Placebo Effect

Although the term placebo effect might appear logically to refer to "the effect produced by a placebo," that definition is not in fact the one most commonly used. It would be more accurate to define the placebo effect as "the mind-body interaction triggered by medical treatment, historically discovered as a result of placebo use." That is, medical science may first have learned about the potential impact of the patient's mental state on healing by observing the effects of placebos ("dummy" or "sham" therapies thought to be lacking in any ingredients capable of producing bodily changes by chemical or physical means). If patients' bodies and symptoms were altered in impressive ways after the administration of placebos, the absence of any chemical explanation for the change suggested that it could only be by means of the patients' minds that such changes occurred. Once this basic observation is made, one may go on to divorce the patients' mental state from the use of dummy or sham remedies. Virtually any aspect of the encounter with a physician or other health worker could stimulate the requisite mental state, whether that state is one of expecting that one will get better, feeling trust in the caregiver, or whatever the precise psychological mechanism may be. It is in keeping with most modern usage to define placebo effect as "a change in a person's health status attributable to the symbolic or emotional impact of a healing intervention."

History

Ancient Greek medicine and the humoral medicine of the Middle Ages and Renaissance simply took for granted that words had the power to both cause or cure disease and that the mind and the body were constantly interacting to determine the individual's state of health. The earliest known reference to deliberate use of a placebo appears in a 1580 essay by Montaigne (1533–1592) describing a hypochondriac who was cured by an enema administered with great fanfare but without any substance actually being injected into the body. It is almost certain, however, that the use of placebos in medicine antedates this essay, probably by many centuries.

Medical science underwent a more materialistic turn and began to ignore the mind during the nineteenth century, but even then, citations appeared in the medical literature testifying to the power of placebos, and to the imagination generally, to alter disease. Placebos were frequently administered in the nineteenth century, in part because the profession lacked more effective medicines for most diseases.

Benjamin Franklin (1706–1790) was one of the first to use a single-blind technique in experiments on the power of mesmerism (hypnosis) conducted in 1785. Franklin was able to show by concealing the hypnotist behind a curtain that subjects' reactions were based on what they thought was happening and not on what was actually happening. Medicine increasingly demanded a blind technique when investigating "unconventional" or "quack" remedies in the nineteenth century but resisted the idea that conventional medical drugs and other remedies ought to be subjected to the same methods. After World War II, medical scientists became more aware of the potential for bias to skew research results if either the subject of the experiment, or the physician observing the experiment, knew who was receiving the "true" medicine, so the double-blind design, with neither party knowing which subject got the study medication and which got the placebo, gradually was adopted as the standard of valid research. Thus, precisely when placebos were less often used in medical practice (because so many powerful new drugs were available), placebos began to be used much more often as a research tool.

Modern medical ethics demands frank disclosure to the patient of the nature of any treatment administered. This, in most cases, rules out the deceptive use of placebos in therapy. But ethics does not rule out the attempt to elicit a placebo effect by creating a positive emotional environment during interaction with the patient. After largely dismissing the mind for many decades as largely unimportant and resistant to scientific study, modern medical science has developed a renewed interest in understanding the mechanisms by which the placebo effect might work. In 2001, the U.S. National Institutes of Health announced a new research program specifically aimed at understanding the mechanisms of the placebo effect and helping practicing physicians to enhance the effect.

Scientific understanding

Two psychological mechanisms appear to contribute to the placebo effect: expectancy (believing that a positive bodily change will occur) and conditioning (being in circumstances that, in the past, produced a positive bodily change). Evidence is accumulating that expectancy of pain relief can produce the release of endorphins, naturally occurring morphine-like chemicals in the brain that produce analgesia. In one study, when patients in pain following surgery were given a visible injection of a narcotic painkiller into their intravenous tubing, they experienced twice as much pain relief as when the same drug was given by hidden injection and the patient was unaware of receiving the drug. When naloxone, a drug that antagonizes the effects of endorphins, is administered to patients in the same manner, the placebo effect can be reversed.

Modern brain imaging techniques promise to expand the understanding of the mechanisms of the placebo effect. Using positron emission tomography (PET) scanning, for instance, patients experiencing a placebo effect in Parkinson's disease were shown to be manufacturing more dopamine in their brains, indicating that the placebo effect in Parkinson's may work by the same biochemical mechanism as the standard drug therapy.

Amidst new findings on how the placebo effect works, some skeptics continue to question whether the effect even exists. A systematic review of 114 randomized double-blind clinical trials (Hróbjartsson and Gøtzsche, 2001) concluded that there is no good evidence that administering placebos in the context of scientific trials produces any significant change in the subjects. (The authors did not intend their findings to address whether the placebo effect might exist in actual medical practice.) The methods used in this review have been challenged by placebo-effect advocates. Regardless, an important lesson from skeptical research such as this is that there are many mimics whose effects must be carefully separated from true placebo effects. Perhaps the most common mimic is the natural history of the illness, or the body's inherent healing powers. Many older studies that are quoted as confirming a powerful placebo effect in fact failed to distinguish between the patient's getting better because the illness was self-limited and the body's defenses were capable of eliminating it (as is the case with most common viral illnesses) and improvement that truly depended on the patient's mental or emotional state.

Implications for religion

Placebo effects may be of greatest interest in one category of so-called complementary and alternative medicine (CAM): methods of healing that rely particularly on religious faith or religious practices.

Religiously-based healing might be thought, by believers, to occur in one of two ways. In what one might call the natural route, faith, prayer, or other religious practices may be seen as stimulating the same chemical and physical processes in the human body as would be produced by any other system of medicine or healing. In what one might term the supernatural route, faith or prayer comes directly from a divine source and does not depend solely upon processes that science can measure or understand.

In religious healing by the natural route, the placebo effect could account for some and perhaps all of the healing observed. Faith and prayer may produce positive expectancies, and religious ritual may be a powerful source of psychological conditioning. So long as one believes that the human mind is part of the natural world, molded by the same creator who is responsible for any other healing modality, it seems logical that one would seek to harness the powers of the mind as part of whatever healing occurs. On this understanding the placebo effect becomes simply one means by which faith can heal.

In religious healing by the supernatural route, it might appear by contrast that if one could show that a placebo effect were occurring, that would exclude the possibility of the postulated healing effect. This seems particularly true for studies of intercessory prayer, in which believers claim that patients can be healed when people pray for them unbeknownst to the patients themselves. By definition, no emotional or mental effect can be generated if the subjects are completely unaware of the intervention. Therefore, to claim that the results of intercessory prayer are a placebo effect would be the same as denying that intercessory prayer works.

Another important implication of the placebo effect for religious healing is shared with other types of CAM: the design of appropriate comparison groups to conduct reliable research. What counts as adequate evidence that any form of CAM, including religious or faith healing, works? Some scientists reject all CAM out of hand as based on superstition and quackery, but more careful scientists are willing to accept CAM insofar as it can be shown to be effective in rigorous scientific studies. The question then arises as to what counts as adequate scientific "rigor" given the subject matter under study.

One way to approach this concern is to view science as a highly systematic way to show with a high level of probability that one explanation is the correct explanation for the phenomenon in which we are interested. Showing this requires that we consider all other plausible explanations and find ways to exclude them, so that we are left with only one explanation that appears to be correct. This is what it means in general terms to have a controlled study. It follows from this analysis that having a placebo or sham-treatment control group is one good way to eliminate several plausible explanations for healing. A placebo control group can eliminate the placebo effect, the natural course of illness, and a number of chance statistical associations as reasons why the subjects receiving the healing intervention got better. Because the placebo control is useful for many study purposes, it is tempting to assume that the only valid scientific study is one with a placebo control, but this would be mistaken. Depending on the question being investigated and which alternative explanations are most plausible, there may be other scientific methods to exclude the alternative explanations with a high degree of reliability. In many possible studies of religious healing, the usual methods to assure scientific rigor will simply not be possible. It is hard, for example, to imagine a population of both believers and nonbelievers agreeing to be assigned randomly to receive real or sham faith-healing.

See also Medicine; Mind-body Theories; Spirituality and Health

Bibliography

amanzio, martina; pollo, a.; maggi, g.; and benedetti, fabrizio. "response variability to analgesics: a role for non-specific activation of endogenous opioids." pain 90 (2001): 205–215.

brody, howard, with brody, daralyn. the placebo response: how you can release the body's inner pharmacy for better health. new york: harpercollins, 2000.

brody, howard. "the placebo effect: implications for the study and practice of complementary and alternative medicine." in the role of complementary and alternative medicine: accommodating pluralism, ed. daniel callahan. washington, d.c.: georgetown university press, 2002.

de la fuente-fernandez, raúl; ruth, thomas j.; sosi, vesna; et al. "expectation and dopamine release: mechanism of the placebo effect in parkinson's disease." science 293 (2001): 1164–1166.

guess, harry a.; kleinman, arthur; kusek, john w.; and engel, linda w., eds. the science of the placebo: toward an interdisciplinary research agenda. london: bmj books, 2002.

hróbjartsson, asbjørn, and gøtzsche, peter. "is the placebo powerless? an analysis of clinical trials comparing placebo with no treatment." new england journal of medicine 344 (2001): 1594–1602.

howard brody

Placebo effect

Definition

A placebo effect occurs when a treatment or medication with no therapeutic value (a placebo) is administered to a patient and the patient's symptoms improve. The patient believes and expects that the treatment is going to work, therefore it does. The placebo effect is also a factor to some degree in clinically effective therapies, and explains why patients respond better than others to treatment despite similar symptoms and illnesses.

Origins

The word placebo is from the Latin "I shall please." Throughout most of medical history, the placebo effect was the principal treatment physicians offered their patients—e.g. reassurance, attention, and belief in treatment would mobilize patients' internal powers to fight their illnesses. This is still true in indigenous cultures using shamanistic healing which places healing power in objects and rituals. In fact placebos are sometimes called sham treatments.

Placebos were used throughout the nineteenth century in blind assessments of medical treatments. These blind assessments were created to test controversial medical treatments of the time (e.g. mesmerism and homeopathy ), and involved using a blindfold on or withholding information from patients so they were unaware of the exact nature of the treatment being studied. For example, in blind assessments of homeopathy conducted in 1834 in France, homeopathic remedies were replaced with an inert placebo substance without the patient's knowledge. These blind assessments were the forerunners to today's double-blind randomized controlled trials used in drug development and in the study of other therapeutic techniques.

According to some medical historians, from the early 1800s through as late as World War II, placebos (usually in the form of sugar pills or saline injections) were regularly prescribed to up to 80% of patients. Doctors used placebos to appease patients when no effective treatment for their symptoms was available, or prescribed placebos to patients they perceived as difficult.

The first documented American clinical study using placebos was conducted in the late 1920s. In 1937 scientists at Cornell University Medical School published a study on an angina drug that used a placebo and blind assessment techniques. They found that the patients who were given a placebo instead of the angina drug experienced an improvement of symptoms. This was the first published account in the United States that discussed the possible therapeutic value of the placebo effect.

Benefits

The placebo effect is usually positive by its nature, because it indicates that a patient believes in the therapy, and the therapy is having some sort of a beneficial effect. The placebo effect has been documented in a wide variety of diseases and disorders. Certain conditions such as headaches, arthritis, and hot flashes are especially responsive to placebos, as are some individuals.

Description

Every available medical treatment is subject to the placebo effect. If a patient believes the therapy will benefit them, it usually will to some degree. Even if the placebo does not improve the symptoms directly, the peace of mind a patient may feel after taking a treatment they believe will help them is often enough to encourage a sense of improved well-being. This is why controlled, scientific studies are so crucial to determining the actual clinical efficacy of medications and therapies.

The person prescribing the placebo treatment may also have an impact on the effect it has on the patient. For example, a doctor's enthusiasm about a new treatment may heighten its placebo effect for his patient. In addition, if a healthcare provider is perceived as a trusted, well-respected figure by the patient, the patient may experience benefits from any treatments the provider prescribes.

Placebos are often used in scientific trials of new medications and treatments to determine their efficacy. A randomly selected group of study subjects known as the control group are given placebo medication (usually a sugar or water-based substance) or treatment while the rest of the subjects are administered the actual therapy. The patients do not know which group they are in during the study, and the researchers and study authors do not know which subjects are in which group (hence the term double-blind). This helps researchers to determine if new treatments work because they are clinically effective, or because the subjects believe they will work.

Overall, the average placebo effect is 33%, though it can range lower and higher. Therefore, to demonstrate that a treatment, procedure, or medication is effective, a trial has to show that it does significantly better than the placebo given to a control group. For example, a study of single-remedy homeopathy was conducted with a group of 487 patients with an influenza-like syndrome. Patients treated with a single, non-individualized remedy were 70% more likely to have recovered within 48 hours than those receiving the placebo.

Preparations

Placebos only have therapeutic value if the patient believes they will work. If an individual chooses a healthcare provider that they trust, respect, and feel comfortable with, there may be a more likely chance that treatments the provider recommends (whether clinically effective or unproven) will be perceived as having a more beneficial effect.

The use of a placebo in scientific studies requires informed consent of the entire population of subjects. The study subjects must know that they have a 50/50 chance of receiving a placebo treatment instead of the treatment under investigation.

Precautions

There are ethical issues involved with administering placebos to patients if the healthcare provider knows there is no therapeutic value to the treatment and other available treatments could possibly benefit the patient. For patients with progressive or life-threatening illnesses, taking a medication or therapy with no clinical value other than its placebo effect can be harmful if it causes them to neglect other proven treatments that could improve their condition.

Some clinical trials of surgical procedures require the placebo, or control subjects to undergo what is essentially unnecessary surgery, involving incisions and other invasive procedures while the final therapeutic portion of the procedure is withheld (the placebo). Although this is standard scientific procedure currently recommended by the U.S. Food and Drug Administration (FDA) for the approval of new medical procedures and devices, it is also commonly accepted knowledge that unnecessary surgery is never beneficial to a patient and can result in serious complications such as infection, hemorrhaging, and conceivably even death.

Side effects

The placebo effect can have a negative influence also, a nocebo. If a placebo is given that the patient believes to be harmful to their health in some way, he or she may develop symptoms appropriate to this belief. A toxic or negative placebo suggests the great degree to which attitudes and expectations can affect one's state of health or course of an illness. People who think they have been cursed or a victim of voodoo have been known to die.

Research & general acceptance

The placebo effect is a well-known phenomena in the scientific community, and clinical trials and other scientific studies are built around the theory. Ethical concerns can arise when there is a risk that patients are not getting the potentially life-saving treatments they need. In some cases, the placebo effect is enough to compensate for this. For example, a study published in the Archives of General Psychiatry found that in 45 controlled trials of antidepressants, subjects in the control group experienced a significant positive therapeutic effect with the placebo only. In cases of treatments involving potentially fatal diseases such as cancer and AIDS , the ethical implications of placebo use may not be as clear-cut.

Surgical placebo procedures, which are a relatively new type of clinical study, are not as universally accepted as placebo drug trials. There is a heated debate in the medical community over the value of such studies. However, the use of placebo surgery for controlled clinical trials is endorsed by the National Institutes of Health, the medical research arm of the U.S. Department of Health and Human Services.

Resources

BOOKS

Harrington, Anne. The Placebo Effect: An Interdisciplinary Exploration. Cambridge, MA: Harvard University Press, 1999.

Shapiro, Arthur K., and Elaine Shapiro. The Powerful Placebo: From Ancient Priest to Modern Physician. Baltimore, MD: John Hopkins University Press, 1997.

PERIODICALS

Kaptchuk, Ted J. "Intentional Ignorance: A History of Blind Assessment and Placebo Controls in Medicine." Bulletin of the History of Medicine 72, no. 3 (1998):389-433.

Paula Ford-Martin

Placebo effect

In research, a scientifically significant response that cannot be explained by physiological variables and is assumed to be psychological in origin.

Placebos are substances with no known pharmacological value that are given to members of a control group in an experiment. In studies determining the effectiveness of a particular drug, for example, the experimental group is given the drug being studied and the control group is given a placebo, which is made to look exactly like the actual drug. Neither group, nor the researchers, knows which received the drug and which the placebo. If the members of each group show similar responses, the placebo effect has been produced. For reasons not completely understood, the patients given the placebo have experienced the effects of the drug without actually taking it. In such cases, the drug itself is considered ineffective.

The placebo effect has been noted since ancient times, when animal parts or other naturally occurring substances were given as treatment for various human diseases and ailments. Throughout medical history, patients have recovered from illnesses after healers employed substances or methods that scientifically should have no effect. It is believed that patients' expectations that their condition will improve plays a major role in producing the placebo effect.

The use of placebos in psychotherapy is controversial, with some critics contending that it links therapists with "quack" treatments rather than legitimate, scientifically measurable methods. However, most researchers agree that the placebo effect, while not completely understood, plays a major and beneficial role in both physiological and psychological treatment.

Further Reading

Atkinson, Rita L.; Richard C. Atkinson; Edward E. Smith; and Ernest R. Hilgard. Introduction to Psychology. 9th ed. San Diego: Harcourt Brace Jovanovich, 1987.

Zimbardo, Philip G. Psychology and Life. 12th ed. Glenview, IL: Scott, Foresman, 1988.