Essay Sample on Placebo Intervention in Clinical Practice

Introduction

There are three major areas in which placebo interventions have an important role: (i) as control interventions in experimental studies to determine specific effects and to reduce bias by enabling blinding; (ii) as experimental interventions in placebo research to study placebo effects; (iii) as a tool in clinical practice. If one searches a major bibliographical database such as Medline for references including the word placebo, the overwhelming majority of articles identified are either placebo-controlled trials or articles referring to such trials. A small minority of articles are review articles on general or specific aspects of the placebo phenomenon, or original reports of experimental placebo research. Only a very small number of articles report empirical investigations or are essays of placebo use or placebo effects in routine practice. In this article, we first describe the relevance of different perspectives among scientists, physicians and patients on what is considered a placebo intervention in clinical practice. We then summarize how placebo effects have been investigated in clinical research under the questionable premise that such effects are produced by placebo interventions. We further discuss why a shift of focus from the placebo intervention to the overall therapeutic is necessary and what research methods can be used for the clinical investigation of the relevance of context effects. In the last part of the manuscript, we discuss why placebo or context effects are seen as positive in clinical practice when they are associated with active treatments, while placebo interventions have to be avoided.

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What Is a Placebo Intervention in Clinical Practice?

According to the classical definition by Shapiro & Morris [1, p. 371] 'a placebo is defined as any therapy or component of therapy used for its nonspecific, psychological, or psychophysiological effect, or that is used for its presumed specific effect, but is without specific activity for the condition being treated'. Shapiro & Morris further distinguish pure placebos, which are 'treatments that are devoid of active, specific components', and impure placebos, which 'contain non-placebo components' (p. 372). While this definition has been severely criticized on a conceptual level [2,3], it is summarizing well the implicit view of placebo interventions in biomedicine. We will not discuss conceptual issues here, but we will demonstrate-by using simple case scenarios of interventions classifying as placebos according to this definition-that, in clinical practice, it is often quite difficult to decide what should actually be considered a placebo (table 1). These difficulties are owing to the fact that the perspective of the definition by Shapiro & Morris is scientific, while physicians providing an intervention and patients receiving it might hold a different view.

Five clinical scenarios and related views of providers, patients and scientists whether the intervention provided is to be considered a placebo.

Scenario Provider Patient Scientist

• 1. saline injection in a pain patient placebo specific therapy (deceptive information) placebo
• 2. antibiotic in a patient with suspected viral infection probably not indicated specific therapy placebo
• 3. homoeopathic remedy in a child with a cold (prescribed by a sceptic but uncertain physician) (probably) placebo specific therapy placebo
• 4. homoeopathic remedy in a child with a cold (prescribed by a homoeopath) specific therapy specific therapy placebo
• 5. arthroscopic debridement in a patient with osteoarthritis of the knee specific therapy specific therapy placebo

In scenario 1, a typical pure placebo (a saline injection) is administered to a pain patient. Both the provider and the scientist 'know' that the intervention is a placebo. The patient is informed in a deceptive manner which makes him believe he is receiving a 'true' treatment. If he were to be informed correctly he would also consider the treatment a placebo.

According to surveys, between 17 and 80 per cent of physicians and between 51 and 100 per cent of nurses have used pure placebos intentionally at some point in their professional career [4]. However, the data also indicate that the actual frequency is rare, because pure placebos are usually applied only once or a few times to a small minority of patients.

There are three basic motivational patterns for such intentional use of a pure placebo. First, the physician aims primarily to promote the patient's wellbeing. For example, in a young patient suffering from severe headaches at risk of becoming dependent on morphine, a physician tried to reduce this risk by substituting some applications with placebo injections without informing the patient or his parents [5]. In another example, a woman with newly diagnosed advanced cancer for which a curative treatment was not possible still had great hopes of being cured. In order not to dash the patient's hopes and making her remaining time unbearable, she received a placebo intervention described as a form of cancer treatment [6]. While in both cases the patient was informed in a deceptive manner and the physician placed the relevance of his intent to help over the patient's autonomy and the ideal of shared decision-making, some authors believe that such placebo applications can be ethically justifiable (e.g. [7]). Physicians move in a grey area, and opinions on the acceptability of using pure placebos vary. The first is a real case in which the mother of the patient filed a professional grievance against the physician and a nurse [5]. The second case is fictive from a survey asking both physicians and patients to assess the acceptability of the placebo treatment. Sixty-three per cent of participating patients and 18 per cent of physicians found the procedure acceptable as it was likely to preserve the patient's hope [6].

A second motivational pattern could be summarized as 'convenience' [8]. For example, several surveys have found that pure placebos are given to difficult or complaining patients, or to avoid conflicts with a patient [9-13]. While understandable to some extent in a busy routine practice, such actions seem highly problematic both on a professional and on an ethical level [8]. It is likely that in reality many intentional applications of pure placebos are owing to a mixture of both the aim to promote wellbeing and convenience.

A third pattern, which seems to have become more and more infrequent but still occurs, is the use of placebo for diagnostic purposes. In such cases placebos are given to see whether the complaints are 'real' or 'simulated' or 'only psychological' [4]. Such a use is not only ethically problematic, but also contrary to the evidence which clearly shows that 'real' complaints can react to placebo applications.

Scenario 2 involves a patient with suspected viral upper respiratory tract infection who asks to receive the antibiotic that has helped so greatly in previous infections, and the physician complies. Antibiotics are potent and highly effective drugs when applied adequately but they are not indicated in viral infections. Therefore, this is considered as a classical example of an impure placebo. Obviously, the patient considers the treatment specific. The physician considers the antibiotic non-indicated, but there might be some uncertainty regarding the viral origin or a risk of bacterial super-infection. Based on general pathophysiological reasoning and clinical trial data, the scientist makes a general judgement that antibiotics do not have an effect over placebo in patients with viral infection.

Surveys show that the non-indicated use of active drugs is much more frequent than the use of pure placebos [11,13,14]. Qualitative interview studies addressing the prescribing of antibiotics in uncomplicated upper respiratory tract infections have shown that physicians are aware of the problems of their behaviour in such situations, but the word placebo does not come up [15,16]. However, when asked explicitly about placebo use [14], physicians seem to accept that such prescriptions can be considered placebo therapy.

The main reason for prescribing antibiotics and other unnecessary treatments is the perceived wish of or pressure from the patient [15-18]. There is some data that physicians overestimate the extent to which patients expect a prescription [19], suggesting that other, possibly subconscious, reasons might also play a role. Placebo prescription in such a situation is not a case of deception, but a conflict between the professional integrity of the physician and the patient's wish [8]. Physicians also often raise the issue of remaining uncertainty as a justification [15,16]. For example, a bacterial origin of the infection or a bacterial super-infection cannot be ruled out. However, one could suggest that convenience is often a more important motivation for using a non-indicated treatment than uncertainty. It has been argued that such a use of antibiotics is unethical, unprofessional and harmful [8,20].

In scenario 3, a mother firmly believing in homoeopathic remedies is seeking a paediatrician for her 2-year-old child suffering from symptoms of a common cold. Homoeopathy is a widely used alternative therapy practised both by physicians and non-medical practitioners. Its most controversial aspect is the use of remedies which are prepared in serial dilution steps with vigorous shaking in between (potentization), commonly to the extent that no molecules of the original substance remain. Homoeopaths believe that during the dilution process information passes from the diluted agent to the solvent, which, in the light of current knowledge, seems implausible. Therefore, many scientists are convinced that highly diluted homoeopathic remedies are placebos. As they often do not contain any 'active substance' in a chemical sense, they might even qualify as pure placebos. From such a perspective, homoeopathy could be considered a pseudo-therapy.

In our scenario, history and physical examination do not provide any indication for relevant risks but the child clearly suffers from bothersome symptoms. The mother asks for a homoeopathic remedy because the child improved very quickly in a similar situation when another physician prescribed the remedy. The paediatrician is sceptical about homoeopathy but he has seen some astonishing cases, so he is not really certain. Furthermore, he considers the risk minimal. He prescribes the remedy saying that he personally is a bit sceptical about homoeopathy, but it might be worth trying, and if the symptoms deteriorate the mother should return.

Surveys have shown that the use of complementary therapies such as homoeopathy, herbal medicines or vitamins by sceptical physicians is also much more widespread than the use of pure placebos [14,21,22]. The motivational pattern fo...