Placebo paradox

I RECENTLY noticed the epithet “….Recognised by the NHS….” in a magazine advert for one of those bracelets which are meant to somehow impart a form of therapeutic power. ‘Recognised’, in a regulatory context, means that an evidenced-based medicine protocol has been applied to a therapy and concluded there is a proven therapeutic effect. It can also mean that it has been ‘noticed and identified as something which one knows about’ without applying any measured attributes. In the latter sense, the NHS is not morally obliged to defend their stance and the perpetrator of the advert will suffer no recriminations.

What concerns me, in terms of medical education and practice, is a more pervasive issue. What started out as ‘alternative therapies’ and then surreptitiously (or covertly) became ‘complementary therapies’ transformed itself into complementary and alternative medicine (CAM). Then it became what we now know as a form of integrative medicine (IM). In Germany it is an accepted part of medical school curricula. In the UK there is a side door approach. The result is CAM therapies are currently ‘recognised’ as valid forms of medical practice in both of the above senses of the word.

Indeed, many universities in the UK and abroad have been offering courses leading to bachelors degrees in some of the most commonly utilised CAM therapies like acupuncture and herbalism: in other words, those which do not have separate colleges for the study of these disciplines (homeopathy, chiropractic and osteopathy). It is extraordinary that, although these courses defy scientific explanation, they are studied within the universities’ science departments. Different commentators have said they would be less critical if these subjects were taught in sociology or anthropology departments.

Placebo effect

Until recently, there had been no concerted effort to demonstrate the therapeutic efficacy of these therapies. This is amazing considering the fact that more patients attend CAM practitioners than GPs in the UK and for very good reasons, including well-demonstrated social, psychological and cultural reasons. Perhaps the most significant factor of all which is presently being addressed by academics is the ‘placebo effect’. This approach is seen as the best means to assess the value of CAM therapies on a firm scientific footing.

Professor Edzard Ernst of the Peninsula Medical School and colleagues have been systematically applying meta-analytical evidence based medicine to individual therapies to overcome the anecdotal assessment and the poorly constructed trials which have historically been used to test their effectiveness. So far, the therapies investigated have shown to be no better than the placebos against which they have been tested in statistically significant, controlled, double-blind trials.

Many researchers are now of the impression that CAM is no better than placebo and what we are dealing with is the placebo effect/response. In drug trials, there is often a significant percentage of patients in the control placebo group who receive a positive therapeutic effect equivalent to those receiving the tested medication.

Paradox

The dilemma in regards to placebo and its effect has been appropriately raised to a new level in a recent BMJ letter¹. Robin Nunn thinks we had better ‘stop thinking in terms of a placebo’ because the term is losing its meaning due to the paradox it creates. What was meant to be inert and have no physiological or pharmacological effect is now eclectic in triggering an ‘effect’ which is real and, for many patients, effective. And this effect extends beyond the symbolic meaning attached to acupuncture needles and the purported ‘memory’ attached to some original homeopathic tinctures which have been diluted to one molecule in all the oceans of the world. The time has come to interpret the meaning associated with the practitioner-patient encounter rather than devote any more time in evaluating treatments which can have no scientific or understandable therapeutic connections to what they claim to treat.

What doctors have to come to terms with is what Howard Brody calls ‘the Healer’s Power’². In addition to the scientific basis of medicine and the clinical skills our trainee doctors acquire, we must impart an understanding of the power of the doctor’s personality. This is not just a communication skills exercise, but a reality which represents and demonstrates the core values of a good doctor (GMC). It begins with a representation of character as fundamental as curiosity (interest in human nature), and progresses to empathy and compassion when appropriate. At times the patient may realise that what they are witnessing is a matter of integrity when the doctor is acting as an advocate on their behalf in their struggle with illness.

There is nothing magical or mystical about it. What doctors do is steeped in science. However, the effect is brought about by the relationship that the practitioner has with the patient – and this is often just as important and effective. It is what CAM practitioners do, and it often makes the patient feel better (the placebo effect or response). Introspective practitioners have applied a scientific understanding to its effect – what Brody calls an ‘inner pharmacy’ or chemical neurotransmitters which are released when a patient feels that they are listened to, attended to and addressed with understanding and knowledge of their condition (not just the name of their disease process). Think about how the CAM practitioner takes what seems like a completely different and lengthy interactive history and pushes many of the right buttons for the expectant patient and compare that with the five minute interview with the GP which ends in the slip of paper for the chemist.

When ‘push comes to shove’ many CAM practitioners admit they do not understand why what they do works and they attribute their success to a ‘holistic’ approach. Which may just be another way of saying they achieve a placebo effect.

Denialism

What may be more profoundly disturbing is the harm that can arise from seeking CAM solutions to life-threatening disease – the extension that comes from patients abandoning proven traditional medical therapy for alternative therapies. Think about what South African president Thabo Mbeki and his health minister have done to the millions afflicted with AIDS in their own country³. They ‘recognised’ a chance to appeal to the cultural traditions of their country and, by making dogmatic statements and expressing their antipathy toward antiretrovirals, have suggested a host of alternative therapies as the African solution to AIDS. And doctors in South Africa have wept over the fate of their fellow country(wo)men.

That kind of denialism, now being extended to cancer and other life threatening conditions, is making inroads in the affluent world and will cause further harm as long as people continue only recognising and not truly understanding.

Dr Peter Nelson is Senior Teaching Fellow at the University of St Andrews Bute Medical School

REFERENCES

1 Nunn R. It’s time to put the placebo out of our misery - Personal view. BMJ 2009; 338:1568

2 Brody, H. The Healer’s Power. Yale University Press; 1992 3 Specter M. The Denialists. Annals of Medicine – The New Yorker; 12 March 2007