MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

migraine

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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