Slipping through the Cracks: Health Canada, Traumeel, and Homeopathy

It’s World Homeopathy Awareness Week. Today’s post is a deeper dive into the world of homeopathic “evidence”. Looking at the science, we’ll highlight the implications of regulators applying two sets of standard to health products: One for medicine, and one for homeopathy. Today’s post is by Kim Hebert, who blogs at Science-Based Therapy, and Scott Gavura, who blogs at Science-Based Pharmacy.

The Traumeel Family

The kindest that can be said about most homeopathic products is that they won’t cause adverse effects. After all, most common “strengths” or “potencies” used in homeopathy are so dilute there’s no possibility of a single molecule of the original substance remaining in the remedy. But what if, instead of diluting a product the typical 30 times, it’s only diluted once or twice? Is it still homeopathy? There’s a very good chance of some molecules of the original substance remaining. That’s the case with today’s case study, Traumeel.

What is Traumeel, and what does it do?

If you haven’t heard of Traumeel, this full-page ad that appeared in the Globe and Mail last month explains:

[click to embiggen]

Traumeel is marketed to treat sports injuries, inflammation, and pain. Conventional treatments, like anti-inflammatories, are effective but can have multiple serious side effects. So any product that’s “safer than anti-inflammatories” and gets “to the source of the pain”, yet is “without side effects”, would be a tremendous medical innovation.

The ointment, gel, tablets, injection, and drop versions of Traumeel all have same labelled use: “For the temporary relief of muscular pain, joint pain, sports injuries and bruising.” and Health Canada (search Natural Health Products Database licenses 80005012, 80005063, 80005218, 80007675, and 80007958) has approved the following statement about Traumeel products:

“Homeopathic preparation used to relieve pain, inflammation and bruising associated with injuries such as sprains, dislocations, contusions; to relieve muscle and joint pain.” 

Are these statements backed up by good science? Let’s start with looking at the ingredient list.

Ingredients and Evidence

When you buy a medicinal product, the active ingredients is disclosed, along with the amount. For example, a 1% ointment is 1 gram of a drug per 100 grams of ointment. Compared to medicine, homeopathic product labels seem not to be designed with consumers in mind. Here’s the listing for Traumeel ointment:

Each 50 g contains: Aconitum napellus 3X (Reduces pain after injury) 0.50 g; Arnica montana, radix 3X (Reduces swelling and bruising) 0.75 g; Belladonna 3X (Reduces swelling and pain) 0.5 g; Bellis perennis 1X (Treats bruising) 0.25 g; Calendula officinalis 1X (Stimulates healing process) 0.75 g; Chamomilla 1X (Soothing pain relief) 0.25 g; Echinacea 1X (Immune support) 0.25 g; Echinacea purpurea 1X (Stimulates healing process) 0.25 g; Hamamelis virginiana 1X (Relieves bruised soreness) 0.75 g; Hepar sulphuris calcareum 8X (Stimulates injury healing) 0.125 g; Hypericum perforatum 6X (Relieves pain) 0.045 g; Mercurius solubilis 8X (Reduces swelling) 0.06 g; Millefolium 1X (Treats minor bleeding) 0.15 g; Symphytum officinale 4X (Relieves joint pain) 0.05 g. Inactive Ingredients: Cetylstearyl alcohol, ethanol, paraffin, purified water, and white petrolatum. 

It baffling, but sounds impressive and technical. Let’s look at one ingredient: Arnica montana. Arnica montana is a plant with the more common name of leopard’s or wolf’s bane. To make homeopathic Arnica montana, the plants are collected, ground up, mixed with alcohol, pressed and filtered. The final liquid is called mother tincture. The mother tincture is then diluted, mixing one unit with nine units of water. The diluted tincture is then shaken or “succussed”. The process is repeated three times in total (i.e., “3X”). So the final product is a 1/1000 dilution of the “mother tincture”. Of that final dilution, 0.75 g of this is used in the ointment. That means the ointment has 0.00075 g of the mother tincture, and the final ointment is 0.0015% Arnica tincture. Not a lot.

Working through the entire ingredient list, we can calculate there is is 4.68 g of diluted tinctures in the 50 g tube. The remaining 45.32 g are the inactive ingredients: alcohol, paraffin, and petroleum jelly. Given the tinctures have all been diluted one to eight times, it’s clear there’s not much “active” ingredient there.

Let’s look at each ingredient more closely and see if there’s any supporting scientific evidence, as either homeopathy or medicine (all evaluations taken from the Natural Medicines Comprehensive Database, an evidence-based compendium):

  • No supportive evidence: Calendula officinalis 1X (garden marigold), Bellis perennis 1X (wild daisy), Hepar sulphuris calcareum 8X (calcium sulfide), Mercurius solubilis 8X (mercury). The purported effects, such as “stimulates the healing process” and “immune support” are too vague to evaluate.
  • No supportive evidence at homeopathic doses: Hamamelis virginiana 1X (witch hazel), Arnica montana radix 3X, Chamomilla 1X (German chamomile), Millefolium 1X (yarrow). Though these ingredients have been researched as natural remedies, there is no evidence to support their use at homeopathic doses.
  • Potentially unsafe: Aconitum napellus 3X (aconite), Belladonna 3X (deadly nightshade), Symphytum officinale 4X (comfrey). These are considered unsafe when taken orally (note: these ingredients are in the pill form of Traumeel); Aconite is also considered unsafe to be used topically.
  • Inappropriate: Echinacea angustifolia 1X, Echinacea purpurea 1X (echinacea), Hypericum perforatum 6X (St. John’s Wort). Echinacea is generally used for coughs and colds and St. John’s Wort is used for depression, so the inclusion of these ingredients is puzzling.
  • Other ingredients: Purified water, Paraffin, White petrolatum, Ethanol, Cetylstearyl alcohol. Traumeel ointment is 13.8% alcohol. Rubbing an alcohol-based ointment into the skin is likely to produce a cooling effect — exactly what you might be looking for if you’ve got a bruise, injury or swelling.

The ingredient list tells us a a lot about the plausibility of Traumeel. There’s no scientific evidence to support the use of any of the key ingredients to treat pain or inflammation and, while there may be a molecule or two of each ingredient left, there won’t be enough to have any meaningful effects by either medicinal or homeopathic principles. But implausible doesn’t mean impossible, so let’s see if there’s any evidence.

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.

Is Traumeel even homeopathy?

Traumeel has a listed range of dilutions between 1X (1/10) and 8X (1/100,000,000). Typical homeopathic remedies are diluted to something nearer to 30C, which is 1/1060, a dilution of 1 in 1,000,000,000,000,000,000,000, 000,000,000,000,000,000,000,000,000,000,000,000,000. Homeopaths believe 30C is a “moderate” potency. But if Traumeel is considered homeopathy at such “weak” dilution, and it’s effective, the major premise of homeopathy is invalidated. Why are 30C dilutions even necessary when something is effective at 1X?

It’s probably more likely that neither dilution is meaningful. The most likely way Arnica could be said to be equally effective at 1/1000 and 1/1060 would be to recognize that they’re both providing placebo effects only. That’s a far more simple and probable explanation for Traumeel, as opposed to rejecting the physical laws of the universe.

Is Traumeel a safe placebo?

Homeopathy is promoted as “safe” because the ingredients are so dilute that they cannot exert a biological effect. Conveniently, dilution gives a substance potent healing properties with no risk of overdose or side-effects. These concepts are antithetical. A medicine cannot have both an extremely potent therapeutic effect and be completely risk-free. It’s a wonderful fantasy, but it’s not chemically possible. And Traumeel illustrates this point.

Alexa Ray Joel (daughter of singer Billy Joel) attempted to overdose on Traumeel tablets. She was hospitalized, but luckily, no overdose was observed. Heel commented on the reports only enough to reiterate that their product is safe and effective. However, doctors say that the reason Traumeel was of little threat was that, contrary to homeopathic claims of potency, Traumeel is far too dilute to cause an overdose with any of its ingredients, even if taken in significant excess. This tragic situation is persuasive evidence against claims of homeopathic potency. Though this story had a happy ending, it illustrated the safety, ethical, and regulatory grey area that Traumeel occupies.

However, Traumeel does contain trace amounts of apparently ineffective, though in some cases potentially dangerous, ingredients. Yet the product avoids having to demonstrate robust clinical efficacy by obtaining the label of homeopathy. This recalls the product Zicam, which was labelled “homeopathic” but contained enough ingredient to cause people to lose their sense of smell. Zicam contained Zincum Gluconicum 1X and Zincum Aceticum 2X — dilutions similar to those seen with Traumeel ingredients. Could a similar situation occur with Traumeel, or another poorly regulated homeopathic product, if someone ingests enough of it?

What’s the bottom line with Traumeel?

While it is possible the diluted ingredients in Traumeel could have drug-like effects, there’s no evidence to suggest any component will have meaningful therapeutic effects, even at much higher amounts. And that’s probably a good thing, because you don’t want to be rubbing mercury into your skin or ingesting nightshade, when all you want to do is treat a sports injury. If there was real interest in evaluating Traumeel’s efficacy, a clinical trial comparing it to placebo and relevant drugs would be straightforward. Unfortunately, no such research exists. And given it’s already been approved by Health Canada with an impressive-sounding recommended use, why would we expect the manufacturer to bother? The homeopathic evidence standard was met, and the product can be sold.

The marketing of Traumeel neatly illustrates a consequence of the regulatory standards for homeopathic products: It’s possible to claim Traumeel has only desired effects and no side-effects. As it’s not immediately obvious that Traumeel is a homeopathic product, few will realize that a different evidence standard was applied. Further, the labelling standard does not clearly communicate to consumers that there are essentially no active ingredients in the products. Nor is the manufacturer required to indicate that homeopathy has not been demonstrated to have any meaningful therapeutic effects. The net result is the veneer of scientific legitimacy.

If the Canadian regulatory system doesn’t properly inform consumers about the content and evidence for homeopathic products like Traumeel, how effective is it? Consumers cannot be expected to make rational decisions about their own health when basic information like ingredients and effectiveness is unavailable. That a product such as Traumeel, with such poor evidence to even justify its ingredients, let alone the claims of efficacy, can have the above statement of efficacy approved by Health Canada is a disgrace and consumers quite literally pay the price.

For More Information

  1. For a homeopathy primer, see Science-Based Medicine’s topic overview.
  2. A Reality Check on Traumeel, from Paul Ingraham at saveyourself.ca

13 Responses to “Slipping through the Cracks: Health Canada, Traumeel, and Homeopathy”

  1. FJ says:

    I am a pharmacist just like you, with a number of postgraduate qualifications and degrees.
    Traumeel works – there is no doubt! The mechanism of action? Nobody knows! Personally I have used it for many years, and given it to my patients (of all ages) for decades – with excellent results. Frankly, I couldn’t care less about the mechanisms of action. It is not important for me.
    Your analysis (reasons) for inclusion of the Traumeel ingredients are mostly not accurate, probably due to an inherent misunderstanding /misconception.
    You tend to compare apples with pears if you bring pharma drugs into the picture – in particular i.r.o. so-called (“[pharmaceutical] clinical trials” (which are not based on any real science in any way, shape or form whatsoever, either). At best, the drug trials are a form of pseudo science which clamour for legitimacy in the same way as homoeopathics and other natural products do. We all know about the flops, falsified data, non-reporting of data, killings, adverse effects, etc., not so?
    Natural medicines do not work in the same way as drugs and the testing protocols are (or should be) very different.
    Too bad Heel and other similar companies are trying to use the concept of “clinical trials” to support their products when it is not really appropriate. I guess they too have to gain legitimacy in the mind of consumers and practitioners.
    But please, do not discard /or pooh-pooh a good product if you have no idea on its mechanism of action or clinical results obtained with it.
    I take it that your attempted Traumeel “expose” is just your opinion – and your opinion alone.
    Thank you.

    • Erik Davis says:

      If clinical trials are not an appropriate means of testing a drug’s safety and efficacy, what do you propose in their stead?

    • Kim Hebert says:

      “Your analysis (reasons) for inclusion of the Traumeel ingredients are mostly not accurate, probably due to an inherent misunderstanding /misconception.”

      Could you please be more specific? What exactly was not accurate? What is our misunderstanding?

      “Natural medicines do not work in the same way as drugs and the testing protocols are (or should be) very different.”

      The question is: Does Traumeel work? If so, its effects can be measured objectively. There’s no logical reason why they can’t. If people report relief, that is a measurable effect. The trick then, is to ensure that this relief is consistently reproducible so that important medical considerations can be sorted out, such as appropriate dose and regimen. Including a placebo group is irrelevant to supposed “natural vs. pharm” effect differences, because RCT study design doesn’t discriminate between mechanisms. Researchers choose an endpoint (i.e., relief of the symptoms that are supposed to be treated) and see if that endpoint occurs significantly more than chance and/or placebo in the treatment group.

      This kind of research is important as a matter of prior plausibility and ethical consideration of patients/clients and cannot be dismissed on the basis of “natural medicine can’t be measured that way”. It absolutely can be. Consider products that are now part of mainstream medicine that were once sold as natural herbs until they were purified and improved to reduce side-effects, the most common example being Willow bark (now Aspirin). There’s no logical reason why one could test Aspirin with an RCT and not Willow bark just because one is “pharm” and the other is “natural” (whatever that means) – they are essentially the same active substance.

  2. FJ says:

    Could you please be more specific? What exactly was not accurate? What is our misunderstanding?
    Homoeopathics work on an energetic level (as far as I know). The hundreds of Materia Medica’s available today (some thousands of years old)will explain in detail what their applications are and how they work. I do not have the time nor the space to go into this in depth on a forum like this. Modern Medicine is barely 100 years old. Compare that against natural knowledge gathered & documented over 5,000 years! I really suggest that you obtain a MM and study it before coming to conclusions that are not sustainable or factually incorrect.
    One should view the MM as a “Handbook of Toxicity” – in other words, the symptoms created by taking an excess of the raw substance are relieved by taking a diluted form of the same substance. This is in essence what it is and how it works. Almost akin to how vaccinations work – “Like cures Like” – very simple.
    The question is: Does Traumeel work?
    Personally I have performed several studies with “results” as endpoint. However, not on Traumeel (since the studies have already been performed), but on Arnica, Chamomilla and Hypericum – all against a placebo. They worked great and relieved the targeted symptoms significantly. Traumeel works, as I said before!
    Having said all this, the Placebo Effect is alive and well in Naturals as well as in drugs.
    The Placebo Effect is also the downfall of so-called “Evidence Based Medicine”. E.g., if a substance relieves the symptoms by a factor of 10, and a placebo relieves the same symptoms to a factor of 6, then the substance has en effect of only 4 (10-6)- not so? I can quote many studies (medical and otherwise) that support this notion, just as you can probably quote many studies that say the opposite. It depends on what you want to believe and who’s “Summary [of a Study]” fits in with your own paradigm.
    E.g., naproxyn relieves the pain in your knee (say), no doubt. The side-effects of naproxyn are numerous (as you know). These socalled “side effects” are in fact “Real Effects” and should be considered as such. The only reason why a person did not develop GI ulceration from the naproxyn previously, is simply that he /she was not susceptible to ulceration at that point. Now when you add a second drug to the regimen which has GI ulceration (say) as one adverse effect, the pt becomes more susceptible to ulceration, until later on the pt may develop ulceration as a second “disease” (iatrogenic) (resulting in a cumulative effect of side effects) for which a third drug is prescribed, and so on. The same is true of herbs and other raw substances. They are not safe if used indiscriminately – regardless of their purity. Impurities of course complicate matters infinitely and the natural community should applaud health authorities to insist on, inter alia, purity standards. Drugs don’t heal – they never have and they never will. If they did heal, how come we have all these repeat prescripotions that go on ad infinitum. Experience taught me that drugs (over-medication) keep you sick and gives the body no chance to recover spontaneously by utilizing its own repair mechanisms (suppressed by the drugs consumed).
    Homoeopathics on the other hand target a specific condition, designed for a specific person with an individual set of symptomatology. Therefore, (as you stated) the end result is what counts and must be measured. Therefore a Clinical Trial, as is used in drugs, is not appropriate! Side effects with homoeopathics are rare.
    The end result in Clinical Trials (almost without exception) are often “cooked”, falsified, incorrectly and /or incompletely reported. What is more disturbing is that (partly due to the statistical inferences that are drawn from the data), researchers often ignore free observations which may be recorded but not included in the statistical data – akin to a recent anti-inflammatory trial disaster. I have first hand experience of this practice.
    Bias in Clinical Trials (of any kind) is a real danger. The “Ideal Clinical Trial” has not been devised yet, and much is to be done in this area.
    However, as “Clinical Trial Practice” stands today, one can only conclude that it is a sham, and only serves as a shield to hide behind to provide legitimacy to pseudo science.
    Thank you.

    • Kim Hebert says:

      “Homoeopathics work on an energetic level (as far as I know).” That’s not specific. That’s vague and undefined. Nevertheless, something working on an “energetic level” can still be measured if the endpoint is patient improvement. So your argument that science can’t measure natural therapies is irrelevant.

      Furthermore, science (such as conducting an RCT) is a tool, not an entity. There is no president of science, only method. The best tool we have is objective observation with appropriate controls. If not science, then what is the objective way to ensure that your endpoints (patient improvement) are real?

      I will not bother to address the many straw men in your response, nor will I respond at all until you answer the very reasonable questions Erik and I posted in our replies. Without this information, we cannot proceed.

  3. FJ says:

    I will not bother to address the many straw men in your response!

    Fine, I did not expect you to respond. Your arguments don’t even remotely take into account the facts I have set forth.
    I hereby withdraw from your rather (incomprehensible) and irrelevant arguments.

    So your argument that science can’t measure natural therapies is irrelevant.

    I never said that! Read the reply once again and perhaps you will see things differently.
    Forget that I ever tried to participate. I have wasted my time – my loss!!
    Thank you.

  4. melanie says:

    My medical doctor who specializes in back pain has recommended this to me. This is the only natural product he’d recommend. This is the only product my physiotherapist carries. I have seen this carried at most massage therapists or physical therapists I’ve gone to for my back problems. The doctor who recommended it was reticent to recommend any natural products other than this one because of the lack of peer reviewed scientific studies; he recommended this based on his observations of it’s efficacy in his patients. I do recall a recent study that showed that arnica cause significant improvements in people with back pain, with arnica being the key active ingredient in this formulation. I am a scientist and I think it’s as important to keep an open mind about products that are not backed by large pharmaceutical companies and look at therapeutic results from patients using the product (treated by physiotherapists and massage therapists). Let’s face it alot of the naturopathic companies do not necessarily have the scientific staff or funds to carry out a scientific study that the larger pharmaceutical companies can afford. I am sure based on it’s usuage and popularity that a larger pharmaceutical company will come out with a similar version shortly. Remember as a scientist you should keep an open mind, evaluate things yourself and talk to professionals using this product.

    • Kim Hebert says:

      Even health practitioners can be fooled by marketing, especially as many do not have time (or don’t make the time) to keep up with research.

      As for the study, could you please link to it? I can’t properly evaluate it otherwise… In any case, one study on arnica doesn’t support the use of homeopathic arnica – these are two different things. Traumeel is a homeopathic preparation.

      “Let’s face it alot of the naturopathic companies do not necessarily have the scientific staff or funds to carry out a scientific study that the larger pharmaceutical companies can afford.”

      So we should just let them get by with substandard evidence for products being sold on the same shelves as scientifically-supported medicines? No thanks. Also that’s not true, there are many RCTs of naturopathic medicines. In any case, Traumeel is not naturopathic, even though it may be prescribed by naturopaths. It is homeopathic.

      “Remember as a scientist you should keep an open mind, evaluate things yourself and talk to professionals using this product.”

      That is exactly what we did. Scott and I are health professionals. We choose not to recommend this product because the evidence doesn’t support it. So, why do you assume we don’t have an open mind just because we don’t think that a particular product, based on the evidence we carefully considered, works? It is possible to be completely open-minded and still conclude that something doesn’t work.

  5. Tirtho says:

    Kim Hebert, I have used traumeel for the last 5 years to help with back pain,

    You are obviously employed by (a) pharmaceutical company,

    Please dont listen to these people and try the product for yourself if you need proof of its effectiveness.

    Regarding all these comments about science, let me indulge you guys on some facts about the human brain and repairing it which we will not be able to do for some 30 years.

    The human brain takes up 10 ^ 25 bits to store the molecular structure of the brain, according to Moores law it will take us 26 years to develop computers able to operate at 10 ^ 31 floating point operations to look at repairing this brain structure.

    The mechanics of homeopathic medications or energy medications are exponentially more complex because its fundamentally requires multi-dimensional thinking.

    Don’t disregard a product if you dont understand how it works, as FJ said ,, I don’t care, its worked for me and its worked for my family.

    Tirtho

    • Kim Hebert says:

      This article was authored by 2 people. Anyway, I’m an occupational therapist. I have zero ties to the pharm industry – zero – as it would be outside of my scope of practice. If you read my bio rather than making convenient assumptions, you would know that. We are reasonable people and you don’t know us personally. A disagreement doesn’t automatically make someone the “enemy”.

      But it doesn’t matter where I (or Scott) work because the evidence is what matters, and there is no conclusive evidence that Traumeel is effective beyond the placebo effect. Just because we don’t agree with you, doesn’t make us ignorant. We looked at the evidence very carefully and simply came to a different conclusion than you have.

      Science is a tool whereby people use careful and systematic methods to investigate a specific question. Unless I’ve misunderstood your third and fourth paragraphs, what part of science do you apparently take issue with? Being careful (to eliminate error)? Being systematic (to eliminate bias)? Being specific (to know what’s being answered)? I’d be happy to have a discussion about our reasoning for our conclusions with you, if you’ll agree to provide information on what it would take to convince you that Traumeel might not work. I’m willing to consider the possibility that it does work, given appropriate evidence. Are you prepared to consider that it doesn’t work? What evidence would it take for you to change your mind and why?

    • Tirtho, let’s back up your bus of pure stupid. It isn’t that we don’t understand how it is supposed to work. We don’t care what the method of action is for something if it doesn’t work. Present the evidence that it works (the burden is on you) before you knock us for dismissing the supposed method of action.

      If something works, we’d like to know ‘how’ but we don’t need to know how it works for us to accept that it does work. It doesn’t work the other way, however. “it should work like this so we’ll use it even though it doesn’t work” is about as silly as it gets. Homeopathy doesn’t work.

      If everyone who speaks out against stupid is a paid shill for big Pharma, big Pharma would have no money to do research. Wholly crap, THAT is why big placebo doesn’t do research? They’re spending all their money on shills?

  6. Greg Pastic says:

    Thirtho says “Please dont listen to these people and try the product for yourself if you need proof of its effectiveness.”

    So, I did. Or should I say, we did. First, I suffered a shoulder injury while curling at the end of March, and then a few days later my wife suffered a neck injury while playing baseball. We’ve both used two or three tubes of Traumeel. And…the results? Nothing. No pain relief, no improvement, nuttin’. The only one better off for it is the owner of the local drug mart where we bought it. Is this anecdotal evidence? No, it was a $230.00 personal trial!

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  • Scott Gavura

    Scott is passionate about improving the way drugs are used. A pharmacist by background, Scott has a professional interest in improving the cost-effective use of drugs at the population level, while helping consumers make more informed decisions about their health. He blogs about pharmacy practice and questionable science at Science-Based Pharmacy and Science-Based Medicine. All views expressed by Scott are his personal views alone, and do not represent the opinions of any current or former employers, or any organizations or associations that he may be affiliated with. All information is provided for discussion purposes only, and should not be used as a replacement for consultation with a licensed and accredited health professional.