Monthly Archives: May 2015
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.
I thought I had a fairly good understanding of homeopathy; well I seem to have been wrong. A German child/adolescent psychiatrist and homeopathic physician has recently published a paper which I find most impressive. Not that it conveys new data or facts, quite the opposite. I find it impressive, because I do not understand a word of it. Here is the summary and the conclusion; if you want to read the full article, this link will take you to it.
Efforts have been made to integrate homeopathy into the system of natural sciences. In this article an alternative approach is offered. The very base of physics and mathematics, on which natural sciences are grounded are time, space and number. Since Immanuel Kant they are believed to be a priori given. Alternatively they can be explained as a consequence of life, such that the outside world in the form, as we perceive it, should no longer be considered independent from us as living beings. Having understood the base of physics, homeopathy does not have to be integrated into an existing system of natural sciences, but can be allowed to be more closely connected to the proper origin of physics, which is life itself.
We come to the conclusion that mathematics and physics are a sequel of life. What we perceive in an outside world is a projection not only of our mind, but also of life itself. It is not an individual projection, but a projection that we share with other living beings. We share some of the aspects of reality with only a few other humans, like the understanding of art, with most humans and some species we share the ability to perceive music or colours. Still broader aspects of what we perceive as reality are common to us and other animal species: firmness, light and sound. With all species we share the aspects of time, space and separateness, oneness. Thus reality is a collective subjective autosuggestion across species. Its outside reality functions on mathematical rules, because mathematics and physics share the common ground, which is time, space and number as a continuation of oneness in time, all sequels of life.
Homeopathy however does not. It does not, because it has a direct connection to life without the detour across outside physics.
If there is someone out there who understands what all this is about, please do enlighten us.
A few years ago, I fell ill with shingles. When patients had consulted me for this condition, during the times when I still was a clinician, I always had to stop myself smiling; they complained bitterly but, really, this was far from serious. Now, affected myself, I did not smile a bit: this was incredibly painful!
I promptly saw my GP in Exeter who, to my utter amazement, prescribed paracetamol. She too seemed to think that this was really nothing to bother her with. As I had feared, the paracetamol did absolutely nothing to my pain. After a few sleepless nights, I went back and asked for something a little more effective. She refused, and I decided to change GP.
Meanwhile, we went on a scheduled holiday to France. I had hoped my shingles would come to a natural end, but my pain continued unabated. People could see it on my face; so our kind neighbour asked whether she could help. I explained the situation, and she instantly claimed to have just the right treatment for me: she knew a healer who lived just round the corner and had helped many of her friends when they had suffered from pain.
“A healer?” I asked, “you cannot be serious.” I explained that I had conducted studies and done other research into this particular subject. Without exception, the results had shown that healing is a pure placebo. “I prefer to carry on taking even something as useless as paracetamol!” I insisted.
But she would have none of it. The next time I saw her, she declared triumphantly that she had made an appointment for me, and there was no question: I had to go.
As it happened, the day before she announced this, I had met up with a doctor friend of mine who, seeing I was in agony, gave me a prescription for gabapentin. In fact, I was just on the way to the pharmacist to pick it up. Thus I was in hopeful that my ordeal was coming to an end. In this optimistic mood I thanked my neighbour for her effort and concern and said something non-committal like “we shall see”.
A few days later, we met again. By this time, the gabapentin had done it’s trick: a was more or less pain-free, albeit a little dazed from the powerful medication. When my neighbour saw me, she exclaimed: “I see that that you are much improved. Wonderful! Yesterday’s healing session has worked!!!”
In my daze, I had forgotten all about the healing, and I had, of course, not been to see the healer. She was so delighted with her coup, that I did not have the heart to tell her the truth. I only said “yes much better, merci”
These events happened a few years ago, but even today, my kind and slightly alternative neighbour believes that, despite having been highly sceptical, healing has cured me of my shingles. To my embarrassment, she occasionally mentions my ‘miraculous cure’.
One day, I must tell her the truth… on second thoughts, perhaps not, she might claim it was distant healing!
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?
These days, I spend much of my time in France (my wife is French), and one striking thing about this country is the popularity of homeopathy. For instance, it is hard to find a pharmacy where the pharmacist does not approach you trying to sell you a homeopathic remedy for your health problem. But, of course, this is all far too anecdotal. The question therefore is, are there any reliable data on France’s usage of homeopathy?
The answer is YES: the aim of this new paper was to analyse data on medicines, prescribers and patients for homeopathic prescriptions that are reimbursed by French national health insurance.
The French national health insurance databases were used to analyse prescriptions of reimbursed homeopathic drugs or preparations in the overall French population, during the period July 2011-June 2012.
The results show that a total of 6,705,420 patients received at least one reimbursement for a homeopathic preparation during the 12-month period. This number equates to 10.2% of the French population, with a predominance in females (68%) and a peak frequency observed in children aged 0-4 years (18%). About one third of patients had only one reimbursement, and one half of patients had three or more reimbursements.
The cost of all homeopathic treatments prescribed during the 12-month period was approximately €279 million (based on the retail price). The observed mean reimbursement rate was 34%. This cost corresponded to nearly €98 million for the French national health insurance and amounted to 0.3% of France’s total drug bill. The most commonly prescribed stock was ‘Arnica montana’, followed by ‘Influenzinum’, Ignatia amara’ and ‘Gelsemium sempervirens’.
A total of 120,110 healthcare professionals (HCPs) prescribed at least one homeopathic drug or preparation. They represented 43.5% of the overall population of HCPs, nearly 95% of general practitioners, dermatologists and pediatricians, and 75% of midwives. Homeopathy accounted for 5% of the total number of drug units prescribed by HCPs. Conventional medicines were co-prescribed with 55% of homeopathic prescriptions.
From these data, the authors concluded that many HCPs occasionally prescribe reimbursed homeopathic preparations, representing however a small percentage of reimbursements compared to allopathic medicines. About 10% of the French population, particularly young children and women, received at least one homeopathic preparation during the year. In more than one half of cases, reimbursed homeopathic preparations are prescribed in combination with allopathic medicines.
So, my impression that homeopathy is much more popular in France than elsewhere was not entirely correct. Like in most other countries, it is used by a minority; but this minority is fairly vocal and gets plenty of press coverage. When discussing homeopathy with friends in France, I have regularly discovered that they have very little understanding about what homeopathy is truly about; they seem to favour it because it is heavily advertised as a harmless solution to benign health problems. In no other country have I seen regular TV commercials for homeopathy! The ones who earn by far the most from this is, of course, the pharmacist – in France, homeopathic products can only be found in pharmacies!
Seen from this angle, the French usage of homeopathy is a triumph of profit over reason: the two most popular preparations (Arnica and Influenzinum) are not just not evidence-based (like all other homeopathic remedies), they have been shown in systematic reviews not to work better than placebos.
Ayurvedic medicine has become highly popular in Western countries; it originates, of course, from India, and is considered to be one of the world’s oldest health care systems. Its adherents claim to create harmony between the body, mind, and spirit, maintaining that this balance prevents illness, treats acute conditions, and contributes to a long and healthy life. In India Ayurveda is mainstream and more than 90% of the population are said to use it. Outside India, Ayurveda is usually classified as an alternative therapy.
Ayurvedic treatments can consist of a range of modalities, including herbal remedies taken by mouth. These preparations have often been reported to be contaminated with toxic metals. Despite several case reports of poisoning from such contamination, the epidemiological evidence is still limited. A new paper on this important topic is therefore welcome. It reports on a cluster of lead and mercury toxicity cases which occurred 2011 among a community of users of Ayurvedic remedies in the US.
Following the identification of the index case, adherents of Ayurveda were offered heavy metals screening. The results showed that 46 of 115 participants (40%) had elevated blood lead levels (BLLs) of 10 μg/dl or above, with 9.6% of BLLs at or above 50 μg/dl.
The authors issued the following warning: this is the largest cluster of lead and mercury toxicity following use of Ayurvedic supplements described in the literature in the US. Contamination of herbal products is a public health issue of global significance. There are few regulations addressing contamination of “natural” products or supplements.
Rasa shastra, the practice of adding metals, minerals or gems to herbal preparations, is a well-documented part of Ayurveda. Adverse reactions to herbs are described in traditional Ayurvedic texts, but practitioners tend to be reluctant to admit that their remedies could be toxic and that reliable information on their risks is not readily available.
Already in 1990, a study on Ayurvedic medicines in India found that 41% of the products tested contained arsenic, and that 64% contained lead and mercury. A 2004 study found toxic levels of heavy metals in 20% of Ayurvedic preparations sold in the Boston area. A 2008 study of more than 230 products found that approximately 20% of remedies (and 40% of rasa shastra medicines) purchased over the Internet from U.S. and Indian suppliers contained lead, mercury or arsenic.
My 2002 systematic review summarised all the available evidence and concluded that heavy metals, particularly lead, have been a regular constituent of traditional Indian remedies. This has repeatedly caused serious harm to patients taking such remedies. The incidence of heavy metal contamination is not known, but one study shows that 64% of samples collected in India contained significant amounts of lead (64% mercury, 41% arsenic and 9% cadmium). These findings should alert us to the possibility of heavy metal content in traditional Indian remedies and motivate us to consider means of protecting consumers from such risks.
Despite these concerns, Ayurveda-fans continue to believe that the toxicity of these remedies is reduced through the purification processes of Ayurvedic remedy preparation. Bizarrely, they may involve prayers as well as physical pharmacy techniques.
The Indian government ruled that Ayurvedic products must be labelled with their metallic content. However, one Indian expert, has been quoted claiming that “the absence of post-market surveillance and the paucity of test laboratory facilities [in India] make the quality control of Ayurvedic medicines exceedingly difficult at this time”. In the US, most Ayurvedic products are marketed without having been approved by the FDA. Since 2007, the FDA has placed an import alert on some Ayurvedic products in order to prevent them from entering the US.
Protecting consumers from heavy metal poisoning by Ayurvedic remedies is certainly not easy – but, in the interest of public health, it is a task that we must tackle with some ungency.
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.
The founder of Johrei Healing (JH), Mokichi Okada, believed that “all human beings have toxins in their physical bodies. Some are inherited, others are acquired by ingesting medicines, food additives, unnatural food, unclean air, most drugs, etc. all of these contain chemicals which cannot be used by the body and are treated as poisons…….. Illness is no more than the body’s way of purifying itself to regain health…… The more we resist illness by taking suppressive medications, the harder and more built up the toxins become…… If we do not allow the toxins to be eliminated from the body, we will suffer more, and have more difficult purification…..on the other hand, if we allow illness to take its course by letting the toxins become naturally eliminated from our bodies, we will be healthier.”
Johrei healers channel light or energy or warmth etc. into the patient’s or recipient’s body in order to stimulate well-being and healing. Sounds wacky? Yes!
Still, at one stage my team conducted research into all sorts of wacky healing practices (detailed reasons and study designs can be found in my recent book ‘A SCIENTIST IN WONDERLAND‘). Despite the wackiness, we even conducted a study of JH. Dr Michael Dixon, who was closely collaborating with us at the time, had persuaded me that it would be reasonable to do such a study. He brought some Japanese JH-gurus to my department to discuss the possibility, and (to my utter amazement) they were happy to pay £ 70 000 into the university’s research accounts for a small pilot study. I made sure that all the necessary ethical safe-guards were in place, and eventually we all agreed to design and conduct a study. Here is the abstract of the paper published once the results were available and written up.
“Johrei is a form of spiritual healing comprising “energy channelling” and light massage given either by a trained healer or, after some basic training, by anyone. This pilot trial aimed to identify any potential benefits of family-based Johrei practice in childhood eczema and for general health and to establish the feasibility of a subsequent randomised controlled trial. Volunteer families of 3-5 individuals, including at least one child with eczema were recruited to an uncontrolled pilot trial lasting 12 months. Parents were trained in Johrei healing and then practised at home with their family. Participants kept diaries and provided questionnaire data at baseline, 3,6 and 12 months. Eczema symptoms were scored at the same intervals. Scepticism about Johrei is presently an obstacle to recruitment and retention of a representative sample in a clinical trial, and to its potential use in general practice. The frequency and quality of practise at home by families may be insufficient to bring about the putative health benefits. Initial improvements in eczema symptoms and diary recorded illness, could not be separated from seasonal factors and other potential confounders. There were no improvements on other outcomes measuring general health and psychological wellbeing of family members.”
Our findings were hugely disappointing for the JH-gurus, of course, but we did insist on our right to publish them. Dr Dixon was not involved in the day to day running of our trial, nor in evaluating its results, nor in writing up the paper. He nevertheless showed a keen interest in the matter, kept in contact with the Japanese sponsors, and arranged regular meetings to discuss our progress. It was at one of those gatherings when he mentioned that he was about to fly to Japan to give a progress report to the JH organisation that had financed the study. My team felt this was odd (not least because, at this point, the study was far from finished) and we were slightly irritated by this interference.
When Dixon had returned from Japan, we asked him how the meeting had been. He said the JH sponsors had received him extremely well and had appreciated his presentation of our preliminary findings. As an ‘aside’, he mentioned something quite extraordinary: he, his wife and his three kids had all flown business class paid for by the sponsors of our trial. This, we all felt, was an overt abuse of potential research funds, unethical and totally out of line with academic behaviour. Recently, I found this fascinating clip on youtube, and I wonder whether it was filmed when Dr Dixon visited Japan on that occasion. One does get the impression that the Johrei organisation is not short of money.
A few months later, I duly reported this story to my dean, Prof Tooke, who was about to get involved with Dr Dixon in connection with a postgraduate course on integrated medicine for our medical school (more about this episode here or in my book). He agreed with me that such a thing was a most regrettable violation of academic and ethical standards. To my great surprise, he then asked me not to tell anybody about it. Today I feel very little loyalty to either of these two people and have therefore decided to publish my account – which, by the way, is fully documented as I have kept all relevant records and a detailed diary (in case anyone should feel like speaking to libel lawyers).
