Prescribing “placebo treatments”: results of national survey of US internists and rheumatologists

Editor.

For the intended benefit of the placebo-effect to occur, the
physician must withhold vital information from the patient. This prevents
the obtaining of valid consent and also denies patient autonomy. Times
have changed and this paternalistic method of medicine ("doctor knows
best") has been consigned to the rubbish tips. Involving patients in their
care and trusting them with the information needed to make decisions is
vital to ensuring a good doctor-patient relationship. Any hint of deceit
will erode this relationship indefinately. Risk this at your peril.

Competing interests:
None declared

This study generated a lot of headlines in the popular press that
were painful to read but easy to explain away.

The problem with
getting info from poplular press, especially papers like the New York
Times and
the AP is that they often have an unstated editorial agenda. It is mainly
to
sell papers and sometimes this happens by sensationalizing a rather weak
conclusion as is the case in this paper.

If you look at the paper, the investigators actually went through a
rather
diabolical system of trying to get doctors to say what the investigators
wanted
them to say and then reached even further in their conclusions to say that

doctors prescribe plecebo treatments.

As an ethicist my job is to discern the truth, and clearly the
authors of this
study and the reporters of the press articles had no interest in the
truth.

The press articles imply that doctors all across america are
prescribing sugar
pills for diseases like skin cancer, when in fact according to the article
only about 2
percent of the doctors studied ever really prescribe what most people
think of
as plecebo treatments, namely sugar pills or saline water.

The article goes through a complex and deceptive survey to get
physicians to
admit what we already know. Sometimes doctors prescribe treatments that
may not
work because the patients ask for them or because physicians think
patients want
them. Many of us are guilty of prescribing a new NSAID for a chronic pain

condition, being pretty sure it will not work, but at the same time
realizing
that it may, and also that there is little downside. We may also be
guilty of
prescribing antibiotics for a cold, being pretty sure that it won't make a

difference, but because we think the patient wants it, and just maybe it
is an
early pneumonia that isn't showing up on xray yet.

I've often ordered and ankle film on a sprained ankle, even though I
know it is a sprain because the patient wants
it, and also because I am fallible and have missed fractures that I was
sure
were sprains.

While this is not exactly great medical care it is a far cry from the
more
ethically circumspect practice of prescribing placebo treatments, yet this
is
what the study investigators conclude. They imply that anyone who writes
antibiotics for what is probably a viral illness, but may be a bacterial
infection is engaging in unethical subturfuge.

These
conclusions are a lie and need to be disputed. They do nothing but
undermine
the doctor patient relationship and society's confidence in the medical
profession.

Sincerly,

Jeffrey Thewes MA, MD

Competing interests:
None declared

One colleague wrote that evidence Based medicine "deprived us and our
patients of the honest and proper use of harmless placebos", but this is
not true.

The randomized clinical trials showed us that the effect of the drugs
is only a little better than that of placebo in many instances, and the
latter one is bigger than the difference between the effect of the drug
and the placebo effect (which I call the intrinsic effect of the drug).

In knee and hip osteoarthritis, for example, the effect of
paracetamol is very close to that of placebo, while the effect of anti-
inflammatory nonsteroidal drugs (AINS) is very close to that of
paracetamol[1]; the intrinsic effect of topical diclofenac (the
difference between the total effect and the placebo effect) is lesser than
the effect of topical placebo on the WOMAC (Western Ontario and McMaster
Universities Osteoarthritis Index) scale (1.4 points against 2.5 obtained
with placebo for pain, 4.5 points against 7.1 obtained with placebo for
the improvement of the physical function, and 0.2 points against 0.6
obtained with placebo for the stiffness)[2]. Concerning the effect of
ketoprofen patch in tendinitis of recent onset (measured on a 100 mm
visual analogue scale), the decrease in pain was of 25.8 mm in the placebo
group, and 38.4 mm in the treatment group (difference = 12.6 mm)[3].

In chronic obstructive pulmonary disease (COPD), a treatment that
improves the score of St George's questionnaire is considered slightly
efficacious for a 4 units change, moderately efficacious for an 8 units
change, and very efficacious for a 12 units change. Placebo improved the
score with almost 3 points, so it was not far from being slightly
efficacious, while the combination salmeterol/fluticasone or tiotropium,
which brought each a 4.5 point improvement, were certainly "slightly
efficacious"[4,5]. We can remark again that, while placebo decreased the
score with almost 3 units, the difference between the combination and
placebo was only 2.2 units, so the effect owed to the treatment was lesser
than that of placebo. We must stress the fact that, while the AINS have
many important adverse effects, both salmeterol/fluticasone and tiotropium
are expansive, while not deprived of adverse effects.

The placebo effect is almost as powerful as the medication effect in
irritable bowel syndrome[6] and depression[7], too.

Concerning the awareness of the patient about the fact that he was
prescribed a placebo - will the placebo effect take place, anymore, if the
patient is aware? I think that informed consent is against the idea of
placebo.

What is really unethical is to prescribe, as placebo, drugs with
important potential adverse effects as antibiotics and AINS.

References

1. Towheed TE, Maxwell L, Judd MG et al. Acetaminophen for
osteoarthritis (Cochrane review). In: The Cochrane Library 2008, Issue 1.
Chichester, UK: John Wiley and Sons, Ltd.

2. Bookman AA, Williams KS, Shainhouse JZ. Effect of a topical
diclofenac solution for relieving symptoms of primary osteoarthritis of
the knee: a randomized controlled trial. CMAJ 2004;171:333¡V8.

3. Mazieres B, Rouanet S, Guillon Y, Scarsi C, Reiner V. Topical
ketoprofen patch in the treatment of tendinitis: a randomized, double
blind, placebo controlled study. J Rheumatol. 2005;8:1563-70.

4. Calverley PM, Anderson JA, Celli B et al for the TORCH
investigators. Salmeterol and fluticasone propionate and survival in
chronic obstructive pulmonary disease. N Engl J Med. 2007; 356:775-89.

5. Casaburi R, Mahler DA, Jones PW et al. A long-term evaluation of
once-daily inhaled tiotropium in chronic obstructive pulmonary disease.
Eur Respir J 2002; 19:217-224.

6. Jailwala J, Imperiale TF, Kroenke K. Pharmacological treatment of
the irritable bowel syndrome: a systematic review of randomized controlled
trials. Annals of Internal Medicine 2000; 133:136-147.

7. Kirsch I, Deacon BJ, Huedo-Medina TB, Scoboria A, Moore TJ,
Johnson BT. Initial severity and antidepressant benefits: a meta-analysis
of data submitted to the Food and Drug Administration. PLoS Med.
2008;5:e45.

Competing interests:
None declared

Many physicians find themselves in a double bind: They want to use
the “powers of the placebo” for the therapeutic benefit of their patients
but at the same time they believe – as Tilburt et al show – that they
cannot confront their patients with the fact of their being offered a
treatment that works through positive expectations or other non-specific
effects rather than through a physiological mechanism triggered by certain
properties of a drug or procedure. But is openly providing placebos really
incompatible with a modern patient-physician-relationship that considers
the patient a partner in therapeutic decisions? From our own ongoing
research involving Swiss primary care providers we gather that a
substantial percentage of physicians fear patients would be disappointed
if they found out they had received a placebo. We are not certain if this
assumption is justified given that many patients use medicine and
unconventional approaches in parallel, many of them hiding the fact of
their “dual use” from their physician. (1) There may be a mutual
misunderstanding of expectations: physicians believing patients would be
disappointed or even insulted if they made use of placebo treatments in an
open way, and patients fearing their physicians would be offended if they
knew their patients were trying approaches patients themselves might
consider as having more to do with their own expectations and
psychophysiological responses than with a specific effect of the
intervention. In order to settle this important issue we urgently need to
investigate the patient perspective and compare it to physicians’
attitudes. It may turn out patients are much more open and willing to
experiment with placebo interventions than is generally assumed.

1. Eisenberg DM, Kessler RC, Foster C, Norlock FE, Calkins DR,
Delbanco TL. Unconventional medicine in the United States: prevalence,
costs, and patterns of use. N Engl J Med 1993;328:246-52.

Competing interests:
None declared