What Is It?
Proponents of homotoxicology (also sometimes known as “complex homeopathy”) present it as an advancement or improvement in homeopathy, one that is more scientific and compatible with conventional medicine than classical homeopathy. It can more accurately be seen as a faction or sect that has split off from mainstream homeopathy with quite different, but equally unscientific, theories about the cause and treatment of disease.
Like classical homeopathy, made up by Samuel Hahnemann in the 19th century, homotoxicology was largely invented by one man, a German homeopath named Hans-Heinrich Reckeweg. Just as Hahnemann created many of the founding principles of homeopathy without regard to contemporary or modern scientific principles, so Reckeweg apparently invented the fundamental principles of homotoxicology. These principles continue to be assumed true by practitioners of homotoxicology, with all subsequent elaboration of the theoretical and practical aspects of the approached being based on these unproven, and implausible ideas.
The core concept of homotoxicology is the “discovery” of yet another One True Cause of all illness. Reckeweg decided that all illness is a manifestation of the body’s struggle to eliminate toxins. As he put it,
According to homotoxicology, all of those processes, syndromes, and manifestations, which we designate as disease, are the expression thereof that the body is combating poisons and that it wants to neutralize and excrete these poisons. The body either wins or loses the fight thereby. Those processes, which we designate as disease, are always biological, that is natural teleological processes, which serve [as] poison defense and detoxification.
Reckeweg went on to describe an elaborate model of stages of detoxification, each with characteristic symptoms, and an encyclopedic list of treatments for particular symptoms dictated by this model.
This is a variation of a popular notion among purveyors of alternative medicine, that disease can be attributed largely to “toxins” and that “detoxification” is the goal of healthcare. The notion is appealing because our innate emotional mechanism of disgust prime us to view things in our environment with certain physical characteristics (strong smells in particular) and things associated with illness, as potentially harmful. To this we add the notion of contagion, a category of sympathetic magic, which suggests that such things can harm us even when distanced from their source. These intuitive concepts make us susceptible to the idea that the symptoms we have and diseases we experience are the result of exposure to contagious, toxic substances. “Miasmas,” “bad air,” and many other vague sources of contagion have been posited as the cause of illness in periods or cultures without a detailed scientific understanding of the mechanisms of common illnesses.
At first glance, these ideas make some sense. There are, of course, infectious and toxic substances in nature which can make us ill. And prior to the development of a scientific understanding of the mechanisms of infection and poisoning, the general tendency to avoid anything which triggered our disgust mechanisms or which was associated with illness in some way was a reasonable precaution. However, this logical foundation cannot support the elaborate and fanciful structures built on it by those who promote the general principles of “toxins” as the cause of all disease. The fact that toxins and infectious organisms cause some disease does not logically mean that they cause all disease, nor does it lend any legitimacy to the proposed methods of “detoxification” often promoted. The kind of vague and mythologized notion of “toxins” behind homotoxicology and other “detoxifying” therapies has no legitimate scientific basis.
The model and practices of homotoxicology overall are a prime example of a pseudoscience, and the marketing of this approach includes many warning signs associated with pseudoscientific therapies. Abundant scientific terminology is employed, often with no clear, specific meaning or recognizable association with how such terminology is used by conventional science. All kinds of things are labeled as toxins, including infectious organisms, true toxic chemicals, substances assumed but not proven to be harmful, and the normal products of metabolism. No rigorous effort is made to demonstrate the assumed relationship between specific substances, the body’s mechanisms for eliminating them, and the course of particular diseases. All of this is simply accepted based on Reckweg’s initial insight and the personal experience of subsequent practitioners of homotoxicology.
Likewise, the choice of remedies for the presumed consequences of the body’s struggle to eliminate toxins is not based on any rational, scientific foundation. While practitioners often accept conventional diagnoses and monitor their patients with the usual tests, the scientific understanding of the conditions treated is not involved in selecting or applying therapy. The remedies used are mostly homeopathic, though they are sometimes made and applied in ways contrary to the principles and standards of classical homeopathy. Remedies are combined rather than given singly, they are often given by injection rather than orally, and they are often less extensively diluted than many homeopathic products.
The instructional materials produced by the company Reckweg founded, Heel Inc., explain in exhaustive detail the use of particular remedies for many conditions. However, the links between the conditions as defined in conventional medicine, the theories invented by Reckweg, and the particular products Heel makes are not made in these materials or elsewhere. There is a lot of smoke and mirrors, including extensive use of technical scientific language and references to in vitro research and basic biology and chemistry not directly related to the methods or claims of homotoxicology. But no clear, direct, consistent, or convincing evidence is provided to support the use of particular remedies for particular medical conditions, only a few in vitro studies showing some possible effects of some preparations.
Because some remedies used in homotoxicology are not ultradilute homeopathic preparations, it is possible that they contain biologically active compounds. These products may be a bit more like herbal remedies than true homeopathic remedies. However, as with herbal remedies, the presence of potentially active chemical compounds doesn’t by itself indicate safety or effectiveness. A plausible mechanism, in vitro and in vivo evidence of bioavailability and measurable effects, evidence concerning side effects, clinical trial evidence of safety and efficacy, and reliable standards for quality control are all necessary to demonstrate a treatment is beneficial and appropriate for general use.
Does It Work?
There is little reliable published research in humans on the clinical application of homotoxicology. A systematic review of the scientific literature found 7 trials with methodologically sound design, of which 6 reported positive results. No two trials looked at the same condition, so there was no replication to demonstrate a consistent, repeatable benefit. There was also a considerable risk of bias which was not controlled for in these studies. Almost half included authors who worked for the company making the remedies studied, and others were funded by this company or published in the Journal of Biomedical Therapy, a publication specifically created by the company to promote its approach and products. Often these potential sources of bias were not disclosed by the authors of the studies.
It is well-established that industry-funded research is more likely to show positive results than independently funded studies regardless of the honest intentions of investigators. It is also clear that negative results are less likely to be published than positive results and industry created journals are untrustworthy marketing organs, not real scientific journals. Such sources of bias are loudly and justly identified when the products of the conventional pharmaceutical industry are at issue. Yet proponents of alternative medicine often seem willing to overlook them when discussing the products of dietary supplement, herbal remedy, or homeopathic remedy manufacturers. In the absence of the strict government oversight that is applied to the pharmaceutical trials, the limited and likely biased evidence produced by proponents and manufacturers of homotoxicology products is simply not reliable.
It is also worth noting that Heel Inc. (under a variety of names) has repeatedly been sanctioned by the Food and Drug Administration for violating the laws and regulations governing the marketing of homeopathic medications. From 1984 through 2005, the FDA has issued multiple warning letters and attempted to ban importation of Heel products due to illegal marketing claims. This sort of behavior further undermines the validity of the limited and already questionable research and marketing information this company supplies. The unfortunate reality is that the manufacturer of these remedies is the main source of information about the safety and efficacy of their own products, which is a far worse example of the fox guarding the henhouse than even the case of the conventional pharmaceutical industry.
Few veterinary studies of homotoxicology methods or remedies have been published. Unsurprisingly, uncontrolled case reports from proponents claim significant benefits. A published study of one Heel Inc. product for arthritis in dogs also claimed a positive result, but close analysis of the study identifies a number of methodological problems and questionable manipulations of the data, though at least there did not appear to be a significant issue of industry influence in this study as in most of the research in humans.
Overall, there is insufficient clinical trial data to clearly establish the effectiveness of homotoxicology treatments for any particular condition. This does not, of course, prove such treatments are not effective, but in consideration of the implausible theories, lack of cogent preclinical evidence, and abundant evidence against effectiveness for classical homeopathic remedies, this lack of evidence does call for significant skepticism. The existing evidence clearly does not justify the confident claims of benefit made by advocates of this approach.
Is It Safe?
I am not aware of any reports of direct harm from homotoxicology treatment. For hose remedies which are ultradilute and contain no active ingredients, as is the case for classical homeopathic remedies, there is clearly no risk of direct injury. Since some products used in complex homeopathy may contain active compounds, however, there may some risk of adverse effects, drug interactions, and allergic reactions.
The absence of any evidence of harm is not really a positive sign in one sense, since it is almost certainly evidence of the absence of any real effect. Side effects don’t occur because “drugs” are bad but because any treatment that has a measurable effect on one part of a complex living system will certainly have other, unintended effects on other parts of that system. If there are no possible risks, there can be no possible benefits. The key to evaluating the safety of a medical therapy is to balance risks and benefits, and though the risk of direct harm is probably little to none for these products, there is also little evidence of any benefit.
Of course, there is certainly risk of indirect harm if homotoxicology is used in lieu of established medical treatments. Many people have been harmed in this way by classical homeopathy. It appears that Heel Inc. and many practitioners of homotoxicology do not recommend their treatments as replacements for conventional therapy, but as adjuncts or as treatment for conditions in which conventional therapy has not been successful. Though it is not at all clear that such uses add any benefit, it seems unlikely that they do any harm.
The theoretical foundation of homotoxicology, that all disease is an expression of the body’s fight against toxins, is not scientifically valid. The remedies used are predominantly homeopathic, and while the ultradilute ingredients are highly unlikely to have any biological effects, there may be active chemical compounds in the less dilute preparations. There is no consistent, reliable preclinical research validating the potential effectiveness of most remedies used in this approach, though isolated studies show some in vitro effects for some preparations. The limited clinical research in humans is mostly associated with a major marketer of homotoxicology remedies and so is at high risk of bias. The even more limited veterinary research is weak and unconvincing. Additional clinical research does not seem justified until the validity of the implausible theoretical foundations of homotoxicology is established through preclinical study. There does not seem to be a significant risk of harm from homotoxicology treatment so long as it is not used in lieu of established therapies.
I am a small animal practitioner currently looking into ‘alternative’ modalities to incorporate into my practice. I too was trained in the Scientific Method, that evidence-based medicine is the foundation of what we practice, and that n=1 does not a convincing argument make. Further, I am wary to the “my sister’s cousin’s friend’s aunt said she tried modality X and it worked for her”, client-borne urban legend. That being said, my skepticism in the way we were trained in veterinary college comes from realizing who paid for my ‘training’. I paid my share – but the buildings, and the faculty salaries, the high-profile research projects were funded by Hills Pet Nutrition, Merial, Pfizer, Bayer etc. So where would unbiased evidence-based medicine in support of ‘Alternative’ therapies originate from? Who would pay for it? Who stands to make millions of dollars should it be proven valid? I cannot imagine Hill’s paying for a large scale, publishable study of raw food diets, or Merial funding an examination of nosodes. I am not trained in any alternative therapy, and am not trying to defend them – I have no cause to at this time. I just feel like my education was shaped by industry mandate, and funded by major pharmaceutical and veterinary nutrition company goals at heart. The reason I approach your blog, is solely for the EBM question with respect to complementary modalities. Who would pay for the large-scale, unbiased studies you would require in order to feel that Alternative Medicine was finally Evidence-Based? – Or conversely, the evidence that its proponents could look to in making informed decisions to no longer support gypsy, foo-foo science?
You hit on a significant problem for veterinary medicine. There is evidence in human medicine that clearly shows a variety of biases in the literature associated with funding source, and clearly some studies will not even get done as a result of the lack of profit potential when industry is the primary source of research funding. On the other hand, there are some studies that should not get done because it is unethical to waste resources on something that is already disproven (e.g. homeopathy) or things that can only work if the fundamental principles of physics are wrong (e.g. Reiki). But I agree that there is undoubtedly a problem with the reliability of the scientific literature when for-profit firms fund most of the research. Politically, I’m in favor of more government funding, but we “liberals” lost that battle decades ago, so we have to work with what we have.
The question, then, is what do we do? The proponents of alternative medicine say, essentially, “Give up! Anecdotes/history/tradition/theory/etc. are all we need.” I believe the scientific researrch we do have is still better that that approach, and we must not make the perfect and unattainable the enemy of the good. There are many methodological ways to minimize bias (study design, pre-registration of studies and primary endpoints with mandatory disclosure of all data in public registries, replication by investigators with competing biases, etc). We cannot eliminate bias from researech, but we can control it much more effectively than the bias inherent in anecdotal data, history and tradition, and the justifications used in the absence of or in opposition to scientific research data.
And in any case, EBM is not a position that says we must have large-scale RCTs for every treatment before we can use it. That is a common misconception. EBM is the explicit, formal appraissal and acknowledgement of the evidence we are using and its limitations, and a preference for the best evidence available. If there is a good RCT, flawed as it undoubtedly will be, it still is mmore reliable than a case report and should be given precendence. If there is nothing but case reporst, we can still make use of a therapy, but we are obliged to recognize that little confidence is justified in the outcome. And informed consent means we are obliged to be open and honest with our clients about the limitations in the evidence and the degree of confidence we can legitimately have in our recommendations.
If I have one study funded by the manufactuer of a drug, I may still offer it, bubt I will certainly tell the client that the evidence likely has uncontrolled bias and should be vieed somewhat skeptically. Likewise, if I have a therapy that is impossible without a major revision of basic science and which either has no controlled trials or has predominantly negative trial results, I’m going to tell the client that, and I’m going to be far less likely to recommend the therapy. There is no perfect solution, but right now veterinarians rarely explicitly consider the limitations of the evidence they use, they rely far to cmofortably and confidently on low-level and low-quality evidence, and they often don’t give clients an accurate understanding of the degree of uncertainty behind treatment recommendations and prognoses. EBM can improve all of these things even if we aren’t able to improve the evidence bas as much as we would like.
Lynn said: “I am not trained in any alternative therapy, and not trying to defend them – I have no cause to at this time.”
May I ask, what is your interest in “looking into ‘alternative’ modalities to incorporate into (your) practice”? I ask simply because it is a question often gone unanswered when trying to reason why conventional vets delve into alternatives, for what reasons. I can only surmise the questions you put to Skeptvet regarding bias in industry funding, have little to do with your interest in alternatives, feel free to correct me if I’m wrong.