‘“IT’S THE CONSULTATION, STUPID!”…ISN’T IT?’
Complementarity and the shortcomings of RCTs
Dr Lionel R Milgrom PhD CChem FRSC LCH MARH RHom
Program for Advanced Homeopathic Studies, 17, Skardu Road, London, NW2 3ES, UK: email@example.com
Background: Homeopathy has been said to violate basic principles of science and biomedicine. At the same time, the relevance of RCTs – being essentially reductionist – has been questioned, and alternative explanations of the efficacy of homeopathy/CAMs proposed, based on more holistic principles derived from quantum theory.1
Thus, light and sub-atomic particles behave as waves or particles, depending on the experimental circumstances; it being impossible to observe both with absolute certainty simultaneously (known as Heisenberg’s Uncertainty Principle). Taken together, however, both observations present a fuller description of reality than either taken alone – they are as Niels Bohr said, complementary. So, what we observe (particle or wave) depends intimately and ultimately on the kind of experiment we do – the answer we get depends crucially on how we ask the question.
‘”It’s the consultation, stupid!”….Isn’t it?’: Recently, Brien et al conducted a five-armed RCT of adjunctive homeopathic treatment in patients with active yet relatively stable rheumatoid arthritis.2 Even though the trial was acknowledged to be underpowered to draw any firm conclusions, sizeable clinically relevant benefits were found which Brien et al attributed solely to the innately empathic nature of the homeopathic consultation; not to any prescribed single or complex homeopathic remedy. So, could a quantum theoretically-derived notion such as complementarity, shed a different light on the outcomes and meaning of Brien et al’s research?3
More background: Nearly a decade ago, Weatherley-Jones et al4 suggested that such a complementary relationship might exist between specific and non-specific effects of a treatment seen in RCTs of the therapeutic process. This means specific and non-specific effects seen in RCTs are not simply separate and additive as is widely assumed, but intimately correlated with each other so that taken together their effect is greater than the sum of their separate parts. This was made explicit1 from the results of recent RCTs of homeopathic provings, understood in terms of such correlations between verum and placebo groups.5, 6
Discussion: In their trial however, Brien et al suggest the exact opposite: specific and non-specific effects of the therapeutic process are deemed additive (i.e., the whole IS the sum of the parts), and that both are amenable to simultaneous testing via the RCT. An alternative interpretation of the Brien et al trial, however, is that it is hinting at complementarity between remedy and consultation. Thus, RCTs that emphasise the medicine might necessarily lose sight of the consultation; while RCTs emphasising the consultation (e.g., Brien et al) might necessarily lose sight of the medicine.
Conclusion: The Brien et al trial is too underpowered to draw firm conclusions as to whether homeopathy’s effects are due solely to the consultation, or a complementary relationship with the remedy. However, by implying the power of the homeopathic consultation, Brien et al might have begun to reveal how the reductionism inherent in the RCTs’ protocol imposes on the therapeutic process an observational stance that allows knowledge EITHER of the medicine OR the consultation, but not BOTH with absolute certainty at the same time.3 This essentially biomedical re-statement of Heisenberg’s Uncertainty Principle suggests all that RCTs can reveal is that the therapeutic process is comprised of complementary parts of a whole real-life integrated phenomenon: not just in homeopathy, but for all healing modalities, including conventional medicine.
Milgrom LR. Journeys in the country of the blind: entanglement theory and the effects of blinding on trials of homeopathy and homeopathic provings. eCAM 2007;4:7. Walach H. Generalised entanglement: A new theoretical model for understanding the effects of complementary and alternative medicine. J Altern Complement Med 2005;11:549–559.
Brien S, Lachance L, Prescott P, McDermott C, Lewith G. Homeopathy has clinical benefits in rheumatoid arthritis patients that are attributable to the consultation process but not the homeopathic remedy: a randomized controlled clinical trial. Rheumatology 2010;49:doi:10.1093/rheumatology/keq234.
Milgrom LR, Chatfield K. ‘“It’s the consultation, stupid!”…Isn’t it?’ J Altern Complement Med 2011;17:1-3.
Weatherley-Jones E, Thompson EA, Thomas KJ. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualised homeopathic treatment. Homeopathy 2004;93:186-9.
Dominici G, Bellavite P, di Staneslao C et al. Double-blind, placebo-controlled homeopathic pathogenic trials; symptom collection and analysis. Homeopathy 2006;95:123-130.
Walach H, Mollinger H, Sherr J, Schneider R. Homeopathic pathogenic trials produce more specific than non-specific symptoms: results from two double-blind placebo-controlled trials. J Psychopharmacol 2008;22:543-552.