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Hi Everyone.

So, in cooperation with the students of my alma mater, the Canadian College of Naturopathic Medicine, and the filmmaker Ananda More of the film Magic Pills, as well as researcher and Homeopath David Brulé, I appeared on a film panel following a screening of Magic Pills during Vitalism Week at CCNM. This panel was recorded, and is available below. I would love to hear what you think about it.

Apparently I was funny.

You can access the panel video here.

Hi Everybody. I do apologize for my lack of posting lately. I have been consumed lately with the writing of a rebuttal to a tremendously bad article on Naturopathic Education, and in the casework for my DHANP certification from the Homeopathic Academy of Naturopathic Physicians. My case writeups totalled about 70 pages so far, so it took up quite a bit of my time!

In addition to this, I also completed the editing of a book. Two books of mine have been published in the last few months, and I decided to write a blog post about them!

The first book is the third volume of my Table of Animals Project. It focuses on the Nematodes and early Arthropods, including the Trilobites, Myriapods (Centipedes and Millipedes), Crustaceans, and Chelicerates (Spiders, Ticks, Scorpions and Horseshoe crabs). This book is the most upto date look at these remedies, and the first dicussion of many of these groups. The Nematodes had never been explored Homeopathically before, and the Trilobites, Crustaceans, and Myriapods had not been examined as a group before. The book can be purchased here.

The second book is a continuation of the first, an exploartion of the Insect remedies within Homeopathy. I was only expecting a few remedies to be available, but this book rapidly became more than 300 pages long, and so needed it’s own volume. This is the most detailed exploration of the Insect remedies available, containing two new triturations of my own. This book can be purchased here.

I have also added some of the triturations within my books as part of my publications page. The Triturations of these animals will be posted upto C4 on my publications page:

I hope you all enjoy these books and provings! More will be coming soon. Up next will be the Table of animals on the Fish, and my presentation at the Healing Skies Conference in Saskatoon in June!

Take care of yourselves!

Hi Everyone. I am just wishing you all a Happy Holidays, Merry Christmas and a lovely New Year.

This song always filled me with Joy, and I hope you all get a bit out of it as well!

Hi Everyone. So a great deal of disscussion has been conducted online about the scientific evaluation of Homeopathy. Given the recent emphasis on Evidence based Medicine, and it’s methods of evaluation, much of the recent discussion has focused on Randomised Controlled Clinical Trials which have generally been accepted as the best methods to evaluate clinicl interventions (although I would refer readers to Harris Coulter’s publication on the subject for a more full view).

In short, a Randomized Controlled Clinical Trial is an examination of the results of an intervention, performed on different, but theoretically identical, populations. The intervention should be indistinguishable, and the evaluation of the patients should be done in such a way that any human element, or analysis, is conducted without knowledge of which group of patients have received which intervention.

This type of study is designed very well for allopathic style interventions. It presumes that the intervention is singular, static, and does not require feedback after administered, ie., as many prescription drugs. Homeopathy is not well suited to this style of trial, without some significant adjustments, for a number of reasons.

  1. Finding the remedy is difficult. The process of remedy selection is a challenging process, involving the consideration of multiple factors, etiology, the mental emotional state, and of course, the eventual success of administration. The only way to determine whether a remedy was Homeopathic to a case is the patient responding to the remedy, that is, feedback. Feedback and dose adjustment
  2. Sensitivity to Homeopathic Remedies varies. Some individuals will aggravate from the lowest potencies of a remedy, others need higher potencies than normal. Many individuals fall somewhere in the middle of susceptibility to remedies. Finding a proper Homeopathic prescription involves finding not only the right remedy, but the right potency.
  3. Potency changes as patient’s course unfolds. Almost universally, when a successful remedy and potency is found, over time the patient will respond progressively less to repeated doses of that potency, eventually failing to respond whatsoever. At this point, a higher, more potentised preparation of the same remedy is required.
  4. Occasionally intercurrent remedies, or remedies addressing a specific issue or obstacle to cure, will become apparent. When this occurs, the case must be retaken, a new remedy or other intervention performed, and the older remedy stopped. Often the older remedy can be restarted after the particular inercurrent remedy has completed it’s work
  5. Remedies change, oftentimes a person will completely resolve their symptom complex with a given remedy, and then will no longer requiring it, either needing no remedy, or another suited to whatever picture emerges.

These traits of Homeopathic care each require detailed feedback and adjustments to therapy. This kind of adjustment is impossible in a placebo controlled setting.

Despite these problems, a number of methodological refinements have been made to the process of clinical trials which do make this method of examination more suited to the examination of Homeopathy.

  1. The first refinement is to have the Homeopathic practitioner select the remedy and do whatever process of feedback needed to settle on an effective remedy, then blind the patient as to whether or not they are receiving the remedy or placebo, and measure their condition under both placebo and verum. The best example of this style of trial is Heiner Frei’s excellent trial of ADHD. You can read this trial here. While this does not address remedies changing, intercurrents, or the need for increased potency, it is certainly an improvement.
  2. The second refinement is to pre select for patients who will respond to a particular remedy. The premier example of this type of trial is Peter Fisher’s older trial where patients who would match the symptoms of Rhus Tox were screened from a population, and administered the remedy. You can read this trial here. While this method also does not account for individual sensitivity to remedies, need for increased potencies, intercurrent remedies or remedies changing, it still is a good method.
  3. A third method is to use prescribers with high levels of accuracy, and have a big enough sample size that it becomes possible to demonstrate smaller improvements, which are the likely outcome with all of the methodological issues described above. Numerous example of these trials exist, but one can be found here.

Despite these issues, as Mathie has demonstrated in his famous 2014 paper, the overall picture of Clinical trial research into individualized Homeopathy as a whole is positive. Due to a lack of trials in Homeopathy, it is difficult to assess individual conditions with any great accuracy. However, a metanalysis has recently been performed with respect to Homeopathic treatment of depression. In it, the researchers found 18 studies, including two placebo controlled trials, both positive, and one with a low risk of bias. Overall the researchers concluded that while the evidence was promising, but that more high quality studies were needed, but that the safety profile was potentially excellent ( as compared with the Standard of care of antidepressants with thier numerous side effects and increased risk of suicide). As Homeopathy research increases in quantity and quality, these suggestions will be met, and numerous other conditions will be studied.

The common line of discussion against Homeopathy is that it lacks evidence. This is fundamentally untrue, and those who repeat it are either ignorant or being actively deceptive. As Mathie demonstrated, the overall trend of Individualized clinical trial data is positive, even if it requires higher quality studies to be absolutely definitive. Taking these methodological issues into consideration when designing clinical trials will result in trials more accurately reflecting Homeopathic practice, and will assist in us producing the good evidence which will likely not silence our critics, but will end any legitimate scientific debate about Homeopathy.

 

Hi Everyone!

So as many of you know, I have a very lively ( and occasionally snarky) twitter account, which can be found under the name @DrPaulND. As in any human endeavor on twitter, there is quite a bit of trolling and unpleasant discourse that occurs. However, being on twitter does give me a great deal of insight into current trends in the discourses of those ideologically opposed to Homeopathy and Naturopathic medicine.

As I detailed in a previous blog post, the most recent and most heavily propagandized systematic review on Homeopathy was the NHMRC review. Using Fake News Tactics, a number of groups promoted this report, despite it’s terrible methodology and numerous problems. Most tellingly, no skeptical organization has, to my knowledge, explored or even acknowledged these problems.

Rachel Roberts of the Homeopathy research institute describes the faults in the study in the following video.

These irregularities are summarized as follows (Taken from my previous blog on Homeopathy research)

  • NHMRC did the review twice
  • The first review, and even it’s existence, was not disclosed to the public
  • the NHMRC, upon questioning, responded that the first review was low quality despite being conducted by the individual responsible for developing NHMRC’s guidelines on how to conduct evidence reviews
  • FOI requests confirm that a member of NHMRC, Fred Mandelsohn, confirmed the first review to be high quality stating ““I am impressed by the rigor, thoroughness and systematic approach given to this evaluation [….] Overall, a lot of excellent work has gone into this review and the results are presented in a systematic, unbiased and convincing manner.” 
  • NHMRC stated their results were based on over 1800 studies, when in fact they were based on only 176
  • NHMRC has used a method which has never been used in any other review, declaring that only trials of over 150 participants would be accepted, excluding the vast majority of high quality homeopathic trials, which due to lack of funding tend to be smaller, and despite the fact the NHMRC routinely conducts studies of less than 150 participants
  • The above rules resulted in exclusion of 171 of 176 studies, leaving only 5 to be used as the basis of the study
  • The chair of the second review, Peter Brooks, signed a conflict of interest form declaring himself “free from any association with any organization whose interests are either aligned or opposed to Homeopathy” when he was a member of the anti homeopathy lobby group “friends of science in medicine”
  • The NHMRC review included no homeopaths or experts in Homeopathy research, despite the NHMRC guidelines requiring such an inclusion

As a result of these irregularities, Rachel made a complaint to the ombudsman of Australia on this report, which being a government agency, is accountable to the public. The Australian Ombudsman, who reviewed the complaint, found it of sufficient merit as to investigate it directly. They have proceeded to investigate this complaint since then, and according to Roberts, this investigation will soon reach a conclusion, as she discusses in this video.

This investigation has recently been maligned by a number of coordinated online campaigns. The skeptical community appears to have been spreading the rumour that this investigation has not, in fact occurred due to the large length of time since the making of the complaint. This is a complete lie. The ombudsman of Australia has very clear privacy policies, listed here. As is the case in most countries with protection of privacy legislation, information on ongoing investigations is held confidential until reports are issued.

The length of the investigation is indeed lengthy. However indeed, some investigations, particularily complex ones, often take months, as is mentioned in this FAQ on the Ombudsman’s website. Lengthy investigations are indeed not unprecedented, particularly in complex matters, as an investigation of a lengthy report in a contentious field would undoubtedly would be.

Secondly the complaints process is generally only communicated to the people in question who have started the complaint. Rachel Roberts, again, being that person, is the only person privy to that information, and her testimony on that subject is, as we have seen above, quite clear. The people spreading these rumours are not privy to the complaint process, and are spreading heresay in an attempt to discredit the fact that the Ombudsman found the complaint made by HRI to be of sufficient merit to warrant the Australian government investing it’s own resources in a very lengthy investigation into wrongdoing by NHMRC in this matter.

Furthermore, to add some extra spice to this already interesting set of circumstances, The Australian Senate recently questioned the NHMRC. One senator, Sterling Griff, questioned the department of health on the NHMRC review of Homeopathy. The answers were provided in writing and are available online see questions 214, 215, 261, 264, 268, 269, 270, 273, 274, and 275 ( And thank you so much to the website yourhealthyourchoice.com for this blog post which went into detail on this subject, who’s work I am largely repeating). While these answers will be discussed in future blogs, I encourage you to read them on your own.

The blog post by yourhealthyourchoice.com was quite succinct in detailing the inconsistencies in the NHMRC’s response to the Senator’s question 268 on the arbitrary limit of 150 per study. Both Question and answer are reproduced below:

Question:
The Homeopathy Review created a rule that trials with less than 150 participants were not ‘reliable’, meaning their results did not “warrant further consideration of their findings” (Information Paper, Appendix C). Does the NHMRC apply this rule to other trials it funds and/or reviews? If so, where else has this rule been applied and what internationally accepted scientific standards were used to authenticate it?

Answer:
Studies with less than 150 participants were not excluded from consideration in the evidence assessment. The Homeopathy Working Committee (HWC) deemed that, for the purposes of drafting evidence statements, the outcomes of studies with less than 150 participants were not sufficiently powered to reliably inform conclusions on the effectiveness of homeopathy to treat a particular clinical condition. NHMRC establishes expert working committees, such as the HWC, under section 39 of the NHMRC Act, to advise NHMRC on the methodology and parameters of evidence evaluation when developing health advice and guidelines. This is in line with international best practice for formulating evidence-based health advice. The HWC has expertise in evidence-based medicine, clinical trials and complementary medicine. There is no ruling as to the number of participants that is appropriate for a trial that applies for funding by NHMRC. Applications are selected for funding through a competitive peer review process. The grant review panel assesses the application against published criteria. Issues such as trial sample size, experimental design and the power are usually assessed under “scientific quality”. If, in the judgement of the expert assessors, the scientific quality is compromised by inadequate trial size, this will be reflected in the score for that assessment criterion.”
This answer is remarkable in it’s deceptiveness. As shown by the Your Health blog, the question was never actually answered. NHMRC, yet again, did not specify why the cutoff of 150 was chosen, and failed to justify it. This is particularily ironic in that NHMRC itself regularily funds and conducts trials of less than 150, as YourHealthYourChoice demonstrated.

Secondly, The answer incorrectly states that the sample size of 150 was not used to exclude trials. However, the NHMRC information paper on page 34-35 and Optum overview report appendices on page 275 both do confirm this. In effect NHMRC specifically crafted it’s protocol to exclude unreliable studies, and then defined, without justification, anything less than 150 as unreliable, reducing massively the pool of studies that they could draw upon to make their conclusion.

Furthermore, their answers to the Senator Griff concealed this from the government, either deliberately, or through ignorance on part of the answering person.

This act of deception, more than anything else, likely explains the length of this investigation. It cannot be expected that a body that went to such length to pervert science to create a given outcome will be particularly with a government investigation of their practices and, dare I say it, motivations for doing so.

I encourage everyone to read the following blog post going into great detail

NHMRC under scrutiny in the Senate – Full and accurate answers not provided

 

 

Hi Everyone. I have a few new releases to share!

The first is my latest E-book! This book is part of the Table of Animals Series and covers the early Ecdysozoa, the Nematodes and early Arthropods, the Trilobites, Crustaceans and Myriaopods. It is an ebook, and will be published as a paperback, hopefully sometime in September. This book can be purchased here.

I have also made a few videos on making remedies. The first, on how to graft a remedy, is below:

The second on how to make an H potency of a remedy, or how to potentize a remedy at home, is below:

 

 

To begin with, the blog post must be acknowledged as being a mere snapshot of a very vast field. I apologize for the incompleteness, but an tire book would be required for a full understanding, and I do suspect that it would be quickly out of date.

As some background, Homeopathy has a long history of clinical trials, and testing in humans. These trials have always generated a great deal of contention, and it has always been disputed that the effect of Homeopathic interventions is due to the effect of the remedies. Other factors, such as the counseling, other lifestyle interventions recommended, and even the poor social skills of allopathic doctors in comparison have been suggested as the factors responsible. The most popular explanation has been the placebo effect, in short, the phenomena of patients healing despite a treatment which is not expected to effect them. Homeopaths have responded to these criticisms with record of the treatment of children and animals, presumably not subject to placebo effect, and experiments on model organisms, plants, cell cultures in test tubes or other biological systems, which most definitely are not placebo susceptible.

Homeopathy has a very long history of evaluation in model organisms. While the primary data of Homeopathy have always been gathered in provings of substances on healthy individuals, many researchers have experimented with homeopathically prepared substances, and their effects on living organisms. The most interesting example of this work in the 19th century is that of Charles Darwin, (Many thanks to Dana Ullman for his excellent work on this subject, which is my primary source). Charles, having yet to write his famous book on evolution, was extremely ill, having failed to gain relief from convention treatment, sought care from Dr James Gully, a medically trained homeopath, whom also used hydrotherapy a great deal (in a therapeutic style that is suspiciously similar to modern Naturopathic medicine).

Darwin was not a great believer in Homeopathy, and was confounded by this recover for the rest of his life. He conducted one of the earlier series of experiments using model organisms, in his case the Drosera plant ( itself also a homeopathic remedy). In his experiments, Darwin was able to show a response by the Drosera plants to 1/20 millions of a grain of an ammonia salt. Darwin was enormously reticent to publish this information, fearing it would detract from the reception of his already contentious evolutionary theory.

Since this rather historically fascinating example, a large number of studies have been conducted. As a May 2018 review of the literature concluded, there were about 183 publications on the subject. Publications averaged about 2 per year from the 1970s-200s with a jump to about 5.5 per year afterwards. Furthermore quality of publications has markedly increased with 13% of publications high quality before 2000 compared to 44% afterwards.

One specific aspect of this research, is Homeopathic research on plant models. One review in 2015 found 157 studies, but that only 48 included adequate information to evaluate them.  A second study done in 2018 found similar results. Several studies were replications, on successful, but 4 unsuccessful, with several possible variables identified.In general standardized procedures were recommended, including negative controls, and better control and identification of interference factors.

Research on abiotically stressed plants ( plants stressed by environmental conditions, instead of pathology) have also been accomplished, with reproducible and significant effects found, including effects beyond Avogadro’s number, although interestingly, one replication occurred generating opposite results. Again the authors stressed the need for replication and standardized procedures. A similar study on diseased plants as well was done in 2009. The authors as well found significant and reproducible effects of Homeopathic preparations on plant models, again beyond Avogadro’s number, though again standardized procedures are required, as is more replication.

Another fascinating body of work is the examination oh Homeopathic remedies through the medium of NMR. This method has, interestingly, been shown by several studies, to be able to detect differences between different Homeopathic potencies. In one recent study, changes in the emission from water was determined to be altered by both crude and ultramolecular homeopathic preparations in water. In another fascinating study, differing triturations of the same remedy at a different potency also displayed differing emission spectra. Another study examined triturated potencies of zincum metallicum in terms of their physical properties. Many properties were not altered, but did find that thermogravimetric and differential scanning calorimetry differed between homeopathically prepared and control samples.

The final say in this matter should perhaps be towards the greatest study on the subject, a 2015 literature review solely on replications in in vitro research in Homeopathy. This paper focused solely on experiments involving potencies diluted beyond Avogadro’s number, with no possible confounding by particles being present.Trials were classified as yielding either compatible results, no results, or opposite results. The null hypothesis of this trial was that no results was the default states, indicating no physiological effect. Of 126 studies found 98% were found to be replications, with 70.4% achieving comparable results, 20.4% obtaining opposite results, and 9.2% no results. With these results, the null hypothesis can be firmly rejected. In terms of raw numbers 28 experimental models were replicated, 24 with comparable results, 12 with no effect, and 6 with opposite effect. Five models were externally and independently replicated with comparable results.

Within this paper we can clearly see definite progress in the in vitro science of Homeopathy. A previous publication in 2007 found similar ( though lower numbers) of results, with a notation that both high quality trials do show effects and that no model was universally reproducible yet.

The issue of methodology looms large in this field of research. To understand this we will follow the ongoing and fascinating saga of one research model’s development, the Basophil model.

The Basophil model of research in Homeopathy began by accident, when a laboratory assistant of Jacque Benviniste, used a wrong (diluted) preparation of Immunoglobulin E, which caused a reaction ( degranulation) in the basophils it was administered to. Beneviniste noticed this phenomena, and began experimenting with it. He discovered that agitated dilutions performed better than simple dilutions, and this drew a strong parallel with Homeopathy, which was much more salient in French medicine than in North America. Beneviniste shared his research with 4 labs throughout the world, which managed to replicate the results.

Beneviniste published his paper in Nature, and it was accompanied by an unprecedented editorial, urging a suspension of judgement over the results, and distancing the editorial team from the research. Subsequently, the magician James Randi (who is not, despite his pretensions, a scientist), and John Maddox and fraud expert Walter Stuart. They, lacking expertise in the technique, in a very small number of attempts, failed to replicate the experiment, and concluded it was a fluke caused by sloppy methods or some other error, ignoring replication having already been done by several skilled teams throughout the world.

Several other teams attempted to replicate the findings, with mixed results. According to a lacture by Dr Peter Fischer, the experiments were replicated about 30% of the time. This was largely to do with the methodology. In Beneviniste’s methods, homeopathic style preparations of Immunoglobulin E were prepared and administered to cultures of basophils. When basophils come into contact with Immunoglobulin E, degranulation is the result. At differing dilutions of Immunoglobulin E, differing rates of degranulation were observed in some cultures, including those beyond avogadro’s number. Numerous factors appeared to be involved in whether basophils degranulated, resulting in the lower 30% reproduction rate.

Not that none of this subtlety in research methodology has ever been reported in the conventional media. Nor has the many replications been mentioned. Beneviniste is still cited as a fraud by many on the basis of a single experiment by non scientists, despite repeated ( though low) replication by other skilled scientists. As I have repeatedly shown (here and here) many organizations opposed to Naturopathic medicine and Homeopathy will use a number of fake news tactics to discredit therapies, despite often very good science in support of them.

Benevinistes model was later modified. As in actual clinical practice, where only people in certain pathological states were found to respond to a remedy, it was found that basophils responded to Homeopathic preparations when in a certain pathological state. Basophils here hence sensitized to pathological stimuli, then exposed to homeopathic dilutions of histamine, and then exposed to an antigen.  The percentage of basophils that degranulated was measured, and found to be lesser in the group treated with Homeopathic histamine. This response did vary with the homeopathic potency of histamine administered, with a bell curve style peak from 15-17C. The main paper with this updated model was published in the journal Homeopathy in 2009.

The advantage of this more complex procedure using presensitization was a procedure which was much more consistent in terms of replication. This model has been replicated repeatedly, one such published replication can be found here. The procedure was, in 2009, replicated by 4 independent laboratories. This number has likely increased considerably in the 9 years since. According to a lecture by Dr. Fisher, this model was about 60% replicable, having far fewer variables influencing results.

The latest methods in this field are achieving consistent and reproducible effects using sensitized organisms, a phenomena that parallels clinical observation in Homeopathy. Interestingly this body of research has confirmed one clinical observation of Homeopathy seen for decades, that of a bell curve. Organisms tend to respond to only a certain range of potentiates, and both higher and lower potencies than their range will produce no results.

This is in strong contrast to the conventional model of pharmacology, which has found S shaped curves far more typically when observing physiological responses to drugs. Drugs, when administered to a responsive system, typically have a threshold below which they have no activity, followed by a phase in 800px-Función_sigmoide_02.svgwhich small increases or decreases in concentrations of a drug cause massive changes in activity, followed by a plateau in which the effects of a drug do not increase very much, compared with the rapid phase. These two curves are displayed in the figure to the right. S curves are shown in blue, and bell curves in red.

This contrast has fascinating ramifications. The first being that Homeopathic medicines do not act like crude drugs, that there is a fundamental activity, profoundly based on the amount of potentisation and triturations, that exerts a physiological effect on the body, independent of chemical constituents. This implies a number of factors playing into biology that have very little understanding within modern biology. A number of profound biological and medical discoveries await for those brave enough to explore the implications of these data.

In the face of this large amount of research, arguments that Homeopathy has no effect are not sustainable. Those who make such arguments are either ignorant, or are deliberately being deceptive.

To summarize, an available research presentation on the latest Homeopathy research is given below.

Thank you for reading!

Image Credit: https://commons.wikimedia.org/wiki/File:Funci%C3%B3n_sigmoide_02.svg

Crocodilians are one of the least well known groups of terrestrial vertebrates. As such any provings of them would be extremely useful. At the moment, only two Alligatoridae are reasonably well proven. We have a few clinical cases of the Crocodylus genus (each without a known species) and no proven members of the Ca1024px-ChineseAlligatorimanidae, Gharials, or Crocodile divisions of the Crocodilians.

Due to the endangered status of many species, provings of species threatened with extinction should be a higher priority. In particular the Chinese alligator, Alligator sinensis, is critical, as only about 120 remain in the wild. Other endangered species such as the Gharial, Gavialis gangeticus, Orinoco crocodile, Crocodylus intermedius, Phillipine crocodile, Crocodylus mindorensis, Cuban crocodile, Crocodylus rhombifer, and the Siamese crocodile, Crocodylus siamensis, are all endangered as well, and would make excellent candidates for proving.

Photo credit: https://en.wikipedia.org/wiki/Chinese_alligator#/media/File:ChineseAlligator.jpg 

Hi Everyone. Happy Naturopathic Medicine Week 2018.

Every year I use Naturopathic Medicine Week as a reason to summarize whole Naturopathic research, highlighting recent research, and summarizing the overall field. I have decided not to focus on research on individual modalities like Acupuncture, Homeopathy or other specific medicines, but to focus on whole Naturopathic research, as this is what patient’s receive from Naturopathic Doctors, like myself. You can find my previous summary here. Contrary to the Fake News style propaganda used by detractors of our discipline, Naturopathic Medicine does have a wonderful research base of articles attesting to it’s efficacy in treating a number of conditions, many of which will be detailed below. We do not receive the large government subsidies for research that allopathic disciplines do in Canada and the United States, but the research we have conducted using the funding available is impressive.

To start with, for those unfamiliar with Naturopathic medicine, here is a great introductory video!

Naturopathic care in Cardiovascular disease was recently examined in a clinical trial. 246 postal workers received Naturopathic care (207 completed the study) in addition to normal family medicine from their MD. Lab chemistry was taken before and after Naturopathic care,and their risk of a major cardiovascular even was computed using the Framingham Risk Score method of computing the likelihood of a Cardiovascular event,  and the Adult Risk Panel III to compute the prevalence of metabolic syndrome. One group in the study received Naturopathic care plus normal medical care, and another received only normal medical care. In this study a highly significantly reduced risk of a major cardiovascular event (risk reduction in control group of 10.81, risk in Naturopathic group of 7.74% for a reduction of 3.07%) and a reduction of metabolic syndrome (48.48% control group, 31.58% Naturopathic group for a reduction 16.9%).

This data was further analyzed in another paper for the economic impact of Naturopathic treatment. The above trial resulted in (corresponding to a 3.3% decreased risk of a Cardiovascular event) in a savings of $1138 in costs to society and $1187 in employer costs per year of Naturopathic treatment. The cost savings of livelong Naturopathic care that could be speculated on based on this remain staggering.

In response to this trial, this MD in CMAJ endorsed the idea of delegating some aspects of Cardiovascular care from Medical to Naturopathic Doctors. Many MDs would oppose this, but a significant minority of our Allopathic cousins would gladly cooperate with us in patient management.

Diabetes has also been examined in this way. In one trial, shown here, showed 65% of patients achieving a favorable outcome with 19% being able to stop antidiabetic medications completely. Furthermore, this trial clearly linked this to the Naturopathic intervention, with a 0.4% reduction in HA1C shown with with poor compliance to the interventions, 1.1% with moderate compliance and 1.7% with excellent compliance. For those who do not know, HA1c is a measure of glycated hemoglobin, a long term measure of blood sugar levels. Higher levels indicated higher chronic blood sugar. A second trial, shown here, in which not only did patient compliance and self care improve significantly, but HA1c also decrease relative to conventional care only at 6 and 12 months, although non-significantly.

I uncovered two other smaller studies on childhood otitis media, or middle ear infections . In the first study, 103 children with otitis media were treated with either a proprietary herbal product, or with an anesthetic and pain was assessed with a visual and an analogue scale over 3 days. Both groups resulted in very similar statistically significant reductions in pain. In the second study 171 children with ear pain were given either an anesthetic. While results were thought to be mostly due to time, the herbal ear drops did report a better outcome/

Naturopathic care of anxiety has a number of trials available now. In the first, published in 2009, 81 participants were randomized to recieve either Naturopathic care of a standardized Psychotherapy treatment. Thier symptoms were tracked with the Beck Anxiety inventory, the Short form-36, Fatigue Symptom Inventory, and MYMOP forms. The patient retention was high ( 75%) for at least 8 weeks. Both treatments resulted in highly significant reductions of the Beck Inventory. However, the Naturopathic treatments resulted in a highly significant ( p<0.003) reduction in anxiety relative to the standardized psychotherapy.

In the second more recent trial 112 patients from a Naturopathic community health centre in King County Washington were followd while undergoing Naturopathic treatment for depression and anxiety. Their initial and ending GAD-7 and PHQ-9 scores (both standardized questionaires to measure anxiety and depression respectively). The patients responded wonderfully, with a reduction of about 50% of their scores (depression average scores: 16.4 initially to 8.4, Anxiety average scores: 12.4 initially to 7.2). these results were highly statistically significant (p<0.0001).

Another Clinical trial on the Naturopathic treatment of rotator cuff tendonitis was recently published. In it, a group of postal workers with diagnosed rotator cuff tendontis received either a stanrd set of physiotherapy exercises to do on thier own (an approach not unlike that which many MDs in family practice will use before a physiotherapy referral) as well as a matched placebo. Pain was measured using Shoulder pain and disability index scores, visual analogue pain score, Short form 36, and MYMOP. 87% of participants completed 8 weeks of treatment, SPADI scores decreased by 54.5% (p<0.0001) in the Naturopathic care group and 18% (p<0.0241) in the Exercise group. All measures showed significant differences in favor of Naturopathic care, with SPADI showing a difference probability of <0.0001 and no major adverse outcomes reported.

In a similar trial 75 postal employees with back pain greater than 6 weeks duration were given either Naturopathic medicine or standardized exercises ( again similar to what they might recieve at an MD practice) for 12 weeks. Progress was measured using the Oswestry disability questionaire, as well as the SF-36, lower back range of motion, weight loss and BMI. 92% completed at least 8 weeks of treatment. Back pain reduced significantly in the Naturopathic group (-6.92 on Oswestry, p<0.0001) and all other measure improved significantly as well.

The above trial was analyzed for economic impact. In the analysis, employees experienced 9.4 more perfect health days and reduced societal ( read employer) costs of $1212 per participant over the course of the study. The intervention cost $154 per day, compared with lost productivity costs of $178 per day, representing a return on investment of7.9%. Individuals participating saved $1096 each. Again this was from a single course of treatment. Imagine the cost savings applied society wide, particularily in countries like Canada with socialized medicine.

Another small Indian study showed significant improvements in PEFR, VC, FVC, FEV1, FEV/FEC%, MVV< ESR and Absolute Eosinophil count in Asthma patients undergoing a Naturopathic and Yogic treatment regimen.

In another study, patient outcomes from Naturopathic and Allopathic medical practices were compared in the treatment of menopausal symptoms. Consistent with other research, Naturopathic patients reported higher income, lower rates of smoking, higher rates of exercise, but interestingly, greater rates of fatigue, insomnia and hot flashes. Both patient groups resulted in improvements in anxiety, hot flashes, vaginal dryness and menstrual changes. Significantly better results were found in insomnia and fatigue.

One study was done on patients with Autism, 67 patients ranging from 3-58 years were given supplementation, with additional naturopathic treatments, such as enzymes, carnitine, epsom salts baths and a diet free of gluten, casein and soy. Lab results show a significant improvement of blood nutrient levels, and nonverbal IQ and autism symptoms also significantly improved.

Another study examines Polycystic ovarian syndrome patients who had undergone a Naturopathic and Yogic regimen for 12 weeks. 25 patients were given the intervention, while 25 others were placed on a wait list. Significant changes were observed in ovarian morphology and body measurements.

Recent Indian research has focused on a number of areas of integration of Naturopathic medicine and conventional care. This paper reviews the multiple ways many Naturopathic agents can aid in modulating cell signalling pathways in cancer. Another paper shows a similar conclusion, with Natural compounds showing great promise in decreasing resistance to one method of cell self destruction in cancers.

Much recent research has focused on the types of patients Naturopathic Doctors see. In one recent study a survey of 300483 visits to a Naturopathic teaching clinic was examined. It was found that Naturopathic clinics saw a similar range of problems to other primary care practices, that patients paid out of pocket more (unsurprisingly) and that Naturopathic clinics offered discounted care far more often.

Another recent study discussed characteristics of Pediatric patients coming to CCNM, a Naturopathic college in Toronto. Furthermore, a cross section of Naturopathic patients as a whole at CCNM was done, showing the incredibly wide variety of issues people come to Naturopathic Doctors with.

Another fascinating direction of research has emerged in the applications of Public health models of research to Naturopathic care, rather than more allopathic models a potential research enterprise with much potential. Another study measured the characteristics of rural Naturopathic practice in Australia, showing the important role played by naturopaths in the provision of underserved rural populations. Another study showed a high level of patient and staff satisfaction resulting from integration of Naturopathic medicine into an acute care hospital.

Perhaps most intriguingly in our survey of research is this paper, published in the Indian Journal of Medical Ethics. India is in the slow process of constructing a healthcare system of Universal coverage (often jokingly termed Modicare after the Indian Prime Minister Narendera Modi). Unlike in Countries such as Canada which have  long traditions of public medicine that were built during the low point of Holistic medicine, in the 1960s, India likely will be including all systems of medicine in it’s public scheme, along with allopathic care. AYUSH is the term in India used for such systems, including Ayurveda, Therapeutic Yoga, Unani, Sidda, Homeopathy and Naturopathy. The above mentioned paper examined the AYUSH systems in light of a report on the Principles of Universal Care produced by the Planning Commission of India. In that paper, the authors conclude that not only does AYUSH meet the standards the India government wishes to see in it’s Universal system, they would actually further it’s goals more effectively in many cases than Allopathic care alone would be able to.

 

 

 

Hi Everyone. This post has been brewing for a considerable period of time. I have decided to release it finally, rather than have the same conversation with people, over and over again, about the evidence base of Homeopathy.

In short: Homeopathy does have an evidence base. This evidence base is, when taken as a whole and evaluated in light of the way Homeopathy is practiced, positive. Homeopathic methodology does indeed contain many aspects which makes evaluating Homeopathy in a clinical trial difficult, but these problems are slowly being overcome through improved clinical methodologies. Other lines of evidence supporting Homeopathy include laboratory studies and historical records of Homeopathy’s use, particularly in infectious diseases.

Now to begin, clinical trials are the standard method by which modern Allopathic medicine evaluates the outcome of most interventions, and have been taken up by other branches of medicine as well. This method is, on the whole, designed to compare a treatment, and a non treatment (often termed a placebo) a treatment deliberately calculated to be ineffective. The results are numerically calculated in some way and compared to one another using a number of statistical tools. Results are either statistically significant (i.e. found by the methods being used to be greater than what would occur by chance) or statistically insignificant (found by methods to be within the bounds of what would occur by chance).

Homeopathy has been evaluated by means of clinical trials for hundreds of years. However the nature of Homeopathic prescribing, the deeply detailed nature of casetaking, the therapeutic nature of casetaking itself, and the multiple adjustments and refinements of potency needed during therapy, which makes placebo control difficult all combine together to make clinical trials challenging to undertake for genuine, pure Homeopathy. Methodological refinements have indeed been made to the clinical trial procedure over the past several difficulties, but they have not been completely successful, often creating outcomes in which the controls of a clinical trial result in data which are less than what one would expect from clinical practice.

Within the basic framework of a clinical trial, many variables can influence results, biasing the results in a particular direction. The kinds of influence have been assessed by researchers over the years, and tabulated. Several such measures exist, but the one in this link is particularly widely used.

Homeopathy has been examined by multiple clinical trials to determine efficacy throughout the years. Many of these trials have been negative. Many have been positive, until recently, the compilation of the data from these trials had not been done in such a way as to examine the validity of Homeopathy as a whole. Recently however this strategy has been adapted. Termed a Meta-analysis, this method has been used in a number of fields with sufficient research, allowing for larger conclusions to be drawn. I will go through them, followed by a summary table at the end of this discussion.

The first meta-analysis was preformed in 1991 by Kleijnen and published in BMJ. It found, in the small amount of clinical trials available at the time, a positive result.

The next meta-analysis was published in the Lancet in 1997 by Linde. Of 185 trials found, 115 met inclusion criterea, with 89 having adequate data for inclusion. Linde did not differentiate methodology, but pooled studies of all varieties of Homeopathy regardless and found an Odds ratio of 2.45 (with a 95% confidence interval of 2.05-2.93). This is a strongly positive result.When corrective factors for publication bias were added, the odds ration decreased to 1.78 (1.03-3.1), weaker but still positive. Analyzing only high quality trials resulted in results of 1.66 (1.33-2.08). Linde was repeatedly criticized for lumping data of different quality together, and for lumping together trials of individualized and nonindividualized homeopathy, so further studies were conducted.

Ernst also conducted several reviews in this period this first (Ernst E: Are highly dilute homeopathic remedies placebos? Perfusion 1998;11:291.) purported to reanalyze Linde’s 1997 analysis in light of criticisms that it evaluated many conditions, included nonindividualized trials, and include lower potency preparations that could potentially contain molecules of the original product.His analysis of the, in his view, higher quality studies, shows an odds ratio of 0. Hahn has criticized this study as including only 5 studies, and thus far less valid than Linde’s original 1997 analysis, despite it’s flaws.

In 1998 Linde conducted a study of clinical trials of individualized Homeopathy. he found a number of methodological and quality issues, but pooling the data regardless, found a positive result with an odds ratio of 1.62 (95% CI 1.17-2.23). However, when the analysis was restricted to only higher quality trials, no significant effect was seen, though a positive trend was observed Odds ratio of 1.12 (0.77-1.44). As discussed above, the many issues in clinical trials of Homeopathy at the time, make this conclusion not terribly surprising, though this problem is remedied in more current research. Linde explored this in a subsequent article in 1999 exploring the effect of trial quality on effect size in Homeopathy studies. He found that higher trial quality often produced smaller effect sizes. This is important, as many critics seized upon this as proof of lack of efficacy of Homeopathy, forgetting that other research has shown this effect to be consistent throughout medical research ( ie not a specific problem to Homeopathy).

In 2000 Ernst again published another Meta-analysis, in which he criticized Linde’s 1998 analysis as flawed due to the weaknesses of the studies used. His response was to extrapolate trends based on Linde’s 1999 study of trial quality, and suggest a linear trend (when in fact the data is asymptotic), that trials with a perfect quality would theoretically move towards results of 0. This is strongly criticized by Hahn as prioritizing imagined and extrapolated data over real data, particularly bizarre when he had access to the real data.

The next meta-analysis was preformed by Cucherat et al in 2000 and published in the European Journal of Pharmacology. It took 118 trials, judged 16 to meet inclusion criteria, and then combined p values together to form a grand p value, an extremely unusual method of analysis, one which Hahn notes to be likely to give the least favorable statistical result to Homeopathy). Despite this odd method of analysis, the results of the analysis were positive with a grand P value of <0.000036 (i.e. the results had a less than 3.6 out of 100 000 chance of being due to chance). Studies with less than 10% dropouts had a slightly lower p value of 0.084 (8.4 out of a 1000 chance of being due to placebo) and studies with less than 5% dropout had a p value of 0.082, on marginally above the generally accepted threshold for statistical significance. However this standard was extraordinarily rigorous, with dropout rates of less than 20% being commonly accepted as adequate.

The next Meta-analysis of Homeopathy as a whole was Shang, published by the Lancet in 2005. This study took an extraordinarily bizarre approach of choosing 110 randomized controlled double blind trials, and then “matching” them to 110 comparable allopathic trials, with some high quality Homeopathy studies being excluded solely due to a comparable allopathic trial not being able to be found. The data in these 110 trials were not combined to creat an odds ratio. Instead the data from all but 21 trials of Homeopathy were excluded due to unspecified quality measures. The authors then excluded, for unclear reasons, all but 8 trials and came up with an insignificant odds ratio of 0.88 (0.65-1.19). Fascinatingly, the identity of these 8 studies were not listed in the original publication, but were released several months later, after the media circus around this result had died down. Skeptical organizations created a vast amount of propaganda using what we now call Fake News something we will also see occurring with the more recent NHMRC report. In both cases, the subsequently revealed errors were not reported in either the popular or skeptical presses.

These results have been heavily criticized by Homeopaths and statisticians, with the overall opinion that this trial should not have been published. These arguments are summarized by the Homeopathy Research Institute, but the most significant perhaps belong to Ludtke and Hahn. Ludtke analyses Shang to find that the results gained out of his analysis are highly dependent on the subsection of trials selected, with his results being almost entirely due to a single large nonindividualized trial of Homeopathy. Hahn comments that the funnel plot tool used by Shang is completely inadequate to evaluate treatment effects in different medical conditions and that in order to reach his conclusions of Homeopathy lacking effect beyond placebo, 90% of clinical trials must be excluded. In fact, it has been determined by Ludtke, that if Shang had included all 21 higher quality trials, even with his bizarre selection criteria, he would have found a statistically significant effect greater than placebo.

The next major metanalyses of Homeopathy was in 2014, by Mathie, published in Systematic review. It included all available RCTs, and rated all of them with several quality assessment measures. Unfortunately, again likely due to methodological issues, no trial rated as no risk of bias in all domains. However the trials that had low or unclear risk of bias in one domain were analyzed. 22 trials were had extractable data, and were subject to analysis creating a significant odds ratio of 1.53 (1.22-1.91). Restricting the analysis to trials rated as reliable evidence created an even higher odds ratio of 1.93 (1.16-3.38). This is explained wonderfully by Mathie himself in the following short presentation:

This analysis stands at the present day (April 2018 as of writing) as the most current, complete and unbiased of all reviews of Homeopathy. The low quality of evidence does merit caution, but the results do clearly indicate that the existing data do suggest that Homeopathy has an effect greater than placebo. This is the current state of the evidence from clinical trials, and to deny this is to go against the existing data.

Ernst has criticized the results as excluding one of his own trials. Mathie graciously explained on Ernst’s blog the exclusion criteria, but added Ernst’s data to his despite not meeting the criteria, finding the same results. This is published in a pdf separate from Mathie’s original article.

The next, and probably lowest quality of analysis is the NHMRC review done in 2015, commissioned by the Australian government to evaluate the evidence of Homeopathy. This review has a number of methodological problems, which have been summarized expertly by the Homeopathy Research Institute. I will summarize them as follows (and much gratitude to HRO for presenting these points so succinctly):

  • NHMRC did the review twice
  • The first review, and even it’s existence, was not disclosed to the public
  • the NHMRC, upon questioning, responded that the first review was low quality despite being conducted by the individual responsible for developing NHMRC’s guidelines on how to conduct evidence reviews
  • FOI requests confirm that a member of NHMRC, Fred Mandelsohn, confirmed the first review to be high quality stating ““I am impressed by the rigor, thoroughness and systematic approach given to this evaluation [….] Overall, a lot of excellent work has gone into this review and the results are presented in a systematic, unbiased and convincing manner.” 
  • NHMRC stated their results were based on over 1800 studies, when in fact they were based on only 176
  • NHMRC has used a method which has never been used in any other review, declaring that only trials of over 150 participants would be accepted, excluding the vast majority of high quality homeopathic trials, which due to lack of funding tend to be smaller, and despite the fact the NHMRC routinely conducts studies of less than 150 participants
  • The above rules resulted in exclusion of 171 of 176 studies, leaving only 5 to be used as the basis of the study
  • The chair of the second review, Peter Brooks, signed a conflict of interest form declaring himself “free from any association with any organization whose interests are either aligned or opposed to Homeopathy” when he was a member of the anti homeopathy lobby group “friends of science in medicine”
  • The NHMRC review included no homeopaths or experts in Homeopathy research, despite the NHMRC guidelines requiring such an inclusion

Rachel Roberts of the HRI presents this set of circumstance expertly in the video below.

The evidence against the NHMRC in frank academic bias and misconduct is so strong the HRI is pursuing a complaint with the relevant Ombudsman in Australia. The initial investigation has found sufficient evidence to warrant a full investigation of NHMRC’s conduct, which is ongoing.

The Skeptical media had a field day with this study, producing a deluge of articles and media misrepresenting the conclusions of the NHMRC review and using Fake News strategies to expand it’s reach to multiple audiences. The subsequent faults and criticisms of this report, and it’s current status of being investigated by the government has gone unreported.

The most recent metaanalysis of Homeopathy was done by Mathie in 2017, and focused on all nonindividualized trials of Homeopathy. This study focused on Randomized, double blinded control trials of nonindividualized Homeopathy, and found 75. 48 trials had high risk of bias, 23 uncertain and 3 had low risk of bias and were listed as reliable. The standard mean deviation was the measure used. 54 trials had extractable data and pooled data shows a SMD of -.33 (CI -.44,-.21) which was statistically significant. Adjusting for publication bias this was adjusted to a still significant -0.16(CI-.46, -.09). Reliable data resulted in an insignificant result of -.18 (CI -.46,+0.09). This result has gone unremarked in the greater skeptical literature on Homeopathy, despite both major negative reviews of Homeopathy (Shang and NHMRC) failing to differentiate these two types of studies.

Skeptical organizations and their sympathizers in the media have utilized the flawed negative studies, presented them without context, and used them as a justification for their already held conclusions that Homeopathy has no effect greater than placebo. This is not just a problem with skeptical organizations, as much of science journalism suffers from similar issues. Skeptical organizations however have embraced Fake News tactics in order to spread their message, having just as much culpability for the modern state of disinformation as other sponsored state actors using those same tactics to advance their political goals.

Metaanalysis Results
Kleijnen 1991 All Types Homeopathy. Positive trend regardless of type of Homeopathy. 81 trials positive, 24 no effect.
Linde 1997 All types Homeopathy. 185 trials, 115, included, 89 data extracted Odds ratio of 2.45 (95%CI 2.05-2.93)
Ernst 1998 Individualised Homeopathy, OR of 0 conducted on 5 trials Ernst found to be high quality.
Linde 1998 Individualized Homeopathy. 32 trials. Data from 19 extracted. All trials produced Odds ratio of 1.62 (95% CI 1.17-2.23). Only high quality trials produced no significant trend.
Cucherat 2000 All types of Homeopathy. Unusual method of combining p values together. All trials p< 0.000036. Less than 10% dropouts p<0.084, less than 5% dropouts (higher standards than most trials considered reliable) p<0.08 (nonsignificant)
Shang 2005 All types Homeopathy. 8 trials selected from 21 high quality trials of 110 selected with unusual criteria. OR of 0.88 (0.65-1.19). Result strongly disputed by Statisticians.
Mathie 2014 Individualized Homeopathy. OR of pooled data from all higher quality individualized double blind, randomized controlled trials. Found Odds ratio of 1.53 (1.22-1.91) for all trials pooled, and 1.93 (1.16-3.38) in reliable trials.
NHMRC 2015 Negative results. Used unprecedented methods, did not combine data, and currently under investigation for outcome shopping.
Mathie 2017 Nonindividualized Homeopathy. Very few higher quality trials. All trials with extractable data had SMD of -.33 (-.44, -.21). Adjusted for publication bias -.16 (-.46,-.09). High quality trials had nonsignificant results of -.18 (-.46, +.09).

Conclusion:

This blog post reviews all the relevant meta-analyses of Homeopathy as a whole preformed. All meta-analyses preformed in at least a somewhat open and rigorous manner have found statistically significant effects suggesting Homeopathy has a greater than placebo effect, or at least a strong trend in that direction. The meta-analyses with questionable methodology, one of which is undergoing government investigation for academic irregularities, found negative results, which have been demonstrated to be a direct result of their exclusion of vast swathes of the Homeopathic clinical trial literature based on arbitrary and unexplained criteria.

The clinical data are flawed. Issues with methodology of randomized controlled clinical trial use in Homeopathy, combined with a lack of research funding have produced a lack of high quality trials and data. However, the data we have point towards Homeopathy having an effect greater than that of placebo.

There can be no argument with this conclusion, aside from new data emerging. Anyone who disputes this is going against the existing set of highest quality evidence on Homeopathy.

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