Questionnaire survey on use of placebo
BMJ 2004; 329 doi: https://doi.org/10.1136/bmj.38236.646678.55 (Published 21 October 2004) Cite this as: BMJ 2004;329:944
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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
We have signed informed consent to publish the details of this case.
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
"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
Competing interests: No competing interests
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
Competing interests: No competing interests
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
Competing interests: No competing interests
Re: Wrong information on previous studies of the clinical use of placebo
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
Competing interests: No competing interests