bogus claims
Dear Professor Robinson,
please forgive me for writing to you in a matter that, you might think, is really none of my business. I have been following the news and discussions about the BLACKMORE CHAIR at your university. Having been a professor of complementary medicine at Exeter for ~20 years and having published more papers on this subject than anyone else on the planet, I am naturally interested and would like to express some concerns, if you allow me to.
With my background, I would probably be the last person to argue that a research chair in alternative medicine is not a good and much-needed thing. However, accepting an endowment from a commercially interested source is, as you are well aware, a highly problematic matter.
I am confident that you intend to keep the sponsor at arm’s length and plan to appoint a true scientist to this post who will not engage in the promotional activities which the alternative medicine scene might be expecting. And I am equally sure that the money will be put to good use resulting in good and fully independent science.
But, even if all of this is the case, there are important problems to consider. By accepting Blackmore’s money, you have, perhaps inadvertently, given credit to a commercially driven business empire. As you probably know, Blackmores have a reputation of being ‘a bit on the cavalier side’ when it comes to rules and regulations. This is evidenced, for instance, by the number of complaints that have been upheld against them by the Australian authorities.
For these reasons, the creation of the new chair is not just a step towards generating research, it could (and almost inevitably will) be seen as a boost for quackery. It is foremost this aspect which might endanger the reputation of your university, I am afraid.
My own experience over the last two decades has taught me to be cautious and sceptical regarding the motives of many involved in the multi-billion alternative medicine business. I have recently published my memoir entitled ‘A SCIENTIST IN WONDERLAND. SEARCHING FOR TRUTH AND FINDING TROUBLE’; it might be a helpful read for you and the new professor.
I hope you take my remarks as they were meant: constructive advice from someone who had to learn it all the hard way. If I can be of further assistance, please do not hesitate to ask me.
Sincerely
Edzard Ernst
The Royal Australian College of General Practitioners (RACGP) just issued an important statement on homeopathy which, in several ways, goes beyond previous announcements on this subject. I take the liberty of reproducing it here in full:
The RACGP supports the use of evidence-based medicine, in which current research information is used as the basis for clinical decision-making. In light of strong evidence to confirm that homeopathy has no effect beyond that of placebo as a treatment for various clinical conditions, the position of the RACGP is:
1. Medical practitioners should not practice homeopathy, refer patients to homeopathic practitioners, or recommend homeopathic products to their patients.
2. Pharmacists should not sell, recommend, or support the use of homeopathic products.
3. Homeopathic alternatives should not be used in place of conventional immunisation.
4. Private health insurers should not supply rebates for or otherwise support homeopathic services or products.
Background
The contention that homeopathy is an effective treatment is not supported by evidence from systematic literature reviews. The National Health and Medical Research Council (NHMRC) analysed the scientific evidence for the effectiveness of homeopathy in treating a range of clinical conditions and released a position statement [1] in March 2015. The NHMRC’s review concluded homeopathy does not produce health benefits over and above that of placebo, or equivalent to that of another treatment.[2] Crucially, the report states that there are “no health conditions for which there is reliable evidence that homeopathy is effective” as a treatment.
While not covered in the NHMRC’s review, it is also the case that homeopathic alternatives to conventional vaccination do not prevent communicable diseases or increase protective antibodies to disease. The National Centre for Immunisation Research and Surveillance has advised that there are no studies of sufficient quality to demonstrate the safety or effectiveness of ‘homeopathic vaccines’ for protection against disease.[3] Indeed, there is no plausible biological mechanism of action by which these products could prevent infection.[4]
Harms associated with homeopathy
Homeopathic products are sometimes considered harmless as they are generally administered at a high dilution. Some may not even contain a single molecule of the original source material. However, there are a number of risks associated with the use of homeopathy.
Delaying or avoiding conventional medical care
When the use of homeopathy causes a person to delay or avoid consultation with a registered medical practitioner or reject conventional medical approaches, serious and sometimes fatal consequences can occur. As evidenced by recent Australian court findings, spurious claims made by homeopathic practitioners[5] and retailers[6] can mislead individuals about the effectiveness of conventional medicine. When homeopathic vaccines are used as an alternative to conventional immunisation, both the individual and the community are left exposed to preventable diseases.
Problems associated with unregulated products
Although homeopathic products manufactured in Australia are regulated as medicines under the Therapeutic Goods Act 1989, products sold on international websites may not meet Australian quality and safety standards. These products may be of particular concern when materials from problematic sources are employed in the preparation (e.g., pathogenic organs or tissues; causative agents such as bacteria, fungi, parasites, ova, yeast, and virus particles; disease products; excretions or secretions; heavy metals and toxins such as aconitum, kerosene and thallium). Impurities of source material and contamination associated with poor manufacturing processes also present threats to the quality and safety of these products.[7]
Direct adverse effects
Various direct harms associated with the use of homeopathic products have been noted in the literature, including allergic reaction, drug interactions, and complications related to the ingestion of toxic substances.[8]
The importance of patient-centred practice
The RACGP supports the concept of patient-centred practice, in which the values, preferences, and personal healthcare philosophy of the patient are respected and individuals play an important role in their own healthcare. An estimated six per cent of Australians use homeopathy over the course of a year.[9] It is important that these patients feel comfortable in discussing their use of complementary and alternative medicines with all members of their treatment team.
It is good practice for medical practitioners to initiate conversations with patients about their use of or intention to use homeopathy, and assist patients to think critically about the efficacy and safety of homeopathy so that they may make informed healthcare decisions.
Private health insurance and homeopathy
Many private health insurers provide ancillary (extras) cover that subsidises homeopathic treatment, and the individual’s costs in taking out this cover are subsidised under the Australian Government’s private health insurance rebate. The RACGP is concerned that health insurance premiums continue to rise as funds disburse significant sums for the use of homeopathy and other natural therapies lacking rigorous evidentiary support. In the 2013–14 financial year, health insurers paid out $164 million in benefits for natural therapies, up by almost 60 per cent from 2010–11.[10]
The RACGP also notes that offering subsidies for the use of homeopathy sends a confusing message to consumers. Listing homeopathic treatments alongside evidence-based modalities in a list of member benefits lends legitimacy to a practice that is not supported by scientific data.
References
1. National Health and Medical Research Council. NHMRC Statement: Statement on Homeopathy. Canberra: NHMRC; 2015.
2. National Health and Medical Research Council. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions. Canberra: NHMRC; 2015.
3. National Centre for Immunisation Research and Surveillance. Homeopathy and vaccination [fact sheet].2014 [cited 2015 April]. Available from http://www.ncirs.edu.au/immunisation/factsheets/homeopathyvaccination-
fact-sheet.pdf
4. Commonwealth Department of Health and Ageing. Myths and realities: Responding to arguments against vaccination. A guide for providers. Canberra: DoHA; 2013.
5. Coronial inquest into the death of Penelope Dingle. State Coroner of Western Australia, 2010.
6. Australian Competition and Consumer Commission v Homeopathy Plus! Pty Ltd. FCA, 2014.
7. World Health Organization. Safety issues in the preparation of homeopathic medicines. Geneva: WHO; 2009.
8. Posadzki P, Alotaibi A, Ernst E. Adverse effects of homeopathy: a systematic review of published case reports and case series. International Journal of Clinical Practice 2012 Dec;66(12): 1178–88.
9. Xue CCL, Zhang AL, Lin V, Da Costa C, Story DF. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of Alternative and Complementary Medicine 2007; 13(16):643–50.
10. Private Health Insurance Administration Council. Operations of the Private Health Insurers Annual Report 2013–14. Canberra: PHIAC; 2014.
I think this is a very good statement:
- it is based on the best evidence currently available,
- it is concise and to the point,
- it covers all the necessary ground,
- it provides valuable and practical recommendations.
Perhaps I should mention that it came as a complete surprise to me, and I was not involved in any way.
Finally, I would like to express my hope that this statement will be adopted in Australia and send a powerful signal to organisations across the world to issue similar recommendations for the benefit of vulnerable patients who still fall victim to bogus claims by homeopaths every day.
On 26/5/2015, I received the email reproduced below. I thought it was interesting, looked up its author (“Shawn is a philosopher and writer educated at York University in Toronto, and the author of two books. He’s also worked with Aboriginal youth in the Northwest Territories of Canada”) and decided to respond by writing a blog-post rather than by answering Alli directly.
Hello Dr. Ernst, this is Shawn Alli from Canada, a blogger and philosopher. I recently finished a critical article on James Randi’s legacy. It gets into everything from ideological science, manipulation, ESP, faith healing, acupuncture and homeopathy.
Let me know what you think about it:
http://www.shawnalli.com/james-randi-disingenuous-legacy.html
It’s quite long so save it for a rainy day.
So far, the reply from skeptical organizations range from: “I couldn’t read further than the first few paragraphs because I disagree with the claims…” to one word replies: “Petty.”
It’s always nice to know how open-minded skeptical organizations are.
Hopefully you can add a bit more.
Sincerely,
Shawn
Yes, indeed, I can but try to add a bit more!
However, Alli’s actual article is far too long to analyse it here in full. I therefore selected just the bit that I feel most competent commenting on and which is closest to my heart. Below, I re-produce this section of Alli’s article in full. I add my comments at the end (in bold) by inserting numbered responses which refer to the numbers (in round brackets [the square ones refer to Alli’s references]) inserted throughout Alli’s text. Here we go:
Homeopathy & Acupuncture:
A significant part of Randi’s legacy is his war against homeopathy. This is where Randi shines even above mainstream scientists such as Dawkins or Tyson.
Most of his talks ridicule homeopathy as nonsense that doesn’t deserve the distinction of being called a treatment. This is due to the fact that the current scientific method is unable to account for the results of homeopathy (1). In reality, the current scientific method can’t account for the placebo effect as well (2).
But then again, that presents an internal problem as well. The homeopathic community is divided by those who believe it’s a placebo effect and those that believe it’s more than that, advocating the theory of water memory, which mainstream scientists ridicule and vilify (3).
I don’t know what camp is correct (4), but I do know that the homeopathic community shouldn’t follow the lead of mainstream scientists and downplay the placebo effect as, it’s just a placebo (5).
Remember, the placebo effect is downplayed because the current scientific method is unable to account for the phenomenon (3, 5). It’s a wondrous and real effect, regardless of the ridicule and vilification (6) that’s attached to it.
While homeopathy isn’t suitable as a treatment for severe or acute medical conditions, it’s an acceptable treatment for minor, moderate or chronic ones (7). Personally, I’ve never tried homeopathic treatments. But I would never tell individuals not to consider it. To each their own, as long as it’s within universal ethics (8).
A homeopathic community in Greece attempts to conduct an experiment demonstrating a biological effect using homeopathic medicine and win Randi’s million dollar challenge. George Vithoulkas and his team spend years creating the protocol of the study, only to be told by Randi to redo it from scratch. [29] (9) I recommend readers take a look at:
Randi’s war against homeopathy is an ideological one (10). He’ll never change his mind despite positive results in and out of the lab (11). This is the epitome of dogmatic ideological thinking (12).
The same is true for acupuncture (13). In his NECSS 2012 talk Randi says:
Harvard Medical School is now offering an advanced course for physicians in acupuncture, which has been tested endlessly for centuries and it does not work in any way. And believe me, I know what I’m talking about. [30]
Acupuncture is somewhat of a grey area for mainstream scientists and the current scientific method. One ideological theory states that acupuncture operates on principles of non-physical energy in the human body and relieving pressure on specific meridians. The current scientific method is unable to account for non-physical human energy and meridians.
A mainstream scientific theory of acupuncture is one of neurophysiology, whereby acupuncture works by affecting the release of neurotransmitters. I don’t know which theory is correct; but I do know that those who do try acupuncture usually feel better (14).
In regards to the peer-reviewed literature, I believe (15) that there’s a publication bias against acupuncture being seen as a viable treatment for minor, moderate or chronic conditions. A few peer-reviewed articles support the use of acupuncture for various conditions:
Eight sessions of weekly group acupuncture compared with group oral care education provide significantly better relief of symptoms in patients suffering from chronic radiation-induced xerostomia. [31]
It is concluded that this study showed highly positive effects on pain and function through the collaborative treatment of acupuncture and motion style in aLBP [acute lower back pain] patients. [32]
Given the limited efficacy of antidepressant treatment…the present study provides evidence in supporting the viewpoint that acupuncture is an effective and safe alternative treatment for depressive disorders, and could be considered an alternative option especially for patients with MDD [major depressive disorder] and PSD [post-stroke depression], although evidence for its effects in augmenting antidepressant agents remains controversial. [33]
In conclusion: We find that acupuncture significantly relieves hot flashes and sleep disturbances in women treated for breast cancer. The effect was seen in the therapy period and at least 12 weeks after acupuncture treatment ceased. The effect was not correlated with increased levels of plasma estradiol. The current study showed no side effects of acupuncture. These results indicate that acupuncture can be used as an effective treatment of menopausal discomfort. [34]
In conclusion, the present study demonstrates, in rats, that EA [electroacupuncture] significantly attenuates bone cancer induced hyperalgesia, which, at least in part, is mediated by EA suppression of IL-1…expression. [35]
In animal model of focal cerebral ischemia, BBA [Baihui (GV20)-based Scalp acupuncture] could improve IV [infarct volume] and NFS [neurological function score]. Although some factors such as study quality and possible publication bias may undermine the validity of positive findings, BBA may have potential neuroprotective role in experimental stroke. [36]
In conclusion, this randomized sham-controlled study suggests that electroacupuncture at acupoints including Zusanli, Sanyinjiao, Hegu, and Zhigou is more effective than no acupuncture and sham acupuncture in stimulating early return of bowel function and reducing postoperative analgesic requirements after laparoscopic colorectal surgery. Electroacupuncture is also more effective than no acupuncture in reducing the duration of hospital stay. [37]
In conclusion, we found acupuncture to be superior to both no acupuncture control and sham acupuncture for the treatment of chronic pain…Our results from individual patient data meta-analyses of nearly 18000 randomized patients in high-quality RCTs [randomized controlled trials] provide the most robust evidence to date that acupuncture is a reasonable referral option for patients with chronic pain. [38]
While Randi and many other mainstream scientists will argue (16) that the above claims are the result of ideological science and cherry picking, in reality, they’re the result of good science going up against dogmatic (17) and profit-driven (17) ideological (17) science.
Yes, the alternative medicine industry is now a billion dollar industry. But the global pharmaceutical medical industry is worth hundreds of trillions of dollars. And without its patients (who need to be in a constant state of ill health), it can’t survive (18).
Individuals who have minor, moderate, or chronic medical conditions don’t want to be part of the hostile debate between alternative medicine vs. pharmaceutical medical science (19). They just want to get better and move on with their life. The constant war that mainstream scientists wage against alternative medicine is only hurting the people they’re supposed to be helping (20).
Yes, the ideologies (21) are incompatible. Yes, there are no accepted scientific theories for such treatments. Yes, it defies what mainstream scientists currently “know” about the human body (22).
It would be impressive if a peace treaty can exist between both sides, where both don’t agree, but respect each other enough to put aside their pride and help patients to regain their health (23).
END OF ALLI’S TEXT
And here are my numbered comments:
(1) This is not how I understand Randi’s position. Randi makes a powerful point about the fact that the assumptions of homeopathy are not plausible, which is entirely correct – so much so that even some leading homeopaths admit that this is true.
(2) This is definitely not correct; the placebo effect has been studied in much detail, and we can certainly ‘account’ for it.
(3) In my 40 years of researching homeopathy and talking to homeopaths, I have not met any homeopaths who “believe it’s a placebo effect”.
(4) There is no ‘placebo camp’ amongst homeopaths; so this is not a basis for an argument; it’s a fallacy.
(5) They very definitely are mainstream scientists, like F Benedetti, who research the placebo effect and they certainly do not ‘downplay’ it. (What many people fail to understand is that, in placebo-controlled trials, one aims at controlling the placebo effect; to a research-naïve person, this may indeed LOOK LIKE downplaying it. But this impression is wrong and reflects merely a lack of understanding.)
(6) No serious scientist attaches ‘ridicule and vilification’ to it.
(7) Who says so? I know only homeopaths who hold this opinion; and it is not evidence-based.
(8) Ethics demand that patients require the best available treatment; homeopathy does not fall into this category.
(9) At one stage (more than 10 years ago), I was involved in the design of this test. My recollection of it is not in line with the report that is linked here.
(10) So far, we have seen no evidence for this statement.
(11) Which ones? No examples are provided.
(12) Yet another statement without evidence – potentially libellous.
(13) Conclusion before any evidence; sign for a closed mind?
(14) This outcome could be entirely unrelated to acupuncture, as anyone who has a minimum of health care knowledge should know.
(15) We are not concerned with beliefs, we concerned with facts here, aren’t we ?
(16) But did they argue this? Where is the evidence to support this statement?
(17) Non-evidence-based accusations.
(18) Classic fallacy.
(19) The debate is not between alt med and ‘pharmaceutical science’, it is between those who insist on treatments which demonstrably generate more good than harm, and those who want alt med regardless of any such considerations.
(20) Warning consumers of treatments which fail to fulfil the above criterion is, in my view, an ethical duty which can save much money and many lives.
(21) Yes, alt med is clearly ideology-driven; by contrast conventional medicine is not (if it were, Alli would have explained what ideology it is precisely). Conventional medicine changes all the time, sometimes even faster than we can cope with, and is mainly orientated on evidence which is not an ideology. Alt med hardly changes or progresses at all; for the most part, its ideology is that of a cult celebrating anti-science and obsolete traditions.
(22) Overt contradiction to what Alli just stated about acupuncture.
(23) To me, this seems rather nonsensical and a hindrance to progress.
In summary, I feel that Alli argues his corner very poorly. He makes statements without supporting evidence, issues lots of opinion without providing the facts (occasionally even hiding them), falls victim of logical fallacies, and demonstrates an embarrassing lack of knowledge and common sense. Most crucially, the text seems bar of any critical analysis; to me, it seems like a bonanza of unreason.
To save Alli the embarrassment of arguing that I am biased or don’t know what I am talking about, I’d like to declare the following: I am not paid by ‘Big Pharma’ or anyone else, I am not aware of having any other conflicts of interest, I have probably published more research on alt med (some of it with positive conclusions !!!) than anyone else on the planet, my research was funded mostly by organisations/donors who were in favour of alt med, and I have no reason whatsoever to defend Randi (I only met him personally once). My main motivation for responding to Alli’s invitation to comment on his bizarre article is that I have fun exposing ‘alt med nonsense’ and believe it is a task worth doing.
This is a question which I have asked myself more often than I care to remember. The reason is probably that, in alternative medicine, I feel surrounded by so much dodgy research that I simply cannot avoid asking it.
In particular, the co-called ‘pragmatic’ trials which are so much ‘en vogue’ at present are, in my view, a reason for concern. Take a study of cancer patients, for instance, where one group is randomized to get the usual treatments and care, while the experimental group receives the same and several alternative treatments in addition. These treatments are carefully selected to be agreeable and pleasant; each patient can choose the ones he/she likes best, always had wanted to try, or has heard many good things about. The outcome measure of our fictitious study would, of course, be some subjective parameter such as quality of life.
In this set-up, the patients in our experimental group thus have high expectations, are delighted to get something extra, even more happy to get it for free, receive plenty of attention and lots of empathy, care, time, attention etc. By contrast, our poor patients in the control group would be a bit miffed to have drawn the ‘short straw’ and receive none of this.
What result do we expect?
Will the quality of life after all this be equal in both groups?
Will it be better in the miffed controls?
Or will it be higher in those lucky ones who got all this extra pampering?
I don’t think I need to answer these questions; the answers are too obvious and too trivial.
But the real and relevant question is the following, I think: IS SUCH A TRIAL JUST SILLY AND MEANINGLESS OR IS IT UNETHICAL?
I would argue the latter!
Why?
Because the results of the study are clearly known before the first patient had even been recruited. This means that the trial was not necessary; the money, time and effort has been wasted. Crucially, patients have been misled into thinking that they give their time, co-operation, patience etc. because there is a question of sufficient importance to be answered.
But, in truth, there is no question at all!
Perhaps you believe that nobody in their right mind would design, fund and conduct such a daft trial. If so, you assumed wrongly. Such studies are currently being published by the dozen. Here is the abstract of the most recent one I could find:
The aim of this study was to evaluate the effectiveness of an additional, individualized, multi-component complementary medicine treatment offered to breast cancer patients at the Merano Hospital (South Tyrol) on health-related quality of life compared to patients receiving usual care only. A randomized pragmatic trial with two parallel arms was performed. Women with confirmed diagnoses of breast cancer were randomized (stratified by usual care treatment) to receive individualized complementary medicine (CM group) or usual care alone (usual care group). Both groups were allowed to use conventional treatment for breast cancer. Primary endpoint was the breast cancer-related quality of life FACT-B score at 6 months. For statistical analysis, we used analysis of covariance (with factors treatment, stratum, and baseline FACT-B score) and imputed missing FACT-B scores at 6 months with regression-based multiple imputation. A total of 275 patients were randomized between April 2011 and March 2012 to the CM group (n = 136, 56.3 ± 10.9 years of age) or the usual care group (n = 139, 56.0 ± 11.0). After 6 months from randomization, adjusted means for health-related quality of life were higher in the CM group (FACT-B score 107.9; 95 % CI 104.1-111.7) compared to the usual care group (102.2; 98.5-105.9) with an adjusted FACT-B score difference between groups of 5.7 (2.6-8.7, p < 0.001). Thus, an additional individualized and complex complementary medicine intervention improved quality of life of breast cancer patients compared to usual care alone. Further studies evaluating specific effects of treatment components should follow to optimize the treatment of breast cancer patients.
The key sentence in this abstract is, of course: complementary medicine intervention improved quality of life of breast cancer patients… It provides the explanation as to why these trials are so popular with alternative medicine researchers: they are not real research but they are quite simply promotion! The next step would be to put a few of those pseudo-scientific trials together and claim that there is solid proof that integrating alternative treatments into conventional health care produces better results. At that stage, few people will bother asking whether this is really due to the treatments in questioning or to the additional attention, pampering etc.
My question is ARE SUCH TRIALS ETHICAL?
I would very much appreciate your opinion.
In the world of homeopathy, the truth is often much weirder than fiction. Take this recent article, for instance; it was published by the famous lay homeopath Alan Schmukler in the current issue of ‘HOMEOPATHY 4 EVERYONE’.
Before you read the text in question, it might be relevant to explain who Schmukler is: he attended Temple University, where he added humanistic psychology to his passions. After graduating Summa Cum Laude, Phi Beta Kappa and President’s Scholar, he spent several years doing workshops in human relations. Alan also studied respiratory therapy and worked for three years at Einstein Hospital in Philadelphia. Those thousands of hours in the intensive care and emergency rooms taught him both the strengths and limitations of conventional medicine. Schmukler learned about homeopathy in 1991 when he felt he had been cured of an infection with Hepar sulph. He later founded the Homeopathic Study Group of Metropolitan Philadelphia, giving free lectures and hosting the areas best homeopaths to teach. He also helped found and edit Homeopathy News and Views, a popular culture newsletter on homeopathy. He taught homeopathy for Temple University’s Adult Programs, and has been either studying, writing, lecturing or consulting on homeopathy since 1991. He wrote Homeopathy An A to Z home Handbook, which is now available in five languages. Alan Schmukler has been practicing homeopathy for more than two decades and is Chief Editor of Hpathy.com and of Homeopathy4Everyone. He says that his work as Editor is one of his most rewarding experiences.
Now, brace yourself, here is the promised text/satire (in bold); I promise, I did not change a single word:
EIGHT REASONS TO VACCINATE YOUR CHILD
- Your child is deficient in Mercury, Aluminum, Formaldehyde, viruses, foreign DNA or other ingredients proven to cause neurological damage.
- Your child has an excess of healthy, functioning brain cells.
- You need more cash. The National Vaccine Injury Compensation program has paid out 2.8 billion dollars to parents of children injured or killed by vaccines.
- You and your husband are feeling alienated and you need a crisis to bring you together.
- You believe that pharmaceutical conglomerates which earn billions from vaccines are more credible than consumer groups.
- You think thousands of parents who report that their children became autistic two weeks after vaccination are lying.
- You don’t see a problem in logic when the government tells you that vaccines work, but that vaccinated children can catch diseases from unvaccinated children.
- You think the government should dictate which healing methods you and your children are allowed to use.
Funny? No!
Bad taste? Very much so!
Barmy? I think so!
Dangerous? Yes!
Irresponsible? Most certainly!
Unethical? Yes!
Characteristic for lay homeopathy? Possibly!
A new study of homeopathic arnica suggests efficacy. How come?
Subjects scheduled for rhinoplasty surgery with nasal bone osteotomies by a single surgeon were prospectively randomized to receive either oral perioperative arnica or placebo in a double-blinded fashion. A commercially available preparation was used which contained 12 capsules: one 500 mg capsule with arnica 1M is given preoperatively on the morning of surgery and two more later that day after surgery. Thereafter, arnica was administered in the 12C potency three times daily for the next 3 days (“C” indicates a 100-fold serial dilution; and M, a 1000-fold dilution)
Ecchymosis was measured in digital “three-quarter”-view photographs at three postoperative time points. Each bruise was outlined with Adobe Photoshop and the extent was scaled to a standardized reference card. Cyan, magenta, yellow, black, and luminosity were analyzed in the bruised and control areas to calculate change in intensity.
Compared with 13 subjects receiving placebo, 9 taking arnica had 16.2%, 32.9%, and 20.4% less extent on postoperative days 2/3, 7, and 9/10, a statistically significant difference on day 7. Color change initially showed 13.1% increase in intensity with arnica, but 10.9% and 36.3% decreases on days 7 and 9/10, a statistically significant difference on day 9/10. One subject experienced mild itching and rash with the study drug that resolved during the study period.
The authors concluded that Arnica montana seems to accelerate postoperative healing, with quicker resolution of the extent and the intensity of ecchymosis after osteotomies in rhinoplasty surgery, which may dramatically affect patient satisfaction.
Why are the results positive? Pervious systematic reviews confirm that homeopathic arnica is a pure placebo. First, I thought the answer lies in the 1M potency. It could well still contain active molecules. But then I realised that the answer is much more simple: if we apply the conventional level of statistical significance, there are no statistically significant differences to placebo at all! I had not noticed the little sentence by the authors: a P value of 0.1 was set as a meaningful difference with statistical significance. In fact, none of the effects called significant by the authors pass the conventionally used probability level of 5%.
So, what so the results of this new study truly mean? In my view, they show what was known all along: HOMEOPATHIC REMEDIES ARE PLACEBOS.
In my last post, I made a fairly bold statement without any evidence to support it: “[this] demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.”
I felt that my statement was supported by so many websites that it was almost self-evident. But, as it happens, I was alerted today to another website that provides impressive first had evidence of what I meant:
“The purpose of this site is to provide the public with information about Craniosacral Therapy
Craniosacral therapists recognise health as an active principle. This health is the expression of life – an inherent ordering force, a natural internal intelligence. Craniosacral Therapy is a subtle and profound healing form which assists this natural bodily intelligence.
It is clear that a living human organism is immensely complex and requires an enormous amount of internal organisation. Craniosacral Therapy helps nurture these internal ordering principles. It helps increase physical vitality and well-being, not only effecting structural change, but also having much wider implications e.g. improving interpersonal relationships, managing life more appropriately etc…
The work can address issues in whatever way the client wishes; physical aches and pains, acute and chronic disease, emotional or psychological disturbances, or simply developing well-being, health and vitality.
Craniosacral Therapy is so gentle that it is suitable for babies, children, and the elderly, as well as adults; and also in fragile or acutely painful conditions. As a whole-body therapy, treatment may aid almost every condition, raising the vitality and enabling the body’s own self-healing process to be utilised.”
I find this text rather typical and very revealing: the authors first make several bland statements which are little more that politically correct platitudes. Eventually, they try to tell us what their therapy is good for: it is suitable for babies adults and the elderly. In other words, it is for everyone!
And what is so truly brilliant, it can be used to treat acute and chronic conditions. In other words, it is effective for every disease afflicting mankind!
Once you have realised it, the strategy of such ‘position statements’ (or whatever they might call it) is all too obvious: behind a smokescreen of empty platitudes, quackery is being promoted for profit. The phraseology used is such that there can be little concrete objections in legal or regulatory terms. All the therapeutic claims are general, cleverly hidden and operate merely by implication.
Quackery? Yes, absolutely!
Craniosacral therapy has not been proven to be effective for anything and, as a therapy, it is therefore not ‘suitable’ for anyone. To me, this is almost the definition of quackery.
A recent post of mine prompted this categorical statement by one of the leading alt med researchers in Germany: “naturopathy does not include homeopathy.” This caused several counter-comments claiming that homeopathy is an established part of naturopathy. Now a regular reader has alerted me to the current position paper on homeopathy by the ‘AMERICAN ASSOCIATION OF NATUROPATHIC PHYSICIANS’ (AANP). It clarifies the issue fairly well, and I therefore take the liberty of citing it here in full:
“Overview of Naturopathic Medicine and Homeopathy
Homeopathy has been an integral part of naturopathic medicine since its inception and is a recognized specialty for which the naturopathic profession has created a distinct specialty organization, the Homeopathic Academy of Naturopathic Physicians. Homeopathy has been recognized, through rigorous testing and experimentation, as having significant scientific evidence supporting its efficacy and safety. Single medicines are given on the basis of an individual’s manifestation of a disease state in comparison to combination remedies which are given on the basis of a particular diagnostic category.
Homeopathic products are being subjected to intensified federal regulations and restrictions. Products are being promoted and marketed as “homeopathic” for a variety of uses ranging from weight-loss aids to immunizations. Many of these preparations are not homeopathic and many have not been satisfactorily proven to be efficacious. Homeopathy is practiced in a variety of traditional and non-traditional forms.
Position of the American Association of Naturopathic Physicians:
- Homeopathy is taught in the naturopathic colleges and its practice should be included in the naturopathic licensing laws. Naturopathic physicians recognize other licensed practitioners of the healing arts who are properly trained in homeopathy.
- The naturopathic profession initiates more clinical trials and provings to further evaluate the effectiveness of homeopathy.
- Naturopathic physicians shall be authorized to prescribe and dispense all products included in the Homeopathic Pharmacopoeia of the United States (HPUS).
- Homeopathic products shall be subject to strict labeling requirements. Preparations which are not prepared in accord with the manufacturing principles in the HPUS should not use the term “homeopathic.” If parents choose homeopathic preparations for their children or their wards for the prophylaxis of infectious disease as an alternative to conventional immunizations, the physician should clearly state that they are unproven and that they are not legal substitutes for the state-mandated requirements.
- Homeopathic prescriptions should be made with careful evaluation of their effect on the entire organism.
- Electro-diagnostic testing is an investigational tool. Electro-diagnostic testing should be used according to accepted protocol and it is recommended that it not be relied on as the sole determinant in homeopathic prescribing.”
So, was Prof Michalsen wrong when he stated that “naturopathy does not include homeopathy. It is established in Germany as the application of nutritional therapy, exercise, herbal medicine, balneotherapy and stress reduction, defined by the German Board of Physicians. In conclusion, my general and last suggestion to these kinds of comments and blogs: Please first learn the facts and then comment.”? Not wrong, perhaps – but just a little Teutonic and provincial? The Germans like their own definitions which do not apply to the rest of the world. Nothing wrong with that, I think. But, in this case, they should make it clear that they are talking about something else than the international standard, and perhaps they should also publish their national drivel in their provincial journals in German language. This would avoid all sorts of misunderstandings, I am sure.
But this may just be a trivial aside. The more interesting issue here is the above AANP-statement itself. The AANP has the following vision: “Naturopathic physicians will guide and empower people to discover and experience improved health, optimal wellness, and effective management of disease through the principles and practices of naturopathic medicine.”
These are very nice words; but they are just that: WORDS. The AANP clearly does not believe in their own vision. If they did, they could never speak of ‘EFFECTIVE MANAGEMENT OF DISEASE’ while condoning the use of therapies that have been shown to be ineffective.
And this is where, in my view, the importance of their ‘position paper’ really lies: it demonstrates once again that, in the realm of alternative medicine, organisations and individuals make statements that sound fine and are politically correct, while at the same time disregarding these pompous aims/visions/objectives by promoting outright quackery. This sort of thing is so wide-spread that most of us just take it for granted and very few have the nerve to object. The result of this collective behaviour is obvious: on the one hand, charlatans can claim to be entirely in line with public health, EBM etc.; on the other hand, they are free to exploit the public with their bogus treatments.
Could this be the true common denominator of naturopathy in Germany and the rest of the world?
A recent comment to a post of mine (by a well-known and experienced German alt med researcher) made the following bold statement aimed directly at me and at my apparent lack of understanding research methodology:
C´mon , as researcher you should know the difference between efficacy and effectiveness. This is pharmacological basic knowledge. Specific (efficacy) + nonspecific effects = effectiveness. And, in fact, everything can be effective – because of non-specific or placebo-like effects. That does not mean that efficacy is existent.
The point he wanted to make is that outcome studies – studies without a control group where the researcher simply observe the outcome of a particular treatment in a ‘real life’ situation – suffice to demonstrate the effectiveness of therapeutic interventions. This belief is very wide-spread in alternative medicine and tends to mislead all concerned. It is therefore worth re-visiting this issue here in an attempt to create some clarity.
When a patient’s condition improves after receiving a therapy, it is very tempting to feel that this improvement reflects the effectiveness of the intervention (as the researcher mentioned above obviously does). Tempting but wrong: there are many other factors involved as well, for instance:
- the placebo effect (mainly based on conditioning and expectation),
- the therapeutic relationship with the clinician (empathy, compassion etc.),
- the regression towards the mean (outliers tend to return to the mean value),
- the natural history of the patient’s condition (most conditions get better even without treatment),
- social desirability (patients tend to say they are better to please their friendly clinician),
- concomitant treatments (patients often use treatments other than the prescribed one without telling their clinician).
So, how does this fit into the statement above ‘Specific (efficacy) + nonspecific effects = effectiveness’? Even if this formula were correct, it would not mean that outcome studies of the nature described demonstrate the effectiveness of a therapy. It all depends, of course, on what we call ‘non-specific’ effects. We all agree that placebo-effects belong to this category. Probably, most experts also would include the therapeutic relationship and the regression towards the mean under this umbrella. But the last three points from my list are clearly not non-specific effects of the therapy; they are therapy-independent determinants of the clinical outcome.
The most important factor here is usually the natural history of the disease. Some people find it hard to imagine what this term actually means. Here is a little joke which, I hope, will make its meaning clear and memorable.
CONVERATION BETWEEN TWO HOSPITAL DOCTORS:
Doc A: The patient from room 12 is much better today.
Doc B: Yes, we stared his treatment just in time; a day later and he would have been cured without it!
I am sure that most of my readers now understand (and never forget) that clinical improvement cannot be equated with the effectiveness of the treatment administered (they might thus be immune to the misleading messages they are constantly exposed to). Yet, I am not at all sure that all ‘alternativists’ have got it.
Twenty years ago, I published a short article in the British Journal of Rheumatology. Its title was ALTERNATIVE MEDICINE, THE BABY AND THE BATH WATER. Reading it again today – especially in the light of the recent debate (with over 700 comments) on acupuncture – indicates to me that very little has since changed in the discussions about alternative medicine (AM). Does that mean we are going around in circles? Here is the (slightly abbreviated) article from 1995 for you to judge for yourself:
“Proponents of alternative medicine (AM) criticize the attempt of conducting RCTs because they view this is in analogy to ‘throwing out the baby with the bath water’. The argument usually goes as follows: the growing popularity of AM shows that individuals like it and, in some way, they benefit through using it. Therefore it is best to let them have it regardless of its objective effectiveness. Attempts to prove or disprove effectiveness may even be counterproductive. Should RCTs prove that a given intervention is not superior to a placebo, one might stop using it. This, in turn, would be to the disadvantage of the patient who, previous to rigorous research, has unquestionably been helped by the very remedy. Similar criticism merely states that AM is ‘so different, so subjective, so sensitive that it cannot be investigated in the same way as mainstream medicine’. Others see reasons to change the scientific (‘reductionist’) research paradigm into a broad ‘philosophical’ approach. Yet others reject the RCTs because they think that ‘this method assumes that every person has the same problems and there are similar causative factors’.
The example of acupuncture as a (popular) treatment for osteoarthritis, demonstrates the validity of such arguments and counter-arguments. A search of the world literature identified only two RCTs on the subject. When acupuncture was tested against no treatment, the experimental group of osteoarthritis sufferers reported a 23% decrease of pain, while the controls suffered a 12% increase. On the basis of this result, it might seem highly unethical to withhold acupuncture from pain-stricken patients—’if a patient feels better for whatever reason and there are no toxic side effects, then the patient should have the right to get help’.
But what about the placebo effect? It is notoriously difficult to find a placebo indistinguishable to acupuncture which would allow patient-blinded studies. Needling non-acupuncture points may be as close as one can get to an acceptable placebo. When patients with osteoarthritis were randomized into receiving either ‘real acupuncture or this type of sham acupuncture both sub-groups showed the same pain relief.
These findings (similar results have been published for other AMs) are compatible only with two explanations. Firstly acupuncture might be a powerful placebo. If this were true, we need to establish how safe acupuncture is (clearly it is not without potential harm); if the risk/benefit ratio is favourable and no specific, effective form of therapy exists one might still consider employing this form as a ‘placebo therapy’ for easing the pain of osteoarthritis sufferers. One would also feel motivated to research this powerful placebo and identify its characteristics or modalities with the aim of using the knowledge thus generated to help future patients.
Secondly, it could be the needling, regardless of acupuncture points and philosophy, that decreases pain. If this were true, we could henceforward use needling for pain relief—no special training in or equipment for acupuncture would be required, and costs would therefore be markedly reduced. In addition, this knowledge would lead us to further our understanding of basic mechanisms of pain reduction which, one day, might evolve into more effective analgesia. In any case the published research data, confusing as they often are, do not call for a change of paradigm; they only require more RCTs to solve the unanswered problems.
Conducting rigorous research is therefore by no means likely to ‘throw out the baby with the bath water’. The concept that such research could harm the patient is wrong and anti-scientific. To follow its implications would mean neglecting the ‘baby in the bath water’ until it suffers serious damage. To conduct proper research means attending the ‘baby’ and making sure that it is safe and well.
