Startled by the power of placebos, doctors consider how to use them as real treatment
By Rebecca Tuhus-Dubrow
Boston Globe
May 9, 2010
You¹re not likely to hear about this from your doctor, but fake medical
treatment can work amazingly well. For a range of ailments, from pain and
nausea to depression and Parkinson¹s disease, placebos -- whether sugar
pills, saline injections, or sham surgery -- have often produced results
that rival those of standard therapies.
In a health care industry fueled by ever newer and more dazzling cures, this
phenomenon is usually seen as background noise, or even as something of an
annoyance. For drug companies, the placebo effect can pose an obstacle to
profits -- if their medications fail to outperform placebos in clinical
trials, they won¹t get approved by the FDA. Patients who benefit from
placebos might understandably wonder if the healing isn¹t somehow false,
too.
But as evidence of the effect¹s power mounts, members of the medical
community are increasingly asking an intriguing question: if the placebo
effect can help patients, shouldn¹t we start putting it to work? In certain
ways, placebos are ideal drugs: they typically have no side effects and are
essentially free. And in recent years, research has confirmed that they can
bring about genuine improvements in a number of conditions. An active
conversation is now under way in leading medical journals, as bioethicists
and researchers explore how to give people the real benefits of pretend
treatment.
In February, an important paper was published in the British medical journal
the Lancet, reviewing the discoveries about the placebo effect and
cautiously probing its potential for use by doctors. In December, the
Michael J. Fox Foundation announced plans for two projects to study the
promise of placebo in treating Parkinson¹s. Even the federal government has
taken an interest, funding relevant research in recent years.
But any attempt to harness the placebo effect immediately runs into thorny
ethical and practical dilemmas. To present a dummy pill as real medicine
would be, by most standards, to lie. To prescribe one openly, however, would
risk undermining the effect. And even if these issues were resolved, the
whole idea still might sound a little shady -- offering bogus pills or
procedures could seem, from the patient¹s perspective, hard to distinguish
from skimping on care.
³In the last 10 years we¹ve made tremendous strides in demonstrating the
biological veracity of the placebo effect,² says Ted Kaptchuk, an associate
professor at Harvard Medical School and one of the coauthors of the Lancet
article. ³The frontier is, how do we utilize what is clearly an important
phenomenon in a way that¹s consistent with patient-practitioner trust, and
informed consent?²
There are limits to even the strongest placebo effect. No simulation could
set a broken arm, of course, or clear a blocked artery. As a rule, placebos
appear to affect symptoms rather than underlying diseases -- although
sometimes, as in the case of depression or irritable bowel syndrome, there¹s
no meaningful distinction between the two. Moreover, placebos have often
received undue credit for recovery that might have occurred anyway. Indeed,
the effect is famously difficult to identify, measure, and even coherently
define. There is debate about the magnitude of the response, with some
calling it modest at best, and opposing the idea of using placebos
clinically.
But according to advocates, there¹s enough data for doctors to start
thinking of the placebo effect not as the opposite of medicine, but as a
tool they can use in an evidence-based, conscientious manner. Broadly
speaking, it seems sensible to make every effort to enlist the body¹s own
ability to heal itself -- which is what, at bottom, placebos seem to do. And
as researchers examine it more closely, the placebo is having another effect
as well: it is revealing a great deal about the subtle and unexpected
influences that medical care, as opposed to the medicine itself, has on
patients.
Phony treatment is hardly a novel concept in medicine. The word ³placebo² --
Latin for ³I shall please² -- has been used in a medical context since at
least the late 1700s, referring to inert treatments given to placate
patients. Arguably, until the scientific breakthroughs of the 20th century,
medical history was little more than one long series of placebos.
But in the postwar era, the profession changed in a way that relegated
placebos to the shadows. New medicines began to emerge that actually cured
diseases. At the same time, the longstanding paternalism of doctors was
yielding to a new ethos that respected the patient¹s right to understand and
consent to treatment. Gradually, fake pills began to seem less like a benign
last resort, and more like a breach of trust. To be sure, some doctors
continued to use placebos -- typically, ³impure² placebos such as vitamins
that had no specific effect on the malady in question. But they did so
quietly, knowing the practice was frowned upon.
As sugar pills were losing their place in the physician¹s arsenal, they
assumed a different role: as a neutral placeholder in drug testing. This
development is usually traced back to a 1955 paper by Henry Beecher, a
Harvard anesthesiologist who argued that the placebo effect was so potent
that researchers needed to account for it when testing new drugs. Today, the
³gold standard² of medical testing is the randomized clinical trial, in
which the new drug must beat a placebo to prove its worth.
In the last decade-plus, however, the accumulating data have sparked a
renewed interest in the placebo as a treatment in its own right. Numerous
studies have shown that it can trigger verifiable changes in the body. Brain
scans have shown that placebo pain relief is not only subjectively
experienced, but that in many cases the brain releases its own internal
painkillers, known as endogenous opioids. (This placebo effect can even be
reversed by the opioid-blocker naloxone.) Another study, published in
Science in 2009, found that patients given a topical cream for arm pain
showed much less pain-related activity in the spinal cord when told it was a
powerful painkiller. A 2009 study found that patients benefited as much from
a fake version of a popular spinal surgery as they did from the real one;
asthma patients have shown strong responses to a mock inhaler.
Impressed by such findings, some researchers and clinicians hope to import
them somehow from the laboratory into the doctor¹s office -- adding placebo,
in a systematic way, to the doctor¹s repertoire.
The first conundrum doctors face is how to honor the principle of informed
consent, their ethical and legal obligation to fully explain a treatment.
Clearly, a doctor would violate this rule by passing a sugar pill off as a
real prescription drug, and thinkers have begun to wrestle with this
challenge.
One audacious tack would be to tell the truth: to notify patients that they
are about to be given a fake pill. The idea sounds absurd, and doctors have
long assumed that would ruin the effect. But there¹s almost no research on
the question, and it may not be as unthinkable as it seems. One reason it
could work involves ³classical conditioning² -- the notion that we can learn
on a subconscious level, like Pavlov¹s dogs, to biologically respond to
certain stimuli. This concept suggests that the brain could automatically
react to the placebo in a way that doesn¹t require conscious faith in the
drug. (The placebo effect has been observed in rodents, which bolsters this
theory.) Another reason is that, according to many researchers, the
trappings of medical care contribute to the response. So in certain
circumstances, doctors could conceivably give a placebo with total
transparency, conspiring with patients to trick their own brains -- though
the lack of research means there is little evidence to support this
hypothesis now.
A second approach may be to integrate placebos with real treatments, and to
reconsider whether this should still be viewed as fakery. A groundbreaking
study published in February in the journal Psychosomatic Medicine found that
in one group, psoriasis patients who received a topical cream treatment,
alternated with placebo ³reinforcements,² did as well as patients who got up
to four times more of the active drug. The authors hypothesized that the
effect was due primarily to conditioning -- the brain learned to associate
the cream with healing and sent the same signals even when the cream was
inert.
This is just one study, but the implications could be profound. It suggests
that in some cases doctors could essentially dilute medications, perhaps
dramatically, and get the same results. Robert Ader, the study¹s lead author
and a psychiatry professor at the University of Rochester, says this
approach has the potential to address maladies that operate through the
nervous systems, such as pain, some auto-immune diseases, and hypertension.
Ader envisions a future in which a physician writes a prescription
consisting of the drug, the dosage, and the ³reinforcement schedule.² Under
a reinforcement schedule of 80 percent, the patient would get a bottle of
100 pills, 20 of which were dummies.
³You¹re talking about many, many, many millions of dollars a year in drug
treatment costs,² says Ader. He adds, ³If [doctors] can produce
approximately the same therapeutic effect with less drug, then it¹s
obviously safer for the patient, and I can¹t believe they wouldn¹t want to
look into doing this.²
In either scenario -- prescribing ersatz medicine alone or cutting active
treatment with it -- it¹s easy to predict the concerns and controversies
that would ensue. Might cost-conscious health care providers and insurers be
tempted to push placebos for financial reasons? Would patients feel cheated
and confused? Whether placebos can be successfully reframed as novel
medicines and helpful ³reinforcements² remains to be seen.
For other researchers, the data have led to very different territory:
They¹re looking for ways to elicit the placebo effect while jettisoning the
placebo altogether.
Some researchers argue that the real source of a placebo¹s effect is the
medical care that goes along with it -- that the practice of medicine exerts
tangible healing influences. This notion has received support from
experiments known as ³open-hidden² studies. Fabrizio Benedetti, a professor
at the University of Turin Medical School, has conducted a number of these,
in which patients receive painkiller either unknowingly (they are connected
to a machine that delivers it covertly) or in an open fashion (the doctor is
present, and announces that relief is imminent). Patients in the ³open²
group need significantly less of the drug to attain the same outcome. In
other words, a big part of the effect comes from the interactions and
expectation surrounding the drug. Some call the disparity between the two
scenarios the placebo effect. (Others, however, say the word ³placebo²
should be reserved for inert treatments, and press for different terms, such
as ³meaning response² or ³context effect.²)
³Medicine is intensely meaningful,² says Daniel Moerman, a professor
emeritus of anthropology at the University of Michigan at Dearborn who
coined the phrase ³meaning response.² ³It¹s this highly stylized, highly
ritualized thing.² He urges us to ³forget about the stupid placebo and start
looking at the system of meaning involved.²
A recent study by Harvard¹s Kaptchuk suggests the importance of ritual and
the doctor-patient relationship. A 2008 paper published in the British
Medical Journal described experiments conducted on patients with irritable
bowel syndrome. Two groups underwent sham acupuncture, while a third
remained on a waiting list. The patients receiving the sham treatment were
divided into two subgroups, one of which was treated in a friendly,
empathetic way and another with whom the doctors were businesslike. None of
the three groups had received ³real² treatment, yet they reported sharply
different results. After three weeks, 28 percent of patients on the waiting
list reported ³adequate relief,² compared with 44 percent in the group
treated impersonally, and fully 62 percent in the group with caring doctors.
This last figure is comparable to rates of improvement from a drug now
commonly taken for the illness, without the drug¹s potentially severe side
effects.
³It¹s amazing,² says Kaptchuk. ³Connecting with the patient, rapport,
empathy . . . that few extra minutes is not just icing on the cake. It has
biology.²
It may be, then, that the simplest and least ethically hazardous way to
capitalize on the placebo effect is to acknowledge that medicine isn¹t just
a set of approved treatments -- it¹s also a ritual, with symbolism and
meaning that are key to its efficacy. At its best, that ritual spurs
positive expectations, sparks associations with past healing experiences,
and eases distress in ways that can alleviate suffering. These meanings,
researchers say, are what the placebo effect is really about.
If this is true, then the takeaway is not necessarily that we should be
dispensing more fake pills -- it¹s that we should think less about any pill
and more about the context in which it¹s given. Whether we call it the
placebo effect or use new terms, the research in this field could start to
put a measurable healing value on doctors¹ time and even demeanor, rather
than just on procedures and pills. And that could change medicine in a way
that few blockbuster drugs ever could.
.............
RELATED LINK:
Pulse on Placebos
http://nhne-pulse.org/resource_pages/the-placebo-effect/
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