An Indian chain of homeopathic clinics, Dr Batra’s, has just opened its first branch in London. The new website is impressive. It claims homeopathy is effective for the following conditions:
Hair loss? Are they serious? Have they not seen pictures of Samuel Hahnemann?
I decided to look into the psoriasis claim a little closer. This is what they state regarding the homeopathic treatment of psoriasis:
Research-based evidences speak clear and loud of the success of homeopathy in treating psoriasis.
A study published in the Journal of the European Academy of Dermatology and Venereology, a conventional medical Journal, showed that psoriasis patients experienced significant improvement in their quality of life and reduction in their psoriasis symptoms with homeopathy. And this was without any kind of side-effects whatsoever. Of the 82 patients involved in the study that went on for 2 years, many had suffered psoriasis for as long as 15 years and had previously unsuccessfully tried conventional treatments.
At Dr. Batra’s we have successfully treated more than 25,000 cases of psoriasis with homeopathy over the last 35 years. Our safe and scientific solutions have brought smiles to many suffering patients of psoriasis. In fact, a study conducted by A.C. Nielson showed that as compared to general practitioners, specialists and local homeopaths, a higher than average improvement is seen at Dr. Batra’s in treatment of skin ailments.
To the reader who does not look deeper, this may sound fairly convincing. Sadly, it is not. The first study cited above was an uncontrolled trial. Here is its abstract:
Design Prospective multicentre observational study. Objective To evaluate details and effects of homeopathic treatment in patients with psoriasis in usual medical care. Methods Primary care patients were evaluated over 2 years using standardized questionnaires, recording diagnoses and complaints severity, health-related quality of life (QoL), medical history, consultations, all treatments, and use of other health services. Results Forty-five physicians treated 82 adults, 51.2% women, aged 41.6 +/- 12.2 (mean +/- SD) years. Patients had psoriasis for 14.7 +/- 11.9 years; 96.3% had been treated before. Initial case taking took 127 +/- 47 min. The 7.4 +/- 7.4 subsequent consultations (duration: 19.4 +/- 10.5 min) cumulated to 169.0 +/- 138.8 min. Patients received 6.0 +/- 4.9 homeopathic prescriptions. Diagnoses and complaints severity improved markedly with large effect sizes (Cohen’s d= 1.02-2.09). In addition, QoL improved (SF-36 physical component score d = 0.26, mental component score d = 0.49), while conventional treatment and health service use were considerably reduced. Conclusions Under classical homeopathic treatment, patients with psoriasis improved in symptoms and QoL.
It is clear that, due to the lack of a control group, no causal inference can be made between the treatment and the outcome. To claim that otherwise is in my view bogus.
I should mention that there is not a single controlled clinical trial of homeopathy for psoriasis that would support the claim that it is effective.
The second study is not listed in Medline. In fact, the only publication of an author by the name of ‘A C Nielson’ is entitled ‘Are men more intuitive when it comes to eating and physical activity?’. Until I see the evidence, I very much doubt that the study cited above produced strong evidence that homeopathy is an effective cure for psoriasis.
Dr Batra’s chain of clinics boasts to provide the best quality and the highest standards of services that percolate down to all levels in an organisation. Everyone in the institute and those associated with it strive for excellence in whatever they do. Measuring the degree of customer satisfaction was the fundamental concept on which this homeopathic institute’s commitment to become a patient-driven institution was built.
Nice words! SHAME THAT THEY HAVE DECIDED TO DILUTE THEIR TRUTH HOMEOPATHICALLY!
The question why patients turn to homeopathy – or indeed any other disproven treatment – has puzzled many people. There has been a flurry of research into these issues. Here is the abstract of a paper that I find very remarkable and truly fascinating:
Interviews with 100 homeopathic patients in the San Francisco Bay Area show that for the most part the patients are young, white and well-educated, and have white-collar jobs; most had previously tried mainstream medical care and found it unsatisfactory. Among the reasons for their dissatisfaction were instances of negative side effects from medication, lack of nutritional or preventive medical counseling, and lack of health education. Experiences with conventional physicians were almost evenly divided: nearly half of the subjects reported poor experiences, slightly fewer reported good experiences. Three quarters of the patients suffered from chronic illness and about half considered their progress to be good under homeopathic care. The majority were simultaneously involved in other nontraditional health care activities.
If you read the full article, you will see that the authors make further important points:
- Patients who use alternative treatments are by no means ignorant or unsophisticated.
- Most of these patients use other treatments in parallel – but they seem to attribute any improvements in their condition to homeopathy.
- Dissatisfaction with conventional medicine seems the prime motivation to turn to homeopathy. In particular, patients need more time with their clinician and want to share the responsibility for their own health – and these needs are met by homeopaths better than by conventional doctors.
- Most homeopaths (63%) adhere to Hahnemann’s dictum that homeopathic remedies must never be combined with other treatments. This renders then potentially dangerous in many situations.
At this point you might say BUT WE KNEW ALL THIS BEFORE! True! Why then do I find this paper so remarkable?
It is remarkable mostly because of its publication date: 1978! In fact, it may well be the very first of hundreds of similar surveys that followed in the years since.
The questions I ask myself are these:
- IF WE KNEW ALL THIS SINCE ALMOST 40 YEARS, WHY HAVE WE NOT DONE MORE ABOUT IT?
- WHY ARE WE SO UNSUCCESSFUL IN GETTING THE FACTS THROUGH TO OUR PATIENTS?
- WHY HAVE WE NOT MANAGED TO IMPROVE CONVENTIONAL MEDICINE SUCH THAT PATIENTS STOP CONSULTING QUACKS?
- WHY ARE WE STILL CONDUCTING SURVEY AFTER SURVEY WHEN THE EMBARRASSING FACTS ARE PLAIN TO SEE?
Wet cupping is a therapy traditionally used in several cultures. It involves superficial injuries to the skin and subsequently the application of a vacuum cup over the injured site. This procedure would draw a small amount of blood into the cup, and this visible effect was taken as a sign that the humors or life forces or whatever are being restored.
The treatment is obviously painful and carries the risk of infection. But does it work? There are not many clinical trials of this form of alternative medicine, and I was therefore thrilled to find a new paper with a randomised clinical trial.
The aim of this clinical trial was to evaluate the effectiveness and safety of wet cupping therapy as the sole treatment for persistent nonspecific low back pain (PNSLBP). The investigators recruited 80 with PNSLBP lasting at least 3 months and randomly allocated them to an intervention group (n=40) or to a control group (n=40). The experimental group had 6 wet cupping sessions within 2 weeks, each of which were done at two bladder meridian (BL) acupuncture points. The control group had no such treatments. Acetaminophen was allowed as a rescue treatment in both groups. The Numeric Rating Scale (NRS), McGill Present Pain Intensity (PPI), and Oswestry Disability Questionnaire (ODQ) were used as outcome measures. Numbers of acetaminophen tablets taken were compared at 4 weeks from baseline. Adverse events were recorded.
At the end of the intervention, statistically significant differences in all three outcome measures favouring the wet cupping group compared with the control group were seen. These improvements continued for another two weeks after the end of the intervention. Acetaminophen was used less in the wet cupping group, but this difference was not statistically significant. No adverse events were reported.
The authors concluded that wet cupping is potentially effective in reducing pain and improving disability associated with PNSLBP at least for 2 weeks after the end of the wet cupping period. Placebo-controlled trials are needed.
Every now and then – well, actually in alternative medicine this is not so rare an event – I come across a study that ‘smells to high heaven’. This one certainly does; to be precise, it has the stench of TOO GOOD TO BE TRUE.
Apart from the numerous weaknesses of the study design, there is the fact that the results are do simply not seem plausible. Low back pain has a natural history that is well-studied. We therefore know that the majority of cases do get better fairly quickly regardless of whether we treat them or not. In this study, the control group did not improve at all, as shown on the impressive graph below (the grey line depicts the symptoms in the control group and the black one those of the cupping group).
To me, the improvement of the experimental group looks much like one might expect from the natural history of back pain. If this were true, the effect of wet cupping would by close to zero and the conclusion drawn by the authors of this trial would be false-positive.
But why was there no improvement in the control group?
I do not know the answer to this question. All I know is that it is this unexplained phenomenon which has created the impression of effectiveness of wet cupping.
This seems to be the question that occupies the minds of several homeopaths.
So was I!
Let me explain.
In 1997, Linde et al published their now famous meta-analysis of clinical trials of homeopathy which concluded that “The results of our meta-analysis are not compatible with the hypothesis that the clinical effects of homeopathy are completely due to placebo. However, we found insufficient evidence from these studies that homeopathy is clearly efficacious for any single clinical condition. Further research on homeopathy is warranted provided it is rigorous and systematic.”
This paper had several limitations which Linde was only too happy to admit. The authors therefore conducted a re-analysis which, even though published in an excellent journal, is rarely cited by homeopaths. Linde et al stated in their re-analysis of 2000: “there was clear evidence that studies with better methodological quality tended to yield less positive results.” It was this phenomenon that prompted me and my colleague Max Pittler to publish a ‘letter to the editor’ which now – 15 years later – seems the stone of homeopathic contention.
A blog-post by a believer in homeopathy even asks the interesting question: Did Professor Ernst Sell His Soul to Big Pharma? It continues as follows:
Edzard Ernst is an anti-homeopath who spent his career attacking traditional medicine. In 1993 he became Professor of Complementary Medicine at the University of Exeter. He is often described as the first professor of complementary medicine, but the title he assumed should have fooled no-one. His aim was to discredit medical therapies, notably homeopathy, and he then published some 700 papers in ‘scientific’ journals to do so.
Now, Professor Robert Hahn, in his blog, has made an assessment of the quality of his work… In the interests of the honesty and integrity in science, it is an important assessment. It shows, in his view, how science has been taken over by ideology (or as I would suggest, more accurately, the financial interests of Big Corporations, in this case, Big Pharma). The blog indicates that in order to demonstrate that homeopathy is ineffective, over 95% of scientific research into homeopathy has to be discarded or removed!
So for those people who, like myself, cannot read the original German, here is an English translation of the blog…
“I have never seen a science writer so blatantly biased as Edzard Ernst: his work should not be considered of any worth at all, and discarded” finds Sweden’s Professor Robert Hahn, a leading medical scientist, physician, and Professor of Anaesthesia and Intensive Care at the University of Linköping, Sweden.
Hahn determined therefore to analyze for himself the ‘research’ which supposedly demonstrated homeopathy to be ineffective, and reached the shocking conclusion that:
“only by discarding 98% of homeopathy trials and carrying out a statistical meta-analysis on the remaining 2% negative studies, can one ‘prove’ that homeopathy is ineffective”.
In other words, all supposedly negative homeopathic meta-analyses which opponents of homeopathy have relied on, are scientifically bogus…
Who can you trust? We can begin by disregarding Edzard Ernst. I have read several other studies that he has published, and they are all untrustworthy. His work should be discarded…
In the case of homeopathy, one should stick with what the evidence reveals. And the evidence is that only by removing 95-98% of all studies is the effectiveness of homeopathy not demonstrable…
So, now you are wondering, I am sure: HOW MUCH DID HE GET FOR SELLING HIS SOUL TO BIG PHARMA?
No? You are wondering 1) who this brilliant Swedish scientist, Prof Hahn, is and 2) what article of mine he is criticising? Alright, I will try to enlighten you.
Here I can rely on a comment posted on my blog some time ago by someone who can read Swedish (thank you Bjorn). He commented about Hahn as follows:
A renowned director of medical research with well over 300 publications on anesthesia and intensive care and 16 graduated PhD students under his mentorship, who has been leading a life on the side, blogging and writing about spiritualism, and alternative medicine and now ventures on a public crusade for resurrecting the failing realm of homeopathy!?! Unbelievable!
I was unaware of this person before, even if I have lived and worked in Sweden for decades.
I have spent the evening looking up his net-track and at his blog at roberthahn.nu (in Swedish).
I will try to summarise some first impressions:
Hahn is evidently deeply religious and there is the usual, unmistakably narcissistic aura over his writings and sayings. He is religiously confident that there is more to this world than what can be measured and sensed. In effect, he seems to believe that homeopathy (as well as alternative medical methods in general) must work because there are people who say they have experienced it and denying the possibility is akin to heresy (not his wording but the essence of his writing).
He has, along with his wife, authored at least three books on spiritual matters with titles such as (my translations) “Clear replies from the spiritual world” and “Connections of souls”.
He has a serious issue with skeptics and goes on at length about how they are dishonest bluffers[sic] who willfully cherry-pick and misinterpret evidence to fit their preconceived beliefs.
He feels that desperate patients should generally be allowed the chance that alternative methods may offer.
He believes firmly in former-life memories, including his own, which he claims he has found verification for in an ancient Italian parchment.
His main arguments for homeopathy are Claus Linde’s meta analyses and the sheer number of homeopathic research that he firmly believes shows it being superior to placebo, a fact that (in his opinion) shows it has a biological effect. Shang’s work from 2005 he dismisses as seriously flawed.
He also points to individual research like this as credible proof of the biologic effect of remedies.
He somewhat surprisingly denies recommending homeopathy despite being convinced of its effect and maintains that he wants better, more problem oriented and disease specific studies to clarify its applicability. (my interpretation)
If it weren’t for his track record of genuine, acknowledged medical research and him being a renowned authority in a genuine, scientific medical field, this man would be an ordinary, religiously devout quack.
What strikes me as perhaps telling of a consequence of his “exoscientific” activity, is that Hahn, who holds the position of research director at a large city trauma and emergency hospital is an “adjungerad professor”, which is (usually) a part time, time limited, externally financed professorial position, while any Swedish medical doctor with his very extensive formal merits would very likely hold a full professorship at an academic institution.
END OF QUOTE
MY 2000 PAPER THAT SEEMS TO IRRITATE HAHN
This was a short ‘letter to the editor’ by Ernst and Pittler published in the J Clin Epidemiol commenting on the above-mentioned re-analysis by Linde et al which was published in the same journal. As its text is not available on-line, I re-type parts of it here:
In an interesting re-analysis of their meta-analysis of clinical trials of homeopathy, Linde et al conclude that there is no linear relationship between quality scores and study outcome. We have simply re-plotted their data and arrive at a different conclusion. There is an almost perfect correlation between the odds ratio and the Jadad score between the range of 1-4… [some technical explanations follow which I omit]…Linde et al can be seen as the ultimate epidemiological proof that homeopathy is, in fact, a placebo.
And that is, as far as I can see, the whole mysterious story. I cannot even draw a conclusion – all I can do is to ask a question:
DOES ANYONE UNDERSTAND WHAT THEY ARE GOING ON ABOUT?
We used to call it ‘alternative medicine’ (on this blog, I still do so, because I believe it is a term as good or bad as any other and it is the one that is easily recognised); later some opted for ‘complementary medicine’; since about 15 years a new term is en vogue: INTEGRATED MEDICINE (IM).
Supporters of IM are adamant that IM is not synonymous with the other terms. But how is IM actually defined?
One of IM’s most prominent defenders is, of course Prince Charles. In his 2006 address to the WHO, he explained: “We need to harness the best of modern science and technology, but not at the expense of losing the best of what complementary approaches have to offer. That is integrated health – it really is that simple.”
Perhaps a bit too simple?
There are several more academic definitions, and it seems that, over the years, IM-fans have been busy moving the goal post quite a bit. The original principle of ‘THE BEST OF BOTH WORLDS’ has been modified considerably.
- IM is a “comprehensive, primary care system that emphasizes wellness and healing of the whole person…” [Arch Intern Med. 2002;162:133-140]
- IM “views patients as whole people with minds and spirits as well as bodies and includes these dimensions into diagnosis and treatment.” [BMJ. 2001; 322:119-120]
During my preparations for my lecture at the 16th European Sceptics Congress in London last week (which was on the subject of IM), I came across a brand-new (September 2015) definition. It can be found on the website of the COLLEGE OF MEDICINE This Michael Dixon-led organisation can be seen as the successor of Charles’ ill-fated FOUNDATION FOR INTEGRATED HEALTH; it was originally to be called COLLEGE FOR INTEGRATED MEDICINE. We can therefore assume that they know best what IM truly is or aspires to be. The definition goes as follows:
IM is a holistic, evidence-based approach which makes intelligent use of all available therapeutic choices to achieve optimal health and resilience for our patients.
This may sound good to many who are not bothered or unable to think critically. It oozes political correctness and might therefore even impress some politicians. But, on closer scrutiny, it turns out to be little more than offensive nonsense. I feel compelled to publish a short analysis of it. I will do this by highlighting and criticising the important implications of this definition one by one.
1) IM is holistic
Holism has always been at the core of any type of good health care. To state that IM is holistic misleads people into believing that conventional medicine is not holistic. It also pretends that medicine might become more holistic through the addition of some alternative modalities. Yet I cannot imagine anything less holistic than diagnosing patients by merely looking at their iris (iridology) or assuming all disease stems from subluxations of the spine (chiropractic), for example. This argument is a straw-man, if there ever was one.
2) IM is evidence-based
This assumption is simply not true. If we look what is being used under the banner of IM, we find no end of treatments that are not supported by good evidence, as well as several for which the evidence is squarely negative.
3) IM is intelligent
If it were not such a serious matter, one could laugh out loud about this claim. Is the implication here that conventional medicine is not intelligent?
4) IM uses all available therapeutic choices
This is the crucial element of this definition which allows IM-proponents to employ anything they like. Do they seriously believe that patients should have ALL AVAILABLE treatments? I had thought that responsible health care is about applying the most effective therapies for the condition at hand.
5) IM aims at achieving optimal health
Another straw-man; it implies that conventional health care professionals do not want to restore their patients to optimal health.
In my lecture, which was not about this definition but about IM in general, I drew the following six conclusions:
- Proponents of IM mislead us with their very own, nonsensical terminology and definitions.
- They promote two main principles: use of quackery + holism.
- Holism is at the heart of all good medicine; IM is at best an unnecessary distraction.
- Using holism to promote quackery is dishonest and counter-productive.
- The integration of quackery will render healthcare not better but worse.
- IM flies in the face of common sense and medical ethics; it is a disservice to patients.
On a blog about alternative medicine, the issue of ‘pseudoscience’ can never be far. Several posts have already focussed specifically on this topic. Recently, I came across an excellent article on homeopathy (which is well worth reading in full). It concluded by listing the techniques commonly used in pseudoscience.
I think this is important and relevant to much of the discussions about alternative medicine. Therefore I take the liberty to cite it here in full. According to the authors of this article,, the techniques are as follows:
- Ignore settled issues in science: We know a great deal about the behavior of water (and evolution, and other contentious topics), but there are many efforts to introduce new science without ever addressing the existing body of knowledge. As such, many of the basic tenets of topics such as homeopathy appear to be ungrounded in reality as we understand it.
- Misapplication of real science: Quantum mechanics is an undeniably successful description of parts of the natural world, but the limitations of its applicability are widely recognized by the scientific community, if not the general public. Pseudoscientists such as homeopaths appear to cynically target this sort of ignorance by applying scientific principles to inappropriate topics.
- Rejection of scientific standards: Over the centuries, science has established standards of evidence and experiment to ensure that data remains consistent and reproducible. But these strengths are presented as weaknesses that make science impervious to new ideas, a stance that is often accompanied by…
- Claims of suppression: Pseudoscience is rejected because it does not conform to the standards held by the scientific community. That community is depicted as a dangerous hegemony that rejects new ideas in order to perpetuate a stifling orthodoxy. This happens in spite of many examples of radical ideas that have rapidly gained not only acceptance, but major prizes, when they were properly supported by scientific evidence.
- A conclusion/evidence gap: Many areas of pseudoscience do not set out to examine a phenomenon but rather have the stated goal of supporting a preordained conclusion. As such, they often engage in excessive logical leaps when the actual data is insufficient to support the desired conclusion.
- Focusing on the fringes: All areas of science have anomalous data and anecdotal findings that are inconsistent with the existing understanding. But those anomalies should not obscure the fact that the vast majority of current data does support the predominant theories. In the hands of a pseudoscientist, these unconnected edge cases are presented as a coherent body of knowledge that supports the replacement of existing understandings.
Perhaps the clearest theme running through many areas of pseudoscience, however, is the attempt to make a whole that is far, far greater than the sum of its parts. Enlarging a collection of terminally-flawed trivia does not somehow strengthen its scientific significance. This is especially true when many of the components of the argument don’t form a coherent whole. For example, quantum entanglement, structured water, and silica are essentially unrelated explanations, and any support for one of them makes no difference to the others. Yet, somehow, presenting them all at once is supposed to make the case for water’s memory harder to dismiss.
END OF QUOTE
A recent article promised to provide details of the ’10 most mind-numbingly stupid alternative therapies’. Naturally I was interested what these might be. In descending order they are, according to the author of the most enjoyable piece:
10 VEGA TESTING
8 CRYSTAL HEALING
7 URINE THERAPY
6 DETOXIFYING FOOT PADS
5 WHEAT-GRASS ENEMAS
4 PSYCHIC SURGERY
3 OZONE THERAPY
2 CUPPING THERAPY
This is quite a list, I have to admit. Despite some excellent choices, I might disagree with a few of them. Detoxifying foot pads will take care of a common and most annoying problem: smelly feet; therefore it cannot be all bad. And drinking your own urine can even be a life-saver! Lets assume someone has a kidney or bladder cancer. Her urine might, at one stage, be bright red with blood. The urine therapy enthusiast would realise early that something is wrong with her, go and see a specialist, get early treatment and save her life. No, no no, I cannot fully condemn urine therapy!
The other thing with the list is that one treatment which is surely mind-bogglingly stupid is missing: CHELATION THERAPY.
I have previously written about this form of treatment and pointed out that some practitioners of alternative medicine (doctors, naturopaths, chiropractors and others) earn a lot of money claiming that chelation therapy (a well-established mainstream treatment for acute heavy metal poisoning) is an effective therapy for cardiovascular and many other diseases. However, this claim is both implausible and not evidence-based. Several systematic reviews of the best evidence concluded less than optimistically:
Despite all this, the promotion of chelation continues unabated. An Australian website, ironically entitled ‘LEADERS IN INTEGRATIVE MEDICINE’, might stand for many others when it informs its readers about chelation therapy. Here is a short passage:
Chelation therapy has the ability to remove the calcium from artery plaques as well as remove toxic ions, reduce free radical damage and restore circulation to all tissues of the body. A growing number of physicians use chelation therapy to reverse the process of atherosclerosis (hardening of the arteries) and as an alternative to angioplasty and bypass surgery.
Chelation therapy is a treatment to be considered for all conditions of reduced blood flow (coronary artery disease, cerebral vascular disease, peripheral vascular disease, angina, vertigo, tinnitus, senility), any situations of heavy metal toxicity or tissue overload and various chronic immune system disorders such as rheumatoid arthritis. Intravenous vitamin C is useful for the treatment of chronic and acute infections, fatigue, pre- and post-surgery and to boost the immune system while undergoing cancer therapies.
Not bad, isn’t it. How come such mind-numbing stupidity escaped the author of the above article? Was it an oversight? Was the choice just too overwhelming? Or did he not think chelation was all that funny? I ought to mention that it is not at all harmless like sampling your own urine or having a Reiki healer sending some ‘healing energy’.
Whatever the reason, I hope for an up-date of the list, he will consider chelation as a seriously mind-numbing contender.
I just came across an announcement which could be important. Here are what I consider the important passages:
The Federal Trade Commission will host a public workshop on Monday, September 21, 2015 in Washington, DC, to examine advertising for over-the-counter (OTC) homeopathic products…
Because of rapid growth in the marketing and consumer use of homeopathic products, the FTC is hosting a workshop to evaluate the advertising for such products. The workshop will bring together a variety of stakeholders, including medical professionals, industry representatives, consumer advocates, and government regulators.
The FTC invites the public to submit research, recommendations for topics of discussion, and requests to participate as panelists. The workshop will cover topics including:
- A look at changes in the homeopathic market, its advertising, and what consumers know;
- The science behind homeopathy and its effectiveness;
- The effects of recent class actions against homeopathic product companies;
- The application of Section 5 of the FTC Act to advertising claims for homeopathic products; and
- Public policy concerns about the current regulation of homeopathic products.
Public comments can be submitted electronically. Paper submissions should be sent to: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue, NW, Suite CC-5610 (Annex B), Washington, DC 20580, or delivered to: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street, SW, 5th Floor, Suite 5610 (Annex B), Washington, DC 20024. Paper submissions should reference the Homeopathic Medicine & Advertising Workshop both in the text and on the envelope. The deadline for submitting public comments is Friday, November 20, 2015.
The FTC also has set up an email box for anyone interested in being a panelist at the event or suggesting additional topics for discussion. It is firstname.lastname@example.org (link sends e-mail), and will be open until August 1, 2015.
The workshop is free and open to the public. It will be held at the Constitution Center, 400 7th St., SW, Washington, DC 20024. The Commission will publish a detailed agenda at a later date…
The Federal Trade Commission works for consumers to prevent fraudulent, deceptive, and unfair business practices and to provide information to help spot, stop, and avoid them. To file a complaint in English or Spanish, visit the FTC’s online Complaint Assistant or call 1-877-FTC-HELP (1-877-382-4357). The FTC enters complaints into Consumer Sentinel, a secure, online database available to more than 2,000 civil and criminal law enforcement agencies in the U.S. and abroad…
In my view, this is a long overdue initiative. Consumers are constantly and outrageously misled by the advertising of homeopathic products. This has the potential to impact negatively on public health.
It would not surprise me, if homeopathy advocates were to try to swamp this event with their promotion of homeopathy. Therefore, I thought it was important to post the announcement on my blog, in the hope that as many scientifically minded people as possible might file their evidence and objections.
Medical ethics comprise a set of rules and principles which are essential for all aspects of medicine, including of course research. The main issues are:
- Respect for autonomy – patients must have the right to refuse or choose their treatments.
- Beneficence – researchers and clinicians must act in the best interest of the patient.
- Non-maleficence – the expected benefits of interventions must outweigh their risks.
- Justice – the distribution of health resources must be fair.
- Respect for persons – patients must be treated with dignity.
- Truthfulness and honesty – informed consent is an essential element in research and clinical practice.
While all of this has long been fairly standard in conventional health care, it is often neglected in alternative medicine. It is therefore timely to ask, how much of research in the realm of alternative medicine abides by the rules of medical ethics?
After more than two decades of involvement in this sector, I have serious and growing concerns. The subject is, of course complex, but the way I see it, in alternative medicine there are two main areas where medical ethics are violated with some regularity.
- Nonsensical research projects
- Lack of informed consent
NONSENSICAL RESEARCH PROJECTS
At best, nonsensical research is a waste of precious resources, at worst it violates the beneficence principle. In alternative medicine, nonsensical research seems to happen ad nauseam. Regular readers of this blog will have seen plenty of examples of such abuse – for instance, if researchers conduct a clinical trial of chiropractic spinal manipulation for improving the singing voices of choir singers, or homeopaths test whether their remedies enhance female fertility. Often, nonsensical research happens when naïve enthusiasts decide to dabble a bit in science in order to promote their trade – but without realising that research would require a minimum of education.
But there are other occasions when it seems that the investigators know only too well what they are doing. Take for instance the plethora of ‘pragmatic’ trials which are currently so much ‘en vogue’ in alternative medicine. They can be designed in such a way that their results must produce what the researchers intended to show; the ‘A+B versus B’ study design is a prominent and obvious example of this type of abuse which I have repeatedly written about on this blog.
I use the term ‘abuse’ intentionally, because that is precisely what it is, in my view. Nonsensical research abuses the willingness of patients to participate by misleading them that it is a worthwhile sacrifice. In reality it is an unethical attempt to generate findings that can mislead us all. Moreover, it gives science a bad name and can lead to patients’ unwillingness to take part in research that does need doing. The damage done by nonsensical research projects is therefore immeasurable.
Informed consent is essential in research for protecting the interests of the volunteering patients. When a clinical trial is first conceived, the researchers need to work out all the details, write a protocol and submit it to their ethics committee. Their submission has to give evidence that all the participating patients have given informed consent in writing before they are enrolled into the study. That means, they have to be told the essential details about what might happen to them during the trial.
In a placebo-controlled trial of homeopathy, for instance, they might be told that they will receive either a homeopathic remedy or a placebo during the study period. They might also be informed that there is some encouraging evidence that the former works, and that the trial is designed to define to what extend this is so. Generating this knowledge, they might further be told, will help future patients and will be an important contribution to improving health care. Based on such phraseology, the ethics committee is likely to allow the study to go ahead, and patients are likely to agree to take part.
But, of course, this information is less than truthful. An honest and full information for patients would need to include the following points:
- you will receive either a homeopathic remedy or a placebo,
- the former contains no active molecules and the totality of the most reliable evidence does not show that it works for your condition,
- this means that you will receive either a homeopathic or a conventional placebo,
- neither of these can possibly help your condition,
- the study can therefore not advance our knowledge in any way,
- during the trial your condition will remain untreated which is likely to increase your suffering unnecessarily.
If any research team would truthfully disclose this information, no ethics committee would pass their protocol. If by some weird mistake they did, no patients would volunteer to participate in the study.
I have chosen here the example of homeopathy (because most readers will understand it quite easily), but I could have used almost any other alternative treatment. The issues are identical or very similar: informed consent is usually misinformed consent. If it were fully and truthfully informed, it would neither pass the hurdle of the essential ethics approval nor would it lend itself to recruiting sufficiently large numbers of patients.
There are, I think, very serious concerns about the ethical standards in alternative medicine research. I have been banging on about these issues since many years (for instance here and here and here and here). Predictably, this did not find much resonance in the realm of alternative medicine. Regrettably, very few ethicists have so far taken this subject seriously; they seem to feel that these problems are trivial compared to the important issues medical ethics face in conventional health care. I remain unconvinced that this is true and believe it is high time to systematically address the ethics of alternative medicine.
Conventional cough syrups do not have the best of reputations – but the repute of homeopathic cough syrups is certainly not encouraging. So what should one do with such a preparation? Forget about it? No, one conducts a clinical trial, of course! Not just any old trial but one where science, ethics and common sense are absent. Here are the essentials of a truly innovative study that, I think, has all of these remarkable qualities:
The present prospective observational study investigated children affected by wet acute cough caused by non-complicated URTIs, comparing those who received the homeopathic syrup versus those treated with the homeopathic syrup plus antibiotic. The aims were: 1) to assess whether the addition of antibiotics to a symptomatic treatment had a role in reducing the severity and duration of acute cough in a pediatric population, as well as in improving cough resolution; 2) to verify the safety of the two treatments. Eighty-five children were enrolled in an open study: 46 children received homeopathic syrup alone for 10 days and 39 children received homeopathic syrup for 10 days plus oral antibiotic treatment (amoxicillin/clavulanate, clarithromycin, and erythromycin) for 7 days. To assess cough severity we used a subjective verbal category-descriptive (VCD) scale. Cough VCD score was significantly (P < 0.001) reduced in both groups starting from the second day of treatment (−0.52 ± 0.66 in the homeopathic syrup group and −0.56 ± 0.55 in children receiving homeopathic syrup plus oral antibiotic treatment). No significant differences in cough severity or resolution were found between the two groups of children in any of the 28 days of the study. After the first week (day 8) cough was completely resolved in more than one-half of patients in both groups. Two children (4.3 %) reported adverse effects in the group treated with the homeopathic syrup alone, versus 9 children (23.1 %) in the group treated with the homeopathic syrup plus antibiotics (P = 0.020).
Our data confirm that the homeopathic treatment in question has potential benefits for cough in children as well, and highlight the strong safety profile of this treatment. Additional antibiotic prescription was not associated with a greater cough reduction, and presented more adverse events than the homeopathic syrup alone.
Let us be clear about what has happened here. I think, the events can be summarised as follows:
- the researchers come across a homeopathic syrup (anyone who understands respiratory problems and/or therapeutics would be more than a little suspicious of this product, but this team is exceptional),
- they decide to do a trial with it (a decision which would make some ethicists already quite nervous, but the ethics committee is exceptional too),
- the question raises, what should the researchers give to the control group?
- someone has the idea, why not compare our dodgy syrup against something that is equally dodgy, perhaps even a bit unsafe?
- the researchers are impressed and ask: but what precisely could we use?
- let’s take antibiotics; they are often used for acute coughs, but the best evidence fails to show that they are helpful and they have, of course, risks,
- another member of the team adds: let’s use children, they and their mothers are unlikely to understand what we are up to,
- the team is in agreement,
- Boiron, the world’s largest producer of homeopathic products, accepts to finance the study,
- a protocol is written,
- ethics approval is obtained,
- the trial is conducted and even published by a journal with the help of peer-reviewers who are less than critical.
And the results of the trial? Contrary to the authors’ conclusion copied above, they show that two bogus treatments are worse that one.
BOB’S YOUR UNCLE!
EVERYONE SEEMS HAPPY: THE RESEARCHERS CAN ADD AN ARTICLE TO THEIR PUBLICATION LIST, BOIRON HAS MORE ‘EVIDENCE’ IN FAVOUR OF HOMEOPATHY, AND THE ETHICS COMMITTEE SLEEP JUST AS SOUNDLY AS THE PEER-REVIEWERS.