MD, PhD, FMedSci, FSB, FRCP, FRCPEd

influenza

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.

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.

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