“It's the Consultation,Stupid!”.… Isn't It?

A n interesting question, which has arisen because of recent research published in the journal Rheumatology, ¹ suggesting that homeopathy works, but only because of the consultation. According to Brien et al., ¹ adjunctive homeopathic treatment produces sizeable clinically relevant benefits in patients with active yet relatively stable rheumatoid arthritis (RA). However, the joint research team (from Southampton University in the United Kingdom and the University of Michigan in the United States) also found these effects could only be attributed to the innately empathic nature of the homeopathic consultation, not any prescribed single or complex homeopathic remedy (seeming to support what homeopathy's detractors have always said about it). The article nevertheless concludes with the ringing endorsement, “Given the magnitude of these effects and the lack of reported side effects, the impact of the homeopathic consultation is of clinical relevance to patients and clinicians alike.”

So, something here for everybody, perhaps. After all, homeopathy is partially vindicated, and detractors can continue saying there is nothing in it. It has even been suggested that conventional doctors could certainly learn from the skill and subtlety of the homeopathic consultation, but then the self-confessed shortcomings of Brien et al. are ignored by asserting its results should simply be taken at face value (i.e., homeopathic remedies are demonstrably implausible and ineffective). ²

This is unusual, as any research in favor of the effectiveness of homeopathy is rarely taken at face value, so why lower standards of acceptability now? In addition, it has been suggested that those who consider that the randomized controlled clinical trial (RCT) is an inadequate research tool for testing complex therapies such as homeopathy ^3,4 are being “illogical.” ² However, homeopaths have also been studying Brien et al. with interest, looking for flaws. And there are some.

The research of Brien et al. is ambitious and well thought-out, using a five-armed RCT methodology conducted over a 7-month period. Participants with active stable RA on conventional therapy were randomized to 24 weeks of treatment into five groups, as follows: three receiving nine homeopathic consultations (further randomized to individualized homeopathy, complex homeopathy, or placebo—groups 1–3, respectively) and two groups receiving nonhomeopathic consultation (further randomized to complex homeopathy or placebo—groups 4 and 5, respectively).

Patients' primary outcomes were assessed against the standard American College of Rheumatology's ACR20* improvement criteria and monthly global assessment (GA).† Secondary outcomes were assessed using the Disease Activity Score (DAS-28) calculator for rheumatoid arthritis‡ (which includes a tender and swollen joint count; disease severity; pain; weekly patient and physician global assessment; and pain, and inflammatory markers), Measure Yourself Medical Outcome Profile, Positive and Negative Affect Schedule, and any adverse events.

The authors then made four contrasting comparisons between the various groups:

Contrast 1: the effect of the consultation by comparing the consultation groups 2 and 3 with the non-consultation groups 4 and 5 (Those receiving individualized homeopathic treatment were excluded because there could be no direct comparison with the nonconsultation group).

Contrast 2: the effect of the complex homeopathic treatment with and without the consultation, by comparing groups 2 and 4 with groups 3 and 5.

Contrast 3: the difference in effect between individualized and complex homeopathic treatment by comparing groups 1 and 2.

Contrast 4: the effect of individualized remedy, comparing groups 1 and 3.

Brien et al. found no significant differences in primary outcomes measured by ACR20 or GA, and no clear difference due to remedy type. However, receiving a homeopathic consultation significantly improved DAS28 mean score, number of swollen joints, and current pain. Other secondary outcomes also detected difference. But as Brien et al. themselves point out, ¹ “This trial was not designed to be definitive or prove the effectiveness of ultra-molecular medication, but to identify the relative effect sizes of the two most important components within homeopathy: the medication and the consultation.” Yet they conclude that homeopathy confers significant clinical benefit only through the consultation process, not the homeopathic medication.

This conclusion has to be suspect because according to their own calculations, the authors state that they needed 110 participants (22 in each arm, allowing for dropout of 20%) to detect a significant difference in the primary outcome measure. Only 77 participants actually began the treatment and only 56 completed the treatment. So by the authors' own admission, the trial was seriously underpowered.

Subsequently, secondary outcomes for this trial were considered as determinants for effect and post hoc analysis confirmed that sufficient participants were recruited to detect significant changes of DAS-28 between consultation and no consultation (Contrast 1). But the trial was underpowered to detect any difference between individualized and complex homeopathic remedy treatment (Contrast 3), where only 12 and 10 participants, respectively, completed follow-up in these arms.

Most crucially however, the trial was also underpowered to detect any difference between individualized treatment and placebo (Contrast 4) where only 12 and 11 participants, respectively, completed follow-up in these arms. Hence, on the basis of this study and its authors' self-confessed shortcomings, one cannot draw the conclusion (as others appear to have done) ² that the individualized remedies prescribed did not have an effect.

Clearly, therefore, to assert ² that Brien et al. should be “taken at face value” is, to say the least, premature. But for argument's sake, let's for the time being, go along with this assertion. There is another conclusion that can be drawn from this work, even taking into account any problems it might have. A clue can be found near the end of Brien et al., where the authors reference the work of Weatherley-Jones et al. ³ : “The use of randomized controlled trials (RCTs) to assess the effectiveness of complex interventions has been criticized [45] as the specific and non-specific effects may not be additive, but could interact in a more complex fashion. These results suggest that we can effectively model the major components of clinical interactions and identify the clinical benefits attributable to each of them using an RCT.”

Recently, there have been attempts to model the therapeutic process ^{5 –8} based on a kind of entanglement similar to that between entities found in quantum theory ⁹ (Caution: This does not mean that homeopathy or any therapeutic modality can be understood using the principles of orthodox quantum theory familiar from physics. …Rather that the interaction between patient, practitioner, and therapeutic modality may be explained using the mathematical discourse of three-way quantum entanglement). ¹⁰

One of the central leitmotifs of quantum theory is the idea of complementarity. ¹¹ This principle was first enunciated by the Danish physicist Niels Bohr in 1928. Depending on the experimental arrangement, the behavior of such phenomena as light and subatomic particles like electrons is sometimes wavelike and sometimes particle-like (i.e., light, subatomic particles, even atoms and whole molecules express wave-particle duality). ¹² But it is impossible to observe both the wave and particle aspects of such phenomena simultaneously. Together, however, they present a fuller description of phenomena than either of the two taken alone: something Niels Bohr acknowledged by adopting the ying-yang symbol on his self-designed coat of arms, bearing the Latin inscription “Contraria sunt complementa” (opposites are complementary). ¹³

Crucially, what this also means is that what we observe (be it particle or wave) is intimately dependent on the kind of experiment we do. In other words, the answer we get depends on how we ask the (experimental) question; and here's the real nub of complementarity and quantum theory: Observer and observed are fundamentally and irrevocably connected—entangled if you like. There cannot be observation without an observer. This is why one cannot even say the act of observation changes that which is observed: without an observer there is no observation in the first place.

This leads to one of the more startling conclusions to come out of quantum theory that several quantum physicists from Max Planck§ onward (e.g., Henry Stapp) ¹⁴ have proposed: Via consciousness, observation in part creates the universe.

Weatherley-Jones et al. ³ were hinting at a similar complementary relationship in the therapeutic process, between the specific and nonspecific effects of a treatment being non-additive (in other words, the whole is greater than the sum of the parts), something which has been made more explicit elsewhere. ⁴ The Brien et al. article appears to be saying the opposite (i.e., that because specific and nonspecific effects are additive—that is, the whole is the sum of the parts), and then they are both amenable to simultaneous testing via the RCT.

However, precisely because the remedy seems to disappear, a different interpretation of the Brien et al. article is that it might actually be hinting at complementarity between remedy and consultation. Thus, conventional RCTs with their concentration on the effect of the medicine/drug necessarily lose sight of the consultation. What the Brien et al. article could be suggesting is that RCTs that attempt to isolate the effect of the consultation lose sight of the medicine: one of the reasons perhaps why the RCT can no longer be regarded as a “gold standard.” ¹⁵ Just as in orthodox quantum theory, we can know fully about the medicine or the consultation as parts of a complementary pair of phenomena making up a whole, but we cannot know both with equal certainty at the same time: a kind of Heisenberg's Uncertainty Principle ¹⁶ for the therapeutic process.

Of course, we have some way to go before we can say this with any certainty! But again, perhaps there is a parallel here with orthodox quantum physics. In 1982, the French physicist Professor Alain Aspect and his research group finally confirmed that quantum entanglement between entities (i.e., acausal instantaneous correlation between entities regardless of their separation in space and time) was a real phenomenon. ¹⁷ This causes—and has caused—huge problems for people (Albert Einstein was very perturbed by the acausal nature of entanglement), ¹⁸ but it appears that is how the universe is. However, it took many years of experimental refinement and interpretations before the Aspect experiment conclusively demonstrated the truth of quantum entanglement (via verification of Bell's Inequalities). ¹⁹ So perhaps it is the same here.

Brien et al. of itself is nowhere near demonstrating entanglement in the therapeutic process per se. But it could be seen as the first inklings of a move in that direction. . . .So perhaps it isn't another “nail” in the coffin of homeopathy, as many of its detractors might be thinking. By implying the power of the homeopathic consultation, and its possible complementary relationship with the prescribed remedy, Brien et al. might actually be beginning to reveal the extent to which like most scientific experiments, RCTs are limited, and that at best, their simplistic separation of specific and nonspecific effects disregards an underlying complementarity between them that is itself a consequence of how we observe a whole, integrated, irreducible, real-life phenomenon, the therapeutic process. More importantly, it should serve as a wake-up call to cease the sterile arguments about whether homeopathy “works” or not, and start looking for new ways of thinking about what the therapeutic process actually entails; not just in homeopathy, but in all healing modalities, conventional medicine included.