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Sometimes you don’t need to read past the headline. If you’re a regular reader of the blog, the headline may seem self-evident and congruent with everything that we know about homeopathy. But should you not understand how homeopaths purport to offer vaccination through magical sugar pills called “nosodes”, and how regulators like Health Canada enable this pseudoscience, read on. We’re going to examine a randomized controlled trial that that compares homeopathy to real vaccines. The findings will not surprise you.

Sugar marketed as medicine

Homeopathy is an antiquated alternative-to-medicine belief system that is possibly popular because it isn’t well understood. Commonly packaged and sold alongside herbal products and “natural” remedies, homeopathy is unique in that remedies contains nothing at all – by design. Of the alternative medicines, homeopathy is the most implausible of them all. Based on the absurd notion of “like cures like” (which is sympathetic magic, not science), proponents of homeopathy believe that any substance can be an effective remedy if it’s diluted enough: raccoon fur, the sunlight reflecting off Saturn, even pieces of the Berlin Wall are possible remedies. And when I say dilute, I mean dilute. The 30C “potency” is common – it’s a ratio of 10-60. You would have to give two billion doses per second, to six billion people, for 4 billion years, to deliver a single molecule of the original material. So remedies are effectively and mathematically inert – they are pure placebo. Not surprisingly, there is no persuasive medical evidence that these products have therapeutic effects.

Canada’s version of the FDA, Health Canada, has approved hundreds of varieties of sugar pills and declared them to be “safe and effective”. Given the regulatory and legislative “veneer of legitimacy” that homeopathy is being granted, you can see how consumers might be led to believe that homeopathic remedies are effective, or that homeopaths are capable of providing a form of health care. Concerningly, Health Canada approved dozens of homeopathic “nosodes” for sale over the years. A “nosode” is a remedy that starts with infectious material, like polio, measles, or smallpox, and then it’s diluted sequentially until mathematically, there’s nothing left but water. Homeopaths promote these products as vaccine substitutes. A few years ago the advocacy group Bad Science Watch launched a public campaign against nosodes, and succeeded in getting Health Canada’s agreement to force commercial manufacturers to place a label on their products stating “This product is not intended to be an alternative to vaccination.” Yet these products are still allowed to be sold, and the extent to which they continue to be promoted as an alternative to vaccination is unknown.

Homeopathy could be written off as a harmless nostrum if it caused no harm, but that’s not the case. Homeopathy can delay patients from seeking science-based treatments. And while nosodes only contain sugar, consumers could be led to believe that they actually provide immunity.

Should we test homeopathy?

Back in 2016, Steven Novella wrote about the study that is my subject for today:

A Canadian academic, Dr. Mark Loeb, who is a respected infectious disease researcher who knows how to conduct high quality research, wants to study homeopathic nosodes. Nosodes are essentially homeopathic vaccines.
Tim Caulfield, a Canadian professor of health law and policy, thinks the study is misguided and unethical. The two are having a respectful public debate about the risks and merits of doing such a study.

And:

Despite the complete lack of scientific plausibility and the negative clinical trials, homeopathy is still a multi-billion dollar industry and enjoys approval by most governments. In the US homeopathic potions are classified as drugs and given automatic approval, although the FDA is reviewing that policy.

Because of this, Mark Loeb argues, it is helpful to conduct high quality research into homeopathy. Even if this research does not convince the true believers, the results, assuming they are negative, can be used to pressure governments to more appropriately regulate homeopathy.

Loeb argues that on this specific question, that of nosodes, there has not been any high quality research. He intends to compare nosodes to vaccines to placebos, looking at the production of antibodies and B and T-cell responses. His hypothesis is that nosodes will be no different than placebo.

Dr. Novella argues this debate cuts to the difference between Science-Based Medicine and Evidence-Based Medicine, suggesting that Loeb may have an EBM philosophy, where evidence is paramount (and perhaps could convince believers) while Novella argues that an SBM, Bayesian approach would hold that the prior plausibility approaches zero, so that even a well-conducted clinical trial will not change the priors.

What did the investigators study?

So let’s now look at the trial itself. It’s entitled “A randomized, blinded, placebo-controlled trial comparing antibody responses to homeopathic and conventional vaccines in university students” and was published in the journal Vaccine. It’s fully open access.

This was a randomized controlled trial where university students (aged 18-24) who had already received routine vaccinations as a child were randomized to one of:

  • diphtheria, pertussis, tetanus, mumps and measles homeopathic nosodes. The products were licensed for sale by Health Canada and had drug identification numbers. “Treatments” were given on days, 1, 2, and 3 with increasingly dilute remedies, starting at 30C. This group also received saline injections, to mimic the actual vaccine injections.
  • placebo. Participants received regular sugar pills and also saline injections.
  • diphtheria, pertussis, tetanus (Tdap), as an intramuscular injection, and measles, mumps, rubella (MMR) subcutaneous vaccine. They also received sugar pills to mimic the nosode dosing.

The exclusion criteria included anyone who had received adult boosters of vaccines. Participants, investigators, lab techs and data analysts were blinded to the randomization.

The primary outcome was antibody levels for diphtheria, pertussis, tetanus, mumps, and measles. Participants had their blood drawn immediately before the injections (placebo or real) and then after 3 weeks.

150 students were enrolled, and the three groups were evenly matched. Interestingly, while most of the participants has protective levels of antibodies for diphtheria (88%) and tetanus (97%), only 52% had adequate antibodies against measles and 66% against mumps. This speaks to the potentially sub-optimal measure of immunity in the community, and doesn’t bode well in a era where, thanks in part to the anti-vaccination movement, preventable infection disease has come back.

As powerful as a placebo

The results are as shown below. No patient in either the nosode group or the placebo group had any meaningful immune response whatsoever.

Table 1. Total (percentage) of response (≥2-fold increase) for each outcome by vaccine groups.

Group N* Mean age (yrs) Number Female (%) Diphtheria Pertussis Tetanus Measles, Mumps,
Homeopathic Vaccine 50 19.9 (SD 1.6) 30 (60) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%) 0/50 (0%)
Conventional vaccine 49 20.2 (SD 2.0) 32 (65) 33/48 (69%) 40/48 (83%) 42/48 (88%) 13/48 (27%) 7/48 (15%)
Placebo 51 20.3 (1.6) 32 (63) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%) 0/49 (0%)
*N refers to the number of participants randomized.
†The denominator is based on the number of participants who completed follow up and were randomized.
‡The response to measles or mumps was combined for the primary analysis, for conventional vaccine the response was 17/48 (35%).

Here are the results shown another way – Geometric Mean Titres. Notice the similarity between nosodes and the placebo group.

https://ars.els-cdn.com/content/image/1-s2.0-S0264410X18312325-gr2_lrg.jpg

As expected, the results for homeopathy are indistinguishable from placebo.

As expected, there were significantly more side effects in the group that received real vaccines. Redness, sore arm, and limited movement were reported more commonly than with homeopathy or placebo.

More research likely not required

The authors conclude that homeopathic nosodes are as effective as placebo, noting,

These findings suggest homeopathic vaccines should not be licensed.

Will Loeb’s research have any effect? Personally I think it’s unlikely, unless it compels regulators to act further – ideally removing these products from the market. Given the convincing data that already existing that homeopathy is a placebo system, one more study is unlikely to convince the true believers. Perhaps it will be more effective with the vaccine hesitant, or to those that may otherwise think that you can gain immunity with these “alternatives”. But as we’ve seen over years in addressing the anti-vaccine movement, this is a messaging issue, not an evidence issue.

While homeopaths, naturopaths, and others may promote homeopathic “remedies” like nosodes are effective, the facts are clear. Nosodes are an area where homeopathy can actively harm. Choosing homeopathy over a vaccine is a decision to forsake immunization, something consumers may not even realize. Why is all this so important? Because the evidence is very clear. Vaccines work. And nosodes are no alternative.

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Posted by Scott Gavura