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Homeopathy and Evidence-Based Medicine: Back to the Future Part V

Homeopathy and Science: Discussion, Summary and Conclusions

I was not surprised by a couple of the dissenting comments after Part IV of this blog. One writer worried that I had neglected, presumably for nefarious reasons, to cite replications of Benveniste’s results; another cited several examples of “positive” homeopathy studies that I had failed to mention. I answered some of those points here. I am fully aware of such “positive” reports, including those seeming to support Benveniste. I didn’t cite them, but not in some futile hope of concealing their existence from the watchful eyes of the readership. I also didn’t cite several “negative” reports, including an independent, disconfirming report of one of the claims of David Reilly, whose words began this series,* and the most recent of several reviews (referenced here) to conclude that “the clinical effects of homoeopathy are placebo effects.” I didn’t cite those reports for the same reasons that I didn’t cite the “positive” studies: they are mere footnotes to the overwhelming evidence against homeopathy.

To explain why, it will be necessary to discuss some of the strengths and weaknesses of the project known as “Evidence-Based Medicine.”

“Evidence-Based Medicine” Primer

Academic defenders of homeopathy and other implausible methods argue that even though such claims are highly implausible, they still ought to be subjected to studies. It would be arrogant, they say, to simply abandon them without investigation, and there is the potential to overlook significant therapeutic advances. They argue that randomized, controlled trials (RCTs), especially those in which both subjects and investigators are blinded to the interventions, will separate the “wheat from the chaff.” This type of study is the “gold standard” for evidence of therapeutic efficacy of any heretofore-unproven treatment, and has been instrumental in the objective determination of both worthwhile and worthless treatments for several decades.

Eventually, several studies of a treatment are examined in the aggregate, in the form of “meta-analyses” (if they are similar enough to combine data) or “systematic reviews” (if they are not). If such reviews can justify a strong conclusion for or against the value of the treatment, it will typically be accepted by physicians as the most rational basis for clinical decisions. This process and its literature are keys to the practice that is collectively referred to as “evidence-based medicine” (EBM). It applies not only to therapeutic decisions, but also to diagnostic tests and other aspects of clinical medicine.

Some might be surprised to find that EBM is not synonymous with “science-based medicine.” Although based on previous, evolving standards of clinical trial designs, statistics, epidemiological methods and other pertinent tools, EBM is a semi-formal movement within modern medicine that has existed for fewer than 20 years; it comprises sets of guidelines for assessing evidence, which will be discussed further below.

EBM and “CAM”

To many in this era of EBM it seems self-evident that all unproven methods, including homeopathy, should be subjected to such scrutiny. After all, the anecdotal impressions that are typically the bases for such claims are laden with the very biases that blinded RCTs were devised to overcome. This opinion, however, is naive. Some claims are so implausible that clinical trials tend to confuse, rather than clarify the issue. Human trials are messy. It is impossible to make them rigorous in ways that are comparable to laboratory experiments. Compared to laboratory investigations, clinical trials are necessarily less powered and more prone to numerous other sources of error: biases, whether conscious or not, causing or resulting from non-comparable experimental and control groups, cuing of subjects, post-hoc analyses, multiple testing artifacts, unrecognized confounding of data due to subjects’ own motivations, non-publication of results, inappropriate statistical analyses, conclusions that don’t follow from the data, inappropriate pooling of non-significant data from several, small studies to produce an aggregate that appears statistically significant, fraud, and more.

Most of those problems are not apparent in primary reports. Several have already been discussed or referenced elsewhere on this site: here, here, here and here, for example. Academics active in the EBM movement are aware of most of them and want to correct them—as a quick scan of the contents of almost any major medical journal will reveal.

It is clear that such biases are more likely to skew the results of studies that are funded or performed by advocates. This has been found in studies of trials funded by drug companies, for example, as referenced here. In the case of “CAM,” the charge is supported by the preponderance of favorable reports in advocacy journals (here, here, and here) and by examples of overwhelmingly favorable reports emanating from regions with strong political motivations.

For those reasons we can predict that RCTs of ineffective claims championed by impassioned advocates will demonstrate several characteristics. Small studies, those performed by advocates or reported in advocacy journals, and those judged to be of poor quality will tend to be “positive.” The larger the study and the better the design, the more likely it is to be “negative.” Over time, early “positive” trials and reviews will give way to negative ones, at least among those judged to be of high quality and reported in reputable journals. In the aggregate, trials of ineffective claims championed by impassioned advocates will appear to yield equivocal rather than merely “negative” outcomes. The inevitable, continual citations of dubious reports will lead some to judge that the aggregate data are “weakly positive” or that the treatment is “better than placebo.” An example is the claim that stimulation of the “pericardium 6” acupuncture point is effective in the prevention and treatment of post-operative nausea and vomiting—a purportedly proven “CAM” method.

Homeopathic “Remedies” are Placebos

After 200 years and numerous studies, including many randomized, controlled trials (RCTs) and several meta-analyses and systematic reviews, homeopathy has performed exactly as described above. The best that proponents can offer is equivocal evidence of a weak effect compared to placebo. That is exactly what is expected if homeopathy is placebo.

Nevertheless, EBM advocates on the whole don’t see it that way. Those who want to see homeopathy vindicated, such as homeopath Wayne Jonas, the former director of the NIH Office of Alternative Medicine, point to the weakly positive evidence. Others, even those who find homeopathy implausible, are so convinced that EBM can answer the question (“Either homeopathy works or controlled trials don’t!”) that they call for more trials, with no end in sight. Such judgments expose a major weakness in EBM that is not apparent when the exercise is applied to plausible claims.

Evidence-Based Medicine and Evidence

When I use a word,” Humpty Dumpty said in a rather a scornful tone, “it means just what I choose it to mean — neither more nor less.
“The question is,” said Alice, “whether you can make words mean different things.”
“The question is,” said Humpty Dumpty, “which is to be master — that’s all.”

There are sources of substantial error in EBM that apply more to trials of implausible than plausible claims, and that are generally not acknowledged by academics. The first is that the EBM “levels of evidence” hierarchy renders each entry sufficient to trump those below it (Figure). Thus a “positive” clinical trial is given more weight than “physiology, bench research or ‘first principles’,” even when the latter definitively refute the claim.

Figure: Oxford Centre for Evidence-based Medicine Levels of Evidence (May 2001)

Level Therapy/Prevention, Aetiology/Harm
1a SR (with homogeneity*) of RCTs
1b Individual RCT (with narrow Confidence Interval‡)
1c All or none§
2a SR (with homogeneity*) of cohort studies
2b Individual cohort study (including low quality RCT; e.g., <80% follow-up)
2c “Outcomes” Research; Ecological studies
3a SR (with homogeneity*) of case-control studies
3b Individual Case-Control Study
4 Case-series (and poor quality cohort and case-control studies§§)
5 Expert opinion without explicit critical appraisal, or based on physiology, bench research or “first principles”

Grades of Recommendation

A consistent level 1 studies
B consistent level 2 or 3 studies or extrapolations from level 1 studies
C level 4 studies or extrapolations from level 2 or 3 studies
D level 5 evidence or troublingly inconsistent or inconclusive studies of any level

For judging homeopathy, EBM deems the equivocal results of clinical efficacy trials to be of more value than other evidence discussed in this series: definitive refutation of the “law of similars”; the doctrine of “infinitesimals” violating the second law of thermodynamics; no coherent bases for predicting consistency or validity of “symptoms” and “provings,” or of the homeopathic prescribing scheme, and studies confirming the lack of such validity; definitive refutations of Hahnemann’s magical “theories” of what diseases are and how homeopathy works, based on his notions of “Dynamic Deranging Irritations of the Vital Force”; later homeopaths’ arbitrary inventions of more implausible treatments, e.g., “nosodes” and “constitutional” prescribing; recent inventions of fantastic theories to explain the failings of the rest, e.g., “water memory,” “non-local” (psychic?) explanations or “quantum-like” effects to explain the “entanglement-disrupting effects of blinding” in clinical trials, and more.

Another way of thinking about this is to observe that homeopathy lacks several criteria that suggest a viable hypothesis: simplicity, conservatism, fruitfulness, and scope. [1] Regarding the last two, is there anything in nature that the tenets of homeopathy—the “eternal, infallible law of nature”—can explain better than can current scientific theory? I can’t think of a single natural phenomenon that homeopathic “theory” can explain at all. [2]  It doesn’t even explain homeopathy in a coherent way. Other, well-characterized but mundane social and psychological factors do that much better.

When this sort of evidence is weighed against the equivocal clinical trial literature, it is abundantly clear that homeopathic “remedies” have no specific, biological effects. Yet EBM relegates such evidence to “Level 5”: the lowest in the scheme. How persuasive is the evidence that EBM dismisses? The “infinitesimals” claim alone is the equivalent of a proposal for a perpetual motion machine. The same medical academics who call for more studies of homeopathy would be embarrassed, one hopes, to be found insisting upon studies of perpetual motion machines. Basic chemistry is still a prerequisite for medical school, as far as I’m aware.

In summary, the evidence that homeopaths’ perceptions are due to something other than what they claim is comparable to the evidence that the earth is spheroid rather than planar, that the planets orbit the sun rather than the earth, that the positions and movements of planets do not affect human affairs, that Newton’s gravitational theory holds to a high degree of precision for everything from apples falling from trees to the motions and long-distance effects of space ships, comets, and other celestial bodies, even though it is incomplete, that electricity and magnetism are the same thing, that mass is conserved, that the earth is several billion years old, that its crust comprises several “plates” that move around, that species evolved by a process of variation and natural selection, that Avagadro’s number is the same on Mars as it is here, and so forth. In other words, it is the sort of basic science that can reasonably be called “established knowledge.”

Is it realistic to assume that this “level” of evidence, when brought to bear on a claim that has no explanatory power in nature, can be overthrown by ambiguous clinical trials of dubious design? EBM makes that assumption.

It wasn’t meant to be like this. When I first discussed with my fellow bloggers the curious absence of established knowledge in the EBM “levels of evidence” hierarchy, at least one insisted that this could not be true, and in a sense he was correct. David Sackett and other innovators of EBM do include basic science in their discussions, but they recommend invoking it only when there are no clinical trials to consider:

Evidence based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions…And sometimes the evidence we need will come from the basic sciences such as genetics or immunology. It is when asking questions about therapy that we should try to avoid the non-experimental approaches, since these routinely lead to false positive conclusions about efficacy. Because the randomised trial, and especially the systematic review of several randomised trials, is so much more likely to inform us and so much less likely to mislead us, it has become the “gold standard” for judging whether a treatment does more good than harm.

That statement is consistent with EBM’s formal relegation of established knowledge to “level 5,” as seen in the Figure. I am not a historian of EBM and don’t care to be, but I suspect that the explanation for this choice is that “they never saw ‘CAM’ coming.” In other words, it probably didn’t occur to Sackett and other EBM pioneers that anyone would consider performing clinical trials of methods that couldn’t pass the muster of scientific plausibility. Their primary concern was to emphasize the insufficiency of basic science evidence in determining the safety and effectiveness of new treatments. In that they were quite correct, but trials of “CAM” have since reminded us that although established knowledge may be an insufficient basis for accepting a treatment claim, it is still a necessary one.

Lacking that perspective, Sackett’s Center for Evidence-Based Medicine promulgates an “Introduction to evidence-based complementary medicine” by “CAM” researcher Andrew Vickers. There is not a mention of established knowledge in it, although there are references to several claims, including homeopathy, that are refuted by things that we already know. Vickers is also on the advisory board of the Cochrane CAM Field, along with Wayne Jonas and several other “CAM” enthusiasts. The Cochrane Collaboration is a highly respected wellspring of “evidence,” in the EBM sense of the term. But its treatment of “CAM” claims suggests that “evidence” means just what the “CAM Field” chooses it to mean—neither more nor less. Perusing the Cochrane reviews of homeopathy reveals just how far down the rabbit hole the ghost of poor Archie Cochrane, the founder, has been led:

“In view of the absence of evidence it is not possible to comment on the use of homeopathy in treating dementia.”

“There is not enough evidence to reliably assess the possible role of homeopathy in asthma. As well as randomised trials, there is a need for observational data to document the different methods of homeopathic prescribing and how patients respond.”

“There is currently little evidence for the efficacy of homeopathy for the treatment of ADHD. Development of optimal treatment protocols is recommended prior to further randomised controlled trials being undertaken.”

“Though promising, the data were not strong enough to make a general recommendation to use Oscillococcinum for first-line treatment of influenza and influenza-like syndromes. Further research is warranted but the required sample sizes are large.”

And so on.

Next Week (or maybe later; this is time-consuming): Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”

[1] Schick, T Jr. and Lewis Vaughn. How to Think About Weird Things; Critical Thinking for a New Age (2nd Edition). Ch. 7. Mayfield Publishing Company. Mountain View, CA 1999

[2] Atwood KC. Homeopathy and Critical Thinking. Scientific Review of Alternative Medicine 5; 3: 146-148. Summer 2001

…………………………..

*The Homeopathy Series:

  1. Homeopathy and Evidence-Based Medicine: Back to the Future – Part I
  2. Homeopathy and Evidence-Based Medicine: Back to the Future – Part II
  3. Homeopathy and Evidence-Based Medicine: Back to the Future–Part III
  4. Homeopathy and Evidence-Based Medicine: Back to the Future Part IV
  5. Homeopathy and Evidence-Based Medicine: Back to the Future Part V
  6. Harvard Medical School: Veritas for Sale (Part III)
  7. The Dull-Man Law
  8. Smallpox and Pseudomedicine

…………………………..

The Prior Probability, Bayesian vs. Frequentist Inference, and EBM Series:

1. Homeopathy and Evidence-Based Medicine: Back to the Future Part V

2. Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”

3. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued

4. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued Again

5. Yes, Jacqueline: EBM ought to be Synonymous with SBM

6. The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part II

7. H. Pylori, Plausibility, and Greek Tragedy: the Quirky Case of Dr. John Lykoudis

8. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

9. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

10. Of SBM and EBM Redux. Part I: Does EBM Undervalue Basic Science and Overvalue RCTs?

11. Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?

12. Of SBM and EBM Redux. Part III: Parapsychology is the Role Model for “CAM” Research

13. Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes

14. Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

15. Cochrane is Starting to ‘Get’ SBM!

16. What is Science? 

Posted in: Basic Science, Clinical Trials, Homeopathy, Medical Academia, Science and Medicine

Leave a Comment (33) ↓

33 thoughts on “Homeopathy and Evidence-Based Medicine: Back to the Future Part V

  1. daedalus2u says:

    I think I have the answer to the problem.

    Any clinical trial must be performed ethically, which means that the “control” group be given what constitutes the “standard of care” best known treatment, and that the “treatment” group is compared not to an absence of treatment, but to treatment that is the standard of care.

    The problem is that there is no “standard of care” treatment that invokes the placebo effect better than a placebo does. Since the placebo effect of most treatments is mediated though the beliefs of the patients, a group of patients will have different beliefs and different placebo treatments will invoke the placebo effect to different degrees in the different patients. Which placebo works better will be an artifact of differences in the control and treatment groups.

    What is needed is an EBM based treatment that works via the placebo effect that placebo mediated CAM treatments can be compared against in clinical trials. Something that is a sort of “uber-placebo”.

    I happen to be working on a treatment modality that will invoke the placebo effect by physiologically increasing basal nitric oxide levels through topical application of commensal surface bacteria.

    http://daedalus2u.blogspot.com/2007/04/placebo-and-nocebo-effects.html

    My understanding of the placebo effect is that it is a CNS based mechanism to regulate the allocation of resources to either immediate needs (such as for responding to a stressor (i.e. running from a bear)), or for less immediate needs (needs that can be put off at least temporarily) such as healing. When resources are maximally allocated to healing, there is nothing more that can be done to make healing occur faster.

    I am quite sure that my bacteria will physiologically invoke the placebo effect stronger than any psychologically based placebo treatment such as homeopathy, acupuncture, chi, or anything else. Once the placebo effect is maximally induced, there is nothing more than any other placebo can do.

  2. Joe says:

    “… recent inventions of fantastic theories to explain the failings of the rest … or “quantum-like” effects to explain the “entanglement-disrupting effects of blinding” in clinical trials, and more.”

    Milgrom’s notions are easily dismissed for a specific reason- he uses “weak quantum theory” (WQT) for his calculations. WQT discards Planck’s constant, yet that (Planck’s constant) is what connects the math of QT with the reality of physics. What Milgrom writes doesn’t only appear inane, it is in fact inane.

  3. pmoran says:

    I enjoyed your very lucid exposition immensely, having once been one of those who “never saw CAM coming”, naively thinking that a few controlled trials would quickly straighten out most of the nonsense.

    I’d like to add that inconsistent or unconvincing results in clinical studies are doubly telling in the case of the investigation of CAM methods. The studies concern areas of medicine that the alternative practitioners have chosen themselves. These are surely the areas where they believe they get their best results!

  4. weing says:

    Too bad we can’t ethically prescribe placebos for patients. Look at all the flap that a lot of the antidepressants are actually no better than placebos. Maybe we can call them homeopathic treatments and use them as alternative medicine?

  5. Freddy the Pig says:

    Is what you are arguing basically that extradorinary (implausible based on current scientific knoledge) claims require extraordinary evidence? Therefore a slightly better than placebo effect with a p value of 0.05 doesn’t cut the mustard when it comes to something like homeopathy, but it might be considered evidence for something which works on a known biochemical reaction and has been demonstrated in the lab etc?

    What people need to be aware of is the inevitability of a weak positve effect of anything that is actually ineffective due to publication bias.

    Also – how do you counter the Semmelweis gambit (a variation on the Galileo gambit) which is popular among advocates of highly implausible therapies.

  6. Aaron S. says:

    “Too bad we can’t ethically prescribe placebos for patients. Look at all the flap that a lot of the antidepressants are actually no better than placebos. Maybe we can call them homeopathic treatments and use them as alternative medicine?”

    When look those up on journals, they seem to have like a 10% efficacy (LOCF and remission numbers were closed on the last study I looked at) over placebo. So calling them placebos seems more that a little unfair.

  7. weing says:

    “When look those up on journals, they seem to have like a 10% efficacy (LOCF and remission numbers were closed on the last study I looked at) over placebo. So calling them placebos seems more that a little unfair.”

    I don’t think that factors in the negative studies that were not published. Anyway, don’t underestimate the power of the placebo. I really think it is unfair that, as physicians, we cannot ethically prescribe placebos. The homeopaths and other CAM practitioners appear to have monopolized them.

  8. daedalus2u says:

    Skeptico has a good blog on why extraordinary claims require extraordinary evidence,

    http://skeptico.blogs.com/skeptico/2008/01/extraordinary-c.html

    and follows it up with an example showing how extraordinary presuppositions can lead extraordinary claims.

    http://skeptico.blogs.com/skeptico/2008/01/extraordinarily.html

    This is the fundamental problem with evidence based reasoning. Unless you are able (and willing) to go back to primary observations of data, extraordinary claims can follow from extraordinary presuppositions and ordinary evidence. If you are unwilling to examine all of your presuppositions, then some of them may be extraordinary and you may with ordinary logic and data make extraordinary conclusions.

    In the case of Semmelweis, doctors of the time had the extraordinary presupposition that there were four humours that caused diseases and that there was no such thing as germs that caused disease (this was before the germ theory had been accepted).

    Homeopaths have the extraordinary presupposition that homeopathy actually works. With that presupposition, it is an ordinary and logical conclusion that any trial that doesn’t show homeopathy to actually work has something wrong with it.

    Skeptico uses the example of presupposing the existence of God, the ability of God to raise His Son from the dead, so the resurrection of Jesus by that God becomes an ordinary and logical outcome. Of course a God with those properties would do those things and take those actions under those circumstances. But that course of action is presupposed by the presumption of a God with those properties.

    One way of looking at these presuppositions are as paradigm of the sort discussed by Thomas Kuhn in his Structure of Scientific Revolutions. Scientists have as their presupposition, the scientific paradigm that they are working in. Even when those paradigms are wrong, most scientists require an extraordinary amount of evidence to abandon it. What they require is another paradigm to use instead. This is not a “skeptical” or “scientific” requirement; it is a “human” requirement.

    Similarly when religious individuals have a “crisis of faith”, usually they simply adopt a different set of extraordinary presuppositions.

    Most individuals have the extraordinary presupposition that they know a lot, and are more expert in a subject than they actually are. This is the source of the “arrogance of ignorance”.

    http://scienceblogs.com/insolence/2008/01/another_example_of_the_arrogance_of_igno.php

    A scientific paradigm is no stronger (and no weaker) than the data which supports it. There is no data which supports homeopathy absent the presupposition that it works. Just as there was no data that supported the idea that disease was caused by the four humours. It is only the extraordinary presupposition of homeopathic advocates that they are correct that maintains their belief in homeopathy.

    There are extraordinary presuppositions in EBM, perhaps one of the most egregious is that of homeostasis (which I have blogged about).

    http://daedalus2u.blogspot.com/2008/01/myth-of-homeostasis-implications-for.html

  9. kathleen says:

    “Anyway, don’t underestimate the power of the placebo. I really think it is unfair that, as physicians, we cannot ethically prescribe placebos. The homeopaths and other CAM practitioners appear to have monopolized them.”

    Unfair?
    The CAM practitioners lie to their patients. Do you honestly think it is unfair that it is unethical for you to do so too?
    As for me, I believe I would derive a powerful placebo effect from going to an honest, truthful and trustworthy physician. How can I assume that my physician is honest if some of their profession are lying to their patients about their medication?

  10. weing says:

    I know it’s not right but do feel we are placed at a disadvantage when it comes to the worried well. We tell them the truth, they prefer woo and go to CAM practitioners that give them what they want. Just look at the amount of $ being spent. When they really do need us and we can give them something, all they get is placebo from the CAM quacks as they are no longer seeing us.

  11. BlazingDragon says:

    Dr. Atwood, I think you make an error when you assume that most doctors understand chemistry (yes, they’ve been forced to take the course, but understanding the how/why is not the same as regurgitating for exams, then promptly forgetting the disparate factoids one memorized for the exam).

    Given how water is constantly recycled (broken apart and recombined) by photosynthesis, respiration, and hydrogen exchange, any claim of water “memory” is laughable… but I don’t think there are many people (including a big chunk of physicians) who understand why the claim is so laughable. To understand why, one would have to sit down and carefully study chemistry and biochemistry to understand the principles involved, rather than just memorizing equations and names (which tends to show up on chemistry and biochemistry exams).

    Thank you for the discussion. It is an enlightening way of looking at this issue and clears up (for me) how clinical trials have been unable to dismiss woo-based therapies.

  12. Badly Shaved Monkey says:

    Thank you for these excellent articles. I had hovered on the margins of the realization that clinical trials of implausible therapies were just muddying the waters but I now have a much more organized perspective on this.

    With regard to homeopathy, one major issue is the frequency of internally contrdictory beliefs held by its advocates. Strictly speaking, although one must accept that even a large number of such dichotomies cannot disprove the validity of the whole therapy, the Bayesian prior probability is eroded progressively by the requirement for “true” homeopathy to be constituted from the correct side of a whole set of contradictory propositions. While accepting that in a strict sense one cannot disprove the whole therapy based just on these contradictions I think that the critics of homeopathy are failing to use this line of attack sufficiently.

    Also, when it comes to the low politics of these debates these contradictions do present a quick way to make homeopathy’s apologists look stupid.

  13. Speaking of high quality studies and homeopathy, has anyone looked to see what cirteria Health Canada, the Canadian drug regulating agecny, uses to decide if homeo remedies are effective?

    In an email to me a HC official stated:

    “In the case of natural health products, prior to sale, the
    company/manufacturer wishing to sell their NHPs in Canada must first obtain a product licence (one for each product) by submitting evidence supporting the safety, efficacy and quality of their products under their recommended conditions of use. Products supported by sufficient evidence will be issued a product licence along with a Natural Product Number (NPN) or Homepathic Medicine Number (DIN-HM) that must appear on the label.”

    On their webpage below, a portion of which I’ve cut and pasted, they cite specific sections of their regulations but I have not checked them myself.

    http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/ehmg-nprh_e.html#1_3

    1.3 Evidence to Support the Use of Homeopathic Medicines

    Applicants are responsible for submitting evidence to support the safety, efficacy and quality of a homeopathic medicine, as per Section 5(g) of the Regulations. The evidence submitted must support the proposed Recommended Conditions of Use (see chapter 1.2) of the homeopathic medicine.

    There are two categories of homeopathic medicines:

    * homeopathic medicines that state a specific recommended use or purpose, and
    * homeopathic medicines that do not state a specific recommended use or purpose (see chapter 7.4.1 for a definition of each category).

    The evidence required will vary depending on which category the homeopathic medicine falls into (specific or non-specific recommended use or purpose) as outlined in chapter 8. Information supporting the recommended conditions of use must be provided by referencing evidence such as clinical trials and/or published homeopathic references. See Appendix 1 for a list of sample references.

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