MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Boiron

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.

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.

Since homeopathy was invented by Samuel Hahnemann about 200 years ago, a steadily growing group of critics have raised their voices more and more loudly. Usually they come from doctors or scientists and only rarely from the legal profession.

Yet, there are exceptions: an Australian barrister and professor of law has published an analysis of “a series of criminal, civil, disciplinary and coronial decisions from difference countries in relation to homeopathic medicine where outcomes have been tragic”. He concludes that “there is an urgent need for reflection and response within the health sector generally, consumer protection authorities, and legal policy-makers about the steps that should be taken to provide community protection from dangerous homeopathic practice”.

He also questions whether homeopathy can ever be registered alongside other health care professionals:

“Until such time as homoeopathy can scientifically justify its fundamental tenets,… it cannot be said that its claims for therapeutic efficacy can be justifiable. This leaves the profession not just exposed to criticisms,… but potentially open to consumer protection actions directed toward whether its representations are false, misleading and deceptive, to civil litigation when its promises have not been fulfilled, and especially when persons have died, and to criminal actions in respect of the financial advantage that is obtained by its practitioners from their representations.

The distressing cases referred to here which led to avoidable deaths and the multiple accusations leveled against homoeopathy require of the profession at least a formal repudiation of the practitioners concerned… In addition, they demand an unequivocal response that homoeopathy will discipline its own in a robust and open way. If the profession is to acquire any scientific credibility, which is difficult to conceive of, the deaths to which homoeopathy has contributed…also require that homoeopathy actively generate a defensible research basis that justifies its claims to efficacy of outcome for its patients. It is only then that the claims of the medical establishment that homoeopathy is a dangerous and too often a lethal form of quackery will be able to be contested rationally. In the meantime, it is timely to consider further the status that homoeopathy has within the general and health care communities and whether that status can be scientifically, ethically or legally justified”.

I believe this legal view to be highly significant. The persistent criticism from skeptics, concerned scientists and doctors has rarely been translated into decisions about health care provision. Homeopaths tended to respond to our criticism by producing anecdotes, unconvincing or cherry-picked data or by producing outright lies, for instance in relation to the “Swiss government’s report” on homeopathy.

In this context, it is worth noting that, in some countries, homeopaths who have no medical qualifications have been accused to practice medicine without a licence. The case of Dana Ullman in the US is probably the most spectecular such incident; this is how one pro-homeopathy site describes it:

Dana is perhaps the person who has done the most for homeopathy since his court case in that he pursues the evangelism of homeopathy through the NCH and his mail order company… He prescribed homeopathic medicine and was arrested for practicing medicine without a license. But he won an important settlement in 1977 in the Oakland Municipal Court in which the court allowed his practice under two stipulations:

  1. that he did not diagnose or treat disease and that he refers to medical doctors for the diagnosis and treatment of disease;
  2. that he makes contracts with his patients that clearly define his role as a non-medical homeopathic practitioner and the patient’s role in seeking his care.

But such cases are not the only occasions for lawyers to look at homeopathy. Recently there has been a class action against the Boiron, the world’s largest manufacturer of homeopathic preparations. It was alleged that Boiron made bogus claims for one of its remedies, and there was a settlement worth millions of dollars. Similar cases  are likely to follow, e.g.:

  • Nelsons Homeopathy (Rescue Remedy, Bach Original Flower Remedies, Pure & Clear, Arnileve, H+Care)
  • CVS Homeopathic Products (Flu Relief, Cold Relief, Cold Remedy, Ear Pain Relief)
  • Nature’s Innovation (Naturasil Skin Tags, Bed Bug Patrol, Naturasil Scabies)
  • Boericke & Tafel Cold/Flu
  • Homeolab USA (Kids Relief Cough & Cold)

In June 2003, a British High Court Judge ordered two mothers to ensure that their daughters are appropriately vaccinated. The ruling concerned two separate cases brought by fathers who wanted their daughters immunized despite opposition by the girls’ unwed mothers

The fact that, in the UK and other countries, homeopathic placebos are still being sold as “vaccines” for the prevention of serious, life-threatening infections is, in my view nothing short of a scandal. The fact that a leading figure at Ainsworth actively misleads the public about these products is an outrage. It is high time therefore that the legal profession looks seriously at the full range of issues related to homeopathy with a view of stopping the dangerous nonsense.

Boiron, the world’s largest manufacturer of homeopathic products, has recently been in the headlines more often and less favourably than their PR-team may have hoped for. Now they have added to this attention by publishing a large and seemingly impressive multi-national study of homeopathy.

Its objective was “to evaluate the effectiveness of homeopathic medicine for the prevention and treatment of migraine in children”. For this purpose, the researchers recruited 59 homeopaths from 12 countries who included into the study a total of 168 children with “definite or probable” migraine. The homeopaths had complete freedom to individualise their treatments according to the distinct characteristics of their patients.

The primary study-endpoints were the frequency, severity and duration of migraine attacks during 3 months of homeopathic treatment compared to the 3 months prior to that period. The secondary outcome measure was the amount of days off school. The results are fairly clear-cut and demonstrated that all of these variables improved in the period of homeopathic care.

This study is remarkable but possibly not in the way Boiron intended it to be. The first thing to notice is that each homeopath in this study barely treated 3 patients. I wonder why anyone would go to the trouble of setting up a multi-national trial with dozens of homeopaths from around the globe when, in the end, the total sample size is not higher than that achievable in one single well-organised, one-centre study. A multitude of countries, cultures and homeopaths is only an asset for a study, if justified through the recruitment of a large patient sample; otherwise, it is just an unwelcome source for confounding and bias.

But the main concern I have with this study lies elsewhere. Its stated objective was “…to evaluate the effectiveness of homeopathic medicines…” This aim cannot possibly be tackled with a study of this nature. As it stands, this study merely investigated what happens in 3 months while children receive 3 months of homeopathic care. The observed findings are not necessarily due to the homeopathic medicines; they might be due to the passage of time, the tender loving care received by their homeopaths, the expectation of the homeopaths and/or the parents, a regression towards the mean, the natural history of the (in some cases only “probable”) migraine, any concomitant treatments administered during the 3 months, a change in life-style, a placebo-effect, a Hawthorne-effect, or the many other factors that I have not thought of.

To put the result of the Boiron-researchers into the right context, we should perhaps remember that even the most outspoken promoters of homeopathy on the planet concluded from an evaluation of the evidence that homeopathy is ineffective as a treatment of migraine. Therefore it seems surprising to publish the opposite result on the basis of such flimsy evidence made to look impressive by its multi-national nature.

I have been accused of going out of my way to comment on bogus evidence in the realm of homeopathy. If this claim were true, I would not be able to do much else. Debunking flawed homeopathy studies is not what I aim for or spend my time on. Yet this study, I thought, does deserve a brief comment.

Why? Because it has exemplary flaws, because it reflects on homeopathy as a  whole as well as on the journal it was published in (the top publication in this field), because it is Boiron-authored, because it produced an obviously misleading result, because it could lead many migraine-sufferers up the garden path and – let’s be honest – because Dan Ullman will start foaming from the mouth again, thus proving to the world that homeopathy is ineffective against acute anger and anguish.

Joking apart, the Boiron-authors conclude that “the results of this study demonstrate the interest of homeopathic medicines for this prevention and treatment of migraine attacks in children”. This is an utterly bizarre statement, as it does not follow from the study’s data at all.

But 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).

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