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THE PLACEBO EFFECT AND ITS RELEVANCE TO
by Charles Wansbrough Published The Homeopath No 67 Autumn 1997 ‘ The art of medicine consists of amusing the patient while nature cures the disease ‘ Voltaire In a recent conference on The Placebo Response , it was brought home to me, very forcefully, how misunderstood this term had become, and how it carries so many negative connotations. Originally the term came from the Latin ‘I shall please’ and was used from the 12 Century onwards, as a term used to denote the practise of singing vespers on behalf of strangers for money and came to mean servile flatterer. The earliest instance of an explanation of the placebo effect comes from a medical dictionary in 1785 ‘ placebos are calculated to amuse for a time rather than for any purpose’ (the word amuse at that time meant deceive)[i] . In 1823 T.Jefferson, an English physician, defined placebo as a ‘pious fraud meant to please the innocent patient and the cunning doctor’. With such a history, its negative associations, became even more pronounced with the advent of orthodox medicine, and an ever-increasing belief in the omnipotence of the medical sciences. At this point in its history, the placebo effect merely became a backdrop to the efficacy of modern medicine, used as a way to monitor the qualitative effects of medicine. But in the very act of placebo controls to test the pharmacological effects of drugs, orthodox medicine came to realise the inherent power in the placebo Effect. The inherent vigour in the placebo effect showed up a strange weakness in the logic of drug trials, and was denied any sort of legitimacy since it at times, invalidated the very foundations of such trials and questioned the scientific rationale of present day medicine. Notwithstanding the awkward philosophical questions which it brings up, there is a vast literature on the subject and even in 1996, there were over 2000 citations in medical journals in that year, which still shows that the basic epistemological paradox of its denial is still a hotly debated topic at the heart of medicine.
Placebo Effect on Medical Treatment Classic trials on the efficacy of the placebo effect were carried out in 1955 by H.K.Beecher [ii] in which he concluded from his analysis of 15 case studies involving over 1000 patients, that the placebo effect has an average effectiveness of over 35 per cent. Later studies showed an even wider scope done by Roberts et al [iii] and others, ranging from anywhere between 0-90 per cent in effectiveness. There is a vast literature on the efficacy of the placebo effect, and placebo effects have been documented to produce toxic effects, withdrawal effects, complete cures, apparent drug addictions, and even seemed to work in one trial in which patients were told that they were on placebos. [iv] As the literature continued to grow on this phenomenon, a Harvard cardiologist Herbert Benson, in the 1970’s became intrigued by Transcendental Meditation, a technique that utilises chanting with a mantra, and conducted research to see if TM really produced any measurable effects on the body. With his fellow researcher, he found ‘".that the repeated mantra replaced the arousing thoughts that otherwise keep us tense during most waking hours. Result: lower metabolic rate, slower heart rate, lower blood pressure and slower breathing." He soon realised that the changes in the body produced by chanting were not dependent upon the specific mantra, and found similar effects to occur in Christians and Jews who practised the standard Western form of meditation-prayer. At this point, Benson wrote up his research in his book, The Relaxation Response, which became a best-seller when it was published in 1975. Relaxation Response is the label he devised to describe the positive physiological changes that meditation and prayer produce in the body. Naturally to an alternative practitioner, this type of research may seem naïve, but since then Professor Benson has founded the Mind/Body Medical Institute at Harvard Medical school, and a few years ago began a journal mapping recent research in the increasing literature on the mind/body complex. In one of the first editions of this journal he writes an interesting editorial [v] stating that present medicine must be likened to a three legged stool that must rely on three aspects of medicine to gain maximum efficacy in its potential to cure. These three aspects, he states are made up of (a) Surgery, and medical intervention when necessary (b) the pharmacological effects of drugs (c)Self Care management encompassing the placebo effect. In this third aspect, H. Benson has had to accept that much of modern disease, is as a result of stress and this third aspect plays by far the major part in creating a state of wellness. Under this
aspect, he includes the whole gamut of what our profession would call, the holistic approach, Nutrition, exercise, relaxation procedures, and the most important the psychobiology of our belief structures and the power of expectancy. Within the arena of the therapeutic encounter, the placebo effect becomes a major factor in creating a state of health, and as a result of its somewhat disparaging negative connotations, he has renamed the placebo effect -‘the Remembered Wellness effect’. This state of therapeutic clarity arising from a meeting between patient and doctor/healer, and depends on three components, which are (a)Beliefs of the patient (b)Beliefs of the Doctor/Healer ( c)Beliefs that arise from the encounter and the subsequent expectations that come into existence What is stressed are the importance and the biological effects of our belief structures, and such an acceptance in the medical profession, arises mainly from the enormous strides made in the fields of psychoneuroimmunology, neuroscience and artificial life, to such an extent that a cognitive revolution is taking place, placing mind not as a controller of the body, but as an embodied entity, that seamlessly weaves a dance between body and mind as aspects of a whole.[vi] The power of the patient’s own belief have been shown to have extraordinary power, when encountered in the therapeutic encounter. A recent analysis of 39 studies of 3,252 depressed patients, presented at the American Psychological Association's (APA) 104th annual convention, found that 50 percent of the drug effect is due to the placebo response. In other words, a patient taking antidepressant medication with a self-reported improvement rate of 10 points, can attribute half of that improvement to the placebo effect. To determine the placebo effect of antidepressant medications, psychologist Guy Sapirstein, Ph.D., at the University of Connecticut, analysed 39 studies of depressed patients from 1974 to 1995. The studies included patients with a primary diagnosis of depression, were randomised, and controlled for patients who received no treatment. Studies that measured the effects of antidepressant medications such as fluoxetine (Prozac), sertaline (Zoloft) and paroxetine (Paxil) were included in the analysis.
Dr. Sapirstein concluded that the pharmacological and non-pharmacological effects of antidepressants indicates that while only 27 percent of the response to medication is due to the medication alone (a true pharmacological effect), 50 percent is due to the psychological impact of administering the medication (placebo effect) and 23 percent is due to other "non-specific factors." "People benefiting from drugs are benefiting because they think that taking the antidepressant medicine is working," Dr. Sapirstein said. "If we take these results and say that improvement is due to what the patients think, then how people think and its effect on how they feel are more powerful than the chemical substance," he added.[vii] In more recent research, links have been revealed between the size, colour, name of a pill and its pharmacological action,[viii] . It was found that blue pills tend to be perceived as sedatives, pink pills as stimulants. It was noted that bitter pills were regarded as stronger than sweet ones. Even brand names seem to have an effect. This can only lead one to speculate on the power and mystery that we sometimes endow our tablets with, and even refuse to tell our patients the names of the remedy. One study showed just how effective the belief of the patient was, when it was shown how even sham treatments produced excellent results, for example 64 per cent of patients who underwent a sham tooth grinding operation for myo-facial pain reported total or near total symptom remission.[ix] The belief of the Doctor/Healer is equally powerful in affecting the outcome of a therapeutic encounter, and it has been shown rather alarmingly, that the initial reports in the enthusiastic phase of a new drug/doctor relationship yielded 70-90 per cent results whereas as enthusiasm waned the effectiveness of the drug fell to 40 per cent.[x] This effect has been noted to occur even at the onset of new surgical procedures which were touted as miracle savers, till results showed otherwise. For example, patients with angina pectoris-chest pain associated with heart disease-have been shown to improve substantially following an operation that involved nothing more than a simple skin incision. Angina also improved following a type of artery surgery once believed effective but later found to be ineffective. And patients who underwent the useless surgeries reported improvement in their angina for up to 12 months following the procedures[xi] Research has even shown that a placebo can work even when the physician is sure he is dispensing an inactive pill, so long as he
expects it to have an effect. This only proves to show that the long history of medical treatments is, for the overwhelming part, a history of the power and biology of belief. The placebo effect can sometimes even overcome a drug's normal action, in one experiment a woman volunteer suffering from intractable nausea and vomiting was given a "new and extremely powerful wonder drug" that would, her doctors promised, cure her nausea. Twenty minutes after she took the drug, her nausea disappeared. The placebo effect is so powerful that its biological roots, have been known to kill individuals, as in the famous cases of Voodoo death. This is well illustrated by a story told by L.Dossey[xii] in his book, relating to a patient who was admitted by the hospital, and after many tests, nothing could be found wrong though the patient was dying, till he admitted a ‘hex’ had been placed on his life. The ingenious doctor managed to concoct some awesome ritual that saved the patient in the end by virtue of the similitude, but the case does illustrate the sheer power of our own belief structures over our life and death. ‘ One is therefore led to the inescapable conclusion that the placebo effect is not only a pervasive force but that every healing intervention will not only have a physiological effect but also a symbolic function’.[xiii] Moreover with the growing interest in the mind/body complex and the subtle interactions between the two domains, the placebo effect can no longer be effectively ignored but has to become a desirable aim in the pursuit of ‘Remembered Wellness’. Explanations for Placebo The placebo was originally demonstrated to take place when endorphins increased in the individual, but this theory was soon discounted, and today it is thought to be mediated through central control mechanisms whose neurobiological details are poorly understood. On the other hand, the psychological and behavioural constructs which are high-level representations of these control mechanisms do offer some possibilities. Faith, conditioning, credulity, suggestibility, trust, and optimism are all concepts associated with placebo reactivity and presumably are represented at a neurobiological level.[xiv] Further neurobiological evidence points to the very clear connection between the act of visualisation and perception, since it was shown conclusively through the use of PET scanners, that exactly the same area of the brain is active when an object was perceived, then with the patients eyes closed he was
again asked to visualise the object. [xv] This indicated for the first time how the internal process of visualisation is not only identical to the process of perception but how the activity could enhance a state of being, hence the key concept so clearly elucidated by H. Benson, that of ‘Remembered Wellness’. It is clear that the placebo effect is not associated with intelligence, suggestibility, gender, personality or age but does go with expectation, the power of our own belief structures, anxiety, and being strongly directed by an external force. What has become clear, is that orthodox medicine can no longer afford to ignore or render illegitimate its relationship to the placebo effect, but it must enhance and even elucidate how the biological effects of our belief structures can have such an awesome effect on our general health. Nevertheless this pursuit for the neurobiological effects of the placebo effect does present some very interesting epistemological dilemmas for our own profession. On the one hand, the placebo effect has been used negatively against our profession to deny that Homeopathy has any biological effects, and on the other hand, the placebo effect as an effective form of medicine is possibly our nemesis. We can continue to effectively believe in the therapeutic and bio-energetic effects of homeopathy, but at the same time we have to acknowledge the powerful effects of the placebo effect. It is a strange dilemma, we find ourselves caught in, since admitting the placebo effect renders our biological effectiveness null and void, and yet we are aware that our own emphasis on the therapeutic encounter which is predominantly heightened in our own unique form of case taking, renders our own form of medicine far more powerful by virtue of the placebo effect. But however we might try and tackle the dilemma, it is clear that we must also emphasise and clearly enhance the biology of the placebo effect in our own therapeutic encounters, and not just hope that the biological effects of our homeopathic remedies produce the desired effects. The biology of belief with its concomitant emphasis on the embodied mind, must be taught as part of an effective curriculum that not only stresses the importance of the neurobiology of individual thought processes, but has to be taught as a separate subject, otherwise we will find ourselves totally absorbed by our medical brethren. Homeopathy and Placebo It seems a supreme irony that with the increasing popularity in alternative medicine, the intensity and research now being carried out just how the mind should influence the body, is leading to a
fundamental albeit, slow, revolution in the field of medicine. Though much research is also being carried out in energy medicine, and it is far more acceptable to contemplate some scientific basis for homeopathy, we must realise that all medicine, is ultimately a result of the therapeutic encounter. Such an encounter will always include a very substantial placebo effect, and in such a sacrosanct space of ‘imagined wholeness’, all medicine, alternative or orthodox, must accept that such a meeting may have no biochemical basis, but may well be fundamentally symbolic, being played out on the archetypal level. But however the wish arises to explain the state of ‘remembered wellness’ it does present some interesting epistemological problems for our entire profession, since the belief of the practitioner is an intimate aspect of the therapeutic encounter and may well contribute more than a substantial part to the health of the patient. So the question arises, since it is impossible to tease away ‘the remembered wellness effect’ from the bioenergetic effects of a remedy, or pharmacological effects of a drug, how is it possible to deny credibility to any method if the end result was health. This particular predicament of results versus methodology remains an ongoing debate that has never ceased to abate, but with the increasing work done on the power and the biological effects of thought processes, it ultimately ceases to be a debate of value but an arena of prejudice, more to do with the politics of ego than the compassion of a healing encounter. Maybe we should start to redesign our own case taking with some time substantially dedicated to taking a placebo treatment history. As suggested by Chaput de Saintonge, D.M. and A. Herxheimer, in an article in the Lancet on Harnessing placebo effects in health care[xvi] . ‘Such a history would look for positive and negative non-specific effects in the patient's previous experiences of treatments for illnesses. One element of this is often the quality of earlier patient-doctor or patient-nurse relationships; another is faith in, or distrust of, a particular form of treatment. A history of non-specific factors associated with positive outcomes is hardly ever sought from the patient, so the opportunity to make use of their therapeutic potential is lost.’ Whatever we do, the placebo effect has now undergone a revolutionary turnabout, from having being totally ignored as a by-product and inconvenience to the power of pharmacology to have become the new frontier in the search for the power and the biology of our belief structures. An intimate thread is now being slowly unravelled which shows just how immediate the effects of the mind can be on the body, it is as if our minds are distributed throughout our body, as one fascinating example described in the International Journal of Neuroscience hints at how our visualising
ability can influence our immune system. A group of students were taught visualisation and given a description of the special functions of certain immune cells. Then every student made up their own personal imagery for increasing the adherence of these cells. After two weeks, saliva and blood samples were tested for immune cell functions and compared before and after the experiment. The only statistically significant change in the immune cells was their ability to stick to foreign objects.[xvii] The evidence is clear, the less time we spend debating correct methodologies and realise just how crucial our own beliefs are in the therapeutic encounter, the more time we can spend on how to maximise the effects of that encounter, and the more chance we have of becoming the energetic medicine of the future. [i] An Eighteenth Century View of the placebo effect -Francis Schiller- Clio Medica 1984 [ii] The Powerful Placebo by H K. Beecher JAMA 1955 Vol 159 [iii] The Importance of the Placebo effects in Pain treatment and research by J.A.Turner, R. A. Deyo, J.D.Loesser, Michael Von Korff, W.E.Fordyce JAMA 1994 Vol 271 [iv] Placebos and Philosophy of Medicine by H. Brody Chicago Press 1980 [v] Mind/Body Journal editorial by H.Benson 1992 [vi] Being There by Andy Clark MIT Press Cambridge Massachusetts 1997 [vii] Presentation: "Listening to Prozac but Hearing Placebo" Guy Sapirstein, Ph.D., and Irving Kirsch, Ph.D., University of Connecticut, Storrs, CT. Session 4169, 12:00 Noon, August 12, 1996, Metro Toronto Convention Centre, Room 104 from the Internet [viii] [1.] de Craen AJM, Roos PJ, de Vries AL, Klejinen J. Effect of colour of drugs: systematic review of perceived effect of drugs and their effectiveness. BMJ 1996;313:1624-6. [ix] As (iii)
[x] Magic or Medicine by R.Buckman K.Sabbagh Macmilllan 1993 [xi] Dymond EC, Kittle CF, Crocket JE. Comparison of internal mammary ligation and sham operation for angina pectoris. Am J Cardiol 1960; 5: 483-86. [xii] Space, Time and Medicine by Larry Dossey New Science Library Shambhala 1985 [xiii] The Placebo effect myth or magic by C.J.Wansbrough Prometheus Unbound Autumn 1995 Vol2 No1 [xiv] Harnessing Placebo Effects in health care by Chaput de Saintonge, D.M.; Herxheimer, Andrew The Lancet, Oct 8, 1994 v344 n8928 p995(4) [xv] Mind, Brain and Human Potential by Brian Lancaster Element Books 1991 [xvi] Harnessing placebo effects in health care. (Placebos in Medicine, part 2)Chaput de Saintonge, D.M.; Herxheimer, Andrew The Lancet, Oct 8, 1994 v344 n8928 p995(4) [xvii] Voluntary modulation of neutrophil adhesiveness using a cyberphysiologic strategy by Hall, H et al,
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Hum Psychopharmacol Clin Exp 2003; 18: 379–384. Published online 9 May 2003 in Wiley InterScience (www.interscience.wiley.com). DOI: 10.1002/hup.490Fluvoxamine versus fluoxetine in major depressive episode:a double-blind randomised comparison1Hoˆpital Neurologique Pierre Wertheimer, F-69003 Lyon, France2University Hospital Maastricht, 6202 AZ Maastricht, The NetherlandsA double-blind, multin