to have the full spectrum of opinion/expertise on my ed-board, and I do think you understand science quite well. our opinions differ but that’s what I think is good for the journal.

think about it – please.

cheers

edzard

On 6 June, she replied as follows:

Hi Edzard,

Great to hear from you, I hope you enjoyed your weekend.

Thank you very much for the kind offer, it’s something I would consider. I certainly have no problem with, and in fact embrace, people who have different opinions and views from my own, so long as I feel that they have integrity in their approach.

Just a few questions / comments:

1) Regarding FACT’s affiliations, what I said in my comment was that it was a publication of the Royal Pharmaceutical Society. According to Wiley’s website, Focus on Alternative and Complementary Medicine is copyright by Royal Pharmaceutical Society. It’s also listed on the Pharmaceutical Press website.

Are you telling me that’s incorrect? That I’m “wrong” in saying there’s a relationship? I obviously need to understand the nature of the publication whose editorial board I’m considering joining. Very confusing that you as editor say there’s no relationship to the RPS and yet they claim copyright over your publication. Incidentally, is FACT self-sufficient, earning all of its income from subscriptions? Or does any financial support come from the publishers?

2) As enticing as a free subscription to FACT is, I have access to more high quality peer-reviewed reading material than I could enjoy in many lifetimes. Because my skills seem to be in high demand and because I already spend 10-20 hours per week doing unpaid volunteer work, any additional projects that I take on at this time would need to be financially compensated. I understand that this may be a deal-breaker.   

3) While I have no issue with you having different views when it comes to medical research, in order to choose to work with your publication, it’s important to me that it’s run by people with a high level of academic integrity and put patient welfare at the forefront of it’s agenda.

In March, you came out in public support of the NICE draft guidelines. You were quoted in the Guardian as saying: “It is good to see that Nice have now caught up with the evidence. Neither spinal manipulation nor acupuncture are supported by good science when it comes to treating low back pain.”

Following this, it was brought to your attention that the recommendations were contrary to best evidence and that the conclusions were unsupportable. While you have the option of following this up to make sure that the record reflects best evidence, you have indicated that you have no interest in evaluating the situation and possibly admitting an error. This behaviour is concerning from the perspective of academic integrity, particularly when it directly leads to increased human suffering (policy in several countries has already been changed based on the draft), and I would be worried that by joining your board I could be associated with such unethical behaviour. 

Perhaps if I understood better your position, which seems to be to ignore the situation, not follow up on the concerns raised, and leave your comments uncorrected even though they may be inaccurate and backing guidelines that cause harm to patients, that might allay certain reservations.

Anyways, these are my initial thoughts. I hope you have an opportunity to enjoy the beautiful weather, and I look forward to hearing from you.

Best wishes,

Mel

At that stage, I began to fear that I had made a mistake. But, giving her the benefit of the doubt, I swallowed my pride and replied as politely as I could to her concerns which, in my view, were odd, to say the least. This is what I wrote on 7 June:

Hi Mel,

Thank you for your reply to my invitation. Let me address your points in turn:

  1. I said that FACT has nothing to do with the pharma industry which is true [when you state that “you as editor say there’s no relationship to the RPS” – it suggests to me that you did not read my email properly]. In their own words, the RPS is the professional membership body for pharmacists and pharmacy in Great Britain and an internationally renowned publisher of medicines information.” [http://www.rpharms.com/home/about-us.asp] They have a similar status as the Royal Colleges. In the 2 decades that I am running the journal, there has been not a single instance of interference of any kind. We use them simply as an excellent publishing house. And yes, FACT is to the best of my knowledge self-sufficient and survives without funds from 3rd parties.
  2. I am delighted to hear that your skills are in demand.
  3. I have stated my position regarding the draft NICE guideline ad nauseam: I prefer to wait until I see their next version of the draft before I make further comments on it. In my view, this is both reasonable and honourable. If you disagree, I can do little about it other than expressing my sincere regrets.

I hope these brief clarifications are helpful for you to arrive at a decision.

Regards

Edzard

On 8 June, I received Mel’s reply:

Hi Edzard,
 
Thanks for your reply.
 
After thinking about it, I’ve decided to pass on your offer for the time being. This is mainly because I’m moving house towards the end of the summer and I’m in the process of simplifying and reducing my responsibilities so I can focus on that and getting settled in. After the move, I plan to reassess what I’d like to be involved with and how I’d like to spend my time.
 
I’d be happy to write the odd article for FACT as and when, if something comes up that you think I can make a helpful contribution to. 
 
Thanks for thinking of me, I appreciate the opportunity.
 
Best wishes,
Mel
I have to admit, I was very relieved, mainly because meanwhile someone had alerted me to the fact that Mel had posted all the correspondence on facebook (I would otherwise not have re-published it here because I usually don’t consider this sort of thing to be very elegant) where her friends were making ample comments. Here are a few (I have omitted the most infantile ones):

How interesting! Is he trying to ‘keep his enemies closer’ or am I being too skeptical? He has recognised your talents and dedication and intellect so he is not altogether stupid after all! I eagerly await his response to your reply.

Those who have studied with Ernst say that he’s a genuine chap and misunderstood – which I know is almost unimaginable given his behaviour – but we always have to allow for the possibility that we have misjudged people however remote! Also, people can turn – especially when they get older and near retirement. Alternatively he may just fancy you!… 

I think it’s an impressive offer. If only we were so lucky to be asked!  
 
“…You understand science quite well”  What a backhanded compliment! Your response is so articulate and balanced. 
 
That’s a compliment. I quite like Edzard. If you go for it hope all goes well. It raises the voice of the profession just in a different way. Best wishes. 
 
“Keep your friends close and your enemies closer” – Michael Corleone.
 
Terrific response Mel!! We’re all proud of you!! 
 
This does bring a chortle. Well done Mel. He’ll be rolling over for you to tickle his tummy before you know it 
 
Wow, quite surprising! If you can, it might be a good idea? To see how the other half lives…? 
 
Wow, this guy is a piece of work!
 
Excellent response Mel.
 
wow the white flag. Maybe thats his way of trying to save face
 
Excellent reply Mel .. indeed a perfect reply. I’m glad to hear that Charlie things Ernst is a genuine guy but having read his blogs and communicated with him quite a bit I would say he’s on the margins of some kind of personality disorder. I would be very cautious of getting into bed with him (as it were)
 
Go For It. A chance to debate is a chance to influence. If you have this opportunity to engage in an INVITED platform this is goldust. 
 
You very much understand science and of course more than ‘quite well’! I would imagine it is a difficult decision to make: both Peter Jonathan and Jani White have made good comments and as long as you are allowed to maintain your integrity within the position (and you can also get out if you want to), it might be a great opportunity to make real changes from within and open up all sorts of possibilitie and closed minds.
 
Well done. Your mind is as sharp as a needle can be.
 
I’ve come to this saga quite late yet regardless of my lack of knowledge..I LOVE paragraph 2…the first sentence especially. Freakin’ brilliant and hilarious!!! 
 
If you can’t beat them, join them. And then beat them! 
 
Curiouser and curiouser and I’m with Sandro but on the other hand I think you can beat them. 

Mel Koppelman Really enjoying hearing y’all’s thoughts on this. I just want to say that If I had thought that the chances of me being able to create positive change by joining FACT were high, I would have tempered the tone of my reply. But the simple fact that EE can’t even be factual or forthright about whose journal it is suggests an irreparable break with reality. And surely there’s an issue (academic? ethical? legal?) with recruiting someone to your board and denying an industry tie when there is one? Not to mention that if the RSP does fund his journal, he’s been lying about his conflicts of interest. Is that someone I want to spend time adding value to that could be spent with family, patients, time in nature or really making positive change by supporting the ANF? I’ll be interested to read his reply if there is one and especially how he responds regarding the relationship between FACT and RSP. Will keep y’all posted. 

Mel, you are amazing! Can’t wait to read how this plays out. Understand your concerns and think the way you have dealt with him is very professional. Go Mel!!
 
Great reply Mel. I would very much share your concerns about getting into bed with EE, so to speak (sorry for that image!). One day Hollywood will make a movie about this…
END OF FIRST SET OF COMMENTS; THE FOLLOWING COMMENTS WERE POSTED AFTER MEL PUBLISHED MY REPLY

Max Forrester keep your friends close; keep your enemies closer…

Ooh. ..he’s not a happy bunny
Such a soap opera…
 
I’m loving all these updates, who needs a telly lol. Jokes aside, thank you Mel for fighting our battles so eloquently. I would definitely buy the book if you decided to write one
 
OK this is interesting. The two American editors of FACT are William M. London who “currently writes and teaches about scientifically implausible and fraudulent health care practices”, and Stephen Barrett of Quackwatch (see a devastating critique of him here: http://www.quackpotwatch.org/quackpots/quackpots/barrett.htm). 
 
De-licensed MD Stephen Barrett. What kind of man would drop out of the medical profession and dedicate his life to STOPPING advancement in the health sciences?> <title>De</title> <base target=
quackpotwatch.org

John McDonald Healthy skepticism! Healthy journal! And it’s 99% fact-free! 

I think your talents are better used elsewhere than being co-opted to the Ernst prejudice-engine, Mel!
END OF COMMENTS

I hope that you find these exchanges as amusing as I did – but are they important? Perhaps not exactly, but revealing certainly. They shed some light on the mind-set of acupuncturists and perhaps other alternative practitioners as well. Let me try to explain.

What struck me first was the degree of suspicion, even outright hostility from the acupuncturists. I had made it quite clear that I was asking Mel to join my Editorial-Board because of her views which vastly differ from mine. In science, differences of opinions and backgrounds can be stimulating and often generate progress. That is not something that seems to be wanted by alternative practitioners; they do not seem to tolerate criticism, different perspectives or views. One cannot help asking to what degree this attitude is immature or even dogmatic.

The next thing that baffled me was the speed with which conclusions are jumped upon. Everyone seemed to be instantly convinced that I was via my journal FACT in the pocket of the pharmaceutical industry. Nobody even bothered to look up what the Royal Pharmaceutical Society truly stand for and to verify that they do NOT represent ‘BIG PHARMA’. This blindness to the possibility of being wrong confirms my fear that alternative therapists are guided by strong beliefs which must not be questioned and are hard to influence, even with facts that take less than a minute to research.

And then there are, of course, the personal attacks which came quick, thick and fast. Its authors might think that such attacks get under my skin. If so, they are mistaken: if anything, they amuse me! I have long been of the opinion that they are important victories of reason. When an acupuncturist went as far as diagnosing me as being borderline psychopathic, I almost fell off my chair laughing! To me, this remark (which has emerged several times before) is emblematic, as it suggests several things at once:

  • The author is obviously rude
  • He/she is incompetent, even stupid
  • He/she lacks empathy – after all, one would expect from a healthcare professional to show some understanding, if I were truly ill! And if not, one would expect more respect towards mentally ill patients.
  • But, of course, he/she did not mean it like that; he/she merely meant to insult me. And employing mental health issues for this purpose shows a remarkable lack of professionalism, in my view.
[Whenever I or someone in a similar position point out such things, the ‘other side’ starts shouting “AD HOMINEM!” Do they not see that my analysis of their attempted insult is merely a reaction to their ad hominem?]

Am I making too much of all this? Perhaps – sorry, I am almost done.

But first I need to briefly address Mel’s doubts about my integrity. She can, of course, question what she likes as often as she wants. My point is that repeating nonsensical arguments ad nauseam does not render then sensical.

Finally, there is Mel’s public claim that I have been lying about my conflict of interests. To me, it suggests a degree of desperation, perhaps even fanaticism, that is only surpassed by her inability to apologize after the truth had become undeniable even to her.

I know that there are some people who would have sued for libel.

Not I!

For that I find all this far too hilarious.

Guest post by Frank Van der Kooy

Some serious flaws in the scientific reporting of two acupuncture clinical trials, for the treatment of infertility and allergic rhinitis, were recently published on this blog. The overly positive way in which the researchers made their mostly negative results public, was also of concern. Both these studies were published by the researcher of the year, Prof Caroline Smith, of the National Institute of Complementary Medicine (NICM), Australia. The stream of comments and discussions that followed made me think of another commonly overlooked aspect when it comes to acupuncture clinical trials. Conflict of interest! In both these studies the authors declared to have no conflicts of interest and in other studies by this author this also seems to be the case. The question can be asked: If you are a practicing acupuncturist who runs a clinical trial of acupuncture, isn’t that, by default, a serious conflict of interest? The intention of this article is not an in-depth discussion of what a conflict of interest is, but rather to compare medical doctors with acupuncturists turned researchers. Let me explain.

Some medical doctors (GPs, surgeons etc.) decide to leave their practice after practicing 10-20 years to become full time researchers (and visa versa). Universities accept these people with open arms because they bring with them a wealth of knowledge regarding the practical side of medicine and healthcare in general. They are thus seen as an asset to any medical research project including clinical trials. Can the same be said about an acupuncturist? They also bring with them years of experience and thus they should also be a major asset to any acupuncture clinical trial. But I am afraid not!

Why? Medical doctors have a multitude of tools (drugs, surgical procedures, diagnostic tools etc.) at their disposal to treat all types of medical conditions. When will their background constitute a conflict of interest? When they publish a positive clinical trial of a specific medical intervention in which they have a vested interest. e.g owning shares in the company producing the medical intervention (financial interest) or if they have been staunch supporters of this intervention during their years of practice (emotional interest). Just imagine that you have prescribed a specific intervention to hundreds of patients over a long period of time, and you swore by it, and now you have to face them with a negative clinical trial result – that will be difficult. The former is easy to declare whilst the latter might be slightly more difficult.

Doctors also tend to focus on a specific disease e.g. cancer and will perform research with the existing tools at their disposal but also try to find new tools in order to improve the risk-benefit profile of the disease treatment. Thus, for a doctor there is the possibility that they might run into a conflict of interest, but due to the multitude of medical interventions out there this is by no means a given.

What about acupuncture practitioners turned researchers? An acupuncturist only has one tool at their disposal to treat all medical conditions. I can hear them say; but we stick needles in different places and depths etc. depending on the medical condition! Yes, but the fact remains that they can only stick needles into people – and that is a single intervention. So is this by default a conflict of interest? I would argue, yes, it is like having only one drug to treat all medical conditions. If you have treated hundreds of patients for various medical conditions with acupuncture and now suddenly you publish a negative clinical trial, you will not only be red faced when you run into your former patients – who paid for your evidence based acupuncture treatment – they might even sue you for misleading them. As an acupuncturist, you cannot allow the single tool that you have to be ineffective, otherwise people might start to question acupuncture. The fact that they have to protect acupuncture means that an acupuncturist will by default have a conflict of interest – no matter what medical condition they aim to treat.

If you have been emotionally and financially invested in acupuncture as a cure-all for 10-20 years, it will be very difficult, if not impossible, to publish a negative result as an acupuncture researcher.

Another aspect is that the acupuncture fraternity is a very tight knit community, where negative results are frowned upon because of everyone’s financial and emotional interests. Surely they will expel you from this community, if you publish negative results?

So how do acupuncture researchers go about running clinical trials? An example: Professors Smith and Bensoussan, both at the NICM, are currently registered as practicing acupuncturists. This means that they can legally practice acupuncture and, because they have been active for decades, they are also well known in the acupuncture fraternity. It is unknown, whether they are still actively practicing in their own practice or part-time in someone else’s practice, or if they have a financial stake in their former or someone else’s practice. Based on the fact that they are still registered as active acupuncturists, I can conclude that they do have an emotional and/or financial interest in the positive outcome of their acupuncture clinical trials.

Because of this inherent conflict of interest, and due to current strict clinical trial regulations, which makes it quite difficult (although not impossible) to fabricate or falsify data, they go for the next best thing – which is the design of their clinical trial e.g. the A+B versus A design. But it doesn’t stop there. As soon as a clinical trial fails to give a positive result, the results will be inflated to make it sound positive.

Why? Because they must prevent themselves from cognitive dissonance, they need to protect the single tool that they have, they must keep the acupuncture fraternity happy and they have to protect themselves against potential lawsuits from former (current) patients or a decrease in patient numbers (and thus financial income). On top of that – how would the media and the public react to an acupuncture clinical trial if the lead researcher declare that they have their own acupuncture clinic?  Surely these factors together amount to a conflict of interest and should be declared as such?

So what, in this context, is the main difference between a doctor and an acupuncturist? A doctor has a multitude of medical interventions. He or she might have a conflict of interest, if they work on a specific intervention in which they have a vested interest. An acupuncturist only has one intervention and therefore they have a vested interest by default – which they never seem to declare!

 

Acupuncture, like most other alternative therapies, is particular popular for indications that are

  1. chronic,
  2. associated with a high burden of suffering,
  3. not easily treatable with conventional therapies,
  4. are frequently resolved without any intervention.

Infertility or subfertility tick most of these boxes. It is therefore not surprising that acupuncturists the world over claim that acupuncture can cure infertility. But is this claim based on evidence or on wishful thinking?

The objective of this new study was to find out. Specifically, the authors wanted to provide preliminary data to explore whether women with subfertility undergoing a course of acupuncture and lifestyle modification compared with an active control of lifestyle modification alone would demonstrate improved reproductive outcomes, improved menstrual cycles, and increased fertility awareness.

In a pragmatic randomised controlled trial, with the A+B versus B design, sub/infertile women were offered an intervention of acupuncture and lifestyle modification or lifestyle modification only. There was a statistically significant increase in fertility awareness in the acupuncture group (86.4%) compared to 40% of the lifestyle only participants. Changes in menstrual regularity were not statistically significant. There was no statistical difference in the pregnancy rate with seven women achieving pregnancy during the course of the study intervention. Those receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group.

The authors concluded that the acupuncture protocol tested influenced women who received it compared to women who used lifestyle modification alone: their fertility awareness and wellbeing increased, and those who conceived did so in half the time.

The first sentences of the authors’ discussion are, I think, revealing: The main findings were that this acupuncture intervention, compared to lifestyle only, resulted in significant increases in fertility awareness and quality of life measures in relation to wellbeing; it increased the ability of the recipients to engage in desired activities, such as exercise or rest, and it shortened the time to conception by half. The findings provide preliminary evidence that the acupuncture intervention is acceptable and is not inert and that acupuncture dose may have a significant influence on outcomes. 

In my view, the main findings of this study are entirely different. Let me propose alternatives:

  • In alternative medicine, if you did a lousy study, you can just call it a ‘pilot study’ and all is forgiven.
  • The infamous A+B vs B design continues to be popular for those who cannot bring themselves to publishing negative findings.
  • It works perfectly for subjective parameters but less convincingly for objective ones, such as pregnancy rates.
  • Doing such research on infertility is good for the cash flow of acupuncturists.
  • Making women aware of fertility increases (surprise, surprise!) fertility awareness.

No need to be so cynical!, some will think. After all, the results showed that women receiving the acupuncture conceived within an average of 5.5 weeks compared to 10.67 weeks for the lifestyle only group. True! But there was no statistically significant difference between these two figures. And that means, the difference was a chance finding (which has no place in an abstract) which probably has no relevance whatsoever.

Or perhaps I am wrong?

I am told to always keep an open mind!

So, let’s keep our minds open to some truly alternative explanations. How about this one: regular acupuncture increases the rate of adultery, which, in turn, decreases the time to conception.

Makes sense, doesn’t it? Has anyone a better idea?

Yesterday, I wrote about a new acupuncture trial. Amongst other things, I wanted to find out whether the author who had previously insisted I answer his questions about my view on the new NICE guideline would himself answer a few questions when asked politely. To remind you, this is what I wrote:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

…Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. What other treatments did each group of patients receive?
  9. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

In the comments section, the author wrote: “after you have read the full text and answered most of your questions for yourself, it might then be a more appropriate time to engage in any meaningful discussion, if that is in fact your intent”, and I asked him to send me his paper. As he does not seem to have the intention to do so, I will answer the questions myself and encourage everyone to have a close look at the full paper [which I can supply on request].

  1. The myriad of lab tests were defined as primary outcome measures.
  2. Two sentences are offered, but they do not allow me to reconstruct how this was done.
  3. No details are provided.
  4. Most were quantified with a 3 point scale.
  5. Mostly not.
  6. Needle insertion at non-acupoints.
  7. The results are a mixture of inter- and intra-group differences.
  8. Patients were allowed to use conventional treatments and the frequency of this use was reported in patient diaries.
  9. I don’t think so.

So, here is my interpretation of this study:

  • It lacked power for many outcome measures, certainly the clinical ones.
  • There were hardly any differences between the real and the sham acupuncture group.
  • Most of the relevant results were based on intra-group changes, rather than comparing sham with real acupuncture, a fact, which is obfuscated in the abstract.
  • In a controlled trial fluctuations within one group must never be interpreted as caused by the treatment.
  • There were dozens of tests for statistical significance, and there seems to be no correction for multiple testing.
  • Thus the few significant results that emerged when comparing sham with real acupuncture might easily be false positives.
  • Patient-blinding seems questionable.
  • McDonald as the only therapist of the study might be suspected to have influenced his patients through verbal and non-verbal communications.

I am sure there are many more flaws, particularly in the stats, and I leave it to others to identify them. The ones I found are, however, already serious enough, in my view, to call for a withdrawal of this paper. Essentially, the authors seem to have presented a study with largely negative findings as a trial with positive results showing that acupuncture is an effective therapy for allergic rhinitis. Subsequently, McDonald went on social media to inflate his findings even more. One might easily ask: is this scientific misconduct or just poor science?

I would be most interested to hear what you think about it [if you want to see the full article, please send me an email].

While looking up an acupuncturist who has recently commented on this blog trying to teach me how to do science and understand research methodology, I was impressed that he, Dr John McDonald, PhD, has just published a clinical trial. Not many acupuncturists do that, you know, and I very much applaud this action, which even seems to have earned him his PhD! McDonald is understandably proud of his achievement – all the more because the study arrived at positive conclusions. This is what he wrote about it:

…So, in a nutshell, acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis which produces lasting changes in the immune system and hence improvements in symptoms and quality of life.    Dr John McDonald

Fascinating! I quickly looked up the paper. Here it is:

This new study was designed as a randomized, sham-controlled trial of acupuncture for persistent allergic rhinitis in adults investigated possible modulation of mucosal immune responses. A total of 151 individuals were randomized into real and sham acupuncture groups (who received twice-weekly treatments for 8 weeks) and a no acupuncture group. Various cytokines, neurotrophins, proinflammatory neuropeptides, and immunoglobulins were measured in saliva or plasma from baseline to 4-week follow-up.

Statistically significant reduction in allergen specific IgE for house dust mite was seen only in the real acupuncture group. A mean (SE) statistically significant down-regulation was also seen in pro-inflammatory neuropeptide substance P (SP) 18 to 24 hours after the first treatment. No significant changes were seen in the other neuropeptides, neurotrophins, or cytokines tested. Nasal obstruction, nasal itch, sneezing, runny nose, eye itch, and unrefreshed sleep improved significantly in the real acupuncture group (post-nasal drip and sinus pain did not) and continued to improve up to 4-week follow-up.

The authors concluded that acupuncture modulated mucosal immune response in the upper airway in adults with persistent allergic rhinitis. This modulation appears to be associated with down-regulation of allergen specific IgE for house dust mite, which this study is the first to report. Improvements in nasal itch, eye itch, and sneezing after acupuncture are suggestive of down-regulation of transient receptor potential vanilloid 1.

These conclusions seem to be based on the data of the study. But they are oddly out of line with the above statement made by McDonald about his trial. What could be the reason for this discrepancy? Could it be that he behaves ‘scientifically’ correct when under the watchful eye of numerous co-authors from the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the School of Medicine, Menzies Health Institute, Griffith University, Queensland, Australia, the National Institute of Complementary Medicine, Western Sydney University, Sydney, Australia, the Health Innovations Research Institute and School of Health Sciences, RMIT University, Melbourne, Victoria, Australia, and the Stanford University, Palo Alto, California? And could it be that he is a little more ‘liberal’ when on his own? A mere speculation, of course, but it would be nice to know.

Anyway, the trial itself raises a number of questions – unfortunately I have no access to the full paper – which I will post here in the hope that my acupuncture friend, who are clearly impressed by this paper, might provide the answers in the comments section below:

  1. Which was the primary outcome measure of this trial?
  2. What was the power of the study, and how was it calculated?
  3. For which outcome measures was the power calculated?
  4. How were the subjective endpoints quantified?
  5. Were validated instruments used for the subjective endpoints?
  6. What type of sham was used?
  7. Are the reported results the findings of comparisons between verum and sham, or verum and no acupuncture, or intra-group changes in the verum group?
  8. Was the success of patient-blinding checked, quantified and successful?
  9. What other treatments did each group of patients receive?
  10. Does anyone really think that this trial shows that “acupuncture is a safe, effective and cost-effective treatment for allergic rhinitis”?

“Conflicts of interest should always be disclosed.”

This is what I wrote in the ‘RULES’ of this blog when I first started it almost 4 years ago. Sadly, very few people writing comments observe this rule. Perhaps, I just thought, I did not observe it either? So, here are my conflicts of interest: none.

Not true!!! I hear some people say. But it is!

I have no financial interest in any ‘Big Pharma’ or  ‘TINY CAM’, and I get not a penny for writing this blog.

How do I pay for my living? Mind your own business… well, on second thought, even that must not be a secret: I get a small pension and have some savings.

Still not convinced?

Perhaps it’s time to define what ‘conflicts of interests’ are. According to Wikipedia, they can be defined as  situations in which a person or organization is involved in multiple interests, financial interest, or otherwise, one of which could possibly corrupt the motivation of the individual or organization.

So, not having financial benefits from my current work does not necessarily mean that I have no conflicts of interest. The above definitions vaguely mentions ‘or otherwise’ – and that could be important. What could this mean in the context of this blog?

Well, I might have very strong beliefs, for instance (for instance, very strong beliefs that acupuncture is by definition nonsense [see below]). We all know that strong beliefs can corrupt motivation (and a lot more). And if I ask myself, do you have strong beliefs?, I have to say: Yes, absolutely!

I believe that:

  • good evidence is a prerequisite for progress in healthcare,
  • good evidence must be established by rigorous research,
  • we should not tolerate double standards in healthcare,
  • patients deserve to be treated with the best available treatments,
  • making therapeutic claims that are not supported by sound evidence is wrong.

These strong beliefs might make me biased in the eyes of many who comment on this blog. In Particular, we recently had a bunch of acupuncturists who went on the rampage attacking me personally the best they could. However, a rational analysis of my beliefs can hardly produce evidence for bias against anything other than the promotion of unproven therapies to the unsuspecting public.

The above mentioned acupuncturists seem to think that I have always been against acupuncture for the sake of being against acupuncture. However, this is not true. The proof for this statement is very simple: I have published quite a bit of articles that concluded positively – even (WOULD YOU BELIEVE IT?) about acupuncture for back pain! A prominently published meta-analysis of 2005 (with me as senior author) concluded:  “Acupuncture effectively relieves chronic low back pain.” (This of course was 11 years ago when the evidence was, in fact, positive; today, this seems to have changed – just like the NICE guidelines [probably not a coincidence!])

Conflicts of interest? No, not on my side, I think.

But what about the ‘other side’?

The unruly horde of acupuncturists (no, this is not an ad hominem attack, it’s a fact) who recently made dozens of ad hominem attacks against me, what about them?

  • They earn their money with acupuncture.
  • They have invested in acupuncture training often for long periods of time.
  • They have invested in practice equipment etc.
  • Some of them sell books on acupuncture.
  • Others run courses.
  • And all of them very clearly and demonstrably  have strong beliefs about acupuncture.

I think the latter point constitutes by far the most important conflict of interest in this context.

And this is where the somewhat trivial story has an unexpected twist and gets truly bizarre:

I have just leant that the same group of conflicted acupuncturists are now planning to publicly attack the panel of experts responsible for drafting the NICE guidelines. The reason? They feel that this panel had significant conflicts of interest that led them to come out against acupuncture.

Perhaps I should mention that I was not a member of this group, but I suspect that some of its members might have links to the pharmaceutical industry. It is almost impossible to find top experts in any area of medicine who do not have such links. You either gather experts with potential conflicts of interest, or you get non-experts without them. Would that bias them against acupuncture or any other alternative therapy? I very much doubt it.

What I do not doubt for a minute is that conflicts of interest are of major importance in these discussions. And by that I mean the more than obvious (but nevertheless undeclared) conflicts of interest of the acupuncturists. It seems that those with the strongest conflicts of interest shout the loudest about the non-existent or irrelevant conflict of interest of those who do not happen to share their quasi-religious belief in acupuncture.

Ad hominem attacks, I have previously pointed out, are victories of reason over unreason. And they are used frequently by supporters of alternative medicine!

If you doubt it, see for yourself.

I recently posted a comment on new Nice guidelines. It generated lots of comments, and mostly they were rational discussions of the issues involved. This changed abruptly when, on 16 May, Mel’s comment started a new, concerted wave of discussion at a time when the usual debate had already subsided. In the course of this new and heated debate, I was repeatedly accused of being rude.

As I have stated repeatedly on this blog, I try to keep rudeness out of the comments as much as I can. Therefore, the claim surprised me and today I reviewed the entire comment section selecting all potential ad hominem attacks. Here are the results:

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS AGAINST ME

Peter Deadman on Tuesday 17 May 2016 at 12:55 Edward Ernst, I always thought you were a bully and a fraud. You’re very macho when it comes to slapping down people who may have experiential reasons for supporting acupuncture and other therapies but don’t have the skill to challenge you on the clinical evidence. Now as soon as somebody does, you back off, cry ‘enough’, say you can’t possibly comment till some undetermined future date and generally act like a wuss. I say put up or shut up. I’d prefer the former because it would be good to see you eat crow but I lean towards the latter because of the substantial harm you are causing and the beautiful silence that would ensue if you did indeed go quiet.

tonto on Tuesday 17 May 2016 at 13:19 You appear as weak in your arguments, as some pendulum swinging, new age dowser, who vainly holds sticks to their guns, not because they can back their position up with scientific evidence, but because it is what they “believe”.

Jill Onyett on Tuesday 17 May 2016 at 14:29 …an unfortunate creature too keen on the sound of his own voice.

Tracey Phillips on Tuesday 17 May 2016 at 13:16 …to date you have been fairly opinionated …

Peter Deadman on Tuesday 17 May 2016 at 16:34  I made an ad hominem response because your blog is all about you as a person. You are constantly rude to others and bypass or ignore responses that you don’t like. It’s you who makes it hominem.

Peter Deadman on Tuesday 17 May 2016 at 16:52 You are hyper-emotional, extremely biased, hostile and contemptuous of anyone you think ‘beneath you’. You gloat over people’s real or imagined inconsistencies and generally come across as a nasty piece of work.

Peter Deadman on Tuesday 17 May 2016 at 19:30 How can such a childish provocateur remain in his post. It demeans the University and it’s time they let him go.

Kylee Junghans on Wednesday 18 May 2016 at 08:42 …you, kind Sir, with your rhetoric and tantrums, are exhibiting a prime example of confirmation bias.

Peter Deadman on Wednesday 18 May 2016 at 08:48 [Ernst] professes a scholarly detachment, a commitment to evidence and an open mind, but in fact is deeply biased… He clearly loves his childish provocative stance and is as far from a disinterested observer as it’s possible to be. I wouldn’t waste my time or breath on him if he didn’t have an influence that far exceeds his worth.

Carol Cooke on Wednesday 18 May 2016 at 09:27 I have followed this discussion with interest. Some of the rudest and most discourteous posts I can see are from Mr Ernst himself. But I get that, I imagine you seek to maintain a bold and authoritative tone simply by dismissing others. Being a bit controversial in your discourse has obviously served you well in that you have built a media profile on it.

ACTUAL OR POTENTIAL AD HOMINEM ATTACKS BY MYSELF

Edzard on Wednesday 18 May 2016 at 09:18 “it is also difficult to get a man to read something, when he is foaming from his mouth”.

I know, this is not really ‘ad hominem’ but I could not find anything more dramatic. Surely, some will disagree this me here, and I do invite them to cite my rudeness from this threat, if they spot it. You are more than welcome!

CONCLUSION

You may think this is a bit trivial, but I disagree. The main reason I did this little exercise is to demonstrate a point which I think is important and carries a relevant lesson for future comments and discussions:

  • WHEN I OR ANYONE ELSE DEFENDING RATIONALITY GET AGGRESSED, WE NATURALLY TEND TO RESPOND SLIGHTLY MORE FORCEFULLY.
  • SUBSEQUENTLY, THE OTHER SIDE OFTEN REACTS BY ATTACKING US PERSONALLY.
  • THIS OFTEN LEADS TO AN ESCALATION OF TONE.
  • EVENTUALLY THE OTHER SIDE CLAIMS WITH INDIGNATION THAT WE ARE THE ONES DOING THE PERSONAL ATTACKS.
  • IT IS A TACTIC THAT IS EFFECTIVE BUT DISHONEST, IN MY VIEW.
  • THE LESSON IS SIMPLE: DO NOT LET YOURSELF GET PROVOKED INTO ISSUING AD HOMINEM ATTACKS, BE POLITE AND PATIENT.

I know this sounds simpler than it is, and I am far from being immune to the problem, but we owe it to reason to give it a try.

 

While over on my post about the new NICE GUIDELINES on acupuncture for back pain, the acupuncturists’ assassination attempts of my character, competence, integrity and personality are in full swing, I have decided to employ my time more fruitfully and briefly comment on a new piece of acupuncture research.

This new Italian study was to determine the effectiveness of acupuncture for the management of hot flashes in women with breast cancer.

A total of 190 women with breast cancer were randomly assigned to two groups. Random assignment was performed with stratification for hormonal therapy; the allocation ratio was 1:1. Both groups received a booklet with information about climacteric syndrome and its management to be followed for at least 12 weeks. In addition, the acupuncture group received 10 traditional acupuncture treatment sessions involving needling of predefined acupoints.

The primary outcome was hot flash score at the end of treatment (week 12), calculated as the frequency multiplied by the average severity of hot flashes. The secondary outcomes were climacteric symptoms and quality of life, measured by the Greene Climacteric and Menopause Quality of Life scales. Health outcomes were measured for up to 6 months after treatment. Expectation and satisfaction of treatment effect and safety were also evaluated. We used intention-to-treat analyses.

Of the participants, 105 were randomly assigned to enhanced self-care and 85 to acupuncture plus enhanced self-care. Acupuncture plus enhanced self-care was associated with a significantly lower hot flash score than enhanced self-care at the end of treatment (P < .001) and at 3- and 6-month post-treatment follow-up visits (P = .0028 and .001, respectively). Acupuncture was also associated with fewer climacteric symptoms and higher quality of life in the vasomotor, physical, and psychosocial dimensions (P < .05).

The authors concluded that acupuncture in association with enhanced self-care is an effective integrative intervention for managing hot flashes and improving quality of life in women with breast cancer.

This hardly needs a comment, as I have been going on about this study design many times before: the ‘A+B versus B’ design can only produce positive findings. Any such study concluding that ‘acupuncture (or whatever other intervention) is effective’ can therefore not be a legitimate test of a hypothesis and ought to be categorised as pseudo-science. Sadly, this problem seems more the rule than the exception in the realm of acupuncture research. That’s a pity really… because, if there is potential in acupuncture at all, this sort of thing can only distract from it.

I think the JOURNAL OF CLINICAL ONCOLOGY, its editors and reviewers, should be ashamed of having published such misleading rubbish.

Polycystic ovarian syndrome (PCOS) is a common condition characterised by oligo-amenorrhoea, infertility and hirsutism. Conventional treatment of PCOS includes a range of oral pharmacological agents, lifestyle changes and surgical modalities. Some studies have suggested that acupuncture might be helpful but the evidence is often flawed and the results are mixed. What is needed in such a situation is, of course, a systematic review.

The aim of this new Cochrane review was to assess the effectiveness and safety of acupuncture treatment of oligo/anovulatory women with polycystic ovarian syndrome (PCOS). The authors identified relevant studies from databases including the Cochrane Central Register of Controlled Trials (CENTRAL), Ovid MEDLINE, EMBASE, PsycINFO, CNKI and trial registries. The data are current to 19 October 2015.

They included randomised controlled trials (RCTs) that studied the efficacy of acupuncture treatment for oligo/anovulatory women with PCOS. We excluded quasi- or pseudo-RCTs. Primary outcomes were live birth and ovulation (primary outcomes), and secondary outcomes were clinical pregnancy, restoration of menstruation, multiple pregnancy, miscarriage and adverse events. We assessed the quality of the evidence using GRADE methods.

Two review authors independently selected the studies, extracted data and assessed risk of bias. They calculated Mantel-Haenszel odds ratios (ORs) and mean difference (MD) and 95% confidence intervals (CIs).

Five RCTs with 413 women were included. They compared true acupuncture versus sham acupuncture (two RCTs), true acupuncture versus relaxation (one RCT), true acupuncture versus clomiphene (one RCT) and electroacupuncture versus physical exercise (one RCT). Four of the studies were at high risk of bias in at least one domain. No study reported live birth rate. Two studies reported clinical pregnancy and found no evidence of a difference between true acupuncture and sham acupuncture (OR 2.72, 95% CI 0.69 to 10.77, two RCTs, 191 women, very low quality evidence). Three studies reported ovulation. One RCT reported number of women who had three ovulations during three months of treatment but not ovulation rate. One RCT found no evidence of a difference in mean ovulation rate between true and sham acupuncture (MD -0.03, 95% CI -0.14 to 0.08, one RCT, 84 women, very low quality evidence). However, one other RCT reported very low quality evidence to suggest that true acupuncture might be associated with higher ovulation frequency than relaxation (MD 0.35, 95% CI 0.14 to 0.56, one RCT, 28 women). Two studies reported menstrual frequency. One RCT reported true acupuncture reduced days between menstruation more than sham acupuncture (MD 220.35, 95% CI 252.85 to 187.85, 146 women). One RCT reported electroacupuncture increased menstrual frequency more than no intervention (0.37, 95% CI 0.21 to 0.53, 31 women). There was no evidence of a difference between the groups in adverse events. Evidence was very low quality with very wide CIs and very low event rates. Overall evidence was low or very low quality. The main limitations were failure to report important clinical outcomes and very serious imprecision.

The authors concluded that, thus far, only a limited number of RCTs have been reported. At present, there is insufficient evidence to support the use of acupuncture for treatment of ovulation disorders in women with PCOS.

This is, in my view, a rigorous assessment of the evidence leading to a clear conclusion. Foremost, I applaud the authors from the Faculty of Science, University of Technology Sydney for using such clear language. Such clarity seems to be getting a rare event in reviews of alternative medicine. To demonstrated this point, here are the most recent 5 systematic reviews which came up on my screen when I searched today Medline for ‘complementary alternative medicine, systematic review’.

The combination of TGP and LEF in treatment of RA presented the characteristics of notably decreasing the levels of laboratory indexes and higher safety in terms of liver function. However, this conclusion should be further investigated based on a larger sample size.

Compared to control groups, both MA and EA were more effective in improving AHI and mean SaO2. In addition, MA could further improve apnea index and hypopnea index compared to control.

CHM as an adjunctive therapy is associated with a decreased risk of in-hospital mortality compared with WT in patients with AKI. Further studies with high quality and large sample size are needed to verify our conclusions.

clinicians may consider Tai Chi as a viable complementary and alternative medicine for chronic pain conditions.

As an important supplementary treatment, TCM may provide benefits in repair of injured spinal cord. With a general consensus that future clinical approaches will be diversified and a combination of multiple strategies, TCM is likely to attract greater attention in SCI treatment.

I think the phenomenon is fairly obvious: authors of such papers are far too often not able or willing to express the bottom line of their work openly. As systematic reviews are supposed to be the ultimate type of evidence, this trend is very worrying, I think. In my view, such conclusions merely display the bias of the authors. If the evidence is not convincingly positive (which it very rarely is), authors have an ethical obligation to clearly say so.

If they don’t do it, journal editors have the duty to correct the error. If neither of these actions happen, funding agencies should make sure that such teams get no further research money until they can demonstrate that they have learnt the lesson.

This may sound a bit drastic but I think such steps would be both necessary and urgent. The problem is now extremely common, and if we do not quickly implement some effective preventative measures, our scientific literature will become contaminated to the point of becoming useless. This surely would be a disaster that affects us all.

There can, of course, be several reasons for the evidence being not positive:

  • there can be a paucity of data
  • the results might be contradictory
  • the trials might be open to bias
  • some of the primary data might look suspicious

In all of these cases, the evidence would be not convincingly positive, and it would be wrong and unhelpful not to be frank about it. Beating about the bush, like so many authors nowadays do, is misleading, unhelpful, unethical and borderline fraudulent. Therefore it constitutes a disservice to everyone concerned.

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