Guest post by Frank Van der Kooy
The BlueBoxTM homeopathic remedy kit, produced by Pegasus Homeopathics, contains 28 easy-to-use remedies for the treatment of just about everything, and therefore; “The BlueBox™ is a must have for every home”. Their marketing strategy is focussed on children and on the ease-of-mind of their parents, with Pegasus telling us that it: “Treats the whole family from infants to the elderly; Safe for babies as well as pregnant and breast feeding mums; Readily taken by children, no alcohol or nasty-tasting syrups; Can’t overdose – even if a child swallows the contents of a bottle it’s the same as one dose.” One of the 28 remedies in this kit is called Anti-virabac 200C, described as a; “natural antibiotic, safe for those allergic to penicillin. Indications: A homeopathic ‘antibiotic’ for use in viral and bacterial infections, that is best implemented at the earliest stage of the infection. Safe for use in penicillin-allergic individuals.”
There is a lot wrong with this, but let’s just focus on what this remedy contains. It is a mixture of nine homeopathic remedies, including Belladonna 200C and Gunpowder 30C, with the purpose of the latter being; “Localises the infection preventing deeper penetration into tissues.” The 200C and 30C indicates that these substances have been diluted by a factor of 10400 and 1060 respectively, and consequently neither contain a single molecule of the original substance. This might be a good thing, especially for Belladonna which is a highly poisonous herb, and something that you definitely do not want to give to your children. Incorrectly diluted Belladonna (in a different homeopathic remedy) has recently been implicated in the deaths of ten infants in the US. As for the Gunpowder 30C, well, some homeopaths are known for diluting the Berlin Wall for the treatment of depression, and a whole host of other conditions, so why not gunpowder?
But let’s step into the mind of a homeopath, and try and explain the logic behind the Gunpowder 30C. Here goes: Gunpowder is used to fire a bullet which will, depending on the entry location,, cause serious harm or death. If you are only wounded, the wound can become infected, the infection might spread throughout your body, and eventually you may die. Using the homeopathic principle of ‘like-cures-like’, it therefore ‘stands to reason’ that when you dilute gunpowder, by a factor of 1060, it will localise and prevent the infection from spreading any further. Because the underlined words look alike, it is irrefutable scientific evidence that Gunpowder 30C is a remarkably effective remedy. I am however only guessing here, but it is clear that the amount of science involved is truly mindboggling (any homeopath reading this, please correct me if I am wrong). A quick search reveals that homeopathic gunpowder is more commonly used for the treatment of septic wounds in people and animals, which I guess, makes more sense in a homeopathic sort of way.
Let’s say that I do not have any scientific background and that I’ve decided to buy the BlueBoxTM. Before coming to this decision, I’ve spoken to a homeopath (a specialist), I’ve discussed it with the extremely helpful people at the pharmacy, I’ve read all the info on the website of Pegasus (the producers), and I’ve even gone as far as to read the lengthy WHO report, which recommends that homeopathy should be integrated with conventional healthcare. All-in-all, it paints a very positive picture and I, and many others, will feel confident in the safety and effectiveness of this product. And hence, I will happily give these remedies to my children. Why not?
But what now if my young child die, due to an infection that I’ve treated with anti-virabac 200C? The infection worsened very quickly, within 48 hours, and upon hospitalisation it was already too late to save his life. At the end of the day, this remedy contains nothing other than the diluent, and will do absolutely nothing against any infection. A fact that is reflected in the Australian NHMRC homeopathy report, where they clearly state that: “People who choose homeopathy may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.” Tragically, this happens quite often, with an unknown number of people dying because they have chosen ineffective homeopathic remedies. Gunpowder 30C for the treatment of infectious diseases and/or septic wounds, really? The number of victims is unknown because the BlueBoxTM, and all other homeopathic remedies, are bought over-the-counter. There is no paper trail and hence no system in place to document ‘adverse events’. So, if you or your child dies, the cause of death will simply read infectious disease or septic wound – and that will probably be the end of it.
Who is to blame for this situation? The homeopath, pharmacist and all other role players are legally doing what they are doing. They are allowed to sell you water as a treatment for many different medical conditions. You, on the other hand, as a parent who’s child died because of these ineffective remedies, can however be taken to court and you might even be send to jail – and this is the ‘Homeopathy Paradox’.
This is also where the important role of Vice Chancellors (VC) come into play. They are instrumental in deciding on what path science will take in a specific country. Their role is becoming more important, especially in light of some politicians nowadays resorting to all kinds of alternative facts. Take someone like Prof Barney Glover, VC of Western Sydney University (WSU), and also the current Chair of ‘Universities Australia – The Voice of Australia’s Universities’. He has influence over the whole scientific landscape in Australia, and quite recently gave a very good speech at the National Press Club, about the necessity and importance for universities to stand up for facts and the truth, because nobody else will. This is very encouraging but, unfortunately, very misleading.
Prof Glover was notified in 2015, that he should urgently investigate the National Institute of Complementary Medicine (NICM), because of their continued (in)direct support of homeopathy and many other disproven complementary medicines. For example: the NICM had a big influence in compiling the WHO report, calling for the better integration of homeopathy (implying that it is an effective healthcare system) with conventional healthcare, and by way of their extended network, has tried to discredit and destroy the NHMRC report on homeopathy. Their incorrect and misleading response to the NHMRC report is now being used by homeopaths, all over the world, to continue to mislead the public regarding the effectiveness of homeopathy.
Unfortunately, neither the VC nor anyone else in WSU’s management has yet taken the very important step of standing up for science. Therefore the VC, and others, were nominated for the Bent Spoon Award in 2016. A nomination that they tried to block, but after independent review, did not manage to do so. VC’s that do not stand up for science can therefore have a far-reaching impact, such as convincing me, who live on the other side of the world, to buy the BlueBoxTM, which in turn, might lead to my child’s death. Let’s call it the ‘butterfly effect’, with a ‘minor’ act (allowing pseudoscience at their university) on one side of the world, causing a lot of carnage on the other side of the world, or the world over.
(The reason for WSUs refusal to investigate the NICM seems to be as simple as increasing their external income. And it works, because quite recently the controversial supplement company Blackmores donated $10 million, and a year or so ago, the extremely controversial organisation, the Jacka Foundation, donated $4 million. These numbers appear to be enough for WSU to continue to hold their hand of protection over the NICM).
WSU is by no means the only university that has put money before science and ethics. Take for example the University of Johannesburg (UJ) who has a ‘Department of Homeopathy’ (they featured on this Blog before – see for instance here). A couple of days ago I emailed the Dept. of Homeopathy, asking for advice regarding homeopathic malaria remedies for my 6yo son before we travel to the Kruger park. They advised me that they do not sell it themselves, but that I should contact a specific pharmacy and ask for….wait for it….a banned herbal remedy and for homeopathic antimalarial drops – the latter, of course, does not contain anything other than solvent. This advice comes straight from a University, and although this issue is still unfolding, I am hopeful to have more luck with UJ’s VC – but I am not holding my breath. So, if you happen to work at any one of these two universities, could you kindly forward this article to your VC? For what it is worth.
Currently, we witness an unprecedented hype about the ALKALINE DIET. It seems to be everywhere: on TV, radio, in the dailies, magazines, books and the Internet. The diet is being promoted for an amazing array of conditions by a dazzling list of VIPs. To me this merely indicates that very important people have paid very little attention when it was explained to them how the body controls its pH. It seems that VIPs tend listen to stuff that is not only factually incorrect but potentially dangerous. (Perhaps ‘VIP’ stands for ‘very ignorant person’?) This website (one of millions on the subject) is as good an example as any for the level of misinformation that is currently out there:
START OF QUOTE
When a food is ingested, digested, and absorbed, each component of that food will present itself to the kidneys as either an acid-forming compound or a base-forming one. And when the sum total of all the acid-producing and the base-producing micro and macronutrients are tabulated, we’re left with a calculated acid-base load.
One common problem with most industrialized societies is that our diets produce what’s called a “low grade chronic metabolic acidosis.” This means we’re in a chronic state of high acidity. Since the body must, at all costs, operate at a stable pH, any dietary acid load ha to be neutralized by one of a number of homeostatic base-producing mechanisms. Although the pH of the body is maintained, many cells of the body will suffer.
A cancerous cell is acidic. If your body is in a constant state of over-acidification, it becomes impossible for healthy cells to regenerate. Cancer cells thrive in an overly acidic environment. By taking action to become more alkaline, you can make it more difficult for cancer cells to regenerate.
Eating an acid/alkaline balanced diet is the key to staying healthy. Understanding the pH of the foods that you eat is relative to the state of your body’s health.
The goal of the acid alkaline balance diet, also known as the alkaline diet and the alkaline ash diet, is to achieve an optimal balance between acid-forming and alkaline-forming foods. The anti cancer diet greatly reduces the strain on the body’s acid-detoxification systems.
END OF QUOTE (I corrected several spelling mistakes)
Personally, I don’t care a hoot whether VIPs eat this or any other diet. When it comes to claiming that the ALKALINE DIET can treat or prevent cancer (or other serious conditions) I do, however, get concerned. Such claims will almost inevitably prompt patients to give up their treatments in the hope that the diet will do the trick. In other words, such claims endanger the lives of patients, and I find this intolerable. Tragically, a recent case seems to demonstrate how real this danger is.
So, allow me to put the record straight: there is no evidence that the Alkaline Diet is effective for the prevention or treatment of any disease, particularly not cancer. For those who find this hard to believe (vis a vis the current hype, this would hardly be surprising), here is the evidence.
One systematic review concluded that despite the promotion of the alkaline diet and alkaline water by the media and salespeople, there is almost no actual research to either support or disprove these ideas. This systematic review of the literature revealed a lack of evidence for or against diet acid load and/or alkaline water for the initiation or treatment of cancer. Promotion of alkaline diet and alkaline water to the public for cancer prevention or treatment is not justified.
Another group of researchers evaluated the following diets: raw vegetables and fruits, alkaline diet, macrobiotics, Gerson’s regime, Budwig’s and low carbohydrate or ketogenic diet. They did not find clinical evidence supporting any of the diets. Furthermore, case reports and pre-clinical data point to the potential harm of some of these diets. The authors concluded that considering the lack of evidence of benefits from cancer diets and potential harm by malnutrition, oncologists should engage more in counselling cancer patients on such diets. Our recommendations could be helpful in this process.
So, yet again we are confronted with the fact that the media create attention, hype and misinformation with no real substance whatsoever. It is high time, I think, that journalists are reminded of their duty to report truthfully and responsibly!!!
Health journalists must be reminded of the undeniable fact that misinformation kills people.
I came across this website which contains an undated ‘open letter’ that I find most remarkable – so much so that I feel I have to blog about it. All I did below was to abbreviate its text slightly and to omit its references which can, of course, be looked up in the original. The footnotes in square brackets are mine and refer to my comments below.
START OF QUOTE
It is now estimated that antibiotic resistant infections may kill an estimated  10 million people a year and cost the world’s economies some $100 trillion annually by the year 2050… As some of America’s leading integrative medicine specialists , we believe it is time to look anew at a modality called homeopathic medicine.
As physicians , we are the first to acknowledge that the diagnostic and surgical tools of conventional medicine are scientific marvels – truly extraordinary and life saving. However, it is also a well-documented fact that many of the drugs currently used by conventional medicine carry risks that are often unacceptable, and in the case of bacterial infections – increasingly ineffective .
Signatories, and tens of thousands of our medical colleagues around the world, have repeatedly used homeopathic medicine to effectively and safely treat patients with a wide range of ailments, including serious, and in some cases, life threatening bacterial and viral infections, without the risk of creating further drug resistant organisms . We reached our decision to employ these medicines after careful experimentation and observation, in search of a drug system that relieved suffering without potential toxic side and after-effects …
Twelve independent research laboratories in North America, Russia, Europe and Asia have now confirmed that all classically-prepared homeopathic medicines studied contain various nanostructures, including source and silica nanoparticles which are heterogeneously dispersed in colloidal solution . The above mentioned laboratories and others have found that homeopathic medicines, like modern engineered nanoparticles, have been found to act by modulating biological function of the allostatic stress response network, including cytokines, oxidative stress and heat shock proteins . Additionally, there are hundreds of peer-reviewed studies including randomly controlled trials and large observational studies on individual cells, plants, animals and humans, that show homeopathic medicines are exceptionally safe  and have measurable and positive biological and therapeutic effects .
Reliable and extensive clinical and public health records have also been carefully examined internationally, looking for evidence of homeopathic medicine’s efficacy during some of the deadliest epidemics of the past 200 years. The main findings of this research show that when homeopathic medicine was employed during these deadly events, mortality rates were routinely very low. This constancy remained regardless of the homeopathic physician, time, place or type of epidemical disease, including diseases carrying a high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever, influenza and pneumonia .
…we are calling for a collaborative effort to investigate the efficacy of homeopathic medicine in the treatment of patients with these increasingly dangerous infections whereby homeopathic medicine is used only as an adjunct to conventional therapies  …
END OF QUOTE
These are my footnotes, questions and comments: Does twice ‘estimated’ result in accuracy, according to homeopathic teaching?  Are we impressed by people who call themselves ‘leading specialists’?  I can see many signatories who I would hesitate to call ‘physicians’.  In the case of antibiotics, it is mostly the over-use and not the drug per se that created their ineffectiveness.  Using homeopathic remedies for infections is not effective and therefore also not safe.  If that were true, they would have clinical trial evidence which they clearly have not.  Even if this were true, it would not mean that the nano-particles cause therapeutic effects.  Even if this were true, it would still not necessarily amount to clinical benefit in sick patients; where are the clinical trials showing that homeopathic remedies are effective antibiotics? I am not aware of any. The references provided certainly do not refer to such clinical studies.  Yes, highly dilute homeopathic remedies contain no active ingredients and are therefore unlikely to cause direct adverse effects.  The totality of the evidence from reliable clinical trials fails to show therapeutic effects.  The epidemiological data can be interpreted in several ways, and the majority of non-homeopaths do not share this interpretation.  About 500 clinical trials are available, and their results suffice to call for an end to such research; it’s a waste of resources – resources which are urgently needed to find solutions for the serious problem of antibiotic resistance.
Who is this letter addressed to? I could not find an answer to this question. It seems to be addressed to nobody – perhaps just as well!
Who would sign such an amateurish letter full of mistakes and dangerously misleading statements? The full (and embarrassingly long) list of signatories is here:
Stephen Albin, ND
Nathalie Allen, ND
Lisa Amerine, ND
David Anderson, MD
Kristy L. Anderson , ND
Yumi Ando, MD
A. M. Aurigemma, M.D.
Jyotsna Ayachit , M.D. CCH, DIH
Linda Baker, MD
Michael Baker, ND
Toni Bark, MD
Alex Bekker, MD
Iris Bell , MD, Ph.D.
Paul Bergquist, MD
Brian Berman, MD
Andrea Bitter, MD
Blossom Bitting, ND
Manon Bolliger , ND
Philip Bonnet, MD
Sue Boyle, ND
Mark Breiner, DDS
Maureen Bunce, MD
Anthony Capobianco, DO
Youngran Chung, MD
Mary Alice Cooper, MD
Mary Ellen Coulter, MD
Karin Cseak, DO
Stephen Davidson, DO
Tim Dooley, MD
Michelle Dossette, MD
Joseph Dubroff, ND
Robert Dumont, MD
Ronald Dushkin, MD
Samuelle Easton, ND
Rebecca Elmaleh, MD
Kristy Fassler, ND
Timothy W. Fior , MD
Laura Firetag, ND
Richard D Fischer , DDS, ND, MIAOMT, FAAO
D Fischer , DDS, ND, MIAOMT, FAAO
Mitchell A. Fleisher, M.D., D.Ht.
Ecaterina Floroiu, MD
Gary Fortinsky, DDS
Glenn Frieder, DC
Joyce Frye , DO
Susana Galle, ND, Ph.D.
Juan Gamba, MD
Stewart Garber, DC, Ph.D.
Harold Goodman, DO
George Guess, MD, DHt
Sohilraj Gupta, MD
Regina Gurevich, MD
Robert Hall, MD
Eashwar Hariharan, MD
Alice Harper, ND
Travis Herring, MD
Sharon Herzfeld, MD
Richard Hiltner, MD
Todd Hoover, MD
Torey Ivanic, PA-C
Jennifer Jacobs, MD
Naseem Jagani, MD
Chris Johnson, NS
Bernice Johnson, DC
Sandra Kamiak, MD
Emily Kane, ND
Polina Karmazin , MD
George Keeler , MD
Elena Klimenko, MD
Edward C. Kondrot, MD, MD(H)
Gary Krarcoff, NMD
Christine Kuhlman, ND
J.W. Kwee, MD
Julie Lachman, ND
Janet Lavatin, MD
Gail Littell, ND
Ian Luepker, ND
Linda Madore, ND
Larry Malerba, DO
Christopher Maloney, ND
Ruth Martens, MD, DHt
Robert Melo, MD
Bernardo A Merizalde, M.D.
Stephen A. Messer, MSEd, ND
Jeff Migdow, M.D.
Jacob Mirman, MD
Lucia Elena Mitrofan, MD
David Moreira, MD
Roger Morrison , M.D.
Richard Moskowitz, MD
Anca Nitulescu, MD
Nick Nossaman , MD, DHt
Stephanie Ogura, ND
Jamie Oskin, ND
Roy Ozanne, MD
Donna Panucci , DDS
Pamela Pappas, MD, MD(H)
Iva Peck, MD
Vladimir Petroci, MD
Luigi Pioli, MD
Liliana Plaesu, MD
Wendy Pollock, DC
Molly Punzo, MD
Danny Quaranto, MD
Ignatiadou Radmila, MD
Rakesh Raj, MD
Vinay Ranade, MD
Ioana Razi, MD
Sandy Reider, MD
Karl Robinson, MD
Henry Rostecki, DVM
Todd Rowe, MD MD(H)
DeeAnn Saber, NMD
Andre Saine , ND
Susanne Saltzman, MD
Lisa Samet , ND
Gundi Schulz, ND
Tova Sebaoun, MD
Irene Sebastian, MD
Joel Shepperd , MD
William Shevin , MD, D.Ht.
Jonathan Shore , MD
Hydie Sobel, MD
Rumen Stoychev, MD
Sergio Suárez, MD
Christine Sutton, ND
Michelle Thatcher, NMD
Anja Troje, MD, Ph.D.
Eric Udell, ND M.Ed.
Corey Weinstein, MD
Richard Weintraub, MD
Judith Weiss, MD
Ronald Whitmont, MD
Melanie Whittaker, ND, RN
Jacquelyn Wilson, MD
Linda Woodward, MD
I happen to know several of these ‘leading integrative medicine specialists’. What did they think when composing this letter?
The answer can only be NOT A LOT.
This is so cringingly embarrassing and pathetic that it beggars belief. If ‘integrative medicine’ ever did have anything resembling credibility, these ‘leading specialists’ would have destroyed it with their letter.
Antibiotic resistance is, of course, a huge, complex and very serious problem, and we need to solve it urgently – but surely not with lies, half-truths, wishful thinking and incompetence.
Guest post by Frank Van der Kooy
“….the concept of circulation of energy is paramount in Chinese Medicine. The Chinese physicians have always said there’s more than just blood circulating in the body, there’s also energy, human energy of some sort circulating in the body. We don’t know how to measure that yet.”
This is a quote from a radio interview where the wonderful and mysterious world of TCM was explained to the unsuspecting Australian public – this interview took place about 16 years ago. You can find more details regarding this very interesting interview here. From the above quote, it is clear that the circulation of “energy” is paramount to TCM and that, at the time, it could not be measured nor could its existence be shown. The quote, however, ends with the word ‘yet’, indicating there is full support for the notion that this energy field do indeed exist and that it is only a matter of time before it will be detected.
Now, just imagine if someone do indeed discover this energy field with a simple experiment that can be independently reproduced by others. As soon as you can measure it, you can influence it and hence control it, which implies that you will be able to significantly improve and personalise your TCM treatments – and this will almost certainly lead to a Nobel prize in medicine and you might even become stinking rich as well. Fame and fortune up for grabs. It therefore stands to reason that TCM researchers worldwide including those at the National Institute of Complementary Medicine (NICM), the latter who are well funded and have excellent research facilities, would have had more than enough incentive and would’ve spent a significant amount of research effort to detect this energy field in the 16 years since they gave the interview.
So, have they done any research on this very fundamental issue? They can vindicate TCM and for that matter most of complementary medicine if they did, never mind the major improvements in healthcare that might flow from this. The short answer is, no, they haven’t. I am not aware of any study done by any TCM researcher, or anyone at the NICM, past or present, investigating this extremely important issue. So, no progress, but also absolutely no interest in studying this extremely important aspect of TCM. But why is this?
The answer is really quite simple: As soon as you conduct a well-designed experiment you are bound to end up with a yes/no answer – or at least this is what you want. Yes, my hypothesis is correct or no, it is incorrect. Granted, you can also design an experiment that will almost always give you a positive result such as the A + B vs B clinical trial (well known to integrative medicine researchers). But for argument sake, let’s assume that they did study this aspect in a well-designed experiment and that they came up empty handed – which is quite likely because you cannot detect something if it does not exist – this will then be further evidence that the fundamental principles of TCM is absolutely rubbish. And this is of course something that they cannot publish or admit, so it is far better for the TCM researchers and the NICM to completely ignore this issue.
A second reason is that they know damn well that this energy field do not exist but they have to continue to sell this idea to the public in order to import more and more TCM modalities into Australia – for them it is all about business (it is that $170 billion TCM market that they want to tap into). This is the most likely explanation for their failure to investigate this fundamental principle of TCM.
There is however a couple of other general issues: There is a true believe that this energy field exist because in the TCM world all modalities work – evidence for this concept is that close to a 100% of TCM clinical trials conducted in China gives a positive result. That the NICM and TCM practitioners believe this (either because they truly believe it or they make as if they believe it for the sake of their business interests) can be seen if you look at the long list of medical conditions for which something like Rhino horn is considered to be an effective treatment; “High fever, sun stroke, trauma, mania, convulsion, sore throat, epilepsy, febrile disease, infectious disease, macula, bad skin conditions, subcutaneous bleeding.” It works for just about everything. And this goes for all TCM modalities. TCM researchers are completely happy to entertain this notion because they are actively trying to sell the energy concept to the public, and once accepted by the public, they will flood the market with TCM modalities.
It is also remarkable to think, and please correct me if I am wrong, that there are still people in China that die due to any medical condition after receiving a specific TCM treatment – if this energy field exist this should not really happen. Granted, due to logistical issues, some people might not receive their lifesaving TCM modalities in time but surely there are people who died even after timely administration of a TCM remedy? And for that matter, if TCM works so well, why would China import or use modern conventional medicine which is, according to the TCM proponents, ineffective, toxic, expensive etc. Surely, you are not going to replace something that works (TCM) with something that doesn’t work (conventional medicine)! Or is maybe the other way around?
Another interesting aspect regarding TCM is that it seems to be impossible to make a mistake (is it even possible to misdiagnose a patient?). Take acupuncture for example: the theory, or should I say, hypothesis, is that pain is caused by either an excess or deficiency of energy (as explained by the NICM in the very interesting radio interview). Acupuncture restores this energy balance and hence your back pain, which might have been diagnosed as an excess of energy, will now dissipates. But what will happen if an inexperienced acupuncturist use too many, or too few needles and maybe even insert them at the wrong acupoints? According to the hypothesis, too much energy will now flow from your lower back and this will cause an excess of energy somewhere else (causing pain in that region), but your backpain will still be there because you now have a deficiency of energy in your lower back. Is this sort of treatment ‘mistakes’ known to happen in acupuncture? Puncturing of an organ or infection due to dirty needles is well known but I am not aware of any examples where the above-mentioned treatment ‘mistakes’ have been documented. If these energy fields do exist this should happen quite regularly. The only explanation that this doesn’t really happen is that these energy fields simply do not exist.
TCM researchers including the NICM have no interest in studying the “energy” aspect of TCM and their only purpose is to sell these pseudoscientific principles to the public. More TCM products means more profit. For the NICM this should pave the way to open their very own TCM hospital in Sydney where the Australian population will be used as guinea pigs. I truly feel sorry for Australians because it appears that it is not only their cricket team that is struggling at the moment, some of their universities are in real trouble because they decided to put profits and pseudoscience, before science, scientific education and the welfare of the public.
When sceptics claim that no positive trials of homeopathy exist, they are clearly mistaken. The truth is that there are plenty of them! But many, if not most are of such poor quality that it is safe to suspect they are false-positives. Here is a recent example of this type of scenario.
This new study investigated the clinical effectiveness of a homeopathic add-on therapy in children with upper respiratory tract infections (URTI). It was designed as a randomized, controlled, multi-national clinical trial. Patients received either on-demand symptomatic standard treatment (ST-group) or the same ST plus a homeopathic medication (Influcid; IFC-group) for 7 days. IFC tablets contain a fixed combination of 6 homeopathic single substances (Aconitum D3, Bryonia D2, Eupatorium perfoliatum D1, Gelsemium D3, Ipecacuanha D3, and Phosphorus D5). IFC was administered according to the following schedule: 8 tablets/day during the first 72 hours, 3 tablets/day during the following 96 hours. Outcome assessment was based on symptom and fever resolution and the Wisconsin Upper Respiratory Symptom Survey-21 (WURSS-21).
A total of 261 paediatric (<12 years) patients (130 IFC-group; 131 ST-group) were recruited in Germany and the Ukraine. The IFC-group used less symptomatic medication, their symptoms resolved significantly earlier, they had higher proportions of fever-free children from day 3 onwards, and the WURSS-assessed global disease severity was significantly less during the entire URTI episode.
Days until symptom resolution (WURSS-21 item 1) in both treatment groups.
The light grey (IFC-group) and dark grey (ST-group) lines are polynomial fit curves. The dashed line estimates the between-group difference in the number of days after which 50% of patients had symptom resolution.
Between-group differences (IFC − ST) with 95% confidence intervals in the proportion of patients without fever during the observational period.
A difference (%) greater than zero indicates a higher proportion without fever in the IFC-group. Day 1 = Baseline.
The authors concluded that IFC as add-on treatment in pediatric URTI reduced global disease severity, shortened symptom resolution, and was safe in use.
On the one hand, this study has many features of a rigorous trial. I am sure that homeopaths will praise its quality, sample size, clever statistical analyses, etc. etc. The trial will therefore be cited by enthusiasts as a poof for homeopathy’s effectiveness and for homeopaths’ laudable research efforts.
On the other hand, one only needs to apply a minimum of critical thinking to find that it has been designed such that it cannot possibly generate a negative result. In fact, the paper turns out to be much more of a marketing exercise than a research effort.
The homeopathic remedy was given as an add-on therapy according to a fairly tedious ritual. It is safe to assume that this ritual created expectations on the parents’ side. These expectations alone suffice to account for the small group differences which seemingly favour homeopathy. The study follows the infamous ‘A+B versus B’ design which (as we have discussed ad nauseam on this blog) is extremely likely to generate false positive findings.
Why do researchers nevertheless plan, conduct and publish such studies (in the case of the paper discussed here, they even published their findings twice! Their previous paper included a larger group of patients of all ages and concluded that the homeopathic treatment shortened URTI duration, reduced the use of symptomatic medication, and was well tolerated.)? The answer can be found, I think, in the small print at the end of the paper:
Declaration of Conflicting Interests: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Robert van Haselen has received a consultancy fee from the Deutsche Homöopathie-Union. Manuela Thinesse-Mallwitz received a fee from the Deutsche Homöopathie-Union for coordinating the study. Vitaliy Maidannyk received a fee from the Deutsche Homöopathie-Union for coordinating the study. Stephen L. Buskin is a member of the Advisory Board of the Deutsche Homöopathie-Union. Stephan Weber received a fee from the Deutsche Homöopathie-Union for contributing to the study. Thomas Keller received a fee from the Deutsche Homöopathie-Union for contributing to the study. Julia Burkart is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid. Petra Klement is an employee of the Deutsche Homöopathie-Union, the study sponsor and manufacturer of Influcid.
Funding: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: The study was funded by Deutsche Homöopathie-Union, Karlsruhe, Germany. Deutsche Homöopathie-Union manufactures the homeopathic medicinal product used in this study and provided the publication fee.
I REST MY CASE
Two of my recent posts directly related to the German ‘Heilpraktiker’ (here and here) and to the risks which this profession poses to public health in Germany. As this is a very German phenomenon, it might be time to provide some explanations to my non-German readers.
The German ‘Heilpraktiker’ (literally translated: healing practitioner) is perhaps best understood by its fascinating history. When the Nazis came to power in 1933, German health care was dominated by lay practitioners who were organised in multiple organisations struggling for recognition. The Nazis felt the need to re-organise this situation to bring it under their control. At the same time, the Nazis promoted their concept of ‘Neue Deutsche Heilkunde’ (New German Medicine) which entailed the integration – perhaps more a shot-gun marriage – of conventional and alternative medicine. I have published about the rather bizarre history of the ‘New German Medicine’ in 2001:
The aim of this article is to discuss complementary/alternative medicine (CAM) in the Third Reich. Based on a general movement towards all things natural, a powerful trend towards natural ways of healing had developed in the 19(th)century. By 1930 this had led to a situation where roughly as many lay practitioners of CAM existed in Germany as doctors. To re-unify German medicine under the banner of ‘Neue Deutsche Heilkunde’, the Nazi officials created the ‘Heilpraktiker‘ – a profession which was meant to become extinct within one generation. The ‘flag ship’ of the ‘Neue Deutsche Heilkunde’ was the ‘Rudolf Hess Krankenhaus’ in Dresden. It represented a full integration of CAM and orthodox medicine. An example of systematic research into CAM is the Nazi government’s project to validate homoeopathy. Even though the data are now lost, the results of this research seem to have been negative. Even though there are some striking similarities between today’s CAM and yesterday’s ‘Neue Deutsche Heilkunde’ there are important differences. Most importantly, perhaps, today’s CAM is concerned with the welfare of the individual, whereas the ‘Neue Deutsche Heilkunde’ was aimed at ensuring the dominance of the Aryan race.
The Nazis thus offered to grant all alternative practitioners official recognition by establishing them under the newly created umbrella of ‘Heilpraktiker’. To please the powerful lobby of conventional doctors, they decreed that the ‘Heilpraktiker’ was barred from educating a second generation of this profession. Therefore, the Heilpraktiker was destined to become extinct within decades.
Several of the Nazi rulers were staunch supporters of homeopathy and other forms of alternative medicine. They hoped that alternative medicine would soon have become an established part of ‘New German Medicine’. For a range of reasons, this never happened.
After the war, the Heilpraktiker went to court and won the right to educate their own students. Today they are a profession that uses homeopathy extensively. The German Heilpraktiker has no mandatory medical training; a simple test to show that they know the legal limits of their profession suffices for receiving an almost unrestricted licence for practicing medicine as long as they want.
You may not believe me – many readers of my blog seem to think that I spend my time spinning the truth – therefore let me show you an article by another author on the same subject:
In Germany, the naturopathic practitioner, the “Heilpraktiker”, is allowed to practice medicine, like medically trained physicians. The German heilpraktiker, a specific German phenomenon embedded in the country’s history, practices medicine without being obliged to undertake any medical teaching or training. Anybody 25 years old or older, with a secondary school certificate, and free of disease can participate in a test, conducted by the local health authorities to “exclude danger to the health of the nation.” In the case of failure, this test can be repeated ad libitum. Having passed this test, the heilpraktiker is allowed to practice the whole realm of medicine, except for gynecology, dentistry, prescription of medication, and healing infectious diseases. There is no more state control during the heilpraktiker’s working life, except in those practices applying invasive methods, such as infusions, injections, oxygen therapy, and acupuncture. These practices are inspected by the public health department based on the Infection Protection Act. Although several cases of fatal errors in treatment are known, the greatest risk in the heilpraktiker’s practice is the omission of proper diagnostics and therapies, which is risk by omission. In this paper, the history of the heilpraktiker in Germany as well as the task of the Public Health Departments in testing the candidates are shown. The data of 345 tests from 2004-2007 in the Rhein-Main area are presented, with 53% of the participants failing. Concerning the hygiene control visits, a concept for hygiene was lacking in 79% of 109 practices, while in 49% a concept for cleaning and disinfection was also missing. In 60% of the practices, a dispenser for hand disinfection was lacking. Recommended improvements were quickly performed in most practices. In conclusion, the current legal regulation, i.e., testing the candidates only once before practicing for a lifetime, does not sufficiently protect the population against danger caused by false diagnostics and (invasive) therapy of the heilpraktiker. Considering the population’s increasing interest and use of complementary and alternative medicine (CAM) with a heilpraktiker being frequently consulted, there are growing concerns in health services, regarding (1) how to regulate CAM professions and natural health procedures, (2) how to incorporate safe CAM into school medicine, and (3) how best to protect the public from a wide range of possible CAM-conventional medicine interactions.
We investigated to what extent psychiatric inpatients consult Heilpraktiker, i.e. non-academically trained providers of complementary and alternative medicine (CAM), which diagnostic and therapeutic methods Heilpraktiker employ, how patients assess Heilpraictikers’ professional competence, CAM in general and issues of satisfaction for those who have had experience with Heilpraktiker. Four hundred and seventy three patients admitted to a psychiatric university department during a 9-month period filled out a questionnaire developed for this investigation. About one third of the patients had consulted a Heilpraktiker, a quarter of these for their current psychiatric illness. Women were in the majority. Patients with the highest secondary school education consulted Heilpraktiker less often. There was considerable ‘customer loyalty’ towards Heilpraktiker. Largely the same diagnostic and treatment methods were employed for mental illness as for somatic complaints. Except for iridology, exotic or dangerous methods played a secondary role. Patients generally revealed a very positive attitude toward Heilpraktiker and CAM, although methods were rated differently. CAM enjoyed greater appreciation among women and patients who had consulted Heilpraktiker. Patients with personal experience were, on the whole, very satisfied with the professional competence, with the atmosphere in the practice and staff concern for the patient’s well-being. Degree of satisfaction correlated closely with frequency of consultation. More patients with neurotic disorders considered the cost unreasonable than others, despite comparatively frequent visits. Psychiatric patients seek out Heilpraktiker to a considerable degree. Especially those who have relevant experience rank Heilpraktiker highly, in particular due to their ‘psychotherapeutic’ attitude, but professional competence is also valued. Methods of CAM received mixed reviews from patients but are generally seen in a positive light. It is recommended that doctors collecting case history data on their patients also ask about experience with alternative practitioners and treatments.
Unsurprisingly, there are numerous reports of Heilpraktiker doing harm to their patients. However, such cases hardly ever get reported in the medical literature. Because there is no effective post-marketing surveillance system in this area, the frequency of harm is essentially unknown.
In my view, it is high time that German officials cast a critical eye on this sector. The incidents mentioned above seem to confirm the urgency of this view.
A thorough report by the Australian group ‘friends of science in medicine’ has just been published. It casts considerable doubt about the therapeutic value of acupuncture. As I think it is a report well worth reading, I reproduce (with the permission of the authors) a large section below:
What could be the mechanisms by which acupuncture might work?
The proponents of acupuncture have postulated possible mechanisms involving neurovascular bundles, trigger points, connective tissue fascial planes, electrical impedance, migration of nuclear tracers, and other factors. These studies are flawed, inconclusive, contradict one another, and have not been replicated. However, interest in acupuncture, particularly for analgesia, has been related to the ‘gate control’ theory (R. Melzack and P.D. Wall, “Pain mechanisms: a new theory”). According to this theory, the activation of large sensory fibres (touch pressure and vibration) inhibits transmission of nociceptive (pain recognising) pathways carried by small unmyelinated nerve fibres. This was postulated to occur in the spinal cord and might explain the effect of ‘rubbing’ the skin to reduce acute pain, the use of ‘counter irritants’, defined by the USA FDA as “externally applied substances that cause irritation or mild inflammation of the skin for the purpose of relieving pain in muscles, joints and viscera distal to the site of application”. It has been suggested that acupuncture could act as a counter irritant. Interest grew, in the 1970s, with the discovery of brain endogenous opioid peptides, which mimic the actions of morphine on pain. These discoveries triggered extensive research, both in China and around the world, on the involvement of endogenous opioid peptides and a plethora of many neuropeptides and purines in acupunctureinduced analgesia (H.M. Langevin et al., “Mechanical signaling through connective tissue: A mechanism for the therapeutic effect of acupuncture,” N. Goldman et al., “Adenosine A1 receptors mediate local anti-nociceptive effects of acupuncture,” Z.Q. Zhao “Neural mechanism underlying acupuncture analgesia”.) The discovery of novel neurotransmitters capable of affecting nociception gave extra impetus to explain some analgesic responses to sensory stimulation (e.g. mini-review on “Acupuncture and endorphins” in Neuroscience Letters). However while the concept that sensory stimulation affects pain sensation is well established, efforts to date have not established that this phenomenon is responsible for acupuncture induced analgesia. Although acupuncture is supposed to be a very specific intervention involving skin penetration with needles and manipulation (twirling), many studies include a plethora of other interventions, assumed to be, to a lesser or greater degree, equivalent. These include acupressure, electro-acupuncture, transcutaneous nerve electrical stimulation (TENS), laser acupuncture, tiny gold beads implanted under the skin, and injection of homeopathic remedies into acupoints. Electro-acupuncture, manipulated by passing electric currents through implanted needles, is widely used and allows a more objective control over stimulating parameters. Electro-acupuncture appears to be able to activate or deactivate a variety of brain regions and promote the release of endogenous opioid peptides, which are responsible for mediating its analgesic effects. Other non-penetrating methods include stimulation with sound, pressure, heat (moxibustion, sometimes with deliberate burn injury), electromagnetic frequencies (laser stimulation, capsicum plaster, an acu-stimulation device such as Electro-acupuncture of Voll [EAV]), chemical (capsicum plaster and Sweet Bee Venom Pharmaco-puncture), vacuum (cupping), color, waving hands over acupoints, and striking the appropriate meridian on an acupuncture doll with a metal hammer (Tong Ren). Even some forms of bloodletting are thought to involve activation of acupuncture points. Because of the aforementioned scientific studies on the neuroscience of nociception, acupuncture seemed to gain somewhat more plausibility than other forms of alternative medicine. Acupuncture has even been said to have positive effects on animals’ cognitive functions.
Acupuncture and the proven principles of Brain Science
Any hypothesis on the mechanism of action of acupuncture and equivalent interventions needs to be placed within the well established, proven principles of the brain sciences. Brain activity is due to the activity of billions of nerve cells, each generating small electrical currents which carry signals from one end to the other of each nerve cell; and, due to communication through the release of small amounts of chemicals, called neurotransmitters, with other nerve cells and with muscle and glands. These electrical and chemical aspects of the nervous system represent the most important foundations of modern brain science. This principle of organisation and function of the nervous system became well-established by the middle of the 20th Century, thanks to the research of the Australian neuroscientist, Sir John Eccles, Nobel prize-winner in Medicine because of this discovery. Since then, a plethora of neurotransmitter substances have been identified in the brain and in peripheral organs. Amongst these are endogenous opioids, as mentioned above, and other neuropeptides; these are recognised as important potential modulators of brain function. Not surprisingly, the idea that activating sensory inputs might affect central neural circuits and that, in particular, acupuncture might well work for analgesia, has triggered extensive research. While there is evidence for the release by various sensory stimuli, including manual acupuncture, of some endogenous opioids and other endogenous chemical mediators potentially capable of modifying pain stimuli, there is little evidence that this is a specific effect related to any anatomical organisation which could correspond to the ‘meridians’ of TCM. In most cases, any physical or chemical sensory stimulus is likely to result in the release of some endogenous anti-nociceptive substances. The highest quality studies have shown that it doesn’t matter where you insert the needles (acupoints or non-acupoints), and that it doesn’t matter whether the skin is penetrated (in one study, touching the skin with a toothpick worked just as well). The one thing that does seem to matter is whether the patient believes in acupuncture.
It is becoming increasingly clear that the brain processes underlying the physiological ‘placebo effect’ in reducing pain perception share similar neurochemical mechanisms with the sensory stimulation caused by acupuncture and other sensory stimulations. Thus the placebo effect is likely to explain many of the subjective improvements of many interventions, including acupuncture. This similarity explains, in part, why it has been so difficult, in practice, to perform satisfactory clinical trials to test the effectiveness of acupuncture separate from the placebo effect. Another myth is that acupuncture must be effective because it works on animals, and they wouldn’t respond to a placebo. But animals can’t talk to tell us to how they feel; their owners must interpret their responses by observing the animal’s behaviour, and the owners are susceptible to suggestion. They might inadvertently influence the animal’s behavior by giving it more attention or treating it differently in some way. They might be convinced that they see a change in the animal’s behavior and think that it means the animal feels better.
Using acupuncture for its placebo effect
Recently, the weight of evidence has convinced some acupuncturists that acupuncture works no better than placebo, but they still advocate using it for its placebo effect. Medical ethicists universally condemn using placebos intentionally since it amounts to lying and can destroy trust in the doctor/patient relationship. In reality, placebos don’t do much; their effects tend to be small in magnitude and short in duration. Patients who use them might defer or reject necessary effective treatment. Placebos can waste time and money, and harm can result when patients are deluded into thinking they are getting better when they really are not. One study found that patients with asthma had the same positive subjective responses to placebos as to an asthma inhaler; but objectively, only the patients in the asthma inhaler group had improvements in lung function. The response to placebos was no better than that of patients in a no-treatment control group. This could have serious consequences, since difficulty in perceiving the severity of an asthma attack is a risk factor for asthma-related death.
Is there clinical evidence for effectiveness of acupuncture in clinical medicine?
The proponents of acupuncture, whether as part of holistic TCM or as a separate technique, advertise that acupuncture can cure a wide range of diseases. Acupuncture has been claimed to be effective for addiction (such as alcoholism), allergies, asthma, bronchitis, carpal tunnel syndrome, chemotherapy-induced nausea and vomiting, constipation, depression, diarrhoea, endometriosis, facial tics, fibromyalgia, gastro-esophageal reflux, headaches, high blood pressure, infertility, irregular menstrual cycles, kidney infections, memory problems, multiple sclerosis, pre-menstrual syndrome, polycystic ovarian syndrome, low back pain, menopausal symptoms, menstrual cramps, osteoarthritis, pain of various natures, pharyngitis, post-operative nausea and vomiting, psychological disorders such as anxiety, sciatica, sensory disturbances, sinusitis, spastic colon (often called irritable bowel syndrome), stroke rehabilitation, tendonitis, tennis elbow, tinnitus, urinary problems such as incontinence, sports injuries, sprains, strains, ulcers, and whiplash.
Acupuncture trials and pitfalls
Clinical research on acupuncture is inherently difficult. The practice of acupuncture is not standardised, and some studies of ‘acupuncture’ are actually of electro-acupuncture, ear acupuncture, or other variants. It’s next to impossible to do double-blind studies, so confounding factors cannot be eliminated. The best studies use a retractable needle in a sheath, so that the patient can’t tell whether the skin has been penetrated or only touched by the needle. The results are highly variable: it’s easy to find studies to support a belief in acupuncture, but it’s even easier to find studies showing that it doesn’t work. The rationale for acupuncture’s acceptance in some aspects of clinical medicine, particularly in emergency medicine and pain clinics, has begun to crumble on closer examination of the evidence, mostly because of the excessively variable nature of the interventions involved in various studies which did not clarify the nature of the sham interventions used and any placebo effects. Recent reviews of the effectiveness of acupuncture on pain in general are rather damning. There have, over several decades, been several thousand acupuncture studies. After all this clinical research, acupuncture has not been clearly demonstrated to be effective for any indication. In short it is more than reasonable to suggest that acupuncture doesn’t work being no more than “a theatrical placebo”. Traditional Chinese acupuncture is no better for treating menopausal symptoms than a ‘sham’ version using blunt needles, according to a University of Melbourne study, published in the Annals of Internal Medicine, involving 327 Australian women over 40 who had at least seven moderately hot flushes daily. Half were given ten sessions of standard Chinese medicine acupuncture, where thin needles were inserted into the body at specific points. The others had their skin stimulated with blunt-tipped needles, which had a milder effect without penetrating the skin. After eight weeks of treatment, both had led to a 40% improvement in the severity and frequency of hot flushes; this was sustained six months later. However, there was no statistical difference between the two therapies. The authors said that both groups might have improved as a result of the placebo effect or because attending a clinic to talk about symptoms helped. The authors also noted that hot flushes tended to improve spontaneously with time adding “This was a large and rigorous study, and we are confident there is no additional benefit from inserting needles compared with stimulation from pressuring the blunt needles without skin penetration for hot flushes.” The most positive results from acupuncture have been for pain and post-operative nausea and vomiting (PONV). But even for those, the evidence is unconvincing. For PONV, the most recent meta-analysis indicated a small effect of P6 acupoint stimulation, but it mixed studies of acupuncture with electro-acupuncture, transcutaneous nerve stimulation, laser stimulation, capsicum plaster, an acu-stimulation device, and acupressure. There were questionable randomisation procedures, incomplete data, and the conclusion of the reviewers (that P6 acupoint stimulation “prevented PONV”) was not justified by the data. There is a lot of ‘noise’ in the data from these studies, but there doesn’t appear to be any ‘signal‘ mixed with the ‘noise’. It has been shown that the analgesic benefits of acupuncture are partially mediated through placebo effects related to the acupuncturist’s behavior. It is becoming increasingly clear that any reported benefits of acupuncture are largely due to the surrounding ritual, the beliefs of patient and practitioner, and the other nonspecific effects of treatment, not to the needles themselves. The team studying PONV also examined ‘Acupuncture for pelvic and back pain in pregnancy: a systematic review’. They concluded “limited evidence supports acupuncture use in treating pregnancy-related pelvic and back pain. Additional high-quality trials are needed to test the existing promising evidence for this relatively safe and popular complementary therapy”. A systematic review of acupuncture for various pain conditions found a mix of negative, positive and inconclusive results. Out of 57 systematic reviews, there were only 4 pain conditions for which more than one systematic review reached the same conclusion: in 3 cases, they agreed that it was ineffective, and in only one (neck pain) was it agreed that it was effective. That finding is suspect, because it doesn’t make sense that a treatment could relieve pain only in one part of the body but not elsewhere. Over the past 10-15 years the Cochrane collaboration has addressed the efficacy of acupuncture for many of these indications. When clinical trials have been performed properly, lack or insufficient evidence of effectiveness for acupuncture was demonstrated in most cases. The following is a list, not exhaustive, of such trials. In thirty trials for depression, with 2,812 participants, manual and electro acupuncture were compared with medication; they found no difference between the two groups. A review by the Cochrane Collaboration on the question ‘Do acupuncture and related therapies help smokers who are trying to quit’ “did not find consistent evidence that active acupuncture or related techniques increased the number of people who could successfully quit smoking”. A study by RMIT researchers in 2016 showed that acupuncture is no better than placebo for menopausal symptoms such as hot flashes. A Cochrane Collaboration study (2014) demonstrated no effects on functional dyspepsia. A similar lack of effect on rheumatoid arthritis was demonstrated in 2005. Even proponents of acupuncture from the team at the RMIT in Melbourne, in their attempt to prove that acupuncture is effective in a “range of health conditions”, admitted, “No solid conclusion of which design is the most appropriate sham control of Ear-acupuncture/ear-acupressure could be drawn in this review”. Very clear experimental work performed by a University of Melbourne team on one of the projects funded by the NH&MRC on laser acupuncture, “Acupuncture for Chronic Knee Pain published A Randomized Clinical Trial on chronic knee pain”, showed that neither needle nor laser acupuncture significantly improved pain and concluded that their findings did not support acupuncture for these patients. A paper in Obstetrics & Gynecology in 2008 “Acupuncture to Induce Labor: A Randomized Controlled Trial” concluded “Two sessions of manual acupuncture, using local and distal acupuncture points, administered 2 days before a scheduled induction of labor did not reduce the need for induction methods or the duration of labor for women with a post-term pregnancy”.
Trials not performed sufficiently well and therefore “need to be repeated”
Despite the several decades of significant funding for, and research on, acupuncture and, in general, on alternative medicines in Australia and around the world, far too often the conclusion from clinical trials is “more research is needed”. The excuses given in the numerous reviews, mostly by the proponents, are insufficient numbers of patients or trials or insufficient control subjects. The reality is more likely due to the reality that there is an absence of effectiveness. For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”. In a review, “Pain Research in Complementary and Alternative Medicine in Australia: A Critical Review”, the authors concluded that, because of the poor design and execution of research papers on pain and alternative medicines, “The quantity and the quality of CAM pain research in Australia is inconsistent with the high utilization of the relevant CAM therapies by Australians. A substantial increase in government funding is required. Collaborative research examining the multimodality or multidisciplinary approach is needed”. It has been claimed that surgery can be performed using only acupuncture anesthesia. A widely publicised picture of a patient allegedly undergoing open-heart surgery under acupuncture anesthesia appears to be a fake: it shows her with an open chest cavity that would make her lungs collapse, she is not on a respirator and a heartbypass machine does not appear to be in use. Also, the incision is in the wrong place for the procedure being described, and the photo is curious in other respects (such as the position of the patient’s head). A recent BBC video of surgery on a conscious patient anaesthetised with acupuncture was similarly misleading. Researchers at the Centre for Complementary Medicine Research at the University of Western Sydney, commenting on studies of acupuncture for menstrual problems stated, “Five systematic reviews were included, and six RCTs. The symptoms of the menopause and of dysmenorrhea have been subject to greater clinical evaluation through RCTs, and the evidence summarised in systematic reviews, than any other reproductive health complaint. The evidence for acupuncture to treat dysmenorrhea and menopause remains unclear, due to small study populations and the presence of methodological bias. For example, a review on “Acupuncture to treat common reproductive health complaints: An overview of the evidence” concluded “Acupuncture to treat premenstrual syndrome or polycystic ovarian syndrome and other menstrual related symptoms is under-studied, and the evidence for acupuncture to treat these conditions is frequently based on single studies. Conclusion: Further research is needed”. Many other studies by the Cochrane Collaboration concluded that there was insufficient evidence for recommending the use of acupuncture for the conditions investigated, as listed as follow: ADHD in children and adolescents (2011); autism spectrum disorders (ASD) (2011); Bell’s palsy (2010); cancer-related pain (2015); glaucoma (2013); depression (2010); dysphagia in acute stroke (2008); tennis elbow (2002); ‘fibromyalgia’ (2013); induction of labour (2013); menopausal hot flushes (2013); mumps (2014); nearsightedness in children (2011); hypoxic ischemic encephalopathy in newborn babies (2013); pain in endometriosis (2011); period pain (2011); chronic asthma (1999); urinary incontinence (2013); stroke rehabilitation (2006); uterine fibroids (2010); labour pains (2011); vascular dementia (2007); nausea and vomiting in early pregnancy (2015); obesity (2015). Even TENS appears to give insufficient evidence for improving dementia (2003).
Reasonable trials with evidence for small effects.
A Cochrane study on acupuncture and dry needling for low back pain, based on 35 randomised clinical trials in 2005, reported a very small effect. Another Cochrane study in 2009 suggested that acupuncture should be considered a treatment option for migraine prophylaxis, despite finding that “there was no evidence of an effect of true acupuncture over sham interventions”. A Cochrane study in 2006 found moderate evidence for a small improvement in chronic neck pain while a review in 2009 suggested that there was benefit from the use of acupuncture to treat Tension-type headache Almost all trials of alternative medicines seem to end up with the conclusion “more research is needed”. After more than 3,000 trials, we should recognise that the need for more trials is dubious…
Acupuncture has been studied for decades and the evidence that it can provide clinical benefits continues to be weak and inconsistent. There is no longer any justification for more studies. There is already enough evidence to confidently conclude that acupuncture doesn’t work. It is merely a theatrical placebo based on pre-scientific myths. All health care providers who accept that they should base their treatments on scientific evidence whenever credible evidence is available, but who still include acupuncture as part of their health interventions, should seriously revise their practice. There is no place for acupuncture in Medicine.[the original report is fully referenced]
Politeness means showing consideration for others and observing accepted social rules. Those who know me personally would probably confirm that I am a fairly polite person. And I had always hoped that politeness might also become a feature of how all of us deal with each other on this blog. Sadly this has not proven to be so.
Don’t get me wrong, I am not trying to say that I am blameless. Firstly I see all the comments before they get posted, and secondly I too have been rather the opposite of polite at times. How come?
My excuse is that I too often let myself get carried away. From my perspective, the typical exchange ending in impoliteness develops as follows:
- My post is formulated such that it provokes some strong reaction. I know, I do this all the time, and I cannot promise that I will not do it in the future. This is because I believe – and experience tells me that I am correct – that one has to provoke in order to get some reaction.
- The person I provoked posts a comment that challenges me or someone else to respond. The nature of the comment is often such that it comes close to a personal attack. For instance, someone might state that I was fired from my Exeter post, that I am paid by the pharmaceutical industry, that I don’t know my subject, etc.
- Often, I do not respond at all to this sort of thing. But sometimes I conclude that facts need to be corrected, and regrettably, I correct them with more provocation.
- This then gets up the nose of the commenter and he or she feels hurt and points out that the discourse has become less than polite – which, of course, is correct.
This is not to excuse anyone or anything; it is just to show how things happen.
The way I see it, there is a bit of a conundrum here: if I write a post without any provocation [which I have done often], there will be no feedback or comments at all [which also happens occasionally]. If I use the method of deliberately provoking people, things can easily escalate. The secret is obviously to get the dose right.
So, when I get it wrong, do blame me!
Politeness is undoubtedly desirable and we should all aim to be polite on this blog and elsewhere. At the same time, we should remember that politeness is not a virtue; it is simply following rules without requiring any moral judgment. Politeness is an artifice. The essence of politeness is form; the essence of virtue is character. A polite bastard is still a bastard! And an impolite man of virtue is still a man of virtue.
Impoliteness may be hurtful but the truth is sometimes hurtful too. And there is a danger in going too far in both directions; exaggerated politeness is close to insincerity. If it were a choice between politeness and truth, I would always opt for the latter.
But luckily this is rarely the case; one can usually have both!
Why am I rambling on about such an issue? Because I want to appeal to all who write and comment here – not least myself – that politeness is a very good thing and enables a better exchange than we sometimes had on this blog. So, lets not escalate things again, let’s understand little provocations for what they are meant to be: a stimulus to have an open, challenging but nevertheless polite debate.
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!
The Swiss interior ministry has yesterday announced its intention to elevate quackery to the same level as conventional medicine.
The 5 therapies were named as
- holistic medicine,
- herbal medicine,
- traditional Chinese medicine
No, this is not an early April fools joke! It might merely a sign that this country is in dire need of some critical thinking.
The 5 therapies will acquire the same status as conventional medicine by May 2017. After being rejected in 2005 by the authorities for lack of scientific proof of their efficacy, complementary and alternative medicines made a comeback in 2009 when two-thirds of Swiss backed their inclusion on the constitutional list of paid health services. As a result of the vote, these treatments are covered by basic compulsory insurance as part of six-year trial period from 2012-2017, during which their efficacy would be examined. The ministry has come to the conclusion that it is impossible to verify the efficacy of these therapies in their entirety. It has therefore opted to accept them on par with other medical disciplines. It plans to continue allowing reimbursements of treatment costs by compulsory health insurance, provided they are administered by certified medical professionals. However, as is the practice for conventional medicine, certain controversial practices under these complementary therapies will be subjected to further scrutiny. The ministry has initiated a consultation process – open until June 30, 2016 – on the proposed modification of the regulations.
There are a few interesting things here:
- What on earth is ‘holistic medicine’? It seems to be an umbrella term under which any type of quackery can be included.
- The lack of proof of efficacy – which since 20015 has only increased – is over-ruled by a popular vote.
- The ministry has come to the conclusion that it is impossible to verify the efficacy of these therapies in their entirety. What does that mean? From a scientific point of view, it means science cannot show that these treatment work, BECAUSE THEY DON’T! But I suspect they did not want to say that. What did they want to say then?
- holidays for citizens who feel ‘under the weather’,
- distance healing,
- botox therapy for wrinkled faces,
- hair transplants,
- pet ownership,
- free champagne for low blood pressure,
Sorry, I just realized that all of the above are already included in the category of HOLISTIC MEDICINE.