S.O. Hansson from the Royal Institute of Technology, Stockholm, Sweden recently published an interesting comment on the law regulating the labelling of homeopathic products. In it he points out that, in the European Union (EU), all pre-packaged food products must contain a list of ingredients and their quantities. The list should be “accurate, clear and easy to understand for the consumer.” Similar requirements apply to pharmaceutical drugs and products – with one notable exception: homeopathic preparations.
For such products, the ingredients need not be disclosed on the label, which should instead specify “the scientific name of the stock or stocks followed by the degree of dilution.” The degree of homeopathic dilutions is, in turn, given in an understandable jargon, such as “C60”, which actually describes a dilution of 1:10120.
The point Hansson is trying to make is that very few health care professionals and even fewer consumers would understand such abbreviations and jargon. This means that, manufacturers of homeopathic products are legally permitted to hide the fact from their customers that their remedies typically contain no active ingredient at all. Considering that homeopathic products are typically bought ‘over the counter’ (OTC), i.e. without interference from a health care professional, just like food products, the exemption seems most surprising.
The most OTC homeopathic remedies are in the “C30” potency; this signifies a dilution of 1: 1 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000 000. The likelihood that any potency higher than “C12” might contain a single molecule of active ingredient is very close to zero. In order to comprehend the degree of dilution in homeopathy more fully, a visual approach might be best: for it to have a reasonable chance to contain just one single molecule of active ingredient, a homeopathic pill in a “C30” potency would need to have a diameter roughly equal to the distance between the earth and the sun. Homeopathy is truly impossible to swallow.
If homeopathic manufacturers were obliged to provide a description that is “accurate, clear and easy to understand for the consumer”, it would need to state that any dilution beyond “C12” contains no active molecule. It seems clear that such accurate, clear and understandable information would discourage most consumers to spend their hard-earned money for such nonsense. It seems thus to be obvious that the EU exemption of homeopathic remedies from honest labelling protects the interests of the homeopathic industry.
But surely, this is deeply wrong. Regulations in health care are not supposed to protect commercial interests, they should protect the consumer. In my view, it is time to change such profoundly misguided EU-regulation – in the interest of honesty, single standards, transparency and foremost in the interest of the patient and the consumer.
Indian homeopaths recently published a clinical trial aimed at evaluating homeopathic treatment in the management of diabetic polyneuropathy. The condition affects many diabetic patients; its symptoms include tingling, numbness, burning sensation in the feet and pain, particularly at night. The best treatment consists of adequate metabolic control of the underlying diabetes. The pain can be severe often does not respond adequately to conventional pain-killers. It is therefore obvious that any new, effective treatment would be more than welcome.
The new trial is a prospective observational study which was carried out from October 2005 to September 2009 by the Indian Central Council for Research in Homeopathy at its five Institutes. Patients suffering diabetic polyneuropathy (DPN) were screened and enrolled in the study, if they fulfilled the inclusion and exclusion criteria. The Diabetic Distal Symmetric Polyneuropathy Symptom Score (DDSPSS), developed by the Council, served as the primary outcome measure.
A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in the 30, 200 and 1 M potencies on an individualized basis. Patients were followed up for 12 months.
Of 336 diabetics enrolled in the study, 247 patients who attended at least three follow-up appointments and baseline nerve conduction studies were included in the analysis. A statistically significant improvement in DDSPSS total score was found at 12 months. Most objective measures did not show significant improvements. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the most frequently prescribed homeopathic remedies.
From these results, the authors concluded that: “homeopathic medicines may be effective in managing the symptoms of DPN patients.”
Does this study tell us anything worth knowing? The short answer to this question, I am afraid, is NO.
Its weaknesses are all too obvious:
1) There was no control group.
2) Patients who did not come back to the follow-up appointments – presumably because they were not satisfied – were excluded from the analyses. The average benefit reported is thus likely to be a cherry-picked false positive result.
3) The primary outcome measure was not validated.
4) The observed positive effect on subjective symptoms could be due to several factors which are entirely unrelated to the homeopathic treatments’ e.g. better metabolic control, regression towards the mean, or social desirability.
Anyone who had seen the protocol of this study would have predicted the result; I see no way that such a study does not generate an apparently positive outcome. In other words, conducting the investigation was superfluous, which means that the patients’ participation was in vain; and this, in turn, means that the trial was arguably unethical.
This might sound a bit harsh, but I am entirely serious: deeply flawed research should not happen. It is a waste of scarce resources and patients’ tolerance; crucially, it has a powerful potential to mislead us and to set back our efforts to improve health care. All of this is unethical.
The problem of research which is so poor that it crosses the line into being unethical is, of course, not confined to homeopathy. In my view, it is an important issue in much of alternative medicine and quite possibly in conventional medicine as well. Over the years, several mechanisms have been put in place to prevent or at least minimize the problem, for instance, ethic committees and peer-review. The present study shows, I think, that these mechanisms are fragile and that, sometimes, they fail altogether.
In their article, the authors of the new homeopathic study suggest that more investigations of homeopathy for diabetic polyneuropathy should be done. However, I suggest almost precisely the opposite: unethical research of this nature should be prevented, and the existing mechanisms to achieve this aim must be strengthened.
If we believe homeopaths, we might get the impression that homeopathy is firmly established in mainstream health care. “They would say that, wouldn’t they?” To convince skeptics, we might want to have a bit more than wishful thinking.
We have just published a systematic review in order to instill some evidence into this debate. Our aim was to evaluate all the data from recent surveys of GPs and assess their involvement with and attitudes towards homeopathy. We searched 7 electronic databases to identify all relevant articles. Data extraction was conducted by three independent reviewers. Thirteen surveys met the inclusion criteria. Their findings suggest that less than 10% of GPs treated patients with homeopathy; referral rates varied hugely and ranged from 4.6% to 73%.
Two surveys also assessed GPs’ endorsement of homeopathy; they suggested that less than 15% of GPs were endorsing homeopathy. One survey asked about GPs’ personal usage of homeopathy and reported less than 10% had used this form of therapy on themselves.
Three surveys investigated adverse events (AEs) from homeopathic treatments. One was solely focussed on AEs which were classified as “serious” (either life threatening or likely to cause disability or sever morbidity) or non-serious. In total, 21 “indirect” serious AEs were reported (e.g., stopping medication, refusing immunisation, refusing cancer treatment, delaying diagnosis). Another survey found that 14% of GPs reported AEs following homeopathic treatment within a year. Other authors reported that the discontinuation of conventional asthma treatment in favour of a homeopathic remedy had led to cardiovascular arrest.
These data shed a much more sober light on the use of homeopathy in the UK. They fail to show that homeopathy is well-accepted by British GPs. More importantly perhaps they disclose serious problems with the use of homeopathy.
Having previously criticised the abundance of mostly rather meaningless surveys in alternative medicine, I now should perhaps admit to having published my fair share of such investigations. The most recent one was only just published.
The aim of this survey was to conduct a follow-up of a previous, identical investigation and to thus ascertain changes in usage, referral rate, beliefs and attitudes towards alternative medicine during the last decade. A questionnaire was posted in 2009 to all GPs registered with the Liverpool Primary Care Trust asking them whether they treat, refer, endorse or discuss eight common alternative therapies and about their views on National Health Service (NHS) funding, effectiveness, training needs and theoretical validity of each therapy. Comparisons were made between these results and those collected 10 years ago.
The response rate was unfortunately low (32%) compared with the 1999 survey (52%). The main findings were similar as 10 years before: the most popular therapies were still acupuncture, hypnotherapy and chiropractic and the least popular were aromatherapy, reflexology and medical herbalism. GPs felt most comfortable with acupuncture and had greater belief in its theoretical validity, a stronger desire for training in acupuncture and more support for acupuncture to receive NHS funding than for the other alternative therapies. Opinions about homeopathy had become less supportive during the last 10 years. Overall, GPs were less likely to endorse alternative treatments than previously shown (38% versus 19%).
I think these findings speak for themselves. They suggest that British GPs have become more skeptical about alternative medicine in general and about homeopathy in particular. It would, of course, be interesting to know why this is so. Unfortunately we are merely able to speculate here: might it be the increasingly obvious lack of evidence and biological plausibility that matter? As a rationalist, I would hope this to be true but our data do not allow any firm conclusion.
Speaking about the data, I have to admit that they are rather soft. This was just a very small survey in one specific part of the UK. More importantly, the flaws in our investigation are fairly obvious. The most important limitation probably is the low response rate. It may be caused by a general ‘survey-fatigue’ that many GPs suffer from. Whatever the reason, it severely limits the usefulness of our paper.
So why publish the survey at all then? The answer is simple: we certainly do already have an abundance of surveys, but we have a dearth of longitudinal data. Because we employed the same methodology as 10 years ago, this investigation does provide a unique insight into what might have been happening over time – albeit with more than just a pinch of salt.
Today, one day after a homeopathic retailer made headlines for advocating homeopathy as a treatment of measles, is the start of WORLD HOMEOPATHY AWARENESS WEEK. This is an ideal occasion, I think, for raising awareness of the often lamentably poor research that is being conducted in this area.
We have already on this blog discussed some rather meaningless research by Boiron, the world’s largest manufacturer of homeopathic preparations. I concluded my post by asking: “what can possibly be concluded from this article that is relevant to anyone? I did think hard about this question, and here is my considered answer: nothing (other than perhaps the suspicion that homeopathy-research is in a dire state)”. Now a new article has become available which sheds more light on those issues.
With this prospective observational study, the Boiron researchers wanted to determine the “characteristics and management of patients in France consulting allopathic general practitioners (AGPs) and homeopathic general practitioners (HGPs) for influenza-like illness (ILI)”. The investigation was conducted in Paris during the 2009-2010 influenza season. Sixty-five HGPs and 124 AGPs recruited a total of 461 patients with ILI. All the physicians and patients completed questionnaires recording demographic characteristics as well as patients’ symptoms.
Most AGPs (86%), and most patients consulting them (58%) were men; whereas most HGPs (57%), and most patients visiting them (56%) were women. Patients consulting AGPs were seen sooner after the onset of symptoms, and they self-treated more frequently with cough suppressants or expectorants. Patients visiting HGPs were seen later after the onset of symptoms and they self-treated with homeopathic medications more frequently.
At enrollment, headaches, cough, muscle/joint pain, chills/shivering, and nasal discharge/congestion were more common in patients visiting AGPs. 37.1% of all patients consulting AGPs were prescribed at least one homeopathic remedy, and 59.6% of patients visiting HGPs were prescribed at least one conventional medication. Patients’ satisfaction with their treatments did not differ between AGPs and HGPs; it was highest for the sub-group of patients who had been treated exclusively with homeopathy.
The authors draw the following conclusions from these data: In France, homeopathy is widely accepted for the treatment of ILI and does not preclude the use of allopathic medications. However, patients treated with homeopathic medications only are more satisfied with their treatment than other patients.
This type of article, I think, falls into the category of promotion rather than science; it seems to me as though the investigation was designed not by scientists but by Boiron’s marketing team. The stated aim was to determine the “characteristics and management of patients…“, yet the thinly disguised true purpose is, I fear, to show that patients who receive homeopathic treatment are satisfied with this approach. I have previously pointed out that such findings are akin to demonstrating that people who elect to frequent a vegetarian restaurant tend to not like eating meat. Patients who want to consult a homeopath also want homeopathy; consequently they are happy when they get what they wanted. This is not rocket science, in fact, it is not science at all.
But what about the impressive acceptance of homeopathic remedies by French non-homeopathic doctors? It would, of course, be an ‘argumentum ad populum’ fallacy [which implies that ‘generally accepted’ equals ‘effective’] to assume that this proves the value of homeopathy. Yet this finding nevertheless requires an explanation: why did these doctors chose to employ homeopathy? Was it because they knew it worked? I doubt it! In my view, there are other, more plausible reasons: perhaps their patients asked for or even insisted on it; perhaps they felt that this is better than causing bacterial resistance by prescribing an antibiotic for a viral infection?
While I find this study as useless as the one I previously discussed on this blog, and while I fear that it confirms the all too often doubtful quality of research in this area, it might nevertheless contain a tiny item of interest. The authors report that “at enrollment, headaches, cough, muscle/joint pain, chills/shivering, and nasal discharge/congestion were more common in patients visiting AGPs”. In plain English, this strongly suggests that patients who decide to consult a homeopath are less ill than those who go to see a conventional doctor.
Does that mean that a certain group of individuals frequent homeopaths only when they are not really very sick? Does that indicate that even enthusiasts do not trust homeopathy all that far? Is that perhaps similar to out Royal family who seem to consult real doctors and surgeons when they are truly ill, while keeping a homeopath on stand-by for the rest of the time? These might be relevant research questions for the future; somehow I doubt, however, that the guys in charge of Boiron will ever address them.
Yesterday, I received a letter from the editor-in-chief of the journal ‘Homeopathy‘ informing me that I have been struck off the editorial board of his publication. As the letter is not marked confidential, I feel that I can reproduce parts of it here:
Dear Professor Ernst,
This is to inform you that you have been removed from the Editorial Board of Homeopathy. The reason for this is the statement you published on your blog on Holocaust Memorial Day 2013 in which you smeared homeopathy and other forms of complementary medicine with a ‘guilt by association’ argument, associating them with the Nazis.
I should declare a personal interest….[Fisher goes on to tell a story which is personal and which I therefore omit]… I mention this only because it highlights the absurdity of guilt by association arguments.
Peter Fisher Editor-in-Chief, Homeopathy
I do agree with Dr Fisher that guilt by association is absurd. However, I disagree with the notion that I used this fallacy in my post the full text of which be found here. After re-reading it several times, I still do not see that it employs a ‘guilt by association argument’. It merely recounts historical facts which are not well-known and therefore worth mentioning. Importantly, the post consits in essence of quotes from my previous publications on the subject. My motives for writing it could not have been clearer and are emphacised in the last paragraph:
So, why bring all of this up today? Is it not time that we let grass grow over these most disturbing events? I think not! For many years, I actively researched this area (you can find many of my articles on Medline) because I am convinced that the unprecedented horrors of Nazi medicine need to be told and re-told – not just on HOLOCAUST MEMORIAL DAY, but continually. This, I hope, will minimize the risk of such incredible abuses ever happening again.
Perhaps a comparison might make it a little clearer why, in my opinion, Fisher’s is so utterly bizarre. Imagine an eminent researcher in the area of psychiatry who has been on the editorial board of a journal in his area for many years and contributed numerous articles to this journal. He then decides to research and subsequently write about the infamous Nazi past of German psychiatry. As a result, he is fired from his editorial board position because the editor feels that he has smeared the reputation of psychiatry.
I think most observers might find this odd and unjustified. Such a thing would not happen, I think, in a field with a mature research-culture. That it did happen in homeopathy might be interpreted as a reflection of the fact that homeopathy lacks such a culture.
So how precisely can we explain my dismissal? My article and my motives for writing it could have been thoroughly misunderstood – in my view, this is unlikely because I explained my motives in some detail both in the article and in the comments that follow the article. Here is my last of several posts clarifying my motives:
i am sorry that some have misunderstood the message of this blog and the reason why i wrote it.
i did certainly not want to engage in the GUILTY BY ASSOCIATION fallacy.
here is the truth:
i have had a research interest in nazi medicine and published about it.
in the course of these activities, i discovered that, contrary to what most people seem to assumue, alt med was involved as well. so i published this too many years ago.
this blog was simply and purely aimed at re-telling this story because it deserves to be re-told, in my view.
i regret that some people have read things into it which i did not intend.
Another explanation could be that Dr Fisher, who also is the Queen’s homeopath, lacks sufficient skills of critical thinking to understand the article and its purpose. Alternatively, he has been waiting for an occasion to fire me ever since I became more openly critical of homeopathy about five years ago.
Whatever the explanation, I think it is regrettable that the journal ‘Homeopathy’ has now lost the only editorial board member who had the ability to openly and repeatedly display a critical attitude about homeopathy – remember: without a critical attitude progress is unlikely!
Samuel Hahnemann, a German physician who was frustrated with the ‘heroic’ medicine of his time, invented homeopathy about 200 years ago. Since then, his followers have applied what we might call ‘selective dogmatism’ to his invention: they have religiously adhered to certain aspects, been considerably more liberal in other respects and abandoned some concepts altogether. It is therefore not unreasonable, I think, to ask what the ‘father of homeopathy’ – if he were still with us – might think of homeopathy as it is being practised today.
TYPES OF HOMEOPATHY
We tend to consider homeopathy to be one single therapy or school of thought, but this is not quite true. There a numerous forms of homeopathy, including the following:
Auto-isopathy (treatment with remedies made from patients’ own body substances)
Classical homeopathy (doctrine based on strict Hahnemannian principles)
Clinical homeopathy (non-individualised treatment based mainly on guiding symptoms; e.g. arnica for bruises)
Complex homeopathy (treatment with combination remedies)
Homotoxicology (treatment based on Reckeweg’s concepts of detoxification)
Isopathy (use of remedies made from the causative agent, e.g. a specific allergen for an allergy)
Pluralistic homeopathy (use of more than one remedy at once)
The list could be extended, and we could discuss the characteristics as well as the pros and cons of each variant. But this would be rather futile and intensely boring; suffice to say that, from all we know about Hahnemann’s views and temper, he would have strongly condemned even the slightest deviation from the strict rules of his doctrine.
CURRENT TYPES OF HOMEOPATHS
So, what about the different ways in which homeopathy (whatever version we might select) is practised by Hahnemann’s disciples today? The way I see it, four different and fairly distinct types of homeopaths currently exist.
The purist homeopath
Samuel Hahnemann himself clearly was a purist. He was adamant that his detailed instructions must be followed to the letter. Amongst other things, this means that homeopathy must be seen as the only true medicine; mixing homeopathy with any other type of medicine is, according to its founder, strictly forbidden; Hahnemann was very explicit that this would weaken or even abolish its effects. Today’s purist homeopaths therefore follow these instructions religiously and employ homeopathy as the sole and only therapeutic option for any symptom or disease.
The liberal homeopath
Purist-homeopaths still do exist today, but they seem to be in the minority. Most homeopathic doctors mix homeopathic with conventional medicines, and most non-doctor homeopaths (they prefer the term ‘professional homeopaths’) accept or at least acknowledge that a mixed approach might often be necessary or preferable. In the words of Hahnemann, these homeopaths are ‘half-homeopaths’ who have ‘betrayed’ his gospel. He would most certainly disown them and point out that this type of approach is doomed to failure and cannot possibly work.
The occasional homeopath
In several countries – Germany is a good example – many doctors use homeopathy on just relatively rare occasions. We might speculate why this is so; my personal impression is that this group of clinicians do not really believe in the effectiveness of homeopathy at all. They employ it because some patients ask for it, or because they want to use a legally defensible and harmless placebo. There can be no doubt, Hahnemann would have not approved of this approach at all. Quite to the contrary, he would have been furious, called them ‘traitors’ or worse and insisted that this is nothing more than a placebo-therapy.
DIY-homeopaths is my term for patients and consumers who have no training in homeopathy but buy homeopathic remedies over the counter and self-administer them without consulting a trained homeopath. They might see it being recommended for a certain health problem and give it a try. If their symptoms subsequently disappear, they are likely to misinterpret this phenomenon and become convinced that homeopathy is effective. This group seems to be by far the largest of all types of homeopaths.
WOULD HAHNEMANN APPROVE?
What would Hahnemann, if we could ask him today, make of all this? I think he would be fuming with anger (from all we know, he was a rather short-tempered man and had no patience with ‘traitors’).
The DIY-homeopaths obviously break every rule in his book: without a long and complicated consultation, it would not be possible to identify the correct, individualised remedy. What follows is simple: according to Hahnemann’s teachings, all these millions of people across the globe are treating themselves with pure placebos. Ironically, this is where most scientists would agree Hahnemann’s verdict!
Hahnemann would certainly direct equal scorn towards the occasional homeopaths who do not even believe in homeopathy. To Hahnemann, belief in his doctrine was essential and the use of his remedies as mere placebos would have been insulting, utterly unacceptable and destined to therapeutic failure.
We do know from Hahnemann’s mouth what he thought of those clinicians he himself called “half-homeopaths”. In his view, they were ‘traitors’ who did not even deserve to be called true homeopaths. There can be no question about the fact that he would have judged their practice as a useless and ineffective abomination.
This leaves us with the purist-homeopath. This relatively small group of dogmatists turns out to be the only one which Hahnemann might have actually approved of. They tend to strictly adhere to (almost) every of the numerous therapeutic instruction he ever put to paper. Like Hahnemann, they believe that homeopathy is the only efficacious medicine and, like Hahnemann, they use it as a true alternative to ‘allopathy’, the derogatory term Hahnemann coined for conventional medicine.
If this analysis is correct, we are today faced with the situation where homeopathy is used by many people worldwide but, according to the teachings of homeopathy’s founder, it is currently badly misused – so much so that, according to Hahnemann’s most clearly and repeatedly expressed views, it cannot possibly result in clinical benefit. Considering that most of today’s homeopaths would insist that the words of Hahnemann as pure gospel, this situation is most bizarre and ironic indeed. It becomes even more ironic when we realise that the only group of clinicians who employ homeopathy in the ‘correct’ way is also the one which is the most serious danger to public health.
As mentioned several times on this blog, homeopathy lacks a solid evidence base (to put it mildly). There are powerful organisations which attempt to mislead the public about this fact, but most homeopathy-fans know this only too well, in my opinion. Some try to bypass this vexing fact by trying to convince us that homeopathy is value for money, never mind the hard science of experimental proof of its principles or the complexity of the clinical data. They might feel that politicans would take notice, if homeopathy would be appreciated as a cheap form of health care. In this context, it is worth mentioning that researchers from Sheffield have just published a systematic review of economic evaluations of homeopathy
They included 14 published assessments in their review. Eight studies found cost savings associated with the use of homeopathy. Four investigations suggested that improvements in homeopathy patients were at least as good as in control group patients, at comparable costs. Two studies found improvements similar to conventional treatment, but at higher costs. The researchers also noted that studies were highly heterogeneous and had numerous methodological weaknesses.
The authors concluded that “although the identified evidence of the costs and potential benefits of homeopathy seemed promising, studies were highly heterogeneous and had several methodological weaknesses. It is therefore not possible to draw firm conclusions based on existing economic evaluations of homeopathy“.
Thre are, of course, several types of economic evaluations of medical interventions; the most basic of these simply compares the cost of one medication with those of another. In such an analysis, homeopathy would normally win against conventional tratment, as homeopathic remedies are generally inexpensive. If one adds the treatment time into the equation, things become a little more complex; homeopathic consultations tend to be considerably longer that conventional ones, and if the homeopaths’ time is costed at the same rate as the time of conventional doctors, it is uncertain whether homeopathy would still be cheaper.
Much more relevant, in my view, are cost-effective analyses which compare the relative costs and outcomes of two or more treatments. The results of such evaluations are often expressed in terms of a ratio where the denominator is a gain in health from a treatment and the numerator is the cost associated with the health gain. The most common measure used to express this is the QUALY.
Any cost-effective analysis can only produce meaningfully positive results, if the treatment in question supported by sound evidence for effectivenes. A treatment that is not demonstrably effective cannot be cost-effective! And this is where the principal problem with any cost-effectiveness analysis of homeopathy lies. Homeopathic remedies are placebos and thus can be neither effective nor cost-effective. Arguments to the contrary are in my view fallacious.
The authors of the new article say they have identified evidence of the potential benefits of homeopathy. How can this be? They based this conclusion only on the 14 studies included in their review. But this is only about 5% of the total available data. Reliable estimates of effectiveness should be based on the totality of the available evidence and not on a selection thereof.
I therefore think it is wise to focus on the part of the authors’ conclusion that does make sense: ” It is… not possible to draw firm conclusions based on existing economic evaluations of homeopathy“. In plain English: economic evaluations of homeopathy fail to show that it is value for money.
During the last decade, Professor Claudia Witt and co-workers from the Charite in Berlin have published more studies of homeopathy than any other research group. Much of their conclusions are over-optimistic and worringly uncritical, in my view. Their latest article is on homeopathy as a treatment of eczema. As it happens, I have recently published a systematic review of this subject; it concluded that “the evidence from controlled clinical trials… fails to show that homeopathy is an efficacious treatment for eczema“. The question therefore arises whether the latest publication of the Berlin team changes my conclusion in any way.
Their new article describes a prospective multi-centre study which included 135 children with mild to moderate atopic eczema. The parents of the kids enrolled in this trial were able to choose either homeopathic or conventional doctors for their children who treated them as they saw fit. The article gives only scant details about the actual treatments administered. The main outcome of the study was a validated symptom score at 36 months. Further endpoints included quality of life, conventional medicine consumption, safety and disease related costs at six, 12 and 36 months.
The results showed no significant differences between the groups at 36 months. However, the children treated conventionally seemed to improve quicker than those in the homeopathy group. The total costs were about twice higher in the homoeopathic compared to the conventional group. The authors conclude as follows: “Taking patient preferences into account, while being unable to rule out residual confounding, in this long-term observational study, the effects of homoeopathic treatment were not superior to conventional treatment for children with mild to moderate atopic eczema, but involved higher costs“.
At least one previous report of this study has been available for some time and had thus been included in my systematic review. It is therefore unlikely that this new analysis might change my conclusion, particularly as the trial by Witt et al has many flaws. Here are just some of the most obvious ones:
Patients were selected according to parents’ preferences.
This means expectations could have played an important role.
It also means that the groups were not comparable in various, potentially important prognostic variables.
Even though much of the article reads as though the homeopaths exclusively employed homeopathic remedies, the truth is that both groups received similar amounts of conventional care and treatments. In other words, the study followed a ‘A+B versus B’ design (here is the sentence that best gives the game away “At 36 months the frequency of daily basic skin care was… comparable in both groups, as was the number of different medications (including corticosteroids and antihistamines)…”). I have previously stated that this type of study-design can never produce a negative result because A+B is always more than B.
Yet, at first glance, this new study seems to prove my thesis wrong: even though the parents chose their preferred options, and even though all patients were treated conventionally, the addition of homeopathy to conventional care failed to produce a better clinical outcome. On the contrary, the homeopathically treated kids had to wait longer for their symptoms to ease. The only significant difference was that the addition of homeopathy to conventional eczema treatments was much more expensive than conventional therapy alone (this finding is less than remarkable: even the most useless additional intervention costs money).
So, is my theory about ‘A+B versusB’ study-designs wrong? I don’t think so. If B equals zero, one would expect exactly the finding Witt et al produced: A+0=A. In turn, this is not a compliment for the homeopaths of this study: they seem to have been incapable of even generating a placebo-response. And this might indicate that homeopathy was not even usefull as a means to generate a placebo-response. Whatever interpretation one adopts, this study tells us very little of value (as children often grow out of eczema, we cannot even be sure whether the results are not simply a reflection of the natural history of the disease); in my view, it merely demonstrates that weak study designs can only create weak findings which, in this particular case, are next to useless.
The study was sponsored by the Robert Bosch Stiftung, an organisation which claims to be dedicated to excellence in research and which has, in the past, spent millions on researching homeopathy. It seems doubtful that trials of this caliber can live up to any claim of excellence. In any case, the new analysis is certainly no reason to change the conclusion of my systematic review.
To their credit, Witt et al are well aware of the many weaknesses of their study. Perhaps in an attempt to make them appear less glaring, they stress that “the aim of this study was to reflect the real world situation“.Usually I do not accept the argument that pragmatic trials cannot be rigorous – but I think Witt et al do have a point here: the real word tells us that homeopathic remedies are pure placebos!
Rigorous studies of homeopathy are a bit like gold dust; they are so rare that we see perhaps only one or two per year. It is therefore good news that very recently one such trial has been published.
This randomized, placebo-controlled study tested the efficacy of a complex homeopathic medicine, Cocculine, for chemotherapy-induced nausea and vomiting (CINV) in non-metastatic breast cancer patients treated by standard chemotherapy regimens.
Chemotherapy-naive patients with non-metastatic breast cancer scheduled to receive 6 cycles of chemotherapy were randomized to receive standard anti-emetic treatment plus either the complex homeopathic remedy or the matching placebo. The primary endpoint was nausea score measured after the 1st chemotherapy course.
In total, 431 patients were randomized: 214 to Cocculine (C) and 217 to placebo (P). Patient characteristics were well-balanced between the 2 arms. Overall, compliance to study treatments was excellent and similar between the 2 arms. A total of 205 patients (50.9%; 103 patients in the placebo and 102 in the homeopathy arms) had nausea scores > 6 indicative of no impact of nausea on quality of life during the 1st chemotherapy course. There was no difference between the 2 arms when primary endpoint analysis was performed by chemotherapy stratum; or in the subgroup of patients with susceptibility to nausea and vomiting before inclusion. In addition, nausea, vomiting and global emesis scores were not statistically different at any time between the two study arms.
The authors’ conclusions could not be clearer: “This double-blinded, placebo-controlled, randomised Phase III study showed that adding a complex homeopathic medicine (Cocculine) to standard anti-emetic prophylaxis does not improve the control of CINV in early breast cancer patients.”
COCCULINE is manufactured by Boiron and contains Cocculus indicus 4CH, Strychnos nux vomica 4CH, Nicotiana tabacum 4CH, Petroleum rectificatum 4CH aa 0,375 mg. Boiron informs us that “this homeopathic preparation is indicated in sickness during travelling (kinetosis). Preventive dosage is 2 tablets 3 times a day one day before departure and on the day of journey. Treatment dosage is 2 tablets every hour. The interval is prolonged in dependence on improvement. Dosage in children is the same as in adults. The tablets are left to dissolve in mouth or in a small amount of water.”
Homeopaths might argue that this trail did not follow the rules of classical homeopathy where treatments need to be individualised. This may be true but, in this case, they should campaign for all OTC homeopathy to be banned. As they do not do that, I suggest they live with yet another rigorous clinical trial demonstrating that homeopathic remedies are pure placebos.