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Title: Is there logic in the placebo? By: Gotzsche, Peter C., Lancet, 00995355, 10/1/1994, Vol. 344, Issue 8927 Database: Academic Search Complete HTML Full Text

IS THERE LOGIC IN THE PLACEBO?

Contents 1. References

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Section: Placebos in medicine See Commentary page 904 A series of articles on placebo effects must begin with definitions. Immediately, we are in difficulties. The placebo effect is the effect seen in patients who have received an intervention which is believed to lack a specific action. This common usage cannot stand logical thought; furthermore, the placebo effect has been defined in a number of other ways, including neutral and negative as well as positive effects.[ 1] Placebo is latin for "I will please"; hence implies something positive and subjective. We will assume the result is positive, as this agrees with the practice of using another word--nocebo (I will harm)--for an intervention which is harmful.[ 2] Consider a self-limiting condition such as a muscle sprain. Without intervention, the sprain will be expected to be less painful after a week. If the patient is given lactose tablets, the pain might go sooner; if given an analgesic, sooner still. According to common usage, the placebo--lactose--has no specific effect on the condition. In these circumstances, neither clinician

nor patient can know what the outcome would have been without intervention; they only know what the condition was before.Under such conditions, a clinician could reasonably claim that any treatment would have an effect in any patient with a sprain. The definition creates other problems, which appear most clearly if we go from the individual to groups of patients. Following the example of the sprain, what can we say if there is no difference in outcome between the placebo group and the natural (untreated) course of the disease? It makes no sense to speak of an effect when there is no difference between intervention and no intervention. The absurdity of the definition becomes most striking for progressive diseases, where the outcome of any intervention will, on average, be negative. If we treated patients with AIDS with loving care and noted that most of them had died after 3 years, we would hardly be willing to speak of loving care as a nocebo effect. We will try again: The placebo effect is the difference in outcome between a placebo treated group and an untreated control group in an unbiased experiment. This definition refers to groups and not to single patients. This is not only because we cannot usually know what would have happened had we not used an intervention in a particular patient; we need an untreated control group to be able to adjust for bias caused by increased skill when a test is performed twice, before and after an intervention. The control group is also necessary to adjust for regression towards the mean. These considerations lead to the conclusion that we should no longer speak of a placebo effect in relation to single patients, since we generally cannot separate the effect from biasing factors in individual cases. The same argument holds for active treatments with specific effects: we cannot know that an antibiotic cured bronchitis; we can only suspect that the patient was better with an antibiotic than without. Having attempted to define the effect, the next problem is to define the placebo itself. This is not easy[ 1] but for a start one could argue that, as the purpose of aplacebo is to improve the patient's condition, there would be no point in using a placebo or in defining it as a concept if it were ineffective. If we accept that aplacebo can be effective, we need to explain the difference between placebos and other active interventions. This may be impossible. One intervention may be more effective than another but that does not make the less effective intervention a placebo. Conversely, the fact that placebo is better than no treatment does not make placebo an active treatment. If we wish to preserve the placebo concept despite these difficulties, we must specify a difference between placebos and other active treatments. We may defineplacebo as an intervention which is believed to lack a specific effect on the disease in question, but which is better than no intervention; but this definition refers to the domain of beliefs rather than knowledge. Although beliefs are common ingredients in placebo definitions, they are not reassuring to an empiricist; and we would have to say what we mean by specific. There is no agreement as to what a specific effect is.[ 3] We could define a specific effect as an effect for which there exists a theory for its mechanism of action.However, the label placebo may then be transitory, since what we believed was a placebo might later be shown to have specific effects. And how should we distinguish between an active intervention whose mode of action is unknown (eg, lithium in depression) and a placebo? Further complicating the issue is the fact that a placebo for one disease may be an active remedy for another--or even a nocebo. There are still more problems. It is common for theories of drug actions to be refuted later. Should we then say that, since the theory was wrong, the active intervention was a placebo until the theory was replaced with a correct one? Of course not. We could introduce an empirical element in the definition: Placebo is an intervention which is believed to lack a specific effect--ie, an effect for which an empirically supported theory exists for its mechanism of action--on the condition in question, but which has been demonstrated to be better than no intervention. This allows us to distinguish between scientific and unscientific medicine. Unscientific practitioners believe that their treatments are active; scientific practitioners believe that those which have an effect at all are placebos, since we do not accept unscientific theories offered for their mechanism of action. However, a new problem arises. There are empirically supported theories for the mechanism of action of placebos; and how do we distinguish between specific and non-specific effects of psychotherapy, for example, where the outcome seems to depend more on the therapist than on the method used? These problems suggest we should discard theplacebo concept altogether, since we could assume that, if we knew enough about any placebo, we would be able to put forward an empirically supported theory for its mechanisms of action. I have tried to define placebo in an unambiguous, logically consistent, and testable way, and I have failed. It gives me some comfort that this state of affairs is not unusual in philosophy. We cannot define what constitutes a chair[ 4] but this fact does not prevent us constructing them. We could choose to view the placeboconcept pragmatically. In scientific trials, we deliberately give patients placebos which, according to our current knowledge, we believe are devoid of any specific effect on the disease, to provide a contrast against which interventions believed to have specific effects can be judged. In clinical practice we do the opposite. We try to maximise the placebo effect, as do practitioners of unscientific medicine, and the gap between scientific and unscientific medicine becomes very narrow if we look at the effect rather than at the difficult-to-define nature of interventions. Clinicians often argue that randomising patients to predetermined regimens in trials is incompatible with the need to individualise treatments. Physiotherapists argue similarly: patients may receive individual mixtures of massage, ultrasound, soft laser, and exercise, and it may be claimed that the combination of treatments is more than the sum of the individual interventions. They therefore fear that, by isolating one factor at a time as in controlled trials, we may end up mistakenly discarding some of their treatments. As an example, it is easy to produce a truly double-blind placebo laser by turning off the current. A meta-analysis of soft-laser treatment in painful rheumatic disorders showed no difference between placebo and laser.[ 5] Thus, the laser beam seems to be worthless; but an important question remains unanswered: does the ritual of using an apparatus add usefully to the therapeutic effect of the physiotherapist? Another problem is the conditioned reflex. If we compare two tablets, lactose or a benzodiazepine, with no treatment in patients with insomnia we may find that both tablets are better than no tablet and that the benzodiazepine tablet is better than the lactose tablet. However, the magnitude of the placebo effect may vary with the patient's past experience.[ 6] Patients used to taking benzodiazepines with good effect may react more favourably to placebo than patients who have never used sleeping pills. As another example, the placebo response in acute pain often resembles the response to an analgesic, with a maximum effect after 1-2 hours. This is difficult to explain if not by a conditioned reflex caused by past experience with the onset of action of drugs. When the placebo response is not constant, drug effects are not constant either, since they are measured in terms of their difference from placebo. Whether something is a placebo or not may depend on the nature of the outcome variable. Patients may enjoy drinking rum toddies when they have colds, but the cold probably does not disappear any sooner than without treatment. Thus, with a generic outcome variable such as patient satisfaction, rum toddy is a placebo, but with a disease specific variable it is not. This suggests that we should divert our focus of interest away from the essentially unsolvable problem of whether or not an intervention is a placebo towards the magnitude of the measured effect and the choice of effect variable. In general, the larger the effect compared with no treatment, the more useful the intervention, whatever its nature. The common denominator for all interventions is money. Imagine that patients with AIDS could choose between a week's holiday on Bali and two months of treatment with zidovudine (the price for both options being about the same). Undoubtedly some would choose Bali, ie, they would choose a generic placebo rather than a disease-specific active drug. The example illustrates how misleading it can be to focus on the nature of interventions rather than on their effect. By relying on theory and speculations rather than on empirical testing, physicians have done much harm to their patients, as shown by the history of blood-letting, gastric freezing for ulcers, radical mastectomy, and routine tonsillectomy. The important thing is that treatments are tested, not what we might choose to call them or their practitioners. Cochrane wrote that all effective treatment must be free.[ 7] The increasing interest in quality-of-life measures may lead to the conclusion that the patient's view is the optimum outcome measure.[ 8] If this is accepted, we also have to accept that placebos may be more powerful than so-called active treatments and that trips to Bali, rum toddies, and tennis matches can be useful interventions. Obviously, the interest in patient satisfaction has highlighted some important issues, partly of priority, partly of demarcation between social welfare and health care. In conclusion, the placebo concept as presently used cannot be defined in a logically consistent way and leads to contradictions. The concept could perhaps be preserved for purely pragmatic reasons, however, provided attention is paid to its shortcomings; in particular it should not be used in individual patients. Because of the logical problems, and since placebos may be powerful interventions, the focus of interest should switch from whether or not an intervention is a placebo, towards the magnitude of the effect and the choice of effect variable. This shift would help to bridge the gap between scientific and unscientific medicine. Untreated control groups are needed in clinical trials if we wish to be able to decide more rationally which interventions a health service should pay for. They are also needed in addition to a placebo-treated group if we wish to know what proportions of the effect of an active intervention are caused by specific and non-specific factors. Without them we cannot conclude, as is current practice, that an intervention is ineffective if no better than placebo. I thank Iain Chalmers and Henrik R Wulff for helpful comments. References

1 Shapiro AK. Semantics of the placebo. Psychiatry Q 1968; 42: 653-95. 2 Kennedy WP. The nocebo reaction. Med World 1961; 95: 203-05. 3 Shepherd M. The placebo: from specificity to the non-specific and back. Psychol Med 1993; 23: 569-78. 4 Wulff HR, Pedersen SA, Rosenberg R. Philosophy of medicine. Oxford: Blackwell, 1986. 5 Gam AN, Thorsen H, Lonnberg F. The effect of low level laser therapy on musculoskeletal pain: a meta-analysis. Pain 1993; 52: 63-66. 6 Peck C, Coleman G. Implications of placebo theory for clinical research and practice in pain management. Theor Med 1991; 12: 247-70. 7 Cochrane AL. Effectiveness and efficiency: random reflections on health services. London: Nuffield Provincial Hospitals Trust, 1972. 8 Ware JE. Measuring patients' views: the optimum outcome measure. BMJ 1993; 306: 1429-30.
~~~~~~~~ By Peter C Gotzsche Nordic Cochrane Centre, Research and Development Secretariat (P C Gotzsche MD) Rigshospitalet, 9 Blegdamsvej, 2100 Copenhagen O, Denmark

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