MD, PhD, FMedSci, FSB, FRCP, FRCPEd

Boiron is the world’s biggest producer of homeopathic remedies. It also is a firm that is relatively active in research into homeopathy. Here is one of their investigations which I find most remarkable.

This study was designed to describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines for influenza-like illness (ILI) or ear nose and throat ENT disorders by pharmacists in France and to investigate the effectiveness of these treatments.

The introduction of the article includes interesting information; it informs us that, although homeopathy is more popular in Europe than in the Unites States, sales of homeopathic medicines in the United States grew by more than 1,000% in the late 1970s and early 1980s and continue to grow. In parallel, the number of physicians specializing in homeopathy doubled between 1980 and 1982. In 2003, sales of homeopathic medicines in the United States were estimated to be between $300 and $450 million, with an average growth rate of approximately 8% per year. Homeopathic drugs are among the top 10 nonprescription products sold in the category of analgesics to treat coughs, colds, and flu. The sale of homeopathic medicines in the United States is controlled by the Food, Drug, and Cosmetic Act and regulations issued by the U.S Food and Drug Administration (FDA). Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines. FDA regulations for the sale of homeopathic medicines in the United States state that they can only be sold without prescription if they are for self-limiting conditions such as the common cold…

Am I mistaken, or does that paragraph read a bit like a text written by the marketing team of Boiron wanting to establish their products in the US?

Anyway, the methodology and results of the study are described in the abstract as follows:

A prospective, observational, multicenter study was carried out in randomly selected pharmacies across the 8 IDREM medical regions of France. Pharmacies that agreed to participate recruited male or female patients who responded to the following inclusion criteria: age ≥ 12 years presenting with the first symptoms of an ILI or ENT disorder that were 
present for less than 36 hours prior to the pharmacy visit. All medicines recorded in the study were recommended by the pharmacists. The following data were recorded at inclusion and after 3 days of treatment: the intensity of 13 symptoms, global symptom score, and disease impact on daily activities and sleep. Two groups of patients were compared: those recommended allopathic medicine only (AT group) and those recommended homeopathic medicine with or without allopathic medicine (HAT group). The number and severity of symptoms, change in global symptom score, and disease impact on daily activities and sleep were compared in the 2 treatment groups after 3 days of treatment. Independent predictors of recommendations for homeopathic medicine were identified by multi-
factorial logistic regression analysis.

A total of 242 pharmacies out of 4,809 (5.0%) contacted agreed to participate in the study, and 133 (2.8%) included at least 1 patient; 573 patients were analyzed (mean age: 42.5 ± 16.2 years; 61.9% female). Of these, 428 received allopathic medicines only (74.7%; AT group), and 145 (25.3%) received homeopathic medicines (HAT group) alone (9/145, 1.6%) or associated with allopathy (136/145, 23.7%). At inclusion, HAT patients were significantly younger (39.6 ± 14.8 vs. 43.4 ± 16.1 years; P  less than  0.05), had a higher mean number of symptoms (5.2 ± 2.5 vs. 4.4 ± 2.5; P  less than  0.01), and more severe symptoms (mean global symptom score: 24.3 ± 5.5 vs. 22.3 ± 5.8; P = 0.0019) than AT patients. After 3 days, the improvement in symptoms and disease impact on daily activities and sleep was comparable in both groups of patients.

From these findings, the authors draw the following conclusions: Patients recommended homeopathic medicine by pharmacists were younger and had more severe symptoms than those recommended allopathic medicine. After 3 days of treatment, clinical improvement was comparable in both treatment groups. Pharmacists have an important role to play in the effective management of ILI and ENT disorders.

And, to make perfectly clear what all this is about, the first sentence of the ‘discussion’ puts it to the point by stating that homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders.

Oh really?

As I have heard it said that Boiron seems to have the nasty habit of threatening their critics with legal action, I ought to be quite cautious in my assessment of this ‘masterpiece of promotion’. Yet a few comments must surely be permitted.

‘To describe the sociodemographic and clinical characteristics of patients recommended allopathic and/or homeopathic medicines’ is not what I personally find an interesting subject of research, nor is it anything that will affect health care meaningfully, I think. Yet ‘to investigate the effectiveness of these treatments’ is certainly interesting and important. I will therefore focus on this second aim of the study.

Hold on, was this really a ‘study’? On closer inspection, it seemed much more like a survey. People who felt that they were suffering from ILI and ENT disorders and thus went to a pharmacy to buy something for their problem were offered either homeopathic or conventional medicines. Those who accepted either of the recommendations were asked to fill out some self-assessment forms and received a phone call three days later to check their symptoms. 94% of all patients in the homeopathy group took homeopathic medicine in combination with ‘allopathic’ medicine (it is interesting, perhaps even telling, that this term used by the authors was invented by Hahnemann as an insult to conventional medicine!). There was no examination by a doctor to verify what condition the survey-participants were truly suffering from, and there was no verification that the information provided during the follow-up telephone call was in any way real. The most frequently recommended homeopathic medicine was Anas barbariae 200C (Oscillococcinum) which is Boiron’s famous homeopathically diluted (about one molecule per universe, I guess) duck-liver heavily promoted in France against colds and similar conditions.

As it turns out, those survey-participants who accepted the homeopathic recommendation were significantly younger than those who accepted the recommendation for a conventional treatment (many surveys confirm that younger people are more prone to trying alternative medicine than older ones). It stands to reason, that the younger (and therefore fitter) patients were in better general health and therefore might recover quicker than the older ones. But, in fact, they did not!

Could this be due to the homeopathic remedies actually delaying recovery? Of course not! Who would be silly enough to claim that homeopathy could have this (or any other) effect? According to the authors, it is due to the fact that this group ‘had more severe symptoms than those recommended allopathic medicine’. But, as I said, we have to take their word for it; there is no independent verification of this. It would, of course, be quite ridiculous to postulate that those survey-participants accepting homeopathy were also a little more introspective or concerned about their own health (perhaps even more gullible) and thus claimed more severe symptoms!

And what about the authors’ conclusion that clinical improvement was comparable in both treatment groups? Well, this is more than a little problematic, in my view: first, we have no independent verification of the ‘improvement’ in either group. Second, we don’t know that the conventional treatments actually worked, and it could well be that both approaches were similarly ineffective, and that the observed outcomes are merely a reflection of the natural history of the condition. And third, one might expect the homeopathic (younger) group to do not similarly well but slightly better, simply because the natural history of the illness would tend to be more benign in younger people.

Before I finish,I should make a brief comment about the authors’ courageous statement that  homeopathic medicine, with or without allopathic medicine, appears to be effective at alleviating the symptoms of ILI or ENT disorders. I think, for the reasons I already provided, this is extremely doubtful. In my view, more critical scientists would have phrased the conclusions differently:

THIS SURVEY SHOWS THAT EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.

But perhaps this would be asking a little too much of the authors; after all, at the end of the article, we find this telling footnote: Laboratoires Boiron provided financial support for the study. Cognet-Dementhon, Thevenard, Duru, and Allaert received consulting fees from Laboratoires Boiron for this study. Danno and Bordet are employees of Laboratoires Boiron.

5 Responses to Boiron’s masterpiece?

  • “… received a phone call three days later to check their symptoms.” Gosh, with this never-before-acquired level of robust evidence for the efficacy of homeopathy, Boiron now reigns supreme in filing law suits against anyone who tries to discredit it.

    What next: A Boiron Mars rover to find evidence for homeopathy having been used on other planets within our Solar System? At the rate homeopathy is accumulating wealth, such a mission is easily affordable — and much more fun than undertaking the proper research, which would clearly demonstrate homeopathy to be less than or equal to placebo.

  • > about one molecule per universe, I guess

    Very far from the mark. Very very far.

    Okay, first, we do not know what a ‘duck-liver-molecule’ looks like and what molecular weight might be associated with it. But even if it was as low as a single atom of hydrogen, the maximum dilution you can get in this universe is D80/C40 since we have ‘only’ 1.0E80 protons and neutrons (the carriers of mass) in our universe as it is currently visible to us, something like 40 billions of lightyears in diameter.

    Use some magic and let each proton and each neutron in our universe grow and each and every one builds a new universe as our own. The total amount of protons and neutrons will be up to 1.0E160, so in this setting we can have D160/C80.

    Repeat the magic with all the protons and neutrons you have now – this leads us to D320/C160. We are then short to dissolve one proton amongst all the other protons by just a factor that equals the number of protons and neutrons in our universe.

    Like this arithmetics?

    The other day I heard a presentation where they were using C1000 Lac equinum….

  • Boiron says: “Homeopathic medicines in the United States are subject to well-controlled regulatory processes that closely resemble those used for allopathic medicines.”

    Not true. The extent of regulation of homeopathic remedies was an issue before a U.S. (federal) district court recently in a suit against Boiron for fraud. The judge ruled:

    “Unlike non-homeopathic OTC [over the counter, that is, drugs sold without a prescription] drugs, homeopathic OTC drugs . . . are not evaluated by the FDA at all. . . . Although the HPUS [Homeopathic Pharmacopoeia of the United States] describes how these ingredients [in homeopathic products] are prepared for homeopathic use, it does not list the drugs as fit to treat specific symptoms, ailments, or conditions. Instead, the HPUS allows the practitioner or manufacturer to set forth the substance’s indications for use.”

    And:

    “The Court is unaware of what standards, if any, exists to ensure that homeopathic OTC drugs are safe and effective. The FDA does not impose additional standards for strength, purity, quality, safety, or efficacy on homeopathic OTC remedies, Indeed, the FDA has advised that unless a homeopathic remedy is ‘being offered for use (or promoted) significantly beyond recognized or customary practice,’ federal policies on health fraud do not apply. And perhaps most significant, ‘[a] product’s compliance with requirements of the HPUS . . . does not establish that it has been shown by appropriate means to be safe, effective, and not misbranded for its intended use.”

    Finally:

    “As evidenced by the FDA guidance documents . . . the Court concludes that the FDA has largely abdicated any role it might have had in creating standards for homeopathic OTC drugs, and has instead attempted to delegate this authority to the non-governmental organization that determines whether homeopathic substances should be included in the HPUS. In addition, the FDA explicitly states that it makes no guarantee about the safety or efficacy of homeopathic OTC drugs even if they meet the unknown standards for inclusion in the HPUS.”

    The Court also remarked that it could find “no record of any [FDA] investigation of homeopathic remedies due to a reported lack of efficacy.”

    The “non-governmental organization” mentioned by the judge is run entirely by homeopaths or those who have a financial interest in companies that sell homeopathic products. Boiron’s statement is actually a quote from an article written by someone with a financial interest in homeopathic products. http://www.sciencebasedmedicine.org/homeopathic-regulation-diluted-until-no-substance-left/

  • Regarding your conclusion

    “EVALUATING THE EFFECTIVENESS OF MEDICAL INTERVENTIONS REQUIRES A MORE RIGOROUS METHODOLOGY THAN THAT OF A SURVEY.”

    I don’y think there is any reason to use any rigorous methodology —- if you believe that it is implausible.

    For any good study – according to the criteria of convectional trials – you can say — it is impossible ——the positive results might be due to ….chance or bias, or other factors.

    And you are done.

  • Boiron might be a bit leery of doing proper RCTs again, because – strange as it may seem – they have done at least one in the past. Or, at least, one which had a Boiron director on the team. No prizes for guessing what the conclusion was!
    Must see if I can find it again.

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