conflict of interest
Systematic reviews are aimed at summarising and critically evaluating the evidence on a specific research question. They are the highest level of evidence and are more reliable than anything else we have. Therefore, they represent a most useful tool for both clinicians and researchers.
But there are, of course, exceptions. Take, for instance, this recent systematic review by researchers from the
- Texas Chiropractic College, Pasadena, the Palmer Center for Chiropractic Research, Palmer College of Chiropractic, Davenport,
- Department of Planning, Policy and Design, University of California, Irvine,
- VA Puget Sound Health Care System, Tacoma,
- New York Chiropractic College, Seneca Falls,
- Logan University College of Chiropractic, Chesterfield,
- University of Western States, Portland.
Dr Gabriella Day is a GP in England who describes herself and her beliefs as follows: “I began training in homeopathy as it is clear that for many conditions conventional treatment options are not effective and can have unwanted side effects. It seemed to me that there must be another way to help people suffering from symptoms such as these… I believe in whole person medicine. No illness exists in isolation. The human body is immensely sophisticated and complicated and we do not understand it fully. Therefore the illness cannot be separated from the person suffering the disease. This may be as simple as stress impairing the immune system to far more complex interactions. Homeopathic treatment seeks to match the underlying disturbance in the system and stimulate the body to correct itself.”
I do not know Dr Day, but she caught my attention recently when she published an article in THE HIPPOCRATIC POST (I had never heard of this publication before!). It is, I think, sufficiently noteworthy to show you some excerpts (the references [in square brackets] were added by me, and they refer to my comments below):
START OF QUOTES
…Homeopathy can be helpful for pretty much any condition , whether as the main treatment , as a complement to a conventional treatment  to speed up the healing process , or to lessen the side-effects of a pharmacological medication . It can be helpful in the treatment of emotional problems , physical problems  and for multi-morbidity patients . I find it an invaluable tool in my GP’s toolbox and regularly see the benefits of homeopathy in the patients I treat …
There are many conditions for which I have found homeopathy to be effective … There are, however, a multitude of symptomatic treatments available to suppress symptoms, both on prescription and over-the-counter. Most symptoms experienced by patients in this context result from the body’s attempt to eliminate the infection. Our immune systems have spent thousands of years refining this response; therefore it seems counter-intuitive to suppress it .
For these types of acute conditions homeopathy can work with the body to support it . For instance, homeopathic Arsenicum album (arsenic) is a classic remedy for diarrhoea and vomiting that can be taken alongside essential oral rehydration . And in influenza I’ve found Eupatorium perfoliatum (ague or feverwort) to be very helpful if the patient is suffering with bony pain .
…Unless it is clinically imperative for a pharmacological intervention, I will always consider homeopathy first  and have successfully prescribed the homeopathic remedy Nux vomica (strychnine) for women suffering from morning sickness . Problems associated with breastfeeding such as mastitis have also responded well to the classic remedies Belladonna (deadly nightshade) and Phytolacca (pokeweed), while I have found Urtica urens (dog nettle) effective in switching off the milk supply to prevent engorgement when the mother stops breastfeeding .
…“heart sink” patients are clearly suffering from pain and discomfort, which is blighting their lives. This is understandably frustrating for them, for they know full well something is awry but there is no medical evidence for this… Homeopathy affords me another approach in trying to help these patients [1,3]. It doesn’t work for them all, but I’m frequently surprised at how many it does help .
The beauty of homeopathy is that it combines mental and emotional symptoms with physical symptoms . When the right remedy is found it appears to stimulate the body to recognise how it is being dysfunctional and corrects this, with no suppression, just a correction of the underlying disturbance . Thus homeopathy not only eliminates unwanted symptoms , it dramatically improves a patient’s overall well-being .
…homeopathy… enables me to reduce the number of painkillers and other drugs I’m prescribing [1,3]. This is particularly true for older multi-morbidity, polypharmacy patients  who are often taking huge amounts of medication.
Contrary to what most homeopaths will tell you, I believe homeopathic treatment does have side-effects – positive side-effects!  It fosters an enhanced doctor patient relationship . The process of eliciting the relevant information to select a remedy enables me to better understand the patient’s condition and helps me to get to know them better . And the patient, seeing that the doctor is interested in the idiosyncrasies and detail of their disease, finds themselves heard and understood . In short, since training in homeopathy I enjoy my job as a GP and my relationship with patients so much more .
Dr Gabriella Day BSc, MBBS, MRCP, DCH, MRCGP, MFHom
END OF QUOTES
- statement without good evidence,
- Hahnemann was vehemently against combining homeopathy with other treatments and called clinicians who disregarded this ‘traitors’,
- statement of belief,
- wrong assumption,
- questionable ethics.
I have recently attempted to slip into the brain of lay-homeopaths and shown how illogical, misguided and wrong the arguments of such enthusiasts really are. Surely, the logic of a doctor homeopath must be better, I then thought. Once you have studied medicine, you have learnt an awful lot of things about the body, disease, therapy, etc., etc., I felt.
Judging from the above article, I might have been wrong.
David Needleman, a pharmacist at Wilkinson Chemist in Barnet, UK, has published a brilliant article explaining that complementary medicine such as homeopathy, nutrition and aromatherapy could make smaller pharmacies “more viable and competitive”, as they look to “survive” the funding cuts across England. In doing so, he made it clear that retail pharmacists are shop-keepers, not healthcare professionals, as previously assumed.
“We need to explore other ways of maintaining profitability. One of these is to enter profitable niche markets”. Mr Needleman – who is also joint principal of The School of Complementary Medicine (TSOCM) – helped set up a homeopathic dispensary in a North London pharmacy while studying for his qualification in 1987. “Within a year, the various homeopathic remedies, various other nutritional supplements and herbal medicines we stocked accounted for nearly 40% of the pharmacy’s turnover, with a considerably higher margin. This 40% turnover was the difference between bankruptcy and survival [of this pharmacy],” he added.
Mr Needleman and his colleague at TSOCM have designed a two-year “comprehensive complementary medicines” course for pharmacists and technicians, which will launch at the London School of Pharmacy in September. “It is going to cover nutrition, homeopathy, herbal medicine, flower remedies, aromatherapy and Chinese medicines and will lead to a [certificate] for pharmacists to become registered with a professional body,” Mr Needleman said. He said “it is early days” but “everyone I have spoken to has shown an interest” in the training. Mr Needleman is now looking to expand the offer to pharmacists across the country, “possibly Manchester next”.
Mr Needleman said he reacted with “sadness” to the news that some clinical commissioning groups (CCG) plan to scrap homeopathy funding. “Homeopathy has been under a lot of threat and a lot of pressure for some considerable time. It is going to disenfranchise thousands of people who can’t afford to pay. When you think that between six and 10 million people a year use complementary medicines…it is rather a large chunk of business that pharmacies are missing out on. There are only about six dedicated homeopathic pharmacies in the country, but there are a number of pharmacies that will dispense remedies and give advice. Anything that can take us away from NHS dispensing has got to be useful for the survival of community pharmacy,” he added. A full copy of Mr Needleman’s letter can be found here.
I want to personally thank Mr Needleman for this statement. It avoids all the BS pharmacists tend to unpack when asked about homeopathy or other bogus treatments they sell. I agree entirely with Needleman, no need to beat about the bush! Pharmacists who sell homeopathic remedies do so mostly to make money, they are essentially shop-keepers. I find it easier to deal with the truth – even though it may be slightly embarrassing for the profession of pharmacists – than with the excuses pharmacists usually provide when asked why they sell disproven nonsense to the unsuspecting public. I guess, I prefer a slight embarrassment to a painfully big one.
The downside of the behaviour of the shop-keepers in the pharmacist profession is, of course, that they violate their own code of ethics. But who cares about ethics? Who cares about responsibly advising patients on the best therapy for their conditions? Who cares about evidence? The aim of the game is not about niceties, it is about saving the pharmacists’ income!!!
In its ‘quick guide’ to homeopathy, the Royal Pharmaceutical Society (RPS) said it “does not endorse homeopathy as a form of treatment because there is no scientific basis for homeopathy nor any evidence to support the clinical efficacy of homeopathic products beyond a placebo effect”.
The ‘Daily Mail’ is not a paper famed for its objective reporting. In politics, this can influence elections; in medicine, it can endanger public health.
A recent article is a case in point, I think.
START OF QUOTE
Traditional Chinese medicines could help prevent heart disease and the progression of pre-diabetes, according to research. Some herbal treatments proved as effective in lowering blood pressure as Western drugs and improved heart health by lowering cholesterol, scientists found. Certain alternative medicines could lower blood sugar and insulin levels, too.
Chinese medicines could be used alongside conventional treatments, say researchers from Shandong University Qilu Hospital in China. Or they can be beneficial as an alternative for patients intolerant of Western drugs, they said in their review of medical studies over a ten-year period. Senior review author from the university’s department of traditional Chinese medicine said: ‘The pharmacological effects and the underlying mechanisms of some active ingredients of traditional Chinese medications have been elucidated. Thus, some medications might be used as a complementary and alternative approach for primary and secondary prevention of cardiovascular disease.”
It’s potentially good news for people living with diabetes, which is now a global epidemic and has proved a tricky condition to manage for many people. High blood pressure is very common too, affecting more than one in four adults in the UK, although many won’t show symptoms and realise it. If untreated, it increases your risk of serious problems including heart disease, the number one killer globally.
The Chinese have used herbs for treating diseases for thousands of years and have become increasingly popular in Europe and North America, mainly as complement to Western medicine. But the researchers also warn that much of the research conducted have limitations and so their long-term effects are not proven.
Herbs for high blood pressure
The blood pressure-lowering effect of herb zhongfujiangya was found to be similar to that of oral anti-hypertension medication benazeprilm, which goes by the brand name Lotensin. Similarly, patients treated for eight weeks with herbal tiankuijiangya had a lower reading than those given a placebo. Herbal Jiangya tablets were found to ‘significantly lower’ systolic blood pressure, that is the amount of pressure in your arteries during contraction of your heart muscle compared to a fake treatment. The herb Jiangyabao also had a significant effect compared to a placebo, but just at night. But overall, compared to the drug Nimodipine, a calcium channel blocker, it worked just as well. Qiqilian capsules also proved more effective compared to a placebo.
Herbs for diabetes
The team report some Chinese medicines medications – such as xiaoke, tangminling, jinlida, and jianyutangkang – have a ‘potent’ effect on lowering blood sugar levels and b-cell function, which controls the release of insulin. Some remedies – such as tangzhiping and tianqi – might prevent the progression of pre-diabetes to diabetes, they note.
Herbs for cholesterol
The researchers looked at research on dyslipidemia, the term for unbalanced or unhealthy cholesterol levels. They found that jiangzhitongluo, salviamiltiorrhiza and pueraria lobata, and zhibitai capsule all have a ‘potent lipid-lowing effect’.
Herbs for heart disease
Some traditional Chinese medicines such as qiliqiangxin, nuanxin, shencaotongmai, and yangxinkang, might be effective in improving function in patients with chronic heart failure, they wrote.
Limitations with trials
But Western scientists often reject Chinese medicine for specific reasons, warned Dr Zhao’s team. Chinese medicines are frowned upon because they do not go through the same exhaustive approval process as trials conducted domestically, they pointed out. Plus, one treatment can be made of many different ingredients with various chemical compounds, making it hard to pinpoint how their benefits work. ‘One should bear in mind that traditional Chinese medicine medications are usually prescribed as complex formulae, which are often further manipulated by the practitioner on a personalized basis,’ said Dr Zhao.
END OF QUOTE
Apart from the fact that this article is badly written, it is also misleading to the point of being outright dangerous. Regular readers of my blog will be aware that Chinese research is everything but reliable; there are practically no Chinese TCM-trials that report negative results. Furthermore, the safety of Chinese herbal preparations is as good as unknown and they are often contaminated with toxic substances as well as adulterated with synthetic drugs. Most of these preparations are also unavailable outside China. Moreover, Chinese herbal treatments are usually individualised (mixtures are tailor-made for each individual patient), and there is no good evidence that this approach is effective. Crucially, the trial evidence is often of such poor quality that it would be a dangerous mistake to trust these findings.
None of these important caveats, it seems, are important enough to get a mention in the Daily Mail.
Don’t let the truth get in the way of a sensational story!
Let’s just for a moment imagine what would happen if people took the Mail article seriously (is there anyone out there who does take the Mail seriously?). In a best case scenario, they would take Chinese herbs in addition to their prescribed medication. This might case plenty of unwanted side-effects and herb-drug interactions. In addition, people would lose a lot of their hard-earned cash. In a worst case scenario, they would abandon their prescribed medication for dubious Chinese herbal mixtures. This could cause thousands of premature deaths.
With just a little research, I managed to find the original article on which the Mail’s report was based. Here is its abstract:
Traditional Chinese medicine (TCM) has more than 2,000 years of history and has gained widespread clinical applications. However, the explicit role of TCM in preventing and treating cardiovascular disease remains unclear due to a lack of sound scientific evidence. Currently available randomized controlled trials on TCM are flawed, with small sample sizes and diverse outcomes, making it difficult to draw definite conclusions about the actual benefits and harms of TCM. Here, we systematically assessed the efficacy and safety of TCM for cardiovascular disease, as well as the pharmacological effects of active TCM ingredients on the cardiovascular system and potential mechanisms. Results indicate that TCM might be used as a complementary and alternative approach to the primary and secondary prevention of cardiovascular disease. However, further rigorously designed randomized controlled trials are warranted to assess the effect of TCM on long-term hard endpoints in patients with cardiovascular disease.
In my view, the authors of this review are grossly over-optimistic in their conclusions (but nowhere near as bad as the Mail journalist). If the trials are of poor quality, as the review-authors admit, no firm conclusions should be permissible about the usefulness of the therapies in question.
As the Mail article is obviously based on a press release (several other papers worldwide reported about the review as well), it seems interesting to note what the editor of the Journal of the American College of Cardiology (the journal that published the review) recently had to say about the responsibility of journalists and researchers:
START OF QUOTE
…I would like to suggest that journalists and researchers must share equally in shouldering the burden of responsibility to improve appropriate communication about basic and clinical research.
First, there is an obligation on the part of the researchers not to inflate the importance of their findings. This has been widely recognized as damaging, especially if bias is introduced in the paper…
Second, researchers should take some responsibility for the creation of the press release about their research, which is written by the media or press relations department at their hospital or society. Press releases are often how members of the media get introduced to a particular study, and these releases can often introduce errors or exaggerations. In fact, British researchers evaluated 462 press releases on biomedical and health-related science issued by 20 leading U.K. universities in 2011, alongside their associated peer-reviewed research papers and the news stories that followed (n = 668). They found that 40% of the press releases contained exaggerated advice, 33% contained exaggerated causal claims, and 36% contained exaggerated inference to humans from animal research. When press releases contained such exaggeration, 58%, 81%, and 86% of news stories, respectively, contained further exaggeration, compared with rates of 17%, 18%, and 10% in the news when the press releases were not exaggerated. Researchers should not be excused from being part of the press release process, as the author(s) should at least review the release before it gets disseminated to the media. I would even encourage researchers to engage in the process at the writing stage and to not allow their hospital’s or society’s public relations department to extrapolate their study’s results. Ultimately, the authors and the journals in which the studies are published will be held accountable for the information that trickles into the headlines, not the public relations departments, so we must make sure that the information is accurate and representative of the study’s actual findings.
END OF QUOTE
Sound advice indeed.
Now we only need to ALL follow it!!!
Currently, over 50 000 000 websites promote alternative medicine, and consumers are bombarded with information not just via the Internet, but also via newspapers, magazines and other sources. This has the potential of needlessly separating them from their cash or even seriously harming their health. As there is little that protects us from greedy entrepreneurs and over-enthusiastic therapists, we should think about protecting ourselves. Here I will provide five simple tips that may fortify you against fake news in the realm of alternative medicine.
Imagine you read somewhere that the condition you are affected by is curable (or at least improvable) by THERAPY XY. It is only natural that you are exited by this news. Before you now rush to the next health shop or alternative medicine centre, it is worth asking yourself the following questions:
- Is the claim plausible? As a rule of thumb, it is fair to say that, if it sounds too good to be true, it probably is too good to be true. Not so long ago, UK newspapers reported that a herbal mixture called ‘CARCTOL’ had been discovered to be an efficacious and safe cancer cure (before that, it was Essiac, shark cartilage, Laetrile and many more). I only needed a minimal amount of research to find that the claim had no basis in fact. Come to think of it, it is not plausible that any alternative therapy will ever emerge as a miracle cure for any condition, particularly a serious disease like cancer. It is also not plausible that a herbal mixture would ever prove to be a cure for a wide range of different cancers. The very idea of such ‘cures’ is a contradiction in terms. If an alternative therapy ever did turn out to be efficacious, it would become mainstream even before the clinical tests to prove its efficacy are fully concluded. The notion of an alternative cure presumes that conventional scientists and clinicians reject a treatment simply because it originated from the realm of alternative medicine. There is no precedent that this has ever occurred, and I am sure it will never happen in future.
- What is the evidence for the claim? In the case of CARCTOL, the claim was based on a UK doctor apparently observing that, in several patients, tumours had been melting like butter in the sun after they took this herbal mixture. One particularly irresponsible headline read: “I’ve seen herbal remedy make tumours disappear, says respected cancer doctor.” This, however, is no evidence but mere anecdotes, and we confuse the two at our peril. Remember: the plural of anecdote is anecdotes, not evidence. With anecdotes, we can never be sure about cause and effect. Therapeutic claims must be based on good evidence, e.g. controlled clinical trials.
- Who is behind the claim? In the UK, the CARCTOL claim emerged around 2004 and originated mainly from Dr Rosy Daniel. In the above newspaper article, she was called ‘a respected cancer doctor’. Personally, I do NOT ‘respect’ someone who makes claims of this nature without having good evidence. And a ‘cancer doctor’ is usually understood to be an oncologist; to the best of my knowledge, Dr Daniel is NOT an oncologist. In fact, she now calls herself a ‘Lifestyle and Integrative Medicine Consultant’. Faced with an important new health claim, one should always check who is behind it. Check out whether this person is reputable and free of conflicts of interest. An affiliation to a reputable university is usually more convincing than being a director of your own private heath centre.
- Where was the claim published? The CARCTOL story had been published in newspapers – and nowhere else! Even today, there is only one Medline-listed publication on the subject. It is my own review of the evidence which, in 2004, concluded that “The claim that Carctol is of any benefit to cancer patients is not supported by scientific evidence.” *** If important new therapeutic claims like ‘therapy xy cures cancer’ are reported in the popular media, you should always check where they were first published (or simply dismiss it without researching it). It is unthinkable that such an important claim is not made first in a proper, peer-reviewed article in a good medical journal. Go on ‘Medline’, conduct a quick search and find out whether the new findings have been published. If the claim does not come from peer-reviewed journals, forget about it. If it has been published in any journal that has alternative, complementary, integrative or similar terms in its name, take it with a good pinch of salt.
- Is there money involved? In the case of CARCTOL, the costs were high. I was called once by a woman who had read my article telling me that she was pursued by the doctor who had treated her husband. Tragically, the man had nevertheless died of his cancer, and the widow was now pursued for £8 000 which she understandably was reluctant to pay. Many new treatments are expensive. So, high costs are not necessarily suspicious. Still, I advise you to be extra cautious in situations where there is the potential for someone to make a fast buck. Financial exploitation is sadly rife in the realm of alternative medicine.
A similar checklist originates from a team of experts. Researchers from Uganda, Kenya, Rwanda, Norway, and England, worked to identify the most important ideas a person would need to grasp thinking critically about health claims. They came up with excellent points:
- Just because a treatment is popular or old does not mean it’s beneficial or safe.
- New, brand-name, or more expensive treatments may not be better than older ones.
- Treatments usually come with both harms and benefits.
- Beware of conflicts of interest — they can lead to misleading claims about treatments.
- Personal experiences, expert opinions, and anecdotes aren’t a reliable basis for assessing the effects of most treatments.
- Instead, health claims should be based on high-quality, randomized controlled trials.
Alternative medicine can easily turn into a jungle or even a nightmare. Before you fall for any dubious claim that THERAPY XY is good for you, please go through the simple sets of questions above. This might protect you from getting ripped off or – more importantly – from getting harmed.
*** After this article had been published, I received letters from layers threatening me with legal action unless I withdrew the paper. I decided to ignore them, and no legal action followed.
In my previous post, I mentioned the current volume of the ‘Allgemeinen Homöopathischen Zeitung’ which contains the abstracts of the ‘Homeopathic World Congress 2017’ (btw: the remarkable opening speech for the WORLD CONFERENCE ON HOMEOPATHY 1937, in Berlin might also be of interest; excerpts from it can be found here). Amongst these abstracts, the collector can find many true gems. Today I have for you a few more abstracts that I found remarkable; they are from what I call pre-clinical (or non-clinical) research.
Homeopathy has a polarized image. Many people experience homeopathic cure, but critics say this is only a placebo-effect. However, there, are 3800 studies and evidence is steadily growing. All comprehensive investigations prove that homeopathy is more efficient than placebo. What are the reasons for this controversy? How do we improve the image of homeopathy? Methods Data collection regarding effectiveness, benefits and mechanisms over 30 years. Order development to archive all data according to their scientific content. Systematic analysis of criticisms towards homeopathy over the last 12 years. Discussions with sceptics to understand their rejections. Findings Main reasons for controversy are: ▪ Since homeopathy does not meet the contemporary scientific concepts, people believe that homeopathy is implausible. ▪ Different homeopathic methods appear contradictory. ▪ Conventional medicine rejects homeopathy. Missing overview regarding scientific principles. ▪ Modern studies are no more understandable. Due to our fast-moving times, people quickly form opinion with their own personal logic, influenced by media information. This causes a systematic interpretation bias. Results The knowledge of homeopathy and potentized remedies will be publicly illustrated: ▪ Information about different methods. ▪ Basics of holistic thinking and limitations of science in medicine. ▪ State of the art regarding effectiveness and benefits. ▪ Scientific principles and body of evidence. ▪ Correcting wrong media information. A special didactic structure was developed to provide this information at the portal: “Homeopathy & potentized medicines” (www.dellmour.org, available autumn 2016). Physicians and patients will find comprehensible information to aquire a plausible picture of homeopathy.
The use of agrochemicals has been associated with environmental and ecological damages. Excessive use of fertilizers, for example, can lead to the groundwater contamination with nitrate, rendering it unfit for consumption by humans or livestock. Water containing large concentrations of nitrate can poison animals by partial immobilization of the hemoglobin in blood, reducing the ability to transport oxygen. These and other environmental effects in the use of agrochemicals are unfortunate consequences in the application of these chemical tools. Researchers are constantly searching for non-chemical solutions in dealing with many of these agricultural needs. Much attention is being paid, for example, to developing “organic” methods of enhancing soil fertility and dealing with pests. The application of homeopathy in agriculture (agrohomeopathy) is an alternative that can help solve the problems caused by agrochemicals. Several countries have begun to implement this new option to solve the problems that have been caused by agrochemicals. The use of agrohomeopathy allows a control of diseases in plants, caused by bacteria, fungi, viruses and pests, it also helps to improve and promote seed germination, as well as by enhancing the growth of plants. Moreover, with the application of agrohomeopathy it is possible to decontaminate soils that have been exposed to agrochemical treatments. The goal of this study is to analyze the major results obtained in agrohomeopathy. Also we demonstrate the importance of botanical models to find out or clarify the mechanism of homeopathy in living organisms.
Dr. Hahnemann improvised homeopathy to such an extent, that his discovery of potentization of homeopathic medicines questioned the fundamental belief systems of the basic sciences. This resulted in a constant disapproval of homeopathic system by the main stream science and was accused as a placebo therapy, yet the clinical efficacy of homeopathy remained unquestionable. Objectives The present study was done to analyze the presence/absence of particles in aurum metallicum 6C to CM and carbo vegetabilis 6C to CM potencies. This is a part of the 31 homeopathic drugs studied by using HRTEM&EDS and FESEM&EDS in Centesimal scale 6C, 30, 200, 1M, 10M, 50M and CM and LM scale in LM1, LM6, LM12, LM18, LM24 and LM30 potencies. Method HRTEM (High Resolution Transmission Electron Microscope), FESEM (Field Emission Scanning Electron Microscope) and EDS (Energy dispersive Spectroscopy) were used for the analysis of samples. Results Plenty of particles in nanometer and Quantum Dots (QD – less than 10nm) scale were seen in aur. with presence of gold in all the potencies of aur. Enormous particles were identified in all the potencies of carb-v. in nanometer scale composed of carbon and oxygen. Conclusion The presence of NPs & QDs in all potencies must be the reason for the cure in diseases and also produce signs and symptoms in Hahnemannian drug proving. This discovery of NPS in all the drug potencies is an important evidence which substantiate the individualized drug selection and place homeopathy an established “individualized nanomedicine” with 200 years of collective clinical experience.
In March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy. This document, designed for the general public, provides a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans. ’The Australian report’, concludes that ”there are no health conditions for which there is reliable evidence that homeopathy is effective … no goodquality, well-designed studies with enough participants for a meaningful result reported either that homeopathy caused greater health improvements than placebo, or caused health improvements equal to those of another treatment”. Such overly-definitive negative conclusions are immediately surprising, being inconsistent with the majority of comprehensive systematic reviews on homeopathy. In-depth analysis has revealed the report’s multiple methodological flaws, which explain this inconsistency. Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence: for a trial to be deemed ’reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ’insufficient quality and/or size to warrant further consideration of their findings’. Setting such a high quality threshold is highly unusual, but the n=150 minimum sample size criterion is arbitrary, without scientific justification, and unprecedented in evidence reviews. Out of 176 trials NHMRC included in the homeopathy review, only 5 trials met their definition of ’reliable’, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ’no reliable evidence’ that homeopathy is effective. A distillation of other detailed findings, presented at conference, reveals further significant flaws in this highly influential report, providing critical awareness of its misrepresentation of the homeopathy evidence base.
An extensive review of the literature dealing on the results obtained by homeopathy during epidemics has revealed important findings about the efficacy of homeopathic treatment. The main findings of this research are: ▪ With more than 25,000 volumes, the homeopathic literature is vast and rich in reports about results obtained by homeopathy during epidemics. The speaker has uncovered over 7,000 references addressing this subject. ▪ Results obtained by homeopathy during epidemics reveal a very important and clear constancy: a very low mortality rate. This constancy remains, regardless of the physician, time, place or type of epidemical disease, including diseases carrying a very high mortality rate, such as cholera, smallpox, diphtheria, typhoid fever, yellow fever and pneumonia. ▪ Interestingly, this low mortality rate is always superior to the results obtained not only by allopathy practiced at that particular time but, as a rule, by allopathy of today, despite benefiting from modern nursing and hygienic care. ▪ Even the lesser-trained homeopaths obtained, as a rule, better results than the highest authorities of the allopathic school. However, the most consistent, predictable and impressive results were obtained by the ones who practiced genuine homeopathy whom are known as Hahnemannians. ▪ Homeopathic remedies have been successfully used to protect large segments of the population from upcoming infectious diseases. Homeopathic prophylaxis is safe and effective combining inexpensive costs. ▪ The results obtained by homeopathy during epidemics cannot be explained by the placebo effect.
It is often considered that a physico-chemical explanation of homeopathy would require a major rewriting of much of physics, chemistry and biochemistry. Yet, despite the fact that the bio-activity of homeopathic dilutions appears to fly in the face of modern science, such an upheaval might not actually be necessary. The aim of this presentation is to demonstrate that we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry. We will start by going over the requirements made of an explanation of homeopathy, such as: memory of the starting substance, compatibility with the dilution/succussion process and finally bio-activity. We will then formulate a minimal set of physical assumptions able to explain the experimental results found in homeopathy. We will show how these assumptions are validated both from the theoretical physics and experimental physico-chemistry side. On the one hand we have, the theoretical predictions of Preparata and DelGuidice of the existence in water structures. These predict the formation of distinct water domains through the stabilising effect of electromagnetic oscillations. On the other hand, we will present a set of experiments from within and outside the field of homeopathy (Demangeat, Elia, Pollack and others). These experiments support the idea that water does form relatively stable structures under certain conditions and that these structures have electromagnetic properties, which could be at the root of the specific biological effects seen in clinical and animal studies. Thus we will show that it is possible to formulate a plausible physico-chemical explanation of homeopathy based on current physic and chemistry. Crucially this formulation is testable, providing important parameters and suggestions for the design of future experiments.
Hilarious, isn’t it? There are many sentences that are memorable treasures in these abstracts. One is almost tempted to book a ticket to Leipzig and listen to the presentations. I particularly love the following statements:
- All comprehensive investigations prove that homeopathy is more efficient than placebo…
- …the clinical efficacy of homeopathy remained unquestionable…
- …overly-definitive negative conclusions are immediately surprising…
- Homeopathic prophylaxis is safe and effective…
- …we can indeed formulate a plausible and testable theory of homeopathy based on current physics and chemistry…
The naivety, ignorance and chutzpa that we observed in the abstracts of clinical studies is mirrored here very clearly. I am therefore inclined to repeat the questions I asked in part 1 of this post: How can a scientific committee reviewing these abstracts let them pass and allow the material to be presented at the ‘World Congress’? How can a Health Secretary accept the patronage of such a farce?
The NHMRC report on homeopathy is the most thorough, independent and reliable investigation into the value of homeopathy ever. As its conclusions are devastatingly negative about the value of homeopathy, it is hardly surprising that homeopaths tried everything and anything to undermine it. This new article gives what I believe to be a fair account of the allegations and their validity:
START OF QUOTE
Since the NHMRC declared homeopathy to be ineffective in treating any health condition, a number of disputes have been made by major organisations in favour of homeopathy. Australia’s two peak industry organisations, Complementary Medicines Australia (CMA) and the AHA, both argue in their letters to the NHRMC that the position was prejudiced based on a draft position statement leaked in 2012 stating it is unethical for health practitioners to treat patients using homeopathy, for the reason that homeopathy (as a medicine or procedure) has been shown not to be efficacious [19,20]. Furthermore, both the CMA and AHA highlight serious concerns regarding the prelude to and instigation of the work of the NHMRC’s HWC as well as the conduct of the review itself to finalise their conclusion on the use of homeopathy. Several grave issues were raised in both letters with five common key flaws cited: (1) no explanation was provided as to why level 1 evidence including randomised control trials were excluded from the review; (2) the database search used was not broad enough to capture complementary medicine and homeopathic specific content, and excluded non-human and non-English studies; (3) no homeopathic expert was appointed in the NHMRC Review Panel; (4) prior to publication, the concerns raised over the methodology and selective use of data by research contractor(s) engaged for the HWC review were abandoned for unknown reasons; and (5) no justification was provided as to why only systematic reviews were used [19,20]. Other serious accusations made by the AHA in their response letter to the NHMRC involved the blatant bias of the NHMRC evident by: the leakage of their draft position statement in April 2011 and early release of the HWC Draft Review regarding homeopathy to the media; no discussion of prophylactic homeopathy i.e. preventative healthcare; and no reference to the cost-effectiveness, safety, and quality of homeopathic medicines .
Despite the NHMRC findings being strongly disputed, they are further supported by positions taken by a number of large and respected organisations. For example, in 2009, the World Health Organization (WHO) advised against the use of homeopathic medicines for various serious diseases following significant concerns being raised by major health authorities, pharmaceutical industries, and consumers regarding its safety and quality . They reported the clinical effects were compatible with placebo effects . Similarly, in Australia, the Australian Medical Association (AMA) further supports the NHMRC findings by stating in their position statement released in 2012 that there is limited efficacy evidence regarding most complementary medicines, thereby posing a risk to patient health . More recently, in May 2015, the Royal College of General Practitioners (RACGPs) strongly advocated in their position statement against general practitioners prescribing homeopathic medicines, and pharmacists against supporting or recommending it, given the lack of evidence regarding its efficacy . This is particularly pertinent to conventional vaccines given the recent case between the Australian Competition and Consumer Commission (ACCC) vs. Homeopathy Plus! Australia Pty Ltd. The Federal Court found Homeopathy Plus! Australia Pty Ltd guilty of contravening the Australian Consumer Law by engaging in misleading and deceptive conduct through claiming that homeopathic remedies were a proven, safe, and effective alternative to the conventional vaccine against whooping cough .
The positions of the NHMRC, WHO, AMA, and the RACGPs regarding homeopathy is further supported by Cochrane reviews, which provide high-quality evidence with minimal bias . Of the twelve homeopathy Cochrane reviews available in the database, only seven address homeopathic remedies directly and were related to the following conditions: irritable bowel syndrome , attention deficit/hyperactivity disorder or hyperkinetic disorder , chronic asthma , dementia , induction of labour , cancer , and influenza . Given most of these reviews were authored by homeopaths, bias against homeopathy is unlikely [26-32]. The overarching conclusions from these reviews fail to reveal compelling evidence regarding the efficacy of homeopathic remedies [26-32]. For example, Mathie, Frye and Fisher show that there is â€œno significant difference between the effects of homeopathic Oscillococcinum® and placebo in prevention of influenza-like illness: risk ratio (RR) = 0.48, 95% confidence interval (CI) 0.17-1.34, p-value = 0.16 . The key reasons given for this failure to provide compelling evidence relate to low quality or unclear data, and lack of replicability, suggesting homeopathic remedies are unlikely to have clinical effects beyond placebo [26-32].
Sadly, the ACCC vs. Homeopathy Plus! Australia Pty Ltd is not the only case that has made headlines in Australia in recent years. An article in the Journal of Law and Medicine coincided with the NHMRC report regarding the number of deaths attributable to favouring homeopathy over conventional medical treatment in recent years . One such case was that of Jessica Ainscough, who passed away earlier this year after losing her battle with a rare form of cancer “epithelioid sarcoma“ after rejecting conventional treatment in favour of alternative therapies . Although doctors recognise Ms. Ainscough’s right to choose her own cancer treatments and understand why she refused the disfiguring surgery to save her life, they fear her message may influence others to reject conventional treatments that could ultimately save their lives . Another near death case was that of an eight-month-old boy whose mother was charged with â€œreckless grievous bodily harm and failure to provide for a child causing danger to deathâ€ after ceasing conventional medical and dermatological treatment for her son’s eczema as advised by her naturopath (an umbrella term that includes homeopathy) . The all-liquid treatment plan left the boy severely malnourished and consequently, he now suffers from developmental issues . This case is rather similar to that of R vs. Sam in 2009, where the parents of a nine-month-old girl were convicted of manslaughter by criminal negligence after favouring homeopathic treatment over conventional medical treatment for their daughter’s eczema. The girl died from septicaemia after her eczema became infected [36,37].[references are provided in the original document]
END OF QUOTE
The NHMRC report stated that
Homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious. 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. People who are considering whether to use homeopathy should first get advice from a registered health practitioner. Those who use homeopathy should tell their health practitioner and should keep taking any prescribed treatments.
Few other reports have previously expressed our concerns about homeopathy so clearly – little wonder then that the world of homeopathy was (and still is) up in arms.
The last time something similar happened was during the Third Reich when homeopathy had been evaluated thoroughly by leading scientists and the conclusions turned out to be just as devastatingly negative. At the time, German homeopaths allegedly made the report disappear, and all we have today about this comprehensive research programme is a very detailed eye witness report of a homeopath who had been intimately involved in the research.
Today, it is thankfully no longer possible to make major research documents disappear. So, homeopaths have to think of other strategies to defend their trade. In the case of the NHMRC report, they act like all cults tend to do and resort to misleading statements and slanderous allegations. This, I feel, is unsurprising and will inevitably turn out to be unsuccessful.
How often have I pointed out that most studies of chiropractic (and other alternative therapies) are overtly unethical because they fail to report adverse events? And if you think this is merely my opinion, you are mistaken. This new analysis by a team of chiropractors aimed to describe the extent of adverse events reporting in published RCTs of Spinal Manipulative Therapy (SMT), and to determine whether the quality of reporting has improved since publication of the 2010 Consolidated Standards Of Reporting Trials (CONSORT) statement.
The Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials were searched for RCTs involving SMT. Domains of interest included classifications of adverse events, completeness of adverse events reporting, nomenclature used to describe the events, methodological quality of the study, and details of the publishing journal. Data were analysed using descriptive statistics. Frequencies and proportions of trials reporting on each of the specified domains above were calculated. Differences in proportions between pre- and post-CONSORT trials were calculated with 95% confidence intervals using standard methods, and statistical comparisons were analysed using tests for equality of proportions with continuity correction.
Of 7,398 records identified in the electronic searches, 368 articles were eligible for inclusion in this review. Adverse events were reported in 140 (38.0%) articles. There was a significant increase in the reporting of adverse events post-CONSORT (p=.001). There were two major adverse events reported (0.3%). Only 22 articles (15.7%) reported on adverse events in the abstract. There were no differences in reporting of adverse events post-CONSORT for any of the chosen parameters.
The authors concluded that although there has been an increase in reporting adverse events since the introduction of the 2010 CONSORT guidelines, the current level should be seen as inadequate and unacceptable. We recommend that authors adhere to the CONSORT statement when reporting adverse events associated with RCTs that involve SMT.
We conducted a very similar analysis back in 2012. Specifically, we evaluated all 60 RCTs of chiropractic SMT published between 2000 and 2011 and found that 29 of them did not mention adverse effects at all. Sixteen RCTs reported that no adverse effects had occurred (which I find hard to believe since reliable data show that about 50% of patients experience adverse effects after consulting a chiropractor). Complete information on incidence, severity, duration, frequency and method of reporting of adverse effects was included in only one RCT. Conflicts of interests were not mentioned by the majority of authors. Our conclusion was that adverse effects are poorly reported in recent RCTs of chiropractic manipulations.
The new paper suggests that the situation has improved a little, yet it is still wholly unacceptable. To conduct a clinical trial and fail to mention adverse effects is not, as the authors of the new article suggest, against current guidelines; it is a clear and flagrant violation of medical ethics. I blame the authors of such papers, the reviewers and the journal editors for behaving dishonourably and urge them to get their act together.
The effects of such non-reporting are obvious: anyone looking at the evidence (for instance via systematic reviews) will get a false-positive impression of the safety of SMT. Consequently, chiropractors are able to claim that very few adverse effects have been reported in the literature, therefore our hallmark therapy SMT is demonstrably safe. Those who claim otherwise are quite simply alarmist.
The website of BMJ Clinical Evidence seems to be popular with fans of alternative medicine (FAMs). That sounds like good news: it’s an excellent source, and one can learn a lot about EBM when studying it. But there is a problem: FAMs don’t seem to really study it (alternatively they do not have the power of comprehension to understand the data); they merely pounce on this figure and cite it endlessly:
They interpret it to mean that only 11% of what conventional clinicians do is based on sound evidence. This is water on their mills, because now they feel able to claim:
THE MAJORITY OF WHAT CONVENTIONAL CLINICIANS DO IS NOT EVIDENCE-BASED. SO, WHY DO SO-CALLED RATIONAL THINKERS EXPECT ALTERNATIVE THERAPIES TO BE EVIDENCE-BASED? IF WE NEEDED PROOF THAT THEY ARE HYPOCRITES, HERE IT IS!!!
The question is: are these FAMs correct?
The answer is: no!
They are merely using a logical fallacy (tu quoque); what is worse, they use it based on misunderstanding the actual data summarised in the above figure.
Let’s look at this in a little more detail.
The first thing we need to understand the methodologies used by ‘Clinical Evidence’ and what the different categories in the graph mean. Here is the explanation:
So, arguably the top three categories amounting to 42% signify some evidential support (if we decided to be more rigorous and merely included the two top categories, we would still arrive at 35%). This is not great, but we must remember two things here:
- EBM is fairly new;
- lots of people are working hard to improve the evidence base of medicine so that, in future, these figures will be better (by contrast, in alternative medicine, no similar progress is noticeable).
The second thing that strikes me is that, in alternative medicine, these figures would surely be much, much worse. I am not aware of reliable estimates, but I guess that the percentages might be one dimension smaller.
The third thing to mention is that the figures do not cover the entire spectrum of treatments available today but are based on ~ 3000 selected therapies. It is unclear how they were chosen, presumably the choice is pragmatic and based on the information available. If an up-to date systematic review has been published and provided the necessary information, the therapy was included. This means that the figures include not just mainstream but also plenty of alternative treatments (to the best of my knowledge ‘Clinical Evidence’ makes no distinction between the two). It is thus nonsensical to claim that the data highlight the weakness of the evidence in conventional medicine. It is even possible that the figures would be better, if alternative treatments had been excluded (I estimate that around 2 000 systematic reviews of alternative therapies have been published [I am the author of ~400 of them!]).
The fourth and possibly the most important thing to mention is that the percentage figures in the graph are certainly NOT a reflection of what percentage of treatments used in routine care are based on good evidence. In conventional practice, clinicians would, of course, select where possible those treatments with the best evidence base, while leaving the less well documented ones aside. In other words, they will use the ones in the two top categories much more frequently than those from the other categories.
At this stage, I hear some FAMs say: how does he know that?
Because several studies have been published that investigated this issue in some detail. They have monitored what percentage of interventions used by conventional clinicians in their daily practice are based on good evidence. In 2004, I reviewed these studies; here is the crucial passage from my paper:
“The most conclusive answer comes from a UK survey by Gill et al who retrospectively reviewed 122 consecutive general practice consultations. They found that 81% of the prescribed treatments were based on evidence and 30% were based on randomised controlled trials (RCTs). A similar study conducted in a UK university hospital outpatient department of general medicine arrived at comparable figures; 82% of the interventions were based on evidence, 53% on RCTs. Other relevant data originate from abroad. In Sweden, 84% of internal medicine interventions were based on evidence and 50% on RCTs. In Spain these percentages were 55 and 38%, respectively. Imrie and Ramey pooled a total of 15 studies across all medical disciplines, and found that, on average, 76% of medical treatments are supported by some form of compelling evidence — the lowest was that mentioned above (55%),6 and the highest (97%) was achieved in anaesthesia in Britain. Collectively these data suggest that, in terms of evidence-base, general practice is much better than its reputation.”
My conclusions from all this:
FAMs should study the BMJ Clinical Evidence more thoroughly. If they did, they might comprehend that the claims they tend to make about the data shown there are, in fact, bogus. In addition, they might even learn a thing or two about EBM which might eventually improve the quality of the debate.
The BMJ has always been my favourite Medical journal. (Need any proof for this statement? A quick Medline search tells me that I have over 60 publications in the BMJ.) But occasionally, the BMJ also disappoints me a great deal.
One of the most significant disappointments was recently published under the heading of STATE OF THE ART REVIEW. A review that is ‘state of the art’ must fulfil certain criteria; foremost it should be informative, unbiased and correct. The paper I am discussing here has, I think, neither of these qualities. It is entitled ‘Management of chronic pain using complementary and integrative medicine’, and here is its abstract:
Complementary and integrative medicine (CIM) encompasses both Western-style medicine and complementary health approaches as a new combined approach to treat a variety of clinical conditions. Chronic pain is the leading indication for use of CIM, and about 33% of adults and 12% of children in the US have used it in this context. Although advances have been made in treatments for chronic pain, it remains inadequately controlled for many people. Adverse effects and complications of analgesic drugs, such as addiction, kidney failure, and gastrointestinal bleeding, also limit their use. CIM offers a multimodality treatment approach that can tackle the multidimensional nature of pain with fewer or no serious adverse effects. This review focuses on the use of CIM in three conditions with a high incidence of chronic pain: back pain, neck pain, and rheumatoid arthritis. It summarizes research on the mechanisms of action and clinical studies on the efficacy of commonly used CIM modalities such as acupuncture, mind-body system, dietary interventions and fasting, and herbal medicine and nutrients.
The full text of this article is such that I could take issue with almost every second statement in it. Obviously, this would be too long and too boring for this blog. So, to keep it crisp and entertaining, let me copy the (tongue in cheek) ‘letter to the editor’ some of us published in the BMJ as a response to the review:
“Alternative facts are fashionable in politics these days, so why not also in healthcare? The article by Chen and Michalsen on thebmj.com provides a handy set of five instructions for smuggling alternative facts into medicine.
1. Create your own terminology: the term ‘complementary and integrated medicine’ (CIM) is nonsensical. Integrated medicine (a hotly disputed field) already covers complementary and conventional medicine.
2. Pretend to be objective: Chen and Michalsen elaborate on the systematic searches they conducted. But they omit hundreds of sources which do not support their message, which cherry-picks only evidence for the efficacy of the treatments they promote.
3. Avoid negativity: they bypass any material that might challenge what they include. For instance, when discussing therapeutic risks, they omit the disturbing lack of post-marketing surveillance: the reason we lack information on adverse events. They even omit to mention the many fatalities caused by their ‘CIM’.
4. Create an impression of thoroughness: Chen and Michalsen cite a total of 225 references. This apparent scholarly attention to detail masks their misuse of many of they list. Reference 82, for example, is employed to back up the claim that “satisfaction was lowest among complementary medicine users with rheumatoid arthritis, vasculitis, or connective tissue diseases”. In fact, it shows nothing of the sort.
5. Back up your message with broad generalisations: Chen and Michalsen conclude that “Taken together, CIM has an increasing role in the management of chronic pain, but high quality research is needed”. The implication is that all the CIMs mentioned in their figure 1 are candidates for pain control – even discredited treatments such as homeopathy.
In our view, these authors render us a service: they demonstrate to the novice how alternative facts may be used in medicine.”
James May, Edzard Ernst, Nick Ross, on behalf of HealthWatch UK
END OF QUOTE
I am sure you have your own comments and opinions, and I encourage you to post them here or (better) submit them to the BMJ or (best) both.