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 a collaboration with Kim Hebert, who blogs at Science-Based Therapy.
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):
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.
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
For a homeopathy primer, see Science-Based Medicine’s topic overview.
A Reality Check on Traumeel, from Paul Ingraham at saveyourself.ca
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Tags: arnica, health canada, Heel, homeopathy, natural health products directorate, nhpd, traumeal, traumeel, trawmeel