Reinventing the Wheel? or the Emperor's New Clothes
Menachem Oberbaum, MD; George Vithoulkas***; Robbert van Haselen, MSc**; Shepherd Singer, MD*
* The Institute of Research on Complementary Medicine, The Center of Integrated Complementary Medicine, Shaare Zedek Medical Center, Jerusalem, Israel.
** The International School of Classical Homeopathy, Alonisos, Greece.
*** The Royal London Homoeopathic Hospital, Greenwell Rd , London W1, UK.
Like Walach, we love homeopathy (Walach 2003). We also agree with his suggestion that "the following propositions are compatible with the known facts about homeopathy":
1. Homeopathy is to some degree effective.
2. There is a long record of research into homeopathy but this has produced conflicting results.
And we are sure that after a short semantic discussion, we could agree with the statement:
3. “There is no such a thing as “true homeopathy”.
However, we reject Walach's wholesale dismissal of the golden standard for the advancement of twenty-first century science, the randomized controlled trial (Barton 2000), in demonstrating homeopathic effects in biological systems. Walach pays lip- service to "a multiplicity of methods", but would abandon RCT's entirely, or so it seems.
To support his conclusions, Walach makes several assertions, which we contest.
Walach claims that the favorable results produced by widely quoted meta-analyses as Linde et al. (Linde et al. 1997) must be updated in the light of more recent data. (Walach 2003). While citing several unsuccessful trials, he omits a number of recent successful studies. Examples are the two studies of Yakir (Yakir 2001, 2003) , Jacobs’ study of otitis media (Jacobs et al. 2001), the Betula study of Aabel et al. (Aabel et al. 2000) and many others published since the appearance of Linde’s work. In a recently published review (Jonas et al. 2003), the authors state that “ there is also evidence from randomized, controlled trials that homeopathy may be effective for the treatment of influenza, allergies, postoperative ileus, and childhood diarrhea”. Walach must agree that these conclusions are at least supported by evidence.
Walach's contention that conventional medicine is in the process of reconsidering its methodological dogmas is precarious at best. In spite of Walach's objections, and Horton's provocative reference, randomized controlled trials are, and will remain for the foreseeable future, for lack of a better alternative, the golden standard against which every intervention is gauged. While we support observational studies, open treatment trials, self-chosen treatment studies etc, in accordance with the prevailing medical convention, these must be recognized as lower grades of evidence.
Walach is right. Assuming that a causative agent in homeopathic medicine does indeed exist, “one does not even know what it might do or consist of, and hence one could not take precautions unwittingly not to destroy it” (Walach 2003). However, should a lack of understanding of the underlying mechanisms of a phenomenon preclude attempts to investigate and verify it? If so, then the non- local interpretation of homeopathy, which Walach supports, has even less of a leg to stand on. While we may have an understanding of some aspects of the localized approach the non-localized approach is as yet much more speculative and theoretical.
If, as Walach proposes, the homeopathic effect were "the result of a generalized version of entanglement", then not only would "every action" disturb this entanglement, but the very act of observing the phenomenon would "disentangle" the event. What opportunity does this present for investigating the homeopathic process? Critics could argue that such exotic theories would actually discourage the empirical investigation of homeopathy, relegating homeopathy to the rank of a ‘pseudo-science’, which immunizes itself against experimental verification.
We maintain that randomized controlled trials are empiric evidence of the effectiveness of homeopathy, irrespective of mechanism. Suppose a homeopathic intervention were shown to be overwhelmingly successful in clinical trials. Would we reject this opportunity to cure an otherwise intractable malady (for example stomatitis in chemotherapy recipients, Oberbaum 2001), simply because the mechanism was not clear?
We share Walach's interest in and hope for elucidation of a plausible homeopathic mechanism. However, we believe this is, and will remain, elusive for the foreseeable future. Till then, would Walach have us sit around and wait? We contend that those same purported interferences against which Walach warns could interfere equally with any other trial model. How can we know?
We cannot agree that premenstrual syndrome, which affects 3-5% of all the women of reproductive age, (Wyatt KM et al. 2002) and which has no effective treatment, has no "conventional impact”. We also do not know the reasons for lack of participation in Walach's proposed early stage rheumatoid arthritis trial, but rheumatoid arthritis patients have been shown to be willing to participate in clinical trials, and are compliant. In long lasting trials, very few do not complete the study (e.g. Hakkinen A et al. 2001).
Walach accuses us of adopting the localist ontology and theoretical framework, without questioning it's adequacy for homeopathy. The Aristotelian notion of cause, with all its limitations, has given us the automobile, the telephone, the airplane,and much much more. We feel it is more prudent to conduct Aristotelian research while remaining aware of it's limitations, than to disregard it entirely, as Walach appears to suggest.
In our article, we considered the possibility, indeed probability, that a non-local effect, i.e. the therapeutic value of the homeopathic interview, would attenuate the differences observed between the treatment and placebo groups. Indeed, much of the beauty and power of homeopathy comes to bear in the homeopathic interview. Thus, even before attacked, we have demonstrated our awareness of, and desire to control for, non-local issues, namely by controlling trial size and power.
It may indeed be thatthe German Carl- und – Veronica- Carstens Foundation and the Robert Bosch Foundation share Walach's view, and have stopped funding blinded clinical trials. However, the Samueli Institute for Information Biology, probably the largest private funding agency, and of which Walach is the European Office Director, continues to support such trials.
In our paper (Oberbaum et al 2003), we attempt to bridge the gap between a non - Cartesian art; homeopathy, and Cartesian science, knowing that in doing so, homeopathy is likely to be compromised and oversimplified. We feel this is an inevitable price to pay for being committed to evidence based medicine.
We absolutly agree with David Reilly's statement that “evidence does not come from one type of research alone but from a mosaic of evidence offered by different approaches and methods” (Walach 2003). Some decades ago, the atmosphere at the faculties of natural sciences suggested that order was “healthy”, “good”, “correct” etc. whereas chaos was connected with terms such as “disease”, “bad”, “pathological” etc. The underlying philosophy of this attitude is now being increasingly replaced by system thinking. (Capra F 1996). Health is not necessarily equated with “order”, rather it incorporates orderly and chaotic elements side by side (Gerock 1990). In analogy to this we are asking; Is it not possible that homeopathy involves both local and non-local elements? Why not promote research in both, or even in additional directions?
Behind his call for diversification of method, Walach hides his real claim, which is that the "local" approach is passé and should be replaced with a new, non-local approach He warns of “putting all one’s eggs into one basket” but seems to advocate the same. Ultimately, we feel the question is one of competition for limited research resources. In an ideal world, all approaches could be investigated ad infinitum. In our world of limited, and shrinking, resources, choices must be made. We agree with Walach that a multiplicity of methods must be employed, however think that, given the lack of a promising alternative, randomized controlled trials must continue to weigh heavily on the homeopathic research agenda.
Walach seems to be showing us "the Emperor's New Cloths".
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