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Warning to Traumeel Users Visiting the Netherlands

Traumeel is sold as a homeopathic product for the relief of muscular pain, bruising and specially promoted for sport injuries. Following a discussion on kloptdatwel.nl I decided to take a closer look at this, because it seems that in the Netherlands Traumeel is different than in the rest of the world. Probably that’s why it is sold under a (marginally) different name: Traumeel H instead of Traumeel S (could be ‘H’ for Holland and ‘S’ for Standard, I guess). But what could be the reason that customers in the Netherlands are offered a different product?

Arnica Montana, one of the main ingredients in Traumeel (image Wikimedia Commons)

When I first looked at the composition I thought ‘this is no real homeopathy‘ because the potencies are quite low. So low that you can actually still find molecules of the original stuff in it. The controversy around homeopathy usually focuses on the ultra diluted products in which you can find no trace of the mother tincture they started with.
But then I was told that  (EU regulations, probably) you can call any product homeopathic if it is derived via potentization from a mother tincture prepared according to homeopathic rules. The law doesn’t demand it has to be diluted until at least D12, or something like that. And it can even be a mixture of such diluted products.

So Traumeel actually contains a tiny bit of the ingredients listed, but that doesn’t mean that it works, of course. Convincing evidence for that doesn’t exist according to a Science Based Pharmacy blog post:

Clinical Trials

Heel makes a number of claims (pdf) about Traumeel, but none are backed up by persuasive evidence. Mostly they compare Traumeel to anti-inflammatory drugs like ASA and ibuprofen, claiming that Traumeel is faster, more effective, and has no side effects.

Unfortunately, there are no well-designed, double-blind, peer reviewed, head-to-head trials that have established this. This is unfortunate, because there’s no information to support the included dosages, nor to suggest that any of these ingredients would even be absorbed into the skin. However, the relatively vague claims that Traumeel is “well-tolerated” and has “almost no side effects” are very plausible, given there isn’t enough of any ingredient to have any medicinal effects.

[NB the original link to the claims (pdf) doesn’t work, I think it’s the document which can be found here].

A 2011 article in the International Journal of General Medicine is more positive on Traumeel, but that one is sponsored by the manufacturer thus should be read with some care. But as even that article doesn’t mention any research which compares Traumeel tablets alone with conventional treatment,  we can safely assume that there is no good evidence that the tablets actually work.
An even more detailed review of Traumeel and other homeopathic or herbal arnica creams can be found on saveyourself.ca: ‘Does Traumeel work?‘ Conclusion from that site:

A few tests of Traumeel and similar products have been mildly encouraging, but mostly old and poor quality one. In all good quality, modern scientific trials so far, they have faired no better than placebo. It is possible that a benefit can still be proven, but it is not likely.

Differences between Traumeel S and Traumeel H

 

Traumeel (S) tablets as sold in the US and Canada

Traumeel H as sold in the Netherlands (therapeutic indications are not longer allowed since July 2012)

The following table gives the ingredients and their potency in Traumeel S and H as listed on www.traumeel.com and www.traumeel.nl:

Ingredient Traumeel S

Traumeel H

Arnica montana D2

15 mg

D4 15 mg
Calendula officinalis D2

15 mg

D4 15 mg
Hamamelis virginiana D2

15 mg

 –  –
Achillea millefolium D3

15 mg

D4 15 mg
Atropa belladonna D4

75 mg

 –  –
Aconitum napellus D3

30 mg

 –  –
Mercurius solubilis Hahnemanni D8

30 mg

D12 30 mg
Hepar sulfuris D8

30 mg

 –  –
Chamomilla recutita D3

24 mg

D4 24 mg
Symphytum officinale D8

24 mg

D8 24 mg
Bellis perennis D2

6 mg

D4 6 mg
Echinacea angustifolia D2

6 mg

 –  –
Echinacea purpurea D2

6 mg

 –  –
Hypericum perforatum D2

3 mg

D4 3 mg

See, the international crowd gets more stuff in their tablets! And less diluted. But it depends on whether you believe anything about homeopathic theories on potencies, if you think this good thing or that the Dutch stuff is just stronger.

Why the differences?

I’m not 100% sure, but it probably has something to do with the recent change in the Dutch regulations concerning homeopathic ‘remedies’. Since July 1st of this year it is not longer permitted to promote a homeopathic product with an indication for the problems it is supposed to solve, if there is no solid scientific evidence presented for such a claim. Moreover, in the law on medicinal products there is an article (article 42 section 3) concerning homeopathic products and whether someone is allowed to market it as homeopathic medicine. It roughly translates as follows:

3.The applicant [for marketing authorization] is not held to provide pre-clinical and clinical data in case the application concerns homeopathic products which satisfy the following conditions:

  1. the product is particularly intended for oral or external use,
  2. neither in or on the packaging, nor in the product leaflet is any mentioning of therapeutic indication, and,
  3. the dillution is such that the product is guaranteed to be harmless and it should in any case not contain more than one part in 10,000 of the mother tincture or less than 1/100th of the smallest dose used in regular medicine.

My guess is that the manufacturer, German company Heel, still likes to sell Traumeel as a homeopathic remedy in the Netherlands (to many people that might sound as a recommendation, strangely enough). The company probably couldn’t present scientific evidence to market it with therapeutic indication, so they changed the composition in order to be in accordance with this particular article. Finding the smallest dose of each subsitance used in regular medicine is a bit troublesome, so they went for the one part in 10,000 of the mother tincture option and dilluted the ingredients to at least potency D4 (which is 1:10,000). Why they left out 6 of the ingredients, I wouldn’t know.

Ethics of Homeopathic Manufacturers

Homeopaths will tell you that one of the main benefits of their trade is that there are no negative side effects of homeopathic remedies. But they also make a lot of fuss about different effects of products in different potencies. So what’s the deal with Traumeel H? Does Heel company think it works the same as Traumeel S?  And what does that mean for the idea of potentization?
Or is it different? And why isn’t that made more obvious by using different packaging and possible warnings for foreign buyers who are expected to buy a product they know from their home country? Marketing two different products and only differentiate those by adding an  ‘S’ or ‘H’ is questionable, if you ask me.

I’ve sent Heel an email asking for some explication on this matter, but I didn’t receive a reply yet.

[Update September 2nd] I finally got a reply from Heel bv., but the main issues are not answered. The reason why Traumeel is different in The Netherlands is indeed because of the legal issues. Those stem from European regulations in 2001 and where implemented in The Netherlands in 2002 and again in 2007. The recent change I mentioned is not a change in the law, more an end to a period in which manufacturers of homeopathic products managed to stall strict implementation of the law by several court cases.
Heel told me that the missing ingredients were left out because there is no indication for their use in the Materia Medica (and so the product could not be called homeopatic with those in the mixture, I guess) and the change of potenziation also was demanded by the law. Heel did not answer however,whether the product according to them is different in its effect, only that both versions are safe. Yeah right, if both don’t do anything, they are both safe to use.

15 thoughts on “Warning to Traumeel Users Visiting the Netherlands

  1. At the strong recommendation of my Osteopath I’m taking Traumeel S to reduce inflammation and pain from a tennis elbow that has now been bugging me for about 4 months. As far as I can tell, taking these Traumeel S tablets does absolutely _nothing whatsoever_. Maybe I don’t know how to judge it, or it’s just hard to tell because the tennis elbow pain comes and goes anyway and is probably affected by what activities my elbow is exposed to, but I just do not get the sense that taking Traumeel S has made any difference whatsoever. Maybe it’s my skepticism of Homeopathic medicine in general that is preventing me from getting the benefits? I think I’m a really open-minded guy, but as far as I can tell this medicine does nothing whatsoever. Not for me, anyway.

    Erik

    1. For medical advice you should seek assistance of medical professionals who practice evidence based medicine, not chiropractors.

  2. I too have used the original formula of Traumeel S and X, and in my opinion there is nothing better for muscle spams, headaches, tmj, arthritis pain,and bruising from falls, etc. My entire family including my children, even when they were young and now my grandson. It’s amazing the results we get, it’s like no other and I like that there is no scent or hot/cold feeling like other ointments. We always kept a couple of tubes at our house and now I can’t find the original formula. I have seen it on ebay but wasn’t sure it was the same. I ordered a tube of the new formula and it is very different and does not work like the original. I’m very disappointed and I don’t think the publisher of this article and/or the ones trying to stop the sale of it have tried it for any real issues, because too many people get immediate results from using it and we find it’s more than a temporary relief, it’s actually healing.

    1. You are so right. I’ve been using the drops for years and it does more than relieve pain, it actually heals the damage already done. The drops have been diluted now and the dosage instructions are still 10 drops each time. I use almost double that dose to get the same relief as before…..still absolutely no side effects. The manufacturer makes more money that way because we need twice as much. I’ve noticed that t-relief is being offered in 2 packs and 4 packs now because people need to buy more of it. But it definitely still works!

      1. If this product was really effective it would be very interesting for the company to register it as medicine. They don’t do that, and that’s probably because they realise very well that the positive results you ascribe to the product will not show up in controlled trials. Why? Most likely because it is just a placebo effect, fine for you if it works for you that way.

  3. I don’t give a darn what they call It!! Or what’s in it! it’s better than opiates and it works !
    Now I’m doing everything in my power to try to find the original Traumeel, it managed to take my headache away in 3 1/2 minutes the T-relieve doesn’t work !
    As for the gentleman wrote the article and everybody who has an opinion about it, (thanks for trying to watch out for us) BUT when you’re really in a lot of pain it really doesn’t matter what everybody else thinks! if the product works for you that’s all that counts !!!
    Right?? I don’t care if it’s a damn placebo, it’s better than heroin .
    Stupid articles like this that end up getting things banned from the US that are basically harmless compared to big Pharma !

    1. I agree. The fact that it actually worked without all the side effects of western medicine pain relief just scared Boig Pharmacy here. They go after natural Dessicated thyroid medicine all the time for the same reason…Traumeel X is the bomb. It is the only thing that worked for me and I have tried them all. My stabbing pain from cervical stenosis always stopped within 30 minutes of using the ointment.

  4. we can’t even buy the original in the u.s. the fda made heel shut down here and the company that bought them has changed the formula and my husband who has arthritic knees finds that this “new improved” formula is no where near as effective as the original. and i can’t find a substitute 🙁

    1. Susan, I bought Traumeel recently on Amazon, from a European supplier. Are you saying that regardless of where you buy it from, the company has changed and the product is not the same as what it was? I purchased Traumeel – S

  5. If a substance, starting with a mother tincture for example, is then prepared by sequential dilution and succussion, even just once or twice, that would be a homeopathic preparation. So technically D2 would count as ‘homeopathic’ because it has been diluted 1:10 once and then the resulting substance again diluted 1:10. So the fact that it is described as ‘D’ something indicates it has been prepared homoeopathically, even though there is still some of the original substance left in the dilution.

    The version sold in the Netherlands seems to use slightly higher potencies than the other one. It may be to do with the toxic nature of the substances, perhaps according to Dutch law they have to be diluted more to render them safer?

    As for the ingredients left out, it sounds like they couldn’t claim a reason for using them for a particular therapeutic effect if it isn’t indicated in the Materia Medica.

    I would have thought that the likelihood of the medicine ‘working’ would be more rather than less, for a homeopathic sceptic, because it would be more akin to a ‘herbal’ remedy or conventional drug where the substance is measurable so I am surprised by your comment.

    There is a lot of confusion between herbal remedies and homeopathic remedies, but generally if the ingredients mentions something with a ‘D’ (or ‘X’ or ‘c’ in other countries) that shows it’s been prepared homoeopathically.

    1. Almost all the issues you raise are answered already in the post itself, which makes me wonder whether you have read it carefully enough
      Concerning the ‘homeopathic skeptic worry’, I myself think that the biggest problem with homeopathic remedies is, that there is no solid evidence that the symptom-remedy associatons are robust, see my critical remarks on the ‘debunk’ by the Science Babe: http://www.pepijnvanerp.nl/2014/10/science-babe-takes-50-homeopathic-sleeping-pills-does-it-debunk-homeopathy/

  6. I don’t know about the current laws here in the Netherlands, but at least a few years ago there were some herbal products sold as “homeopathic” even though they weren’t. E.g. some Alfred Vogel products which had quite reasonable amounts of herbs (no mention of potencies at all) and the same products were sold as non-homeopathic ones outsides of this country…

    1. I think it’s quite clear the manufacturers of homeopathic products only see ‘homeopathic’ as a positive label, which attracts people who still think it’s has something to do with ‘natural’ or ‘non-toxic’ medicine. They’ll change their products to keep that label, whatever it takes, It’s the label they are selling, not a product.

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