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| Hpathy Ezine - April, 2005 | ||||
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Proving Homeopathy -- Neil D. Shere |
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| Part III – Other Considerations For a number of years, there was only one man in the world, who was subjected, or subjected himself, to medicinal provings, and that, naturally, was Hahnemann himself, in the early years of evolution of homeopathy. As time progressed, he collected around him a small group of gentlemen that assisted him throughout the subsequent years in proving new remedies. It was a small group, that Hahnemann found to be conscientious and skillful in the work, and who possessed qualities he considered characteristic of an effective prover: “…temperate in all respects, [and] of delicate feelings...” (Aphorism 137). Proving Symptoms and the “homeopathic” prescription. Critics of homeopathy often express confusion that a tiny dose of a homeopathic remedy is enough to cause an aggravation in a patient, and to cure disease, but that in a proving trial, dramatic symptomatic displays have never been observed. Simply put, the effects of homeopathic remedies appear to evaporate, as the remedy performs no better than placebo, in provoking proving symptoms. Two simple observations suffice to clarify the apparent dilemma, which turns out to be based in a lack of understanding of homeopathic principles and practice. First, the responsiveness of the patient is to a remedy that has been selected specifically for him - in short, the prescription has been individualized. In the proving trial, on the other hand, needless to say the remedy has been “prescribed” (administered) to the entire group, and may simply not be a match for many of the participants. Second, and perhaps more to the point: although the changes in condition of health of the patient, in treatment, may be dramatic, they are achieved by application of the famous minute homeopathic dose, so that aggravations are usually very mild, barely even perceptible. Remember, that a key in homeopathy is to produce a rapid, but “gentle” cure – which means that effects of medications may be subtle in their appearance, or even barely perceptible. A result of this is that, in the proving trial, if there is any slack in efforts to harvest symptoms rigorously, some of the subtle signs of remedy action may easily be missed. I hasten to add, though, that as with most of the points I raise in this paper, this may not be a major hurdle to showing action of homeopathy; but failure to address the question will nevertheless, with certainty, introduce at least a small additional measure of doubt, regarding the satisfactoriness of the research methodology used to judge homeopathy. The layman (including the research scientist) should keep in mind, in this regard, that homeopathic remedies operate on the principle of “like cures like,” which is to say, they are active primarily when applied to a patient (or, in fact, a prover) who happens to possess characteristics (symptoms) that are similar to the characteristic action of the remedy. This is markedly different an effect, than found in conventional, or “allopathic” medications, which are designed to act on a specific symptom or set of symptoms, regardless the characteristics of the patient himself. This creates a much more direct and satisfying access to an efficacy trial for conventional medication, for the researcher knows precisely what to look for in each and every case. Harvesting symptoms. In the homeopathic research trial, harvesting symptoms becomes a key issue, for the two reasons alluded to above: variability of the individual response to the remedy, and mildness of effects. Note, for example, the lengths to which Hahnemann goes, in his provings, to ensure identifying symptomatic responses: On experiencing any particular sensation from the medicine, it is useful, indeed necessary, in order to determine the exact character of the symptom, to assume various positions while it lasts, and to observe whether, by moving the part affected, by walking in the room or the open air, by standing, sitting or lying the symptom is increased, diminished or removed, and whether it returns on again assuming the position in which it was first observed - whether it is altered by eating or drinking, or by any other condition, or by speaking, coughing, sneezing or any other action of the body, and at the same time to note at what time of the day or night it usually occurs in the most marked manner, whereby what is peculiar to and characteristic of each symptom will become apparent (Aphorism 133). Hahnemann specifies further that the prover “…must note down distinctly the sensations, sufferings, accidents and changes of health he experiences at the time of their occurrence, mentioning the time after the ingestion of the drug when each symptom arose and, if it lasts long, the period of its duration. The physician looks over the report in the presence of the experimenter immediately after the experiment is concluded, or if the trial lasts several days he does this every day, in order, while everything is still fresh in his memory, to question him about the exact nature of every one of these circumstances…” (Aphorism 139). Compare this process, to the relatively casual approach to harvesting symptoms in one recent proving trial of belladonna: The study medication was taken twice daily…. Subjects recorded, daily during the study, any new symptom that could not be attributed to any other cause, or any exacerbation of pre-existing symptoms…. Subjects were telephoned weekly to monitor …” progress. * Aside from the infrequent professional monitoring (once a week), note that symptoms were to be excluded from the subject’s diary, if the subject felt the symptom could be accounted for by “any other cause.” One is forced to withdraw to sarcastic wonderment, and to inquire what diagnostic criteria these trial participants employed, in determining, differentially, whether a particular response was due to the remedy or to some other cause. Such distinctions, after all, are not necessarily easy to make even for the experienced professional; leaving them in the hands of untrained trial participants is not a “technique” well calculated to encourage confidence in the ‘scientist’s’ findings. In addition, subjects were substantially limited in their reporting to a selection from 5 symptoms on a provided checklist, drawn from the established proving record of Belladonna. But, as one example of that record, we have the Materia Medica Pura, in which Hahnemann lists 1,440 symptoms. It seems to me, in all frankness, that findings presented in such a report, are hardly to be credited with even a sneeze in recognition. In consideration of the sharp debate in the scientific community, as between research statisticians and homeopaths, regarding the credibility of findings from research trials such as this, it is prudent to insist on the most stringent adherence to the most conservative guidelines of clinical practice, as the standard against which methodology in trials are judged. True, I agree with the opinion that has it, that such absolute rigor will ultimately be found to be unnecessary; but until the time when the quality of these trials have improved sufficiently, as to enable them to measure responses to homeopathic remedies in the first place, as much should be done as is practically possible, to eliminate concern for any possible influence from as many potential confounding factors as we can. Sensitivity. In Aphorism 281, Hahnemann notes “There are patients whose impressionability compared to that of the insusceptible ones is like the ratio as 1000 to 1.” In practice, this leads to a wide variability, in how much of a remedy constitutes an effective “minimum dose” for one patient as compared to another. The first patient may have, for example, a strong reaction to merely sniffing at the opening to the remedy bottle, and taking none of the physical remedy itself, while his neighbor might have but little reaction to 3 teaspoons of the liquid. In the treatment situation, the homeopath is able to exercise his professional judgment, and modify the size of the dose according to the sensitivity of the individual patient. This helps to assure consistency of response, from one patient to the next. In the proving trial, on the other hand, all subjects are treated alike, and this means that everyone, the least sensitive to remedies as well as the most sensitive to them, will be given the same, relatively small dose. To one degree or another, this built-in limit imposed on size of dose, will necessarily have an impact on reducing possible numbers of symptomatic responses in the verum group, as, past a certain, conjectural point, the most unresponsive of subjects, as well as some of those toward the middle of the continuum, will never receive a dose large enough to cause a reaction. Obviously, one way around this problem is, as I have already suggested, building in a progression in dosing routine, so that non-responders are given increasingly large doses. But another possibility is to select as trial participants, subjects whose profile suggests that they are at the more sensitive end of the spectrum. On the one hand, this provides better assurances that a larger percentage of subjects will show proving symptoms; on the other hand, it simply moves the risk, of untoward reactions, further down the continuum, as the non-responders are eliminated from the trial group. In any case, this strategy has the other advantage, of, presumably, permitting a larger percentage of responders while the dosing routine is still at a relatively small size of dose. In this way, any untoward reactions might at least be minimized in frequency and severity. Other considerations. Other considerations may be mentioned briefly, including effects of diet and other antidoting factors, especially consumption of drugs and conventional medications, in reducing production of symptoms in the verum group. Of interest, is the possibility that these same factors could actually increase production of “placebo response” in the control group! After all, if a substance, such as even spicy foods much less a strong medication, effects an individual in the control group, any symptoms he produces will be interpreted as placebo, thus, effectively, improving performance of placebo, while its antidoting effects serve to reduce performance of verum! Calculation of this effect is complicated by the fact that, among verum subjects, some will produce both real and “false” (stimulated by “antidoting influences”) symptoms, but the ironic fact remains, that this consideration actually favors placebo statistically. As with other points I have raised in this paper, I do not mean to over dramatize the importance of this effect, which I suspect would be of marginal significance, at best. Still, when there are numerous factors, each of which are suspected in compromising the integrity of research, to one degree or another, the cumulative impact of multiple confounders can be significant, even if the effects taken individually are negligible. Conclusion I have argued in this paper that the key element in constructing a successful research trial, proving efficacy of homeopathic remedies, is size of dose. I remain uncertain how far a variety of confounding factors might limit trial group reactions, but I operate under the general assumption that, if the size of dose is given a broad scope, it will show favorably for homeopathy under almost any conditions. However, the important caveat, attached to this idea, is that the more liberty one gives to the research team, to administer larger and more frequent doses, the more risk one runs of harmful effects on trial participants. This has obvious practical and ethical implications that will need to be addressed, in each new trial design. The major problems identified above, in research trials carried out to date, are, in summary: failure to identify size of dose as the premier factor stimulating symptomatic response to remedy; failure to understand individual sensitivity of subjects as a limiting factor in verum response as a group; failure to adequately harvest proving symptoms; failure to control for antidoting influences; underestimating the difficulty of arranging a viable proving trial, due to failure to understand differences implicit between homeopathic treatment and proving methods – the minimum dose of treatment is not optimal for the purpose of stimulating symptomatic response in the proving trial; and minimizing the need to scrutinize protocol design in the first place, due to a misplaced confidence in the idea that, an instrument of “proven” value in measuring efficacy of conventional medicines could be considered, ipso facto, of equal value in measuring efficacy of homeopathic remedies. It has been an important objective in this essay, to clarify some of the problems with the last assumption, and I will consider this paper successful if it has contributed even a little to clarifying problems inherent in that point of view. Needless to say, none of the preceding puts homeopathy outside the range of RCT. Yet, these observations are intended to highlight that statistical research into homeopathic effects is not so straightforward as might be expected, and requires attention to details of observation and measurement, of a type and to a degree, that are not required, for example, when examining effects of conventional medicines. It is my strong belief, that substantial flexibility is possible in such trials, so long as a few basics are adhered to. In the present paper, however, I have tried to delineate a reasonably full range of the most demanding standards, so that, in reviewing future trial results, we may have a clear sense of the context in which decisions regarding protocol design are made. It has been too long that research scientists have built their observations upon incompetent experimental designs, and then complained that homeopaths are backpedaling when, after conclusion of the trial, they nitpick the results. It is time to build some Quality Assurance into the trial design process in the first place, so that some reasonable work may be accomplished in pursuit of greater understanding of homeopathic process. The future evolution and progress in research technology itself, will also be a beneficiary of increasing the preparedness of researchers, who may not be well equipped, otherwise, to study corners of the scientific world with which they are not personally well acquainted. The issues are too important, to tolerate any further such lame excuses, if nevertheless popular in some corners of the research community, such as it being unnecessary to understand that which is being tested. Such a mockery of the tools of enlightenment will not be missed, when the errors introduced on its account are revealed in future trials, through the instrumentation of improved, more reasonable research practices. Footnote |
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