The placebo effect or how powerful the power of suggestion is. Placebo effect - what is it?

This effect was established by doctors. It is based on a deliberate or unconscious suggestion by a doctor or experimenter that a certain factor (drug, method of action) should lead to desired result. The faith of subjects or patients can really work miracles, although the factor itself does not play any effect. If patients expect that the drug should help improve their condition, then they actually experience changes for the better. In medicine, placebo (Latin placere - to like) means a drug that does not have medicinal properties(“fake medicines”). The term “placebo effect” was introduced into scientific circulation by the American physician Henry Beecher in 1955, who found that about a third of patients recovered from “dummy” pills that did not contain active ingredients. Serious study of the placebo effect began during World War II. When there was a shortage of painkillers in the front-line hospital, anesthesiologist Henry Beecher became convinced that in some cases, an injection of saline solution had almost the same effect as real medicine. Returning from the war, a doctor with a group of colleagues from Harvard University began to study this phenomenon. He summarized the results of his research in 1955 in the article “Strong Placebos.” The strongest factor in placebo effects is the faith of doctors and staff themselves in the power of drugs. Many double-blind experiments have been conducted in which the placebo effect has been demonstrated. One of them is a textbook case of studying the effectiveness of reserpine. In 1953, psychiatrist E. Mendel worked at the St. Elizabeth Psychiatric Hospital near Washington in a department that treated people from Puerto Rico and the Virgin Islands. Most patients were hospitalized due to attacks of hostile and aggressive behavior. Some of them were so dangerous that they were kept in special shirts, and Mendel was accompanied in the hospital by two guards. Communication was also difficult because the patients did not know in English, and Mendel - Spanish. At that time, a new tranquilizer, reserpine, became popular, which gave good results specifically for such patients. Hospital officials decided to test these drugs using a special double-blind method. The patients were not informed that some received real medicine, while others received so-called “dummy” drugs (just sweet pills). Doctors did not know which of the patients received the drug and which only thought they were receiving it. Mendel told patients about the new drug, its effectiveness, speed of action and lack of side effects. The patients knew those participating in the study. The experiment lasted several months. However, very soon Mendel came to the conclusion that the drug had a very positive effect on patients. The patients became calmer, communicated more affably with the doctor, and soon he allowed them to abandon straitjackets. Mendel himself experienced a spiritual upsurge; he believed that reserpine would revolutionize psychiatry, especially in relation to aggressive patients. However, he was shocked when he learned that his patients were receiving a “dummy.” After analyzing all the events, Mendel realized that positive changes occurred precisely because of his behavior and kind attitude towards the sick. The doctor believed that his patients received reserpine and therefore became calmer, they had friendly looks, smiles, and gestures. Mendel saw signs of improvement everywhere mental state sick. The doctor realized that the patients simply began to respond to his calm attitude, which was the result of the doctor's confidence that reserpine was working. He simply began to treat his patients better, and they responded with friendly behavior; they were pleased that they were treated as full-fledged people. Manifestations of the placebo effect are associated with the patient’s unconscious expectation, his ability to be influenced, and the degree of trust in the psychologist. This effect is used to study the role of suggestion under influence conditions. medical supplies, when one group of subjects is given the real drug whose effects are being tested, and the other is given a placebo. If the drug really has positive effect, then it should be greater than from using a placebo. The typical rate of positive placebo effect in clinical trials is 5-10%. In studies, it is also easy to cause a negative nocebo effect, when 1-5% of subjects experience discomfort (allergy, nausea, cardiac dysfunction) from taking a “dummy”. Clinical observations indicate that nervous personnel produce nocebo effects, and prescribing anxiety-reducing medications to patients significantly reduces anxiety among doctors themselves. This phenomenon was called “placebo rebound.” For particularly emotional patients who are prone to self-hypnosis, doctors prescribe neutral drugs that will help improve a person’s condition and avoid taking unnecessary medications. Positive influence homeopathic medicines partially explained by the placebo effect. It works not only in experiment, but also when simulating a certain medical procedure, under the influence of a conversation, when a person’s psychological reserves are mobilized. Even when using impeccably studied drugs, they try to trigger the placebo effect. Bright and large tablets work better than vague and small ones, and drugs (“bioequivalents”) from well-known companies give greater effect than medicines from modest manufacturers with the same composition. The basis of the placebo effect is the suggestion that the drug has a certain effect, and the expected effect appears because the brain begins to stimulate the production of endorphins, which partially replace the effect of the drug, and the “mobilization effect” also works - increasing immunity, mobilizing the body’s defenses. The manifestation of the placebo effect depends on the level of self-hypnosis and the physiological capabilities of the formation of the necessary chemicals. Doctors have long used the placebo effect. Famous therapist of the 19th century. M. Ya. Mudrov treated patients with special powders with the names “golden”, “silver”, “simple”. These names corresponded to the color of the paper in which the medicines were wrapped. Mudrova's powders cured many diseases and had a real miraculous effect. After the doctor's death, it turned out that it was just ground chalk. Therefore, it is clear that psychological perception, emotions, and trust in the doctor had a healing effect. The doctor himself, a practitioner of placebo therapy, wrote: “The art of a doctor lies in creating “medicines for the soul” that would console the angry, calm the impatient, stop the violent, frighten the impudent, make the shy bold, the unsociable frank, the desperate reliable.” The effect of the placebo effect enhances the authority of the doctor, so any medicine from the hands of a famous luminary has a much more effective effect on patients than those prescribed by a local doctor from a local clinic. According to research, placebo affects all people, but most of all - on extroverts who are anxious, dependent, emotionally labile, flexible and trust their doctors. Placebo non-responders are more likely to be introverted, distrustful and suspicious. Neurotic people with low self-esteem, insecure people who tend to believe in miracles are more exposed to the placebo effect. IN medical practice it has been confirmed that placebo works better in people with lungs psychosomatic disorders, for example, mild insomnia or mild depression. It has been found that the placebo effect can occur even if patients know that they are simply receiving neutral pills. In a study conducted at Johns Hopkins School of Medicine, 15 people were treated for anxiety and given a sugar pill once a week. They were frankly explained that these were “dummies”, but they noted that they help some patients. After completion of treatment, 14 patients reported that their anxiety had decreased significantly, of which 9 believed that the improvement was due specifically to the action of the pill, 6 suspected that the pills contained active substances, 3 complained side effects(blurred vision, dry mouth). Such complaints are typical when taking some psychotropic drugs. Since 1970, placebo and double-blind methods have been mandatory for evaluating the effectiveness of new drugs and comparing like ones. Over the past 10-20 years, the interest of both psychologists and physicians in placebos has grown significantly and its study continues.

Identified in the mid-twentieth century by doctors, but in fact, wearing purely psychological character, The Placebo effect still proves today what possibilities human faith and self-hypnosis can open up.

Religion is not the opium of the people. Religion is a placebo for the people.
Dr. House

Excursion into history

Placebo, in the medical community, is a medicine that does not have healing power (“dummy drug”).

The concept of the "Placebo effect" arose in medical literature 1955, when the American doctor Henry Beecher discovered that some patients began to feel better by taking medications that had no healing properties at all.

Back during World War II, while working as an anesthesiologist in a military hospital, he noticed that sometimes the effects of saline solution and real medicine were almost the same. After the war, Henry Beecher began to seriously study this phenomenon, collecting the findings of his work in the publication “Potent Placebo” in 1955.

The key to this phenomenon is not only the faith of the patient and the attending physician in the power of the medicine, but also the faith of the entire staff. Many experiments have been conducted in placebo research, one of which is particularly recorded in the history of psychiatry.

In 1953, in one of psychiatric hospitals near Washington, where residents of Puerto Rico and the Virgin Islands were being treated, a group of patients with strong manifestations aggression. This group of patients was supervised by psychiatrist E. Mendel.

The doctor decided to test the new tranquilizer reserpine using a double-blind experiment. Some of the patients were given the real drug, and some were given ordinary sweet pills. The doctors themselves did not keep track of which group received which pills. And all the patients were sure that they were taking a tranquilizer.

A few months later, from the calm behavior of the patients, it became clear that the new remedy was quite productive. The renowned psychiatrist was impressed by the effects of reserpine, but it soon became clear that many patients were receiving placebos.

Mendel soon realized that the patients' condition returned to normal only because of his belief in the improvement of the patients' behavior. He began to treat his charges calmly, and they responded to him in the same way.

Secrets of the placebo effect

One of the secrets of this unique phenomenon is associated with the ability of a person, or rather a patient, to succumb to suggestion and unconsciously trust the attending physician and psychologist.

Thanks to the effect of placebo, doctors determine the quality medicinal drug. If one patient took a placebo and another took the real medicine, but the result was approximately the same, then the drug does not have a sufficient positive effect.

Along with placebo modern medicine Another directly opposite phenomenon is also known - the nocebo effect. It can manifest itself in the form of nausea, allergies, dizziness and increased heart rate in patients taking " fake medicine" According to strange statistics, the nocebo effect is caused by nervous hospital staff, and by prescribing medicine to calm patients, the doctor thereby calms himself down.

This phenomenon is called " placebo rebound».

The placebo effect is also the basis of homeomatic medicines that are popular today. When talking and simulating the treatment process in this case, all human reserves are activated.

The placebo effect has become a new vector not only in medicine and psychiatry, but also in the development of pharmaceutical products. For example, many drug manufacturers are trying to produce bright, large pills that are much more effective than small, “nondescript” pills. And patients calmly use drugs from familiar companies, the names of which they hear on television, rather than products with the same content, but from unknown manufacturers.

Self-hypnosis activates the release of endorphin, which sometimes replaces the effect provided by the drug, and includes a “mobilization function,” which implies strengthening the immune system. The strength of the placebo effect depends on the person's exposure to the influence and the ability to produce the necessary chemicals.

The effect of the placebo effect on different categories of people

The placebo phenomenon works in all people, but the strength of its effect varies depending on the person's personality type.

For example:

1. In children, the placebo phenomenon is much more pronounced than in adults;
2. The placebo effect is stronger on emotional and dependent people

In medicine, there have been cases where patients recovered by taking drugs whose effectiveness has not been proven. Moreover, clinical researches confirm that the medicinal value is approaching zero. In this case, there is a placebo effect - healing oneself practically with the power of thought.

Placebo: what is it?

Almost two hundred and fifty years ago, doctors described the facts of recovery of patients after taking substances that were not medicines, but were passed off as such.

In simple words we can say that the patient receives a “dummy” that imitates a tablet, capsule, or injection. It does not contain medicinal components and logically it shouldn’t “work”. But in reality, it turns out that the patient receives “treatment” and recovers.

The phenomenon was called “placebo” and was repeatedly studied by psychologists and doctors.

For the purity of the experiment, double-blind studies are often carried out. In the experimental group, the experiment is controlled by neutral scientists. At the same time, neither the patients nor the doctors treating them know which of the patients receives the drugs and which receives their imitation.

Example 1: Psychiatry

Doctor psychiatric clinic, located in a US city, treated patients suffering from violent attacks. Their behavior was aggressive life-threatening and the health of others.

On initial stages Most of the clinic's patients were kept in conditions of deprivation of activity - in straitjackets.

The clinic's management embarked on an experiment in which, by prior agreement, Dr. Medel's patients began to receive new, hitherto unknown, but very effective medicine. This medicine made it possible to stabilize and socialize violently insane and mentally deranged patients.

Even the doctor himself didn’t know who was getting the pills and who was getting the placebo. After some time, the doctor began to notice that the patients became calmer. They show adequate behavior, make contact, and violent attacks become rare.

The patients talked, smiled, and the doctor was able to give up the security he had previously been with.

Imagine his surprise when he learned the results of the test treatment. None of the patients in the insane asylum received medication; all took placebos.

The therapy worked because neither party in the experiment (neither the doctor nor the patients) knew who was receiving the drug. Patients believed that a drug had been found that would help overcome their problems. And so it happened.

The doctor did his best to see results, changes in the behavior and consciousness of his patients. He actually “saw” them, thereby unwittingly influencing the patients.

A drug reserpine entered the history of psychiatry as the most effective placebo capable of treating people with mental disorders.

Example 2. Tuberculosis

At the turn of the 19th and 20th centuries, patients with pulmonary tuberculosis were observed in one of the German clinics. Scientists had not yet invented a medicine that could defeat the disease, and the mortality rate was extremely high.

Taking a risk, the medical staff notified patients that a rare, very effective and equally expensive drug, which can defeat the disease within a month. The mentioned characteristics of the drug had important: new, effective, expensive.

Under the guise of know-how, patients received acetylsalicylic acid. But the conviction of the effectiveness of the new medicine, delivered to the hospital especially for them, potential suicide bombers, made it possible for 80% of the patients to be cured.

Example 3. Pediatrics

In the United States, drugs with a placebo effect are widely used in pediatrics. American doctors are deeply and unshakably convinced that children should not be drugged unless absolutely necessary.

Not only children, but also their parents often need a “magic” pill. Therefore, drugs of this type are sold in pharmacies and consist of safe components that are approved even for small children.

Pills “for laziness”, “for fear”, for diseases that develop against a background of uncertainty, and phobias are extremely popular. What’s most surprising is that they bear fruit.

List of drugs considered placebo

The list of drugs marked as “dummy” is quite long. According to the Russian Academy of Medical Sciences, about a third of the drugs on the modern pharmacological market are dummies. Many of them are expensive and popular with both doctors and patients.

1. Medicines to improve blood circulation and microcirculation - Actovegin, Cerebrolysin, solcoseryl;
2. Immunomodulatory drugs;
3. “Heart” drugs - ATP, cocarboxylase, riboxin;
4. and (Linex, bifidumbacterin, bifidok, hilak forte and others);
5. Means for improvement cerebral circulation– piracetam, nootropil, tenoten, phenibut, pantogam, aminalon, tanakan, preductal;
6. Mildronate, mexidol;
7. Bioparox;
8. Polyoxidonium, influenpol, gromecin;
9. Chondroprotectors – chondrosamine, glucosamine, chondroitin;
10. Valocordin, Valoserdin, Novopassit;
11. The antithrombotic drug thrombovasim;
12. Essentiale N, mezim forte.

What enhances the placebo effect?

Pharmaceutical companies, producing separate groups medicines, they know marketing moves. These methods not only increase the popularity (and therefore the level of sales) of dummy drugs. They also help patients, despite the lack of active ingredient in the composition medicinal product:

• Patients like large, brightly colored tablets more than small, faded, colorless ones. Patients subconsciously develop trust in externally noticeable medications;
• Expressed therapeutic effect manifests itself in patients after taking drugs from well-known manufacturing companies in comparison with modest competitors, even if the composition is the same active substance;
• Expensive medicines they “treat” faster, more effectively and there is more trust in them than in cheap analogues;
• After completing or interrupting the placebo “treatment” course, 5% of patients experience withdrawal syndrome with pronounced symptoms;
• Between 5 and 10% of patients experience the stated side symptoms, although there are no substances that can cause them in the medicine;

Placebos work better in people with labile psyche, anxious, gullible. They consider the doctor to be the last resort and trust him. Such people, extroverts, are easily suggestible. Low self-esteem and secret readiness for a miracle allow the placebo to “work” in full force.

Patients who are suspicious, suspicious, and who test any information “to the teeth” are less susceptible to the influence of placebo. They do not trust miracles and the charlatans who propagate them. After all, it is the subconscious and the willingness to believe that play a key role in treatment with pacifiers.

Types of placebo

Placebo treatment is not limited to banal pills with a magical effect. There are several types of placebos:

Drugs

The most popular and extensive group. Under the influence of “powerful” pacifiers, migraines go away and return to normal arterial pressure, bleeding stops, even tumors, including malignant ones, resolve.

There are many such examples described in the medical literature. In each case, the effectiveness is recorded and cannot be explained only by the effect on the conscious and subconscious.

Imaginary surgical interventions

Surgeons use the placebo effect by replacing real operation imaginary and achieve the same result as with a real intervention.

Surgeon David Callms has been practicing spinal surgery after severe injuries and fractures for many years. He decided to experiment, during which some of the patients were actually operated on. The other part was informed about the operation, although in reality there was no such operation.

But what really happened was reliable preparatory work with patients, an identical environment in the operating room.

As a result of a high-quality performance, the patients’ well-being improved. At the same time, the pain went away and functions were restored. This means that slightly different regeneration mechanisms come into play.

Placebo – acupuncture and homeopathy

Instilling in the patient faith in the possibility of getting rid of a serious illness by installing needles on the skin and taking homeopathic medicines, makes it possible to achieve enormous success in the treatment of mental and somatic diseases.

And yet, how does it work?

In psychology, the placebo effect is used not only for correction personal qualities, but also for training and education, development, stabilization at any age. The basis of a placebo is suggestion. Properly executed suggestion triggers hidden mechanisms in human body. This allows you to mobilize your own resources and defeat the disease.

Every doctor knows that there are patients for whom outside attention medical worker- already treatment. People are suspicious, suggestible, ready to believe in magic pill, unique procedure, rejuvenating apples and living-dead water, they are easily tempted to be cured with the help of a miracle remedy.

Their body produces substances necessary for treatment, rejects pathological cells, promotes tissue regeneration, because the brain, confident in the effectiveness of the treatment, gives the necessary commands.

For this category of patients good doctor the one who prescribes medications will treat, and will not explain how to do without them. It is in such cases that a placebo promotes treatment and does not harm the body, most likely causing damage only to the wallet.

It has long been known that faith works miracles. Placebo is the belief in the possibility of becoming healthy again despite prognosis and possible negative options.

Placebo (Latin placere - to like, to be appreciated) means a drug that obviously does not have any healing properties. In the 18th century, the word entered the medical lexicon and began to mean “fake medicine.”
This is how the Big Encyclopedic Dictionary defines this term: “A dosage form containing neutral substances. Used to study the role of suggestion in the therapeutic effect of any medicinal substance, as a control when studying the effectiveness of new drugs.”
A more detailed definition is given by encyclopedic Dictionary medical terms: “Pharmacologically indifferent substance, in appearance and taste imitating some medicine. Used in research pharmacological effect medicinal substances, as well as in therapeutic practice." A placebo is defined as “an inert substance that acts as a result of the patient's expectations and is unable to act directly on the conditions it is prescribed to change.”
In medical practice, there are two types of placebos. In some cases, indifferent substances are used to study the placebo effect, in others - special mixtures corresponding to the compositions dosage forms study drugs. In this case, placebo is used for differentiated assessment therapeutic effect active substance contained in pharmacological drug. It should be noted that there are no absolutely indifferent substances for the body. We can only talk about relative or absolute indifference in relation to specific action the object of research being studied.
The phenomenon in which the expected effect of a substance determines the body's reaction to it is called placebo effect. This reaction is manifested by changes in physiological and psychological states person after taking harmless drug, prescribed under the guise of any effective drug, compared with a control group not receiving any drug. The existence of a placebo effect may demonstrate the psychotherapeutic effect of the very fact of taking the drug. It is not associated with the specific effects that a placebo substance may cause.
The positive placebo effect is positive changes that are expressed in the form of improved well-being, relief from anxiety and restlessness; temporary normalization of sleep, indicators of cardiovascular and respiratory systems; reducing the severity of symptoms of cough, runny nose; reducing the frequency of attacks bronchial asthma, angina pectoris, headache; increasing the range of motion with radiculitis; improvement in condition allergic rhinitis, peptic ulcer; weight loss; changes in emotional sphere(reducing the severity of depression, improving mood); pain relief of various origins, swelling due to inflammation of the joints. Consequently, we can talk about a subjective improvement in well-being and an objective manifestation in the form of a weakening of the symptoms of the disease.
The term “placebo effect” was coined in 1955 by American physician Henry Beecher, who discovered that about a third of patients recovered from dummy pills that contained no active ingredients.
There are very few detailed works on placebos in the Russian-language literature. The monograph by I.P. deserves attention. Lapina, written on the basis of the author's many years of experience in studies of the placebo effect in healthy individuals and patients. He summarized and systematized a significant amount of information about placebos, placebo effects in various diseases, placebo control and placebo therapy. A lot of information about the placebo effect can be gleaned from the book of Dylan Evans, a researcher from the University of Bath (UK).
The question of whether there is a placebo effect was the subject of a systematic review by the Cochrane Library.
Subjects of the placebo effect. Specific manifestations of the placebo effect depend on the social and personal characteristics of a person, his condition and expectations. Myths include the fact that placebos only work on patients with hysteroidal character accentuation. According to statistics, placebos affect all people, just with different strength. It has been noted that there are more placebo reactors among extroverts (i.e. people whose feelings are directed outward). Such patients are anxious, dependent, emotionally labile, different high level consent, ready to cooperate with doctors. At the same time, placebo non-responders are more common among introverts (people directed inward), distrustful and suspicious. Greatest reaction Placebos are given to neurotics, as well as people with low self-esteem, insecure, and inclined to believe in miracles. Placebos work best in patients suffering from mild psychosomatic disorders, such as insomnia or mild severe depression.
Properties of placebo. There are several stereotypes in the minds of many people about what medications should be. First of all, they must be bitter. Secondly, the tablets must be either very large or very small. Large ones are associated in the patient’s mind with a large dose of medication, and small ones with high efficiency. Thirdly, we strongly active medicine there must be side effects such as nausea, dizziness, headache, feeling tired. If positive expectations create the prerequisites for recovery, then negative ones can influence healing process, slowing him down. Negative placebo effects are called nocebo. If the patient knows what side effects the drug has, then in 77% of cases they occur when he takes a placebo. Belief in a particular effect can cause the appearance side effect. When comparing placebo and fluoxetine, the nocebo effect was slightly more pronounced in women than in men. It has been proven that the nocebo effect is not only psychological in nature, and placebo-induced hyperalgesia is caused by cholecystokinin and is eliminated by its antagonist, proglumide.
The results of numerous studies indicate that social environment in which drugs are used directly mediates placebo effects. So, clinical observations for patients showed that:
tension among staff causes nocebo effects;
Prescribing anxiety medications to patients significantly reduces anxiety among medical staff (this phenomenon has been called “placebo rebound”);
skepticism of doctors and staff greatly reduces the effect of drug therapy;
a placebo effect was recorded in the control group of patients undergoing ambulatory treatment, compared with those who took the same drugs but were isolated in a hospital;
belief in the power of the doctor's medicine and nurses is considered the main determinant of placebo effects.
Devices or carefully designed procedures were more effective than taking pills. It is believed that the most pronounced placebo effect occurs when it is administered by injection.
Scientists have found that the placebo effect depends on appearance and colors of tablets. Thus, in a study of the analgesic effect of placebo tablets in 24 patients with rheumatoid arthritis depending on the color, it was found that it decreased when they were taken in the following sequence: red, blue, green, yellow. At the same time, the color of the tablets did not affect the effectiveness of the active drugs.
According to a cross-sectional study, 48 patients with anxiety disorders Diazepam tablets that were green in color were the most effective, red were less effective, and yellow was the least effective. On the contrary, for depression, pills were more preferable yellow color, less green and least red.
In a double-blind crossover trial, the effect of orange and blue pills was studied in 120 patients before a small surgical intervention. The patients believed that they were being given a tranquilizer. Individuals who did not express a preference were excluded from the analysis. In the remaining group, 62% of men preferred orange pills, and 61% of women are gay.
In a blinded study, medical students were asked to take sedative or stimulant medications in the form of blue or pink placebo pills. Those who received the blue pills felt less anxious (66%) and also more sleepy (72%) than students who took pink pills (26%).
In a randomized crossover trial, 96 surgical patients received a hypnotic or placebo on the first night. On the second night, they all took another drug of the same color. At the same time, patients who received blue capsules fell asleep faster than those who were prescribed orange capsules (103 and 135 minutes, respectively; p<0,05). После приема голубых капсул больные спали дольше (379 и 346 мин соответственно; р<0,01).
An analysis of 12 publications showed that red, yellow and orange tablets are associated with a stimulant effect, while white and green tablets are associated with a tranquilizing effect. It has been established that red tablets or capsules are more effective in treating children.
For the placebo effect to occur, an important factor is the number of tablets taken. Thus, after analyzing 71 controlled studies of the treatment of people with peptic ulcers using endoscopy, the author came to the conclusion that placebo is effective in about a third of patients. Although none of the trials identified treatment-naïve patients, the number of indifferent tablets prescribed varied. The results of a meta-analysis conducted by other researchers showed that the treatment effect was statistically more significant among those who used 4 rather than 2 tablets.
When prescribing drugs, the authority of a specialist plays an important role: any medicine taken from the hands of a “deserved”, gray-haired famous doctor, professor, academician for many will be much more effective than the same medicine received in a district clinic. The price of the drug also has a similar effect: if the drug is expensive, rare, and difficult to obtain, then it will have a more effective effect on neurotics. Therefore, many people buy medicines from Western manufacturers, in bright packaging, although they can buy a domestic analogue much cheaper. It has been established that a placebo under a brand name has a more pronounced effect than a little-known drug.
The inclusion of additional ingredients in the placebo that mimic the side effects of the study drug, but do not have a specific effect, had a more pronounced effect.
Factors that affect the placebo effect are presented in the table.
Placebo effects. It is believed that serious study of placebo effects began in the United States during World War II. Front-line hospitals were in dire need of painkillers and narcotics. Convinced once again that an injection of saline has an effect almost identical to that of morphine, anesthesiologist Henry Beecher, returning home, and a group of colleagues from Harvard University began studying this phenomenon. In 1955, he summarized his observations in the article “Potent Placebo,” where he argued that placebos could “cause significant physiological changes,” including “objective effects in target organs that may be greater than those due to potent pharmacological effects.” Based on the results of 15 studies that included 1,082 participants, he found that when taking a placebo, 35% of patients experienced significant relief when, instead of conventional medications for a wide variety of conditions (cough, post-operative pain, headaches, irritability, etc.). received a placebo. It was subsequently proven that the effectiveness of placebo in the treatment of depression is 59% of that of psychotropic drugs.
A placebo can act not only as an indifferent, pharmacologically inert substance, but also as a therapeutic procedure and even verbal influence. Anything that mobilizes a patient's health expectations and beliefs can act as a placebo.
Often the placebo effect is found with surgical treatment, since it is more obvious to patients. Thus, in one study conducted in Denmark, 15 people during the experiment were operated on due to a disease of the inner ear (Meniere's disease), the other 15 underwent placebo surgery. After three years, 10 people in each group (the same number!) almost completely got rid of the symptoms of the disease.
In another reported case, patients undergoing dental surgery were prescribed ultrasound therapy. As a result, a decrease in the severity of pain and swelling was noted not only among those exposed to ultrasound, but also among those who underwent an imitation of the procedure with the device turned off.
Interesting results were obtained in another study. A group of people with Parkinson's disease underwent surgery to transplant special nerve cells into the brain - so-called dopamine neurons, and 20 others were told that they had undergone the same operation, while in fact they had not undergone any surgical intervention. At the same time, double-blind control was carried out, that is, neither patients nor medical staff knew who was actually implanted with new cells. A year later, in both groups of patients there were both those who believed that after the operation they began to feel better, and those in whom doctors found clear objective signs of improvement.
The placebo effect has also been proven in acupuncture when doctors performed acupuncture using points that are not biologically active. At the same time, a positive effect of treatment was observed in 35-50% of patients, and the effect on truly biological points was effective in 55-85% of cases.
In a randomized crossover study of 44 patients with chronic cervical osteoarthritis, the treatment modalities used (acupuncture, sham acupuncture, and diazepam) were equivalent. The most pronounced result was obtained after using placebo.
Undoubtedly, the placebo effect is present when prescribing homeopathic medicines, as well as with other types of treatment. Some researchers, after conducting a series of laboratory tests, found no evidence that homeopathy is any more effective than placebo. The authors believe that some people feel better after taking homeopathic remedies, but attribute this effect to psychological factors, the experience of therapy in general, and the time and attention that the homeopath gives to the person. It should be noted that the researchers were not homeopaths and did not know the principles of prescribing homeopathic medicines.
Subsequently, a pronounced placebo effect was described in chronic pain syndrome, chronic fatigue syndrome, arthritis, headaches, allergies, arterial hypertension (in some cases), insomia, asthma, chronic digestive tract disorders, depression, anxiety, and Parkinson's disease. Under the influence of a placebo, an excess of leukocytes appeared in a person’s blood and the levels of proteins and lipids decreased.
The placebo effect is a significant boost in clinical conditions such as pain, mental illness, hypertension, obesity and perimenopause.
There was a recorded case where a patient suffering from Parkinson's disease received a placebo, considering it to be just another drug. As a result, his tremors decreased significantly. This result surprised the doctors who conducted the experiment so much that they even suggested that there was some substance in the placebo tablet of milk sugar that caused such a pronounced therapeutic effect. However, mixing the placebo substance into the milk did not cause any therapeutic effect, since the patient did not know about it. The placebo only worked when the patient believed he was taking the medicine.
During a study of mild mental depression, patients were replaced with placebos. The results were exactly the same as when taking medications. In 25% of people, the improvement was so pronounced that they were considered completely healthy and were forced to be excluded from the group in which the effectiveness of real drugs was tested.
For a number of years, the National Institute of Geriatrics in Bucharest conducted a so-called double-blind experiment to test a new drug that enhances the activity of the endocrine system, which in turn can increase the chances of longevity. The experiment involved 150 people aged 60 years living in approximately the same conditions. They were included in three groups of 50 people. The first group was not prescribed anything, the second received a placebo, and the third received a new drug. Surveys were carried out year after year. The indicators in the first group coincided with the data typical for Romanians of this age. The second and third groups, those taking the placebo and the drug, had significant improvements in overall health, similar levels of health, and lower mortality rates compared to the first group.
The placebo effect was convincingly demonstrated in one of the first studies of the effects of anabolic steroids (J.H. Wilmore, D.A. Costill, "Physiology of Sports"), when 15 athletes who had been engaged in strength training loads for the previous two years agreed to take part in an experiment involving the use of anabolic steroids during strength training. They were told that those who achieved maximum strength gains during the 14-month pre-training period would be eligible to participate in the second phase of the anabolic steroid experiment. The subjects were told that they would be taking 10 mg of Dianabol (an anabolic steroid) daily, when in fact they were given a harmless drug as a placebo. Strength development data were recorded for 7 weeks before the start of placebo consumption and for 4 weeks of placebo use. It turned out that the increase in strength during the placebo period was significantly higher. Study participants improved their performance by an average of 10.2 kg (2%) during the run-in period and by 45.1 kg (10%) during the placebo period. This corresponded to an average increase in strength of 1.5 kg per week during the run-in period and 11.3 kg per week during the placebo period, i.e. almost 10 times.
One study examined whether the nature of the initial response predicted the occurrence of recurrent depression. Patients who were treated with fluoxetine for 12–14 weeks were then randomized to treatment with either placebo or fluoxetine. Moreover, patients who initially responded positively to placebo responded similarly to continued administration of placebo and to fluoxetine. At the same time, those who received the true drug responded more strongly when switched to placebo.
It has been found that the placebo effect can occur even when patients know that they have been given a sugar pill. In a study conducted at Johns Hopkins Medical School, 15 participants receiving outpatient treatment for anxiety disorder were given one sugar pill per week. At the same time, they were openly told that these were sugar pills and that they helped many people. Of this group, 14 patients reported that their anxiety had decreased significantly; 9 – directly related the results obtained to taking the pills; 6 – it was suspected that the tablets contained active ingredients; 3 – complained of side effects: blurred vision and dry mouth (such side effects are observed when taking some psychotropic drugs).
Scientists have proven that placebo has a sustained analgesic effect. Many double-blind experiments have been conducted to study the effectiveness of placebos in relieving pain. The reduction in pain with placebo was 55% of that achieved with morphine.
The SYDNEY study examined the effectiveness of a-lipoic acid in patients with diabetes. The patients stayed in the hospital for a whole month, which made it possible to normalize nutrition, daily routine, physical activity and glucose-lowering therapy. Positive neuropathic symptoms were chosen as the main criterion for the clinical effectiveness of the drug due to the fact that they primarily disrupt a person’s quality of life. It is known that the sensations of patients are placebo-dependent, especially “shooting” pain and burning. A decrease in the severity of these symptoms when using placebo was noted in more than 30% of patients. That is why the placebo effect in the study was minimized by the presence of a run-in period and the presence of a comparison group receiving placebo. However, analysis of the dynamics of scores on a special scale (TSS) for individual symptoms showed that in relation to “shooting” pain, burning and paresthesia, the placebo effect was undoubtedly present (despite the run-in period). The only symptom that was truly insensitive to placebo was a feeling of numbness. In this regard, it is extremely important that the improvement was obtained using another scale (NISLL), which does not show significant changes when using placebo. The decrease in the number of points on this scale after treatment occurred mainly due to the revival or appearance of reflexes and, to a lesser extent, due to an improvement in the state of sensitivity of various modalities.
Mechanisms of the placebo effect. Many experts believe that the secret of placebo lies in self-hypnosis. However, this hypothesis does not explain many of the oddities of the placebo effect, such as its geographic selectivity. Experiments have shown that at different geographical latitudes the percentage of successful exposure can differ quite sharply.
Some scientists view the placebo effect as a type of hypnosis. It has been proven that the placebo effect increases in direct proportion to the intensity of suggestion. Suggestion itself means the ability to succumb to the influence of words, implement them in behavior, and bring them to life. The effectiveness of hypnotherapy for any disease is also known as a method of psychoprophylaxis.
It has been proven that the expectation effect is also important in the manifestation of the placebo effect. Three treatments were studied in three study groups: intravenous morphine for post-thoracectomy pain, intravenous diazepam for post-thoracectomy anxiety, and subthalamic nucleus stimulation for idiopathic Parkinson's disease. In each group, some patients were informed about the treatment and others were not. In all groups, treatment effectiveness was higher when patients waited for the procedure.
Patients' "expectation" influences the effect of placebo and active substance. Asthmatic patients who believed that the inert substance was a bronchodilator or bronchoconstrictor responded accordingly. It has been demonstrated that “waiting” for patients changes or even distorts the effect of some pharmacological agents.
James Frazer's The Golden Bough and Harry Wright's Witness to Witchcraft provide many striking examples of the psychological power of placebo effects in primitive tribes. “Once, for example, it happened that a New Zealand chief of high rank and great holiness left the remains of his food on the side of the road. After he left, the slave, a burly, hungry fellow, arrived in time, saw the remaining food and, without asking, ate it. Before he had finished his dinner, he was informed with horror that the food he had eaten belonged to the leader. I knew the unfortunate criminal well. “He was a man of remarkable courage, who covered himself with glory in inter-tribal wars,” the traveler said, “but as soon as the fatal news reached his ears, he began to have exceptional cramps and cramps in his stomach, which did not stop until his death, which followed at sunset. day..."
A significant role in the implementation of the placebo effect is played by the doctor’s personality, his experience, qualifications and ability to positively interact with the patient. Receiving a placebo from a doctor and believing that it is a medicine, the patient experiences relief. When taking the same medication for a long time, a kind of conditioned reflex arises. Apparently, this is why the placebo effect is more often detected in chronically ongoing diseases, as well as anxiety states and pain syndrome.
Do psychological factors alone determine the placebo effect?
One study compared placebo effects in 70 patients in the treatment of three anxiety disorders. Treatment responses and patient expectations from treatment were examined in three randomized controlled trials. The results found that patients with obsessive-compulsive disorder responded significantly less to placebo than those with generalized social phobia or panic disorder. These findings cannot be explained by different patient expectations.
A study was conducted on the placebo effect in people suffering from chronic depression. 25 of them received antidepressants (fluoxetine and venlafaxine) for 8 weeks, 26 received empty tablets. The results of treatment were assessed based on the condition of the patients, as well as on the results of encephalographic studies characterizing the activity of various parts of the brain. Marked improvement was observed in 13 patients (52%) receiving medication and 10 in the placebo group (38%). This effect was accompanied by fundamentally different changes in brain activity. Thus, antidepressants predominantly activated the prefrontal region of the brain, which is responsible for a person’s emotional state, and the placebo had only a general stimulating effect on the brain, that is, it did not so much relieve depression as contribute to a general increase in mental activity. “For many years, doctors have known that even sham treatment improves a patient’s condition,” said Edrew Leichter, who led the study. “Our results only confirmed the assumption that the placebo effect in its mechanism has nothing to do with conventional treatment. Perhaps we can use it for our own purposes, combining it with classical methods of therapy.”
A series of publications concluded that natural opioids (endophins) play a significant role in placebo-induced analgesia. Placebo-induced analgesia has been found to be partially reduced by administration of the opioid antagonist naloxone. Researchers at the University of Michigan measured the activity of the brain's β-opioid system, which is part of the body's natural pain-relieving system and is involved in transmitting pain signals from one nerve cell to another. We examined 14 healthy male volunteers who received saline injections into the jaw. For 20 minutes, participants had to record how severe the pain was every 15 seconds, rating it on a 100-point scale. They recorded their pain sensations and then added up their scores. In randomized trials, some volunteers took painkillers (analgesics), while others were given a placebo. All participants in the experiment who expected to receive the medicine, but received a “dummy,” increased the activity of the body’s endorphin system. Activity in four persistent brain regions was observed, however, activity in other brain regions was also consistent with the volunteers' descriptions of pain. For example, activity in the dorsolateral prefrontal cortex correlated well with expectations of the pain-relieving effects of a drug. Subjects using placebo reported a decrease in pain. Using positron emission tomography, it was shown that after taking a placebo pill, a person's brain began to produce more natural opioids. The authors hypothesized that the opioid system of the brain is involved in the formation of the placebo effect: “These data deal a serious blow to the idea that the placebo effect is purely psychological, devoid of physical basis. We saw firsthand how the endorphin system was activated in pain-related areas of the brain. Similar activity was observed when the volunteer was told that he had received pain medication." However, the response of people who replaced real drugs with placebos was not always the same. The researchers divided patients into “little reactive” and “highly reactive” (whose pain was reduced by more than 20%). “It is not yet clear what determines such a different reaction; this will be the subject of further research, during which it will be necessary to identify changes associated with age, gender and other factors, such as the presence of diseases,” the scientists note. According to some experts, patients who respond to placebo have an innate brain quality - self-regulation, which is most likely short-lived.
In another study, researchers at the University of Texas demonstrated the existence of a placebo effect in men who suffered from depression and took Prozac or a placebo for 6 weeks. Comparing positron emission tomography scans of the patients' brains, they found that in both groups, activity in the cerebral cortex - the "thinking" part - increased, while activity in the limbic part, which controls emotions, was observed to decrease. 15 people experienced improvement in neurological symptoms, 8 of whom took placebo. What did differ in the responses of the compared groups of patients was that those taking Prozac had changes in both the brainstem and the hippocampus. The authors suggest that the reduction in brainstem and hippocampal metabolic activity likely supports positive cortical or limbic changes, promoting longer-lasting drug effects.
The placebo activates the function of the cerebral cortex, and this, in turn, stimulates the endocrine system and the production of adrenal hormones, which have pronounced anti-stress and anti-inflammatory effects.
As is known, Parkinson's disease is associated with low levels of dopamine in the blood, and for its treatment drugs are used that stimulate the production of this substance. However, when six patients began to receive injections of simple saline instead of medication, their health continued to improve, as before. As tests showed, as a result of the procedure, the level of dopamine in the blood of these patients more than doubled. Of course, the patients themselves knew nothing about this and, out of habit, expected that the injection given by the nurse would bring them relief. These studies were carried out by Professor John Stoisle and his colleagues at the University of British Columbia.
British radiologists studied the effect of apomorphine and placebo on the release of dopamine in patients suffering from parkinsonism. It turned out that the administration of saline solution causes the same effect as the administration of the drug. Using positron emission tomography, it was found that placebo stimulates the biosynthesis of dopamine in the striatum. The expectation of relief plays a key role in creating the placebo effect, regardless of the type of disease. As soon as anticipation arises, the brain triggers other mechanisms that target the source of the disease. This confirms the fact that the patient is able to transform the hope of healing into tangible biochemical reactions.
Placebo therapy. Researchers of the placebo effect quite reasonably asked the question: if placebo pills for some diseases are only slightly inferior in effectiveness to real medicine, then wouldn’t it be better to use it? However, is this ethical? An article published in the British Medical Journal that Israeli doctors use placebos (and not without effect) could not help but attract attention. It turned out that about 60% of doctors, in order to satisfy the “unjustified” demands of patients, use substances in their medical practice that have nothing in common with a drug in the usual sense. Therefore, you can resort to a placebo so as not to “refuse help” and not cause harm with an unnecessary drug. They use a placebo, so to speak, for diagnostic purposes: “it will help” - that means the disease is imaginary.
Published research results indicate a high incidence of cures using placebo: headaches - 62%, colds - 45%, rheumatism - 49%, motion sickness - 58%, intestinal disorders - 58% of cases. However, there were also low cure rates: sleep disorders - 7% of cases, bronchial asthma - 5%, epilepsy - 0%, mental disorders - 0%. This indicates that the healing properties of drugs are actually much lower than is commonly believed, since the placebo effect was not taken into account when testing them.
In the last 10-20 years, interest in placebos has increased significantly. Particularly revealing were studies conducted at the University of California, which amounted to a volume of papers on placebos. These trials showed that a placebo can act like a drug (sometimes even a powerful one) and also cause changes in the body's reactions.
The placebo effect occupies a special place in the treatment of mental and psychosomatic diseases.
There is no single theory of the occurrence of psychosomatic diseases. Diseases of this kind are considered to be the result of the destructive effects of stress. At the same time, the stressful state is fixed in long-term memory, that is, it is able to remind itself of itself years later. Scientists believe that the frequency of psychosomatic disorders in general medical practice is up to 60%.
Back in the 18th century, during his medical experiments with magnetism, Anton Mesmer noticed that very often relief and recovery of patients occurred without the touch of the magnets he used for treatment (once he simply forgot them at home).
The importance of the impression a doctor makes on a patient is well known from history, from the experience of G.A. Zakharyin (1829-1897). This eminent physician used the following setting during consultations with wealthy patients. After the examination, the professor, alone in a special darkened room, considered the diagnosis and treatment. At this time, complete silence was required in the house. From such a consultation, the impression made on the patient and his relatives had a favorable effect on the results of treatment and allowed the doctor to achieve amazing success.
In 1807, American President Thomas Jefferson wrote in his diary how one of the most successful doctors he knew admitted that in his practice “he used more bread balls, drops of tinted water and ash powder than other remedies combined.” Without condemning the doctor at all, the president called this practice a “good lie.”
I would like to remember the famous 19th century therapist M.Ya. Mudrova, who treated with “special” powders with the names “golden”, “silver”, “simple”. The names corresponded to the color of the paper in which the product was wrapped. These powders had miraculous effects and cured many diseases. After the doctor’s death, it turned out that their composition included well-ground chalk. The admiration and joy with which the patients took these “medicines” were more useful than the medications themselves. The great practitioner of placebo therapy wrote: “The art of the doctor lies in creating a “spiritual” medicine that would console the angry, calm the impatient, stop the frantic, frighten the impudent, make bold the timid, frank the hidden, trustworthy the desperate.”
Trust in the physician is an essential component of the effect of a placebo. When a patient is afraid of something or something hurts, his senses are heightened. Meanwhile, the debate continues among doctors who consider it unethical to deceive a patient, and among those who rely on Plato, according to whom “lying does not benefit the gods, but is useful to people as medicine.” It should be noted that even a layman can act as a healer when resorting to placebo-type effects.
A white lie, the placebo effect is the basis of “shamanic medicine” - this is what opponents of the use of placebos in medical practice say. Proponents of placebo therapy are no less categorical: for a number of diseases, a “dummy” can successfully replace medications, and if we take into account the growing high cost of new drugs, then a placebo is economically beneficial. However, there is a middle ground; adherents of this position believe that placebo is an interesting area of ​​medicine that requires attention and study.
Critical perspectives on the placebo effect. Some authors have expressed doubts about the existence of a placebo effect. There have been numerous discussions on this topic that continue to this day.
Researchers at the University of Copenhagen and the International Medical Center, which specializes in assessing the quality of clinical trials, analyzed the results of 114 published studies involving 7,500 patients suffering from 40 different diseases, including hypertension, asthma, pain, depression, schizophrenia, and epilepsy. They concluded that placebo had no significant effect in secondary administration and may have little subjective benefit in long-term treatment of the disease. Scientists have not found reasonable evidence to support the generally accepted idea that, on average, the condition of every third patient who is given pseudo-medicines improves after taking them. Researchers became interested in where this figure came from, and it turned out that the authors of all the articles in which it appeared referred to the work of G. Beecher. After analyzing the data from this work, they discovered a number of shortcomings. Firstly, the range of disorders for which the placebo effect was confirmed by research results was limited only to various types of pain syndromes (after surgery, headache, angina and osteoarthritis). Only one study found support for the effectiveness of placebos for coughs, colds, motion sickness and anxiety. Secondly, in most of the trials described, there was no control group that received no treatment at all. Therefore, the presence of a placebo effect cannot be judged with certainty from these results. In addition, in one study, some patients did not receive treatment, and there was no difference between them and the placebo group.
The reason for this misconception, scientists believe, is the incorrect interpretation of statistical data. The fact is that in many diseases the condition of patients itself either improves or worsens, and these fluctuations are mistakenly attributed to the effect of placebo. Success from placebo may coincide with the natural (positive) course of the disease. This fact, well known to doctors of the past, is almost forgotten in modern clinical practice.
It is known that in many diseases the condition of patients does not change monotonously, but varies, and periods of deterioration are replaced by periods of improvement. It is these natural variations in the course of the disease that are mistaken for the placebo effect. Hippocrates wrote about this: “The disease reveals paroxysms and conditions both according to the time of year and according to the return of its periods, one in comparison with the other, they occur daily, or every other day, or after a long time.”
Studies in which treatment results were compared not only with the effect of a placebo, but also with the results of no treatment at all, showed that placebos and complete inaction by doctors often have almost the same effect on the condition of patients.
Medical statisticians at the Houston Cancer Center supported the Copenhagen researchers because it has long been a statistical observation that a patient who feels terrible one day will almost always feel better the next day, no matter what doctors do. Scientists at the Center for Biomedical Ethics at the University of Virginia also agree with the results of the Danish study, considering placebo effects to be a medical legend.
At the same time, other medical statisticians do not find this work very convincing, since the statistical method of meta-analysis used by the Danes can give erroneous results. The placebo effectiveness may have been overestimated quantitatively, but in many cases it was still quite significant. D. Evans notes that if they had analyzed the data carefully, they would have found that the placebo effect was not statistically significant only in studies that used a binary scale (presence of a positive or negative effect). In contrast, in those studies that used a continuous scale when using placebo, a significant statistically significant positive effect was noted. The range of conditions studied in the mentioned test was very wide - their number amounted to four dozen. It is especially significant that placebos act differently for different diseases, that is, they are not a panacea or a universal cure.
The Copenhagen researchers acknowledged that in some cases they also noted a weak placebo effect, manifested in particular in patients' subjective judgments of their pain, but assessed this as insignificant and almost imperceptible. Most likely, these are subjective misconceptions: some patients instinctively want to answer the doctor interviewing them that they seem to feel better. Meanwhile, from the point of view of scientific (evidence-based) medicine, it would be logical to find out whether a placebo really causes any significant changes in the course of any diseases, and to build an attitude towards the use of placebos based on scientific data. Such a study is quite difficult to conduct, since placebo administration is difficult to separate from the accompanying actions of medical personnel. Therefore, the placebo effect is usually identified with the entire set of conditions surrounding the provision of treatment.
It has been suggested that the placebo effect also occurs with conventional therapy. Thus, the condition of patients with depression who received pharmacotherapy improved by 33% over time compared to those who were prescribed placebo. At the same time, those who took a placebo had a 200% improvement in treatment compared to patients who were on a waiting list and did not receive any treatment at all. According to the authors' estimates, about 25% of the effect of antidepressants is due to spontaneous remission, 50% is due to the placebo effect, and only 25% is due to the pharmacological action of the drugs. However, if the additional 25%, which the actual effect of antidepressants gives, leads to the fact that the condition of patients begins to be characterized not by an average, but by an insignificant severity of functional disorders, then the effect of pharmacotherapy is very important.
A study was conducted of the significance of so-called positive and negative consultations in people with functional pathology. In the first case, the patient was informed that he did not have a serious illness and that he would get better in the near future; in the second, that the nature of the disease is not entirely clear. In both groups, some patients were prescribed a placebo, while others were not recommended to take medications. Recovery occurred significantly more often and faster in the first group; in both groups, there was no difference in treatment effect between participants who received placebo and those who did not receive any drugs. It follows that in everyday practice the placebo effect is quite common and largely depends on the personality of the doctor.
Meanwhile, these data are not very convincing to placebo opponents. Thus, Ted Kaptchuk, a professor at Harvard University who has participated in many clinical studies using placebos, states: “Although inert tablets have shown little effectiveness in relieving pain, I see no justification for their use outside of clinical trials.” He insists that future studies should compare the placebo effect not only with the effect of real drugs, but also with no treatment at all.
What effect an imitation of a therapeutic effect – a “dummy” – has is today practically unknown, because very few studies have been conducted that would compare the condition of those who take a placebo and those who receive nothing but diagnosis and observation. Moreover, it is impossible to study the natural course of the disease in modern conditions without interventions, since not a single ethics committee will agree to conduct such studies.
Placebo in clinical trials. In the 19th century, the prevailing practice in medicine was to evaluate the effectiveness of treatment on the basis of pathophysiological theories and the doctor's "impression" that the drug or treatment was helping the patient. Already in the 30s of the last century, Bradford Hill introduced randomized selection of patients both into the main group and into the control (comparison) group when determining the effectiveness of the test drug. The decisive decision was the US Food and Drug Administration (FDA), adopted in 1962, that new drugs should be subjected to clinical trials before they are widely used. Evidence of effectiveness was subsequently obtained through randomized placebo-controlled trials, and placebo control became the gold standard for clinical drug trials.
In recent decades, evidence-based decision-making, which integrates individual experience with the results of clinical trials, has become widely accepted in clinical practice. The rapid development of evidence-based medicine also introduced doctors to the term “placebo,” used in clinical drug trials as indispensable evidence that the drug being tested is better than a “dummy.”
Clinical trials of new drugs usually compare two groups of patients in whom the natural history of the disease and the nonspecific effects of therapy would be approximately equivalent. When active treatment is assigned to one group and placebo to the other, the differences are attributed to the specific effect of the treatment. Over the past 40 years, using this method, high results have been achieved in assessing the effectiveness of many drugs.
Since 1970, placebo and double-blind studies have been mandatory to evaluate the effectiveness of new drugs, test the effectiveness of established drugs, and compare similar drugs. There is an open method, when all participants in the treatment or trial know about the drug, and a simply blind method, when the patient does not know what medicine he is taking. In the double-blind method, the test drug is compared with its placebo counterpart, but neither the subjects nor the experimenters know which drug is being used for the protocol studies. Patients should not know about this, because their expectations affect the results of treatment; doctors - because they can unwittingly influence the well-being of subjects who detect the slightest changes in the doctor’s behavior. Only a third party has complete information. The double-blind method eliminates the influence of bias on treatment results, since the doctor cannot exert a psychological influence on the patient and is not sufficiently objective to assess the effect of therapy. The effect of a medicinal substance is considered scientifically proven if the difference between the measured effects from the drug being studied and its double reaches a statistically significant value. Medicine as a science is gradually replacing medicine as an art. That is why it is necessary to use treatment whose effectiveness has been proven by objective data.
However, using a placebo comparison to prove the benefit of a new drug poses its own challenges. For example, can a placebo be used when testing a drug for the treatment of acute and severe conditions (anaphylactic shock, ketoacidotic coma) or cancer? Is it ethical to prescribe a placebo to one group of cancer patients and a new, obviously effective drug to another? Based on this, the ethical committees of European countries are very strict in the design of clinical trials, demanding that the use of placebos be impeccably justified. Thus, according to the Declaration of Helsinki, in any medical study (including clinical trials), all patients, in particular those included in the control group, must be properly examined and receive appropriate treatment. Refusal to use placebo in some pathological conditions, when patients (from the control group) cannot be left without treatment, should be considered completely justified in ethical terms. If the effectiveness of a drug has already been established, a placebo-controlled trial should not be conducted, even if required by licensing authorities.
Modern requirements for conducting GCP (Good Clinical Practice) clinical trials include mandatory compliance with ethical standards, which, in addition to the decision of the ethical committee to conduct a trial, also include the informed consent of the patient. However, the latter, as some studies show, may affect the outcome of the test. If worsening is observed after placebo administration, the patient should be withdrawn from the study or transferred to active treatment within the same trial. There are strong arguments that clinical trial participants in many cases are aware that they are being prescribed a "dummy". They make similar conclusions based on the absence of side effects. Thus, in one clinical study that compared the outcomes of two antidepressants and a placebo, 78% of patients and 87% of doctors correctly identified who took the drugs and who took their imitation. Another study found that in 23 of 26 studies, the identification of patients receiving active and inactive drugs was more accurate than random guessing.
In order to distinguish between the true pharmacological effect and the placebo effect when taking the drug, it is proposed to use four parallel groups instead of two. In addition to those taking a drug, an inactive drug, and no treatment at all, an “active placebo” group can be formed. In this case, the patient also does not receive the study drug, but takes a drug that mimics its side effects. For example, when testing antidepressants, atropine can be used. In this case, the subjects will experience one of the often developing side effects - dry mouth, and they will feel that they are receiving a specific treatment.
Conclusion. The placebo problem seems to be somewhat broader than clinical trials themselves. In the positive effect of a drug, there seems to always be a component of the patient's expectation of an effect, just as there is from taking a placebo. This component of expectation, hope for an effect depends not only on whether the outwardly inert, indifferent substance is similar to the real medicine in color, shape, and smell. In anticipation of the effect, a large role belongs to the doctor himself, his relationship with the patient.
The mechanism of placebo action still has more questions than answers. Although it is generally accepted that the secret of placebos lies in autosuggestion, this assumption does not explain many of the oddities of its action. There are already many systems that are based only on the effect of faith. However, the task of scientists is to learn how to use self-healing mechanisms without taking a placebo. Research in this area is still ahead. Irving Kirsch, a psychiatrist who has studied the placebo effect for many years, noted: “The only thing we can say for sure is that we don’t know anything about it.”
Placebos are an extremely interesting medical phenomenon. It is likely that in the future the essence of a placebo will make it possible to understand how the body of a person who believes in a medicine heals itself. “The only thing we know for certain about the placebo effect is that it is not caused by sugar pills, since they are inert,” writes Daniel Moerman, an expert in the study of the placebo effect with thirty years of experience.
In recent years, interest in studying the placebo problem has somewhat revived. Thus, by decision of the US National Institutes of Health, 14 new clinical studies aimed at studying the mechanisms of the effect of placebo on the patient’s body were approved in the budget year.
Based on the evidence accumulated to date, it can be assumed that the placebo effect is present in any therapeutic intervention and its importance should not be underestimated. This is according to Anne Arrengton, a professor at Harvard University and author of the book “The Placebo Effect.”
So, based on our own many years of experience in studying the general principles of pharmacotherapy, we propose to highlight the following body responses to the effects of a drug:
1. Psychosomatic (in the presence of a placebo effect).
2. Pharmacological (pharmacodynamic).
3. Metabolic (related to the metabolism of the drug in the body).
4. Response-nonspecific (nonspecific reaction in response to the introduction of a foreign substance).
5. Response-physiological (to any change in pathophysiological processes in the body, a reverse specific reaction occurs).
The features of the manifestation of the listed reactions depend on the dose of the drug (strength of influence), the frequency and pattern of the pharmacological effect, the characteristics of the body to respond to it depending on the stage of development of the pathological process, as well as on the constitutional-genetic, age and gender characteristics of the body to perceive the effect and respond to it .
All these issues require deep fundamental study. At the same time, modern medicine has a theoretical justification for the practical use of only pharmacological effects and takes little into account the entire versatility of the body's response to it.

In addition, the term placebo effect call the very phenomenon of improving a person’s health due to the fact that he believes in the effectiveness of some effect, which is actually neutral. In addition to taking the drug, such an effect may be, for example, performing certain procedures or exercises, the direct effect of which is not observed. The degree to which the placebo effect occurs depends on the suggestibility of the person and the external circumstances of the “treatment” - for example, on the appearance of the placebo, its price and the overall difficulty of obtaining the “medicine” (this increases confidence in its effectiveness due to the reluctance to consider efforts and money wasted) , degree of trust in the doctor, authority of the clinic.

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  The name "placebo effect" originated in the Middle Ages from the songs of funeral mourners who were paid to perform funeral services for the dead, which included the words "Placebo Domino" in the lyrics. Michel de Montaigne, writing in 1572, noted that “there are people on whom medical attention alone is effective.”

  It was first mentioned in a medical context in the 18th century. In 1785 it was defined as “a common method or medicine”, and in 1811 it was defined as “any medicine selected for the satisfaction of the patient rather than for his benefit.” Sometimes the patient's condition deteriorated, but the “treatment” could not be called ineffective. Placebos were common in medicine until the 20th century; doctors used them as a “necessary lie” to alleviate the patient’s condition.

  Effect mechanism

  The placebo effect is based on therapeutic suggestion. This suggestion does not require any special skills, since the criticality of consciousness (“I don’t believe it”) is overcome by linking the suggested information to an actual object, usually a pill or injection without any real effect on the body. The patient is informed that this drug has a certain effect on the body, and, despite the ineffectiveness of the drug, the expected effect is manifested to one degree or another. Physiologically, this is due to the fact that, as a result of suggestion, the patient’s brain begins to produce substances corresponding to this effect, in particular endorphins, which, in fact, partially replace the effect of the drug.

  The degree of manifestation of the placebo effect depends on the level of suggestibility of a person and the physiological ability to form the necessary chemical compounds.

  Placebo in pharmacotherapy

  A placebo can slightly alleviate the patient’s suffering, reduce pain or nausea, but in general, the use of a placebo cannot change the course of the disease, therefore the therapeutic value of the placebo effect in medicine, according to modern scientific ideas, is extremely small. There is currently no evidence to support the use of placebo as a treatment for any disease. Some relatively early studies' findings about the clinical effectiveness of placebos can be largely explained by statistical regression to the mean: statistical regression to the mean predicts that patients selected at the extremes of a measure will, on average, improve in their performance, i.e., their condition will regress toward average value regardless of the presence of treatment.

  Another disadvantage of placebos is that the effects are unreliable and unpredictable. In addition, the common claim that placebos do not cause side effects is erroneous: the patient's negative expectations may actually make people feel worse, despite the absence of actual negative effects; Side effects may occur that correspond to those of the drug with which the patient mistakenly identifies placebo.

  In addition, if a medical professional passes off a pure placebo as an effective treatment, especially if there is a treatment with proven effectiveness for a given disease, he is grossly violating the principles of medical ethics. The use of placebos involves deceiving the patient into thinking that they are receiving active treatment. In developed countries, this is not allowed by legislation that requires patients to be treated in accordance with the principle of voluntary informed consent.

  Placebo in evidence-based medicine

  At the same time, many modern drugs act integrally, so their therapeutic effect also contains a “placebo component”. Therefore, bright and large tablets are generally more effective than small and nondescript ones, and drugs from well-known companies (of the same composition and the same bioequivalence) give a greater effect than drugs from “market outsiders,” etc.

  Placebo in clinical trials

  It is used as a control drug in clinical trials of new drugs, in the procedure for quantitative assessment of the effectiveness of drugs. One group of subjects is given the test drug, which has been tested on animals (see preclinical trials), and the other is given a placebo. The effect of the drug must be significantly greater than the placebo effect for the drug to be considered effective. If necessary, the placebo may contain a small amount of the active substance (for comparative analysis with the effect of the corresponding medicinal product).

  Placebos are also used to study the role of suggestion in the action of drugs.

  The typical rate of positive placebo effect in placebo-controlled clinical trials averages 5-10%, and its severity depends on the type of disease. In most trials, a negative placebo effect (nocebo effect) also appears: 1-5% of patients experience some form of discomfort from taking a “pacifier” (the patient believes that he has an allergy, stomach or cardiac manifestations). [ ] For some people, the unpleasant expectations of a new drug can take the form of severe pharmacophobia or pharmacophilia.

  The authors of a systematic review of studies of placebo in various diseases (Hróbjartsson and Gøtzsche, 2001) showed that the clinical effect of placebo was observed only for pain and phobias, and the analgesic effect of placebo corresponded to only one third of the effect of conventional non-steroidal anti-inflammatory drugs. Other researchers examined the same data set and concluded that although placebo effects exist and should not be ignored, they are small in magnitude. In 2010, Hróbjartsson and Gøtzsche published another systematic review (over 200 studies) and came to conclusions similar to those they formulated in 2001.

  Placebo in psychiatry

  The placebo effect is widely used in psychiatry. The first reason for this is that the human brain, through self-hypnosis, more easily corrects its own work than the work of other organs. Therefore, placebos are especially effective for mental disorders. The second reason is that for many mental disorders - such as insomnia, depression, nightmares - effective drugs have not yet been found, or these drugs are effective only for a small part of patients.

  Placebo in addiction medicine

  Placebos are widely used in Russian narcology for the treatment of people addicted to alcohol and drugs.

  A Russian narcologist treats alcohol addiction using such methods as “Capsule”, “Torpedo”, “Coding”, “Binder”, “MST”, “SIT”, “NIT” or non-existent ones (and not included in the State Register of Medicines ) medications such as: “Vitamerz Depot”, “Actoplex”, “Disulfison”, “Algominal” - exploits the so-called “placebo effect”, that is, the patient’s faith and his desire to get well. The mechanism of action is that the doctor convincingly tells his patient: “If you drink, you will die.” These methods use people's "ignorance" and their "belief" to maintain fear, which causes people to abstain from drinking alcohol.

  Doctors use a variety of methods to induce fear. Before the filing, or coding, procedure, the patient signs a legal document. The doctor offers the patient a contract that determines the time of “filing” and in which it is written that the patient bears all responsibility for the consequences of the failure. The document also provides for the possibility of “unstitching” (usually a single dose of a substance that stops the action of the implant), which is performed by the same specialist. The belief in “filing” is strengthened by dramatic stories passed down from mouth to mouth about “filed” friends, acquaintances or acquaintances who died after drinking alcohol.

  Technologies for using placebos in narcology include various actions: from intravenous injections of a solution of nicotinic acid (vitamin PP), magnesium sulfate - which causes a feeling of heat and suffocation, to imitation of surgical operations with an imaginary “filing”. During these procedures, the doctor uses the so-called “provocation”, that is, he gives the patient to drink alcohol in order to cause a reaction and increase the fear of death.

  The use of placebos in narcology is practiced only in the Russian Federation and some CIS countries and grossly contradicts the world practice of treating drug addicts.[source does not contain confirmation]

  • Tablets have recently been released in the USA Obecalp, containing (in addition to the capsule base) only sugar and intended to “treat children from laziness.” The effect of using this “medicine” is clear if you read the English name of the drug backwards (placebo).

  see also

  Notes

  1. "Placebo" Big Encyclopedic Dictionary (BED),
  2. Lancet 2005; 366: 726–732.
  3. See medical publication class A: Eur J Clin Pharmacol. 2000 Apr;56(1):27-33