Rapid Responses to:
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Rapid Responses: Rapid Responses published:
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![[Read Rapid Response]](/icons/misc/sectionDOWN.gif)
Wrong information on previous studies of the clinical use of placebo
- Asbjørn Hróbjartsson (20 September 2004)
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Sugar pill or bitter pill?
- Su Reid (24 September 2004)
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It is a pity some drug company does not produce a wide range of placebos –Archie Cochrane said!
- Ioannis DK Dimoliatis (27 September 2004)
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The peculiar category of placebo: The socio-psychological affects of personal agency
- Rory Coughlan (23 October 2004)
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Diagnostic test?
- Dr John Rumbold (26 October 2004)
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Placebo: from deception to a new alliance in general practice
- Franco Del Zotti (5 November 2004)
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A case study of placebo use in forensic psychiatry
- Jonathan C Haynes, Arden Tomison (9 November 2004)
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Re: Wrong information on previous studies of the clinical use of placebo
- Pesach Lichtenberg (11 March 2005)
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Asbjørn Hróbjartsson, Senior researcher The Nordic Cochrane Centre, H:S Rigshospitalet, DK-2100 Copenhagen Ø, Denmark
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In their paper on the clinical use of placebo Nitzan and Lichtenberg claim that ‘No study has recently attempted to assess the use of placebos in clinical settings’ (1). This information is prominently featured in the box entitled ‘What is already known on this topic’. Furthermore, the article discusses only one previous study by Goodwin et al. published in 1979 (2). However, the article’s information on previous studies is wrong. In June 2003 we published a large study on the clinical use of placebo and the attitude to placebo interventions in a national cohort of 772 randomly sampled Danish doctors. Furthermore, at least five additional studies on the clinical use of placebo has been conducted since 1979 (4-8); one in 1999 (4), and one in 1997 (5). If the authors had conducted simple PubMed searches they would have identified five of the six studies published since 1979 (3,4,6-8). A ‘Related Articles’ search, based only on the Goodwin publication, would have identified four studies (3,4,7,8). It is reasonable to expect authors to identify and comment on previous studies, enabling readers to put new findings into context and to assess the originality of the research. 1) Nitzan U, Lichtenberg P. Questionnaire survey on use of placebo. BMJ doi:10.1136/bmj.38236.646678.55 2) Goodwin JS, Goodwin JM, Vogel AV. Knowledge and use of placebo by house officers and nurses. Ann Intern Med 1979;91:106-10. 3) Hróbjartsson A, Norup M. The use of placebo interventions in medical practice - a national questionnaire survey of Danish clinicians. Eval Health Prof 2003;26:153-65. 4) Berger JT. Placebo medication use in patient care: a survey of medical interns. West J Med 1999;170:93-6. 5) Ernst E, Abbot NC. Placebos in clinical practice: results of a survey of nurses. Perfusion 1997;10:128-130. 6) Thomson RJ, Buchanan WJ. Placebos and general practice: attitudes to, and the use of, the placebo effect. N Z Med J 1982; 95:492-4. 7) Lynøe N, Mattsson B, Sandlund M. The attitudes of patients and physicians towards placebo treatment - a comparative study. Soc Sci Med 1993;36:767-74. 8) Gray G, Flynn, P. A survey of placebo use in a general hospital. General Hospital Psychiatry 1981;3:199-203. Competing interests: None declared |
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Su Reid, Health administration NSW Department of Health, Australia 2060
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Try as I may, I just can't see the difference between a doctor who uses placebos without informing his/her patients, and any other purveyor of sham medicines or "health products". Competing interests: None declared |
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Ioannis DK Dimoliatis, Assistant Professor of Hygiene & Epidemiology University of Ioannina Medical School, Ioannina 45110 Greece
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"It is important to distinguish the very respectable, conscious use of placebos. The effect of placebos has been showed by RCTs to be very large. Their use in the correct place is to be encouraged. What is inefficient is the use of relatively expensive drugs as placebos. It is a pity some enterprising drug company does not produce a wide range of cheap, brightly coloured, non-toxic placebos." Archibald L Cochrane. Effectiveness and Efficiency. The Nuffield Trust, 1972: Chapter 5, subchapter b, second bullet 1. Competing interests: None declared |
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Rory Coughlan, Professor of Health Psychology Department of Psychology,Trent University, 1600 West Bank Drive, Peterborough, Ontario, Canada.
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The peculiar category of placebo: The socio-psychological affects of personal agency Rory Coughlan Placebos are the ghosts that haunt our house of bio-medical objectivity, the creatures that rise up from the dark and expose the paradoxes and fissures in our own self-created definitions of the real and active factors in treatment” 1 One of the important aspects of the scientific biological model of treating illness that is often ignored, actively avoided and poorly understood is what has often been referred to as the placebo effect. According to the more experimental conception of medical practice the placebo effect is something that is seen as a possible error that can invalidate the evaluation of medical interventions and as much as possible should be avoided. In actuality, it can be seen as the physician’s and patient’s best friend as recovery can occur fortuitously. 1 Many commentators and physicians have noted that part of this effect is linked to the patient belief in the treatment process (a psychological variable) and this belief can be augmented by many aspects of medical and other social relationships. These include the trust the patient has in the physician, the physician’s belief in the treatment protocol, a will to recover because of a religious belief, or love of or support by family or friends, to name just a few examples. 2 All of these possible reasons for this effect are social and psychological variables. If physicians give time to their patients, respect them, include them co-operatively in decisions regarding treatment, patients learn to have respect and trust in themselves. This trust in their own ability to heal is part of the placebo effect. 2,3,4. The most interesting aspect of this is that all of these aspects point to communicative and social means of augmenting the patient’s personal agency and it is this that has a major influence on outcome through psychological processes. 5 Randomized control trial evaluation protocols became the gold standard for medical research of efficacy after World War 2. Before this time efficacy of illness management was judged by whether or not the patient recovered. The focus was the patient. After approximately 1945 the ground shifted from this “beneficent model” to an “informed consent and autonomy” model. 4 The evaluation questions and criteria changed from “will this work?” to “how does it work?” This different approach is less interested in the absolute effects on recovery and more in terms of its relative effects in comparison to something else. 2 There is an assumption of a scientific judgment because treatments have to work by a method that is commensurate to a biological model of mechanical causation and quantification. It remakes medicine from an art into a replication of an experimental science. 1 Evaluations are asking whether treatment protocols work by a legitimate or a non-legitimate method. 4 These are fine questions to ask of medical responses to illness and they can be immensely useful in differentiating between effective and ineffective interventions. However, this model often delegitimizes many psychological, social and societal aspects of individuals’ lived experience that have been demonstrated to be important in patient recovery. It is well known that in medical trials, of those getting the placebo, approximately 30% of people will report some beneficial effects. 6 According to the scientific model of evaluation, in practice, ambiance, context, environment, doctor-patient relationship, belief system of the practitioner or patient are all non-legitimate forms of intervention or measures of efficacy. This delegitimation of these aspects as “merely placebos” can be viewed as an ideological proposition designed to deflect doubts about the over-biologization of medical practice. 4 In addition, it also presents the individual sufferer contextualized by their culturally embedded experiences, as practically immaterial to the evaluation. Such evaluations use aggregate research designs and make pronouncements on effectiveness comparing abstract measures of means and standard deviations contextualized by measures of probability. The individual experience of illness, recovery, and suffering has little if any importance in this model. By extension an argument could be made that human agency to regain health is not only deligitimated but becomes almost implausible in the experimental medical model that attempts to map how the treatment independent variable causes changes in the organism. References 1 Harrington, A. (1999). The Placebo Effect: An Interdisciplinary Exploration. Cambridge, MA. Harvard University Press. 2 Gordon, J. (1996). Manifesto For a New Medicine. New York. Addison - Wesley. 3 Kaptchuk, E. (1998). Intentional ignorance: A history of blind assessment and placebo controls in medicine. Bulletin of History of Medicine, 72, 389-433. 4 Kaptchuk, E. (1998). Powerful placebo: The dark side of the randomized controlled trial. Lancet, 351, 1722 . 5 Mullett, J. & Coughlan, R. (1998). Clinician and seniors’ views of Reference Based Pricing: Two sides of a coin. Journal of Applied Gerontology, 17, 3, 296-317. 6 Wolch, S. (2000) Rethinking Medicine. Toronto. CBC Publishing. Competing interests: None declared |
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Dr John Rumbold, n/a West Midlands
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I would suggest using a placebo for diagnostic purposes is not evidence-based and positively dangerous - placebo responders are no more likely than non-responders to have psychosomatic disease. A second point - the response of a placebo control is due to other factors as well as placebo effect (placebo vs nocebo). Competing interests: None declared |
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Franco Del Zotti, general practitioner 37122 VERONA - Italy
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Nitzan and Lichtenberg’s article(1) evokes the debate concerning the ethical risk tied to treachery in using placebos. Actually, many contemporary drugs are effective because they deceive nervous receptors. This means we must distinguish the misleading interpersonal relationship from the tricky techniques within an agreed therapeutic alliance. The first must be discouraged, while the second must be controlled, yet not stopped; otherwise we’ll see more and more paradoxes. For example, while today it is allowed to prescribe, even on a long- term basis, hazardous Non-steroidal anti-inflammatory drugs (NSAID’s)and Cox-2 inhibitors (Coxib) drugs, the legislation and medical praxis does not yet supply efficient strategies for explicit agreements with patients, on the use of placebos, in pain syndromes where, even if among doubts, its biological plausibility remains strong (2). The GPs, that continuously visit patients with chronic pain, could be the major users and major researchers of placebos. Maybe a change would take place, if there were a major increase in general practice of participation in trials, which in many cases establish the use of placebos. The achievement of a friendly and shared science, between doctors and patients in general practice, could be the necessary condition for a correct and extensive “informed consent” that could include the use of placebos in medical practice. Del Zotti Franco- general practitioner Corso Porta Nuova 3 –Verona (Italy)- delzotti@libero.it 1.Nitzan U, Lichtenberg P. Questionnaire survey on use of placebo. BMJ 2004:329: 944-6 2. Tor D. Wager, James K. Rilling, Edward E. Smith, Alex Sokolik, Kenneth L. Casey, Richard J. Davidson, Stephen M. Kosslyn, Robert M. Rose, and Jonathan D. Cohen Placebo-Induced Changes in fMRI in the Anticipation and Experience of Pain. Science 2004; 303: 1162-1167 Competing interests: None declared |
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Jonathan C Haynes, Staff Grade Psychiatrist Fromeside Clinic, Blackberry Hill Hospital, Bristol. BS16 1ED., Arden Tomison
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CASE SUMMARY X is a 40 year old single man, currently detained under Section 3 of the Mental Health Act (1983). He was first admitted under psychiatric care aged 25, and diagnosed with schizophrenia. Over the next 8 years he had 3 admissions, one informal, before presenting aged 33, having been arrested for arson. Further fire setting in a general adult ward resulted in transfer to the medium secure unit where he is now resident. His core delusions throughout have been that he is infected with venereal disease, and that his body is infested with worms and insects. He admitted that there was no outwardly visible manifestation of this disease, but insisted on investigation and medication. If such management was refused, X became angry, aggressive and on several occasions assaulted staff in various healthcare settings. X was very reluctant to engage in any psychological therapy, refusing to accept that there was anything but an organic cause of his disease. He was thoroughly investigated by the genito-urinary medicine department in an attached general hospital, becoming irate when a diagnosis of syphilis was not confirmed and he was not given tablet medication. He has exposed himself to risk by using over -the-counter preparations inappropriately and ‘borrowing’ medication from others. X was treated with a series of antipsychotic and adjunctive treatments. His compliance was variable as he felt that medication was not controlling his venereal disease. He received extended trials of depot medication, but his symptoms proved resistant to these. Clozapine and adjunctive medication also failed to bring about resolution of his delusions. After four years of such treatment, X remained fixed in his beliefs, varying between extreme despondency and hostility, believing the staff to be purposefully withholding treatment. He was encouraged to use art therapy to express his frustration, producing pictorial representations of his disease. PLACEBO PRESCRIPTION Due to X’s fixation with the need for oral medication, he was offered placebo medication. It was clearly explained to him in the presence of his advocate, that the tablets that he would be receiving had no active ingredients and that they would be unlikely to affect him in any way. X understood this information, but chose to accept them, believing that they might work in a way that doctors did not understand. A firm protocol of fortnightly review of placebo medication was agreed upon, on the understanding that all other medication would remain unchanged. Over the subsequent months, X’s medication was optimised and remained stable, whilst his placebo medication was changed on a regular basis. He continues to believe that he is infected with syphilis but is now engaging with staff and experiencing fewer episodes of despondency or hostility. DISCUSSION X is being treated under Section 3 of the Mental Health Act and is receiving medication under Section 58 of the Mental Health Act, as he has insufficient capacity to give or withhold valid consent. As may be seen from the above paragraph, X also lacks the capacity to consent to placebo medication, as he believes the information he has been given regarding the medication to be false. This medication is administered under common law, as the Mental Health Act Commission has suggested that: “As an inert substance, a placebo does not fall within the definition of ‘medicine’ and therefore, falls outside the provisions of Section 58”. 8th Biennial Report 1997-99, The Stationery Office (1999). It is normally accepted under common law, that a patient lacking capacity, may only be lawfully treated when: 1. Treatment is necessary to save life or prevent a deterioration or ensure an improvement in the patient’s physical or mental health; and 2. In accordance with the practice accepted as proper by a responsible body of medical men skilled in that particular area It would appear that the above case clearly meets the first criterion, and after much local discussion, it appeared that it also met the second criterion. In the view of his RMO and his therapeutic team X lacks capacity in respect of his treatment. This view was supported by the Second Opinion Doctor. One of the delights of mental health practice is the continual challenge to engage creatively with patients who pose often unique problems. The need to achieve a good result for them without compromising ethical principles is often difficult. We believe that this case offers an ethical solution to a perhaps unique combination of features, but invite comments. References: 1. 8th Biennial Report 1997-99, The Stationery Office (1999). Competing interests: None declared Editorial comment
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Pesach Lichtenberg, Unit chief Herzog Hospital, Jerusalem 94518, Israel
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To the editor, We wish to thank Professor Asbjorn Hrobjartsson for his enlightening comments. Of course, thankfulness was not the only emotion which his letter aroused. We also felt a good deal of embarrassment. He is of course correct that more people have examined the issue of placebo prescriptions in clinical use than we had realized. Professor Hrobjartsson’s research is particularly germane, insofar as it includes a nationwide survey recently conducted on the use of the placebo. After our own medline searches did not produce any articles on the topic, we sought help from the medical school library, which was kind enough to assist us. The efforts produced only the Goodwin paper. We are pleased that the findings of other research efforts support our conclusion that the use of the placebo in clinical practice is widespread and deserving of greater attention amongst clinicians and ethicists. We believe that our methodology, which involved obtaining information from one senior doctor and one senior nurse in every medical and surgical department at two large hospitals, advances our knowledge of what transpires in clinical practice. We regret that we were not aware of previous reports at the time of preparation of the manuscript, and hope that Prof. Hrobjartsson and the other researchers to whom he refers will accept our sincere apologies. Pesach Lichtenberg Competing interests: None declared |
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