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| Hpathy Ezine - April, 2005 | ||||
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Proving Homeopathy -- Neil D. Shere aka “bach” |
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| Introduction There are two principle research applications of the Randomized Controlled Trial (RCT), in proving efficacy of homeopathic practice. Trials measuring effectiveness of homeopathic treatment of diseases are the most familiar and natural-seeming method, but are nevertheless the more difficult of realization. The second is the proving trial, which focuses on the narrower, and presumably easier to judge question whether the homeopathic remedy has any effect of any sort on the human organism. In short, the proving trial is not directly concerned with healing effects of homeopathy, but with the more foundational question, whether there is anything substantial, or “real,” in homeopathic remedies in the first place. In Part I, following, I will briefly discuss the homeopathic treatment trial, primarily with an aim to identify a few of the key issues that, from the homeopathic point of view, have invalidated trial outcomes in the past. I will not pursue this thorny topic very far, but will be satisfied to identify a few problems that have characterized research trials conducted in this venue to date, in hope that work may begin, in appropriate quarters, to meeting these concerns and to developing more adequate research instruments. In Part II, the main question of this paper will be addressed, namely, how to design an efficacious trial, that is, an RCT that can claim to measure accurately the effects of homeopathic remedies upon trial participants. Although it is normal to speak of a trial measuring the “efficacy” of a medication, I propose that we are justified, in view of the consistent failure of RCTs to measure any effect in homeopathic remedies, to question the “efficacy” of the RCT itself. This section will conclude with a recommendation - astonishing in its simplicity - that, frankly, should guarantee unmistakable evidence, in fully replicable experimental protocols, in proving trials of the future. Finally, in Part III, a number of additional questions will be addressed, that should be kept in mind in designing an appropriate RCT. Together, these considerations, with the recommendations included in Part II, provide a range of parameters that should satisfy any critic, that the perspicacious researcher has fulfilled his obligations, to design and implement a credible scientific trial of homeopathy, by combining – at long last – academic and logical scruples, with his technical and statistical finesse. Part I – Research in Homeopathic Treatment The problem conducting research into homeopathic treatment is at once easy to define, difficult to understand, simple to rectify in principle, and intractable of resolution in practice. The problem can be stated with reference to the by now trite idea, that homeopathy operates according to a paradigm that is different from the paradigm of conventional (“allopathic”) medicine, and cannot be measured utilizing the same research instruments. This seems the most natural statement of fact to the homeopath, but is infuriating to the research scientist, who protests that, if a school of medicine claims to heal, by whatever means, then it ought to be possible to observe the fact that the patient has been healed – which is all the RCT wants to accomplish. In fact, the researcher’s objections are perfectly reasonable. But so are the reservations expressed by the homeopath. And the two positions are not even difficult to reconcile, at least in principle, though once again, the hydra headed monster, practicality, laughs implacably at our efforts to find a direct route to a satisfactory conclusion. Commonly, those skeptical of homeopathic claims will say something to the effect, “let’s design a trial to show that homeopathy can cure high blood pressure.” Of course, any other disease state can be substituted. Immediately, the rejoinder is heard, that homeopathy treats the whole person, that prescriptions in homeopathy are made upon the patient’s totality of symptoms, and not upon a discrete pathological entity. The homeopath concludes, therefore, that it is impossible to test homeopathy in reference to a discrete diagnosis. However, if one considers choice of words more closely, it will be realized that the conventional, or “allopathic” diagnosis, whatever clinical entity is chosen, is but a different way of referencing what, from the homeopathic point of view, would (or could in some cases) be termed the patient’s “chief complaint.” And, in fact, in homeopathic treatment, therefore, one would expect that the chief complaint, or “presenting diagnosis,” would be resolved, or cured, by the end of a successful course of treatment. The problem arriving at that end, in a research trial, is simply that the trial is not individualized. This is easy to overcome, as by now has often been observed: select a diagnostic entity to treat, gather a sample population, and allow the homeopaths to treat their patients according to their own methods, individualizing to their heart’s content. In fact, this should work, though it has not as yet been implemented in a way that would truly satisfy the requirements of individualization, in homeopathic practice. In short, to be successful, there are at least three main requirements, in designing such a trial that must be met, to establish efficacy of the trial, that is, to establish that the trial protocol is sufficient to the task of measuring homeopathic action: First, the homeopaths participating in the study must be adherents of classical methods, of Hahnemannian homeopathy. Such practitioners would pass the ‘test’ of mainstream practice, in adhering to the four basic tenets of classical homeopathy: single remedy, single dose, minimum dose, wait and watch. The reason for insisting on this point, is that there are by now so many variants on classical methods, that we must focus clearly on our task: if we are testing “homeopathy,” then we are not testing combination remedies, preventative homeopathy, homeopathic remedies as specifics, or any number of other derivative practices. This is not to suggest there is no value in such practices, only that, practically speaking, a research trial will show different treatment results, if different treatment methodologies are used. Now, granted, it may be worthwhile to do research into these other methods, and the variable uses to which homeopathic remedies may be put, but that is not the same as testing homeopathy. Simply put, our ideal research trial must define its terms rigorously, and test what it says it wants to test. Second, there can be no limitation upon the homeopath’s choice of remedy. Often, trials such as these are published, with a view to demonstrating efficacy, for example, of Arnica in treating pain. But this commits the cardinal sin of treating a homeopathic remedy as a specific; in this circumstance, even though Arnica is, indeed, well known for its successful application to treatment of pain in some circumstances, it is far from the only remedy to consider and, furthermore, its ultimate selection must be made on the basis not only regarding the chief complaint, but the totality within which that complaint is embedded. Plainly, it must be understood, that Arnica is not as “good,” if by that we mean “reliable,” as aspirin, in resolving complaints of “pain;” but, homeopathy is certainly as good as “aspirin,” that is, if the prescription for pain is individualized, then we have a right to expect success in as “good” a percentage of cases as we get from aspirin, though that will mean we are not limited to prescribing Arnica, but can draw freely from the homeopathic pharmacopoeia. Even here, however, hydra-headed individualization rears it’s ugly countenance: the individualized prescription is more likely to be wrong, than a prescription of an allopathic drug that was, after all, specifically designed to address (suppress) the precise symptoms in question. So, in this circumstance, an efficacious trial must permit the homeopathic prescriber additional time to follow and possibly re-evaluate the case, for a second or even third prescription. Needless to say, this creates interpretive problems, as with an increase in time, more patients are, in fact, likely to show improvement just in the nature of the disease. Third, and finally, there can be no limitation upon the length of the homeopathic treatment. This is true in all circumstances, but more so when the trial is attempting to measure treatment of a chronic problem. The longer standing the illness, the more the patient has been exposed to traditional, suppressive medical interventions, the older the patient, the more complex the case, then very likely, the longer treatment may last, even into years. This is not a circumstance that would be looked at in kindly lights, by those wishing to either fund or implement a research trial. But the fact remains, in homeopathy, the presenting complaint may be the first thing mentioned - and the last thing cured. But individualized treatment means, simply, “individualized treatment,” and that means it lasts as long as it takes. This introduces obvious problems: financial; organizational – holding the research team together for such a sustained effort; participatory – being able to count on the trial participants to “stay the course.” All of these considerations suggest that such a trial would be on shaky ground to begin with. They suggest, further, that to the extent such a trial might be considered, it would be advisable to begin with a study of treatment of acute conditions in a young and generally healthy population. This does not mean that all treatment of all participants can be expected to be completed within 30 days, or even 6 months, but at least could be counted on to lessen the average duration of treatment. Even so, the research scientist, who may not be well versed in clinical practice, should understand at the beginning, that even acute disorders can take root in compromised soil, becoming part of a pre-existing chronic disorder, or susceptible constitution, and this can easily lead to lengthy treatment. Such practical considerations cannot be avoided, even though the researcher complains that they raise potentially insurmountable obstacles. It is the nature of the beast. It can be measured, but not without considerable effort, insight, and patience. Of course, another implication is the fact that the homeopath, “treating” the control group, may after awhile conclude that his patient is in fact taking only placebo, from the lack of any clinical response, good or ill, over a sustained period of time and numerous prescriptions. In this circumstance, it is possible that the trial will come to an early end, by identification of the placebo group, and this, in fact, could form the basis for an interesting, testable hypothesis of its own! In any case, it is fortunate that these complications do not represent the only avenue available, in the pursuit of statistical evidence for homeopathy. Part II – The Homeopathic Proving Trial Once properly understood, there is nothing complicated nor difficult standing in the way of a proving trial for a remedy, that will show favorably for effects of homeopathy. Not the only element, but the key to the matter is this: size of dose. Indirectly, Hahnemann points us in this direction in Aphorism 32: “Every real medicine … acts at all times, under all circumstances, on every living human being, and produces in him its peculiar symptoms (distinctly perceptible, if the dose be large enough), so that evidently every living human organism is liable to be affected…” (Emphasis added). Of course, in the treatment situation, the dose is kept small in order to minimize symptomatic response to the medication (aggravation). Similarly, in provings, the dose starts out small, and is given, according to Hahnemann, “…on an empty stomach, daily from four to six very small globules of the thirtieth potency of such a substance, moistened with a little water or dissolved in more or less water and thoroughly mixed, and let him continue this for several days” (Aphorism 128). Note, however, that already, in the proving situation, Hahnemann has increased the size of the dose, which in treatment situations, as we see repeatedly, he recommends use of a single globule only. Further, if there is no response to the initial dose, in a proving trial, Hahnemann recommends that “If the effects that result from such a dose are but slight, a few more globules may be taken daily, until they become more distinct and stronger and the alterations of the health more conspicuous…” (Aphorism 129). And when the purpose of a proving is simply to identify the symptoms associated with a substance, then Hahnemann is even more specific, in stating that “…in that case the preferable course to pursue is to give … [the remedy] for several successive days, increasing the dose every day” (Aphorism 132). In short, the utilization of relatively large doses, repeated often, is the critical feature of homeopathic provings, as compared to treatment process, and forms the kernel around which credible research trials into homeopathic provings should be built. Note that Hahnemann is seeking more dramatic symptoms, “more distinct and stronger” symptoms, quite the contrary to practice in homeopathic treatment. This, of course, is nothing new for the clinician, who realizes that the smallness of dose in treatment is designed to reduce aggravations, while the relatively large size of the dose in a proving is designed to increase them, that is, the proving is specifically designed to create a symptomatic response. In the professional proving, the reason for this is to discover the medicinal qualities of a substance. But in the research trial, the purpose is, just as obvious, to demonstrate that the remedy has a real, physical effect on the human organism. Practically speaking, increased size of dose to 2-3 teaspoons of liquid remedy, repeated 3-4 times a day for perhaps a month, should certainly suffice to overcome resistance of even the most non-responsive of provers. But that is an extreme, even a ‘worst case’ scenario, which I have created for emphasis; more than likely, much less will be required. Safety. But this brings us around again to the question of individualization, to which I will turn momentarily. First, however, I should say that the preceding considerations reflect the likelihood, as far as I can tell, that by incorporating the idea of increasingly large doses into protocol design, we have done enough to guarantee that the outcome of a proving trial shall show favorably for homeopathy, that is, the remedy will outperform placebo in production of symptoms. The only caveat, is that the administrators of the trial, and of course the provers themselves, be aware of the possible need to increase the size of the dose very considerably beyond normal levels. This, in turn, introduces questions of potential severity of symptomatic response in provers, and therefore their health and safety. This consideration, therefore, suggests the need to introduce an extra measure of supervision to the trial proceedings, to monitor participant response in the event of untoward reactions, as well as ethical considerations, which must be addressed first. |
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