In addition, the term placebo effect called the very phenomenon of improving human health due to the fact that he believes in the effectiveness of some effect, in reality neutral. In addition to taking the drug, such an effect can be, for example, the performance of certain procedures or exercises, the direct effect of which is not observed. The degree of manifestation of the placebo effect depends on the suggestibility of the person and the external circumstances of the "treatment" - for example, on appearance placebo, its price and the overall difficulty of obtaining a “medicine” (this increases confidence in its effectiveness due to the reluctance to consider efforts and money spent in vain), the degree of trust in the doctor, the authority of the clinic.
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The name "placebo effect" originated in the Middle Ages from the songs of mourners at funerals, who were paid to bury the dead, and whose lyrics contained the words "Placebo Domino". Michel de Montaigne, writing in 1572, noted that "there are people on whom only the attention of medicine is already effective."
In a medical context, it was first mentioned in the 18th century. In 1785 it was defined as "a banal method or remedy", and in 1811 it was defined as "any remedy chosen for the satisfaction of the patient rather than for his benefit". Sometimes there was a deterioration in the patient's condition, but the "treatment" could not be called ineffective. Placebo was common in medicine until the 20th century, doctors used it 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”) is overcome by linking the suggested information to the actual object, usually a pill or injection, without any real effect on the body. The patient is told that this drug has a certain effect on the body, and, despite the inefficiency of the drug, the expected effect is manifested in one way 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 action, 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 possibility of the formation of the necessary chemical compounds.
Placebo in pharmacotherapy
A placebo may 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, so the therapeutic value of the placebo effect in medicine, according to modern scientific ideas, is extremely small. At present, there is no evidence to support the use of placebo as a treatment for any disease. Made in some relatively early works placebo clinical efficacy findings are largely explained by statistical regression to the mean: statistical regression to the mean predicts that patients selected at the extremes of the measured variables will, on average, experience an improvement in performance, that is, their condition will regress to the mean regardless of the presence treatment .
Another disadvantage of placebos is the unreliability and unpredictability of effects. In addition, the common claim that placebo does not cause side effects is erroneous: the patient's negative expectations can actually worsen well-being, despite the absence of real negative impacts; may occur side effects corresponding to those of the drug with which the patient mistakenly identifies placebo.
Besides, if medical worker passes off pure placebo as effective remedy, especially if there is a treatment with proven effectiveness for this disease, it grossly violates the principles of medical ethics. The use of a placebo is associated with deceiving the patient, as he is made to think that he is receiving active treatment. IN developed countries this is prevented by legislation that requires patients to be treated according to the principle of voluntary informed consent.
Placebo in evidence-based medicine
At the same time, many modern medications act integrally, so their therapeutic effect also contains a "placebo component". Therefore, bright and large tablets generally act stronger than small and nondescript ones, and drugs well-known firms(and the same composition, and the same bioequivalence) give a greater effect than the drugs of "market outsiders", etc.
Placebo in clinical trials
It is used as a control drug in clinical trials of new drugs, in the procedure for quantifying the effectiveness of drugs. One group of subjects is given a test drug tested in animals (see preclinical trials), and the other is given a placebo. The effect of the use of the drug must significantly exceed the effect of the placebo in order for the drug to be considered effective. If necessary, the placebo may contain active substance in small quantities (for comparative analysis with the effect of the corresponding drug).
Placebo is also used to study the role of suggestion in the action of drugs.
Typical rate of positive placebo effect in placebo-controlled clinical trials averages 5-10%, while its severity depends on the type of disease. In most trials, a negative placebo effect (nocebo effect) is also manifested: 1-5% of patients feel some form of discomfort from taking a “pacifier” (the patient believes that he has allergies, gastric or cardiac manifestations). [ ] In some people, the unpleasant anticipation of a new drug may take the form of severe pharmacophobia or pharmacophilia.
The authors of a systematic review of studies on the effect of placebo in various diseases(Hróbjartsson and Gøtzsche, 2001) have shown that the clinical placebo effect is observed only in relation to pain and phobias, with the placebo analgesic effect corresponding to only one third of the effect of conventional non-steroidal anti-inflammatory drugs. Other researchers reviewing the same body of data concluded that although placebo effects exist and should not be ignored, they are not significant. In 2010, Hróbjartsson and Gøtzsche published another systematic review (more than 200 studies) and reached similar conclusions as they did in 2001.
Placebo in psychiatry
The placebo effect is widely used in psychiatry. The first reason for this is that the human brain, through autosuggestion, more easily corrects its own work than the work of other organs. Therefore, when mental disorders ah placebo is especially effective. The second reason is that from many mental disorders - such as insomnia, depression, nightmares- effective drugs have not yet been found, or these drugs are effective only for a small proportion of patients.
Placebo in addiction
Placebo is widely used in Russian narcology for the treatment of alcohol and drug addicts.
Russian narcologist provides treatment alcohol addiction methods such as "Capsule", "Torpedo", "Coding", "Filing", "MST", "SIT", "NIT" or non-existent (and not included in State Register drugs) drugs such as: "Vitamerz Depot", "Actoplex", "Disulfizon", "Algominal" - exploits the so-called "placebo effect", that is, the patient's faith and his desire to recover. 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 "faith" to maintain the fear that makes people abstain from drinking alcohol.
To create fear, doctors use the most different methods. Before the filing or coding procedure, the patient signs 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 breakdown. The document also provides for the possibility of "detaching" (usually a single dose of a substance that stops the action of the implant), which is performed by the same specialist. Faith in the "file" is strengthened by word of mouth dramatic stories about "file" friends, acquaintances or familiar acquaintances who died after drinking alcohol.
Technologies for the use of placebo in drug addiction include various activities: from intravenous injections solution of nicotinic acid (vitamin PP), magnesium sulfate - causing a feeling of heat and suffocation, before imitation surgical operations with an imaginary "filing". During these procedures, the doctor uses the so-called "provocation", that is, he gives the patient alcohol to drink in order to cause a reaction and increase the fear of death.
The use of placebo in narcology is practiced only in the Russian Federation and some CIS countries and grossly contradicts the world practice of treating narcological patients.[source not confirmed]
- Pills have recently been released in the US Obecalp containing (in addition to the base of the capsule) only sugar and intended for " treating children from laziness". The effect of the use of this "medicine" is clear if you read the English name of the drug in reverse (placebo).
see also
Notes
- "Placebo", Big encyclopedic Dictionary(BES),
- Lancet 2005; 366: 726-732.
- See Class A medical publication: Eur J Clin Pharmacol. 2000 Apr;56(1):27-33
Pharmaceutical companies spend a lot of money on the discovery of new drugs every day, and yet some people carry the drug in their head without knowing it. A placebo is a substance that can play a huge role in the treatment of a person, while not having any obvious medicinal properties. To put it simply, the placebo effect lies in a person's faith. Let's find out the principle of placebo effect on the human body.
The mysterious word placebo - a cure or not
The name "placebo" comes from Latin and translates as "like". In the common people, the substance is usually called "dummy". So, what is hidden in this mysterious word? First of all, it is worth saying that a placebo is not a medicine in the medical sense of the word. It lacks medicinal properties that can affect the body, although in taste and appearance it is no different from real drugs. So how does it work? It's all about the effect on the psyche of the patient, more precisely in self-hypnosis. For example, a doctor prescribes a medicine to a person, whom the patient tends to blindly believe. The prescribed medication may look like regular pills, and it will contain vitamin C, which will slightly increase the patient's immunity at most. However, the doctor so stubbornly praises the medicine " the latest development", that a person involuntarily believes him, and when the patient diligently takes such pills for their intended purpose, he suddenly notes that he has become much better. And now he happily rushes to the doctor's office to praise " the latest medicine”, which is actually a placebo.Definition of placebo in psychology
Placebo is one of the mysteries in the field of psychology. It is not known exactly how this substance has a miraculous effect on the body. However, all psychologists agree on one opinion - self-hypnosis and sincere faith of a person can work wonders. In psychiatry, the pacifier effect is often used to help patients overcome disorders such as depression and insomnia.How the placebo works
Psychologists suggest that as a result of self-hypnosis, the patient's brain produces a large number of endorphins, which replace the therapeutic effect of the drug. The body goes into a state of fighting the disease, immunity increases and defense mechanisms are activated. All this leads to an improvement in the patient's condition and possibly even further recovery.Interesting. One study that was conducted on subjects with an anxiety disorder showed that this method could work even when patients were told that they were taking a pacifier.
Placebo power - for whom the effect will be stronger
Of course, the effect of a pacifier will be much stronger if a person is naturally suggestible. It is easy for some people to inspire the effectiveness of a medicine, for others it is more difficult. The strength of the effect directly depends on the patient himself. This explains why terminally ill people are willing to visit healers and esotericists. In the hope of being cured, a person is ready to believe in anything.Advice. If you recognize yourself in this description, then you should think about it. Of course faith is great feeling. But blind faith in a dummy can also have a negative effect on your health.
The pacifier has the strongest effect on children. In the US, they even release comic tablets "Obecalp" containing pure sugar and are shown to "treat children from laziness."What are the types of placebos? List of drugs
There are quite a few types of placebos, here are some of the most common:- Tablets
- syrups
- lasers
- Injections
As such, there is no list of placebo drugs, but there are drugs whose effectiveness has not been proven, and accordingly there is every reason to doubt therapeutic actions these medicines.- Validol. Medicine that supposedly helps with pain in the heart. Has a calming, minty effect, but is unlikely to help with a heart attack
- Erespal - is available both in the form of tablets and syrup. Indicated for use in SARS. The effectiveness of this remedy has not been proven.
- Novo-passit - sooner homeopathic remedy than real medicine
- Wobenzym - is available in the form of tablets. According to the assurances of the manufacturers, it has a miraculous remedy for the entire body. Efficiency in laboratory conditions not studied
- Most drugs for the treatment colds are placebo and the maximum effect that they can have is to bring down the temperature. Some of these: Imunomax, Engystol, Imudon, etc.
- Hilak-Forte, Bifiform and many other probiotics. Doctors in Russia love to prescribe them. In other countries, probiotics are extremely wary.
When is a placebo appropriate?
Remember that placebo is not complete medical treatment. This is just creating an illusion to raise the morale of the patient. To impact on clinical picture it is incapable of illness. Simply put, if a person has a headache, then after taking a dummy, the headache the pain will pass and hypertension remains. The use of the substance is advisable when there is no anesthetic at hand, and the patient is in pain. In such cases, the placebo will not make the situation worse, but will make the person feel better. The substance is sometimes prescribed to people suffering from the syndrome increased anxiety or hypochondriacs who are too obsessed with their health. In this case, the placebo effect will fully justify itself.Important! Unfortunately, the world is designed in such a way that there will always be people who use placebos in bad faith. Under the guise of drugs, the substance is often sold to patients with oncology. Passing it off as "the same" remedy that will help to heal. Do not fall for such tricks and always consult a doctor.
And yet, in order to finally verify the effectiveness of placebo, let's give an example from life. Some evidence suggests that a placebo can have an effect even on terminally ill people. So for example a man old age diagnosed with cancer. Immediately after that, he lost his will to live, doctors predicted his death with a 95 percent probability. However, one of the patient's doctors did not want to give up. He taught the patient self-hypnosis. Every day the patient had to convince himself that he was on the path to recovery, and his cancer cells gradually excreted from the body through the kidneys. The results of such self-hypnosis exceeded all expectations. Two months later, the man regained all his strength and defeated cancer.
That is why you can talk for a long time about the expediency of placebo treatment, or you can simply set yourself up in a positive way and believe in yourself and your body. After all, as they say, most diseases are generated by our thoughts.Placebo therapy: video
This video explains in detail the concept of "placebo therapy".Hello.
In this article I will talk about the effect of a placebo, what is it in simple terms. This topic has been discussed by doctors and scientists for several centuries. Some of them consider the action positive for the treatment of diseases, others reject the effectiveness of therapy and refer to the unethical nature of this kind of treatment process.
The placebo effect is the use of dummy drugs that do not therapeutic effect on the body, but contribute to recovery due to the patient's self-hypnosis. The patient's belief in the efficacy of the drug, which is maintained external factors(reputation of a doctor, clinic, pharmacological company), helps to mobilize internal forces body to fight disease.
Mechanism of action
What is the placebo effect and how does it work? For the treatment of patients, tablets, capsules, injections are used that do not contain active active ingredient. Tablets and capsules are usually composed of lactose or starch, and injections include saline. Before starting treatment with pacifiers, the doctor talks about the high effectiveness of the drug for treating the disease. Patient suggestion includes mental processes for the purpose of recovery.
In addition to the psychological positive action in the body, the necessary physiological processes. For example, under the influence of suggestion, endorphins are synthesized, which have analgesic, anti-inflammatory, immunostimulating effects. Activation of biological reactions normalizes homeostasis and improves overall well-being.
The placebo method is more effective in the case of psychosomatic pathology, when physical suffering is caused by a violation in the psychological sphere. The work of the brain lends itself better to the processes of suggestion, which allows you to get rid of the disease. Required condition methods - the presence of an object with which faith in recovery is associated. Such objects are various forms drugs, less physical exercise or procedures.
placebo in medicine
What is placebo in medicine? This is a treatment with pacifiers with an obligatory suggestion in the positive effect of therapy. Therapy with "false" drugs is rarely used in modern medicine, and this method of healing is considered unethical in many countries. According to the world's leading doctors, the patient should know what medications he is taking and what their effect is. But white lies are allowed when other treatments are dangerous or inappropriate in this particular case.
For example, a patient has phobias that cannot be treated with antidepressants, and long-term use of drugs causes addiction and side effects. The use of pacifiers with suggestion for recovery brings a quick result and allows the patient to return to full life. And there are many such examples in medicine, especially in the case of psychosomatic pathology.
The principles of placebo are also used in the pharmaceutical industry at the stage of testing the effectiveness of drugs before releasing them to the free market. To do this, create 2 experimental groups, one of which takes the study drug, and the other dummy. If the effectiveness of the drug is approximately the same in the two groups, then the pharmaceutical preparation is considered ineffective. The serial production of a medicinal product is started if the effectiveness of the drug is significantly higher than that of an empty tablet.
The ethical side of the issue and the withdrawal syndrome
How does the placebo effect work if the ethical side of the issue is resolved? Scientists have proven that the patient's awareness of taking pacifiers does not reduce the effectiveness of therapy. At the same time, the suggestion about the effectiveness of treatment comes to the fore. Doctors warn the patient about taking pacifiers, but note that such therapy has helped many patients and is considered promising. In this case, faith in recovery triggers psychological and physiological mechanisms to fight the disease without "deception" of the patient.
In addition, it has been found that pacifiers can cause withdrawal symptoms, just like drugs. This indicates a huge influence of suggestion and self-hypnosis on the functioning of the brain. Negative consequences on the part of organs and systems after discontinuation of the drug cause no chemical substances and psychological attitudes. For example, the doctor informs the patient that the healing remedies can cause headache and stool disorders. As a result, the patient receives the listed side effects without an objective reason.
External factors that enhance the effect of empty tablets
The placebo effect works with a high result if the object of suggestion seems more attractive to the patient. For example, the color of the tablets, the colorfulness of the package, the number of capsules taken affect the effectiveness. One tablet seems less effective than two, and a bright color is more acceptable. Suggestion is influenced by the reputation of the clinic and the attending physician. If therapy is prescribed by a well-known doctor, professor, honored specialist, then the effectiveness of therapy will be much higher. The same applies to the reputation of a pharmaceutical company, the cost of drugs - the higher the price, the more effective the therapy.
Replacement of medicinal substances with pacifiers
Empty tablets are included in the therapy regimen for the gradual withdrawal of drugs. Long-term use pharmacological substances is addictive and can lead to side effects. To reduce the dose of the active substance, pacifiers are introduced into the therapy regimen, which allow you to consolidate a positive result without worsening the general condition.
placebo works
And now I will tell you the most important thing. The placebo works and actually saves us from even the most serious diseases, such as cancer. But why is this happening? What is the miracle? Everything is very simple. Our body is capable of miracles, I wrote about this in a previous article. Be sure to follow the link and read. You will learn a lot.
The body itself, without outside help and all kinds of medicines, can get rid of diseases. You just need to start the process of self-healing. How to run it?
Today we begin to understand all this complex mechanism. And I will open the curtain for you to this secret.
To heal from diseases, it is necessary to stop the uncontrolled process of our psyche, when it devours all our energy, giving rise to negative thoughts and emotions. Only then will all the liberated energy go to the body, the body and the process of self-healing will start on its own. To stop the malfunctioning of the psyche, many methods are used, for example, or. But it is precisely a similar stop that occurs when a person inspires himself that he has drunk a wonderful medicine and will soon recover. He shifts the mode of perception, tunes his body to healthy state, relaxes, increases the level of its energy and a miracle happens. But in reality there is no miracle. There is only the process of self-healing, which is triggered by the placebo effect.
This leads to an important conclusion that few people understand and apply in life. And even those who knew did not completely believe, thinking that all this was prejudice, because they did not understand, as they say, the physics of the process. Today you will know everything.
If you get sick and start to worry about this, as well as wind up bad thoughts like: "How bad everything is, how unhappy I am, my illness can lead to grave consequences what will happen to me or my children now" and stuff like that, then you will never recover. Thus, you have launched the wrong work of the psyche or ego, which in itself leads to illness. What kind of getting rid of the disease do you want. You will only make matters worse, as most people do.
To recover, you need to find strength in yourself, believe in a positive outcome and tune in to a positive wave. And also trust your body and do not interfere with it. Only in this case, the process of self-healing will start and save you from the disease.
Belief in self-healing will be a placebo effect for you, which will lead to positive result and you will be healthy and happy.
Now you know what the placebo effect is and how it works. The effectiveness of the technique depends on the pathology, the state of the patient's mentality, and emotional mood. In many cases, self-hypnosis helps to get rid of the disease and mobilize the internal reserves of the body.
And once again, I propose to watch an excerpt from the movie "The Secret". Despite the fact that I already cited it in the last article, I repeat, because. it is very important in understanding that the placebo effect works. Look who didn't watch:
Placebo (lat. 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."
Here is how the Big Encyclopedic Dictionary defines this term: “A dosage form containing neutral substances. They are used to study the role of suggestion in the therapeutic effect of any medicinal substance, as a control in the study of the effectiveness of new drugs.
A more detailed definition is given by the Encyclopedic Dictionary medical terms: "Pharmacologically indifferent substance, in appearance and taste imitates 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 according to the expectations of the patient and is not able to act directly on the conditions for which it is prescribed to change."
IN medical practice There are two types of placebo. In some cases, indifferent substances are used to study the placebo effect, in others - special mixtures corresponding to the compositions dosage forms investigational drugs. In this case, placebo is used for a differentiated assessment therapeutic effect the active substance contained in pharmacological preparation. It should be noted that absolutely indifferent substances for the body do not exist. One can speak only of relative or absolute indifference in relation to the specific action of the studied object of research.
The phenomenon in which the expected action of a substance determines the body's response to it is called placebo effect. This reaction is manifested by a change in the physiological and psychological states a person after taking a harmless drug administered under the guise of an effective drug, compared with a control group receiving no drugs. The existence of a placebo effect may demonstrate the psychotherapeutic effect of the mere fact of taking the drug. He is not related to specific effects that a placebo substance can cause.
A positive placebo effect is a positive change, which is expressed in the form of improved well-being, relief of anxiety and anxiety; temporary normalization of sleep, indicators of the functioning of the cardiovascular and respiratory systems; reduce the severity of symptoms of cough, runny nose; reducing the frequency of seizures bronchial asthma, angina pectoris, headache; increase in the volume of movement with sciatica; improvement in allergic rhinitis, peptic ulcer; weight loss; changes in emotional sphere(reducing the severity of depression, improving mood); relief of pain of various origins, swelling with inflammation of the joints. Therefore, 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 the American physician Henry Beecher, who found that about a third of patients recovered from empty pills containing no active ingredients.
There are very few detailed works devoted to placebo in the Russian-language literature. The monograph by I.P. Lapin, written on the basis of the author's many years of experience in studies of the placebo effect in healthy individuals and sick. He summarized and systematized a significant amount of information about placebo, 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.
placebo effect objects. Specific manifestations placebo effect depends on social and personality traits person, his condition and expectations. Myths include the fact that placebo only works on patients with hysterical accentuation of character. According to statistics, placebo affects all people, only with different strengths. It has been noted that there are more placebo-reacters among extroverts (i.e. persons 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 who are directed inward), incredulous and suspicious. The greatest reaction to placebo is given by neurotics, as well as persons with low self-esteem, insecure, inclined to believe in miracles. Placebo works best in patients suffering from mild psychosomatic disorders, such as insomnia or mild depression.
placebo properties. In the minds of many people there are several stereotypes about what medicines should be. First, 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 medicine, and small ones with high efficiency. Thirdly, 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 affect the healing process, slowing it 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 one or another effect can cause the appearance side effects. When comparing placebo and fluoxetine in women, the nocebo effect was slightly more pronounced than in men. It has been proven that the nocebo effect is not only of a psychological nature, but 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 determines the placebo effects. Thus, clinical observations of patients showed that:
tension among staff causes nocebo effects;
prescribing anti-anxiety drugs 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 who underwent ambulatory treatment compared with those who took the same drugs but were isolated in a hospital;
faith in the power of medicines of the doctor himself 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 with the injection route of its administration.
Scientists have found that the placebo effect depends on the appearance and color of the pills. Thus, in the 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 taken in the following sequence: red, blue, green, yellow. At the same time, the color of the tablets did not affect the effectiveness of active drugs.
According to cross study, in 48 patients with anxiety disorders The green diazepam tablets were the most effective, the red ones were the least effective, and the yellow ones were the least effective. On the contrary, for depression, pills were more preferable. yellow color, less green and least red.
A double-blind cross-over trial examined the effect of orange and blue tablets in 120 patients before a small surgical intervention. The patients thought they were being given a tranquilizer. Individuals who did not show a preference were excluded from the analysis. In the remaining group, 62% of men preferred orange pills and 61% of women preferred blue pills.
In a blind study, medical students were asked to take sedative or stimulant drugs in the form of blue or pink placebo pills. Those who received the blue pills felt less anxious (66%) as well as more sleepy (72%) than students who took pink pills (26%).
In a randomized crossover trial, 96 surgical patients received the hypnotic agent 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 (103 and 135 min, 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 stimulating effect, while white and green tablets are accompanied by a tranquilizing effect. It has been established that red tablets or capsules are more effective in the treatment of children.
For the manifestation of the placebo effect, an important factor is the number of pills taken. Thus, after analyzing 71 controlled studies of the treatment of persons with peptic ulcer using endoscopy, the author concluded that placebo is effective in about a third of patients. Although none of the trials identified untreated patients, the number of indifferent tablets administered 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 will be much more effective for many than the same remedy obtained in the district clinic. The price of the drug has a similar effect: if the drug is expensive, rare, difficult to obtain, then it will act more effectively on neurotics. Therefore, many people buy medicines from Western manufacturers, in bright packages, although you can buy a domestic analogue for an order of magnitude cheaper. A brand-name placebo has been found to have a more pronounced effect than a little-known drug.
The inclusion of additional ingredients in 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. Serious study of placebo effects is believed to have begun in the United States during World War II. Front-line hospitals were very short of painkillers and drugs. Convinced once again that the injection of saline has an effect of almost the same severity as that of morphine, the anesthesiologist Henry Beecher, having returned to his homeland, with a group of colleagues from Harvard University began to study this phenomenon. In 1955, he summarized his observations in "The Powerful Placebo" in which he argued that the placebo can "cause significant physiological changes", including "objective effects in target organs that may be more pronounced than due to strong pharmacological effects." Based on the results of 15 studies, which included 1082 participants, he found that when taking a placebo, 35% of patients experienced significant relief when instead of conventional drugs for a wide variety of diseases (cough, postoperative and headache, irritability, etc.) received a placebo. In the future, it was proved 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 medical procedure and even verbal influence. Anything that mobilizes the patient's expectations and beliefs about health can act as a placebo.
Often the placebo effect is found in surgical treatment, since it is more pronounced for patients. So, in one of the studies conducted in Denmark, 15 people during the experiment were operated on in connection with a disease of the inner ear (Ménière's disease), the other 15 underwent placebo surgery. After three years in each group, 10 people (the same number!) Almost completely got rid of the symptoms of the disease.
In another described 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 into the brain of special nerve cells - the so-called dopamine neurons, 20 others were told that they had the same operation, when in fact they were not subjected to any surgical interventions. At the same time, a double-blind control was carried out, that is, neither the patients nor the 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 the doctors found clear objective signs of improvement in their condition.
The placebo effect has also been proven with acupuncture in the case when doctors performed acupuncture using points that are not biologically active. At the same time, a positive effect of the treatment was observed in 35-50% of patients, and the effect on true biological points was effective in 55-85% of cases.
In a crossover randomized study of 44 patients with chronic cervical osteoarthritis, the treatment methods used (acupuncture, sham acupuncture and diazepam) were equivalent. The most pronounced result was obtained after the use of placebo.
Undoubtedly, the placebo effect is present in the prescription of homeopathic remedies, as well as in other types of treatment. Some researchers, after conducting a series of laboratory tests, found no evidence that homeopathy is somehow more effective than placebo. The authors believe that some people feel better after taking homeopathic remedies, however, they attribute this effect to the psychological factor, the experience of therapy in general, the time and attention that the homeopath pays to the person. It should be noted that the researchers were not homeopaths and did not know the principles of prescribing homeopathic medicines.
Later, a pronounced placebo effect was described in chronic pain syndrome, chronic fatigue syndrome, arthritis, headache, allergies, arterial hypertension (in some cases), insomia, asthma, chronic digestive disorders, depression, anxiety, Parkinson's disease. Under the influence of a placebo, an excess of leukocytes appeared in the blood of a person and the level of proteins and lipids decreased.
The placebo effect is a significant boost in clinical conditions such as pain, mental illness, hypertension, obesity, and perimenopause.
A case was recorded when a patient suffering from Parkinson's disease received a placebo, considering it to be another drug. As a result, his tremor significantly decreased. This result surprised the doctors who conducted the experiment so much that they even suggested that there was some substance in the placebo milk sugar tablet that caused such a pronounced therapeutic effect. However, mixing the substance that is part of the placebo into the milk did not cause any therapeutic effect, since the patient did not know about it. The placebo worked only when the patient believed he was taking the medicine.
During a study of mild psychiatric depression, patients had their medications replaced with a placebo. The results were exactly the same as with medication. In 25% of individuals, the improvement was so pronounced that they were recognized as completely healthy and were forced to be excluded from the group on which the effectiveness of real drugs was tested.
For a number of years, the National Institute of Geriatrics in Bucharest has been conducting 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 who lived in approximately the same conditions. They were included in three groups of 50 people. The first group was given nothing, 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. In the second and third groups, taking placebo and the drug, there was a significant improvement in overall well-being, about the same level of health and a lower mortality rate compared to the first group.
The placebo effect was convincingly demonstrated in one of the first studies on the effects of anabolic steroids (J.H. Wilmore, D.A. Costill, "Physiology of Sports"), when 15 athletes who had been involved in strength training loads over the previous two years agreed to take part in an experiment involving the use of anabolic steroids in the process of strength training. They were told that those who achieved the maximum increase in strength during the 14 months of the preliminary training period would be eligible to participate in the second phase of the experiment using anabolic steroids. The subjects were told that they would take 10 mg of Dianabol (an anabolic steroid) daily, when in reality they were given a harmless drug as a placebo. Data on the development of strength were recorded within 7 weeks before the start of placebo consumption and during 4 weeks of its 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 trial period and by 45.1 kg (10%) during the placebo period. This corresponded to an average increase in strength of 1.5 kg/week during the pre-period and 11.3 kg/week during the placebo period, ie. almost 10 times.
One study examined the ability to predict the occurrence of recurrent depression from the nature of the primary response. Patients who were treated with fluoxetine for 12-14 weeks were then switched at random to treatment with either placebo or fluoxetine. At the same time, patients who initially responded positively to placebo responded similarly to the continued administration of placebo and to fluoxetine. At the same time, those who received the true cure responded more strongly when switched to a placebo.
It has been found that the placebo effect can occur even when patients know they have been given a sugar pill. In a study conducted at Johns Hopkins School of Medicine, 15 participants receiving outpatient treatment for an anxiety disorder received one sugar tablet 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 was significantly reduced; 9 - directly associated the results with taking the pills; 6 - suspected that the tablets contained active ingredients; 3 - complained of side effects: blurred vision and the appearance of dry mouth (such side effects are observed when taking certain psychotropic drugs).
Scientists have proven that placebo has a stable analgesic effect. Many double-blind trials have been conducted to test the effectiveness of placebos in relieving pain. Pain reduction with placebo was 55% of that achieved with morphine.
The SYDNEY study examined the efficacy of a-lipoic acid in patients with diabetes mellitus. Patients were in the hospital for a whole month, which made it possible to normalize nutrition, daily routine, physical activity and hypoglycemic therapy. Positive neuropathic symptoms were chosen as the main criterion for the clinical efficacy of the drug due to the fact that they are the first to disrupt the quality of human 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 with placebo was noted in more than 30% of patients. That is why the placebo effect in the study was minimized by the presence of an introductory (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 actually insensitive to placebo was a feeling of numbness. In this regard, it is extremely important that the improvement was obtained using a different scale (NISLL), which does not show a significant change when using placebo. The decrease in the number of points on this scale after treatment was mainly due to revival or the 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 the 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 form 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, to realize them in behavior, to bring them to life. The effectiveness of hypnotherapy in 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 groups of study participants: intravenous morphine for pain after thoracoectomy, intravenous diazepam for anxiety after thoracoectomy, and subthalamic nucleus stimulation for idiopathic Parkinson's disease. In each group, some patients were informed about the treatment, while others were not. In all groups, the effectiveness of treatment was higher when patients were waiting for the procedure.
The "expectation" of patients influences the effect of the placebo and the active substance. Asthmatic patients who believed the inert substance to be a bronchodilator or bronchoconstrictor responded accordingly. It has been demonstrated that the "expectation" of patients changes or even distorts the action of some pharmacological agents.
James Frazer's The Golden Bough and Harry Wright's Witness to Witchcraft provide many vivid examples of the psychological power of placebo effects in primitive tribes. “Once, for example, it happened that a New Zealand leader of high rank and great holiness left the remnants of his food on the side of the road. After his departure, a slave, a hefty hungry fellow, arrived in time, saw the remaining food and, without asking, ate it. Before he had finished eating, he was told 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 intertribal wars, the traveler said, but as soon as the fateful news reached his ears, he began to experience convulsions and abdominal cramps of exceptional strength, which did not stop until his death, which followed at sunset of the same days..."
A significant role in the implementation of the placebo effect is played by the personality of the doctor, his experience, qualifications and ability to positively interact with the patient. Receiving a placebo from a doctor and believing that this is a medicine, the patient experiences relief. With prolonged use of the same medication, a kind of conditioned reflex occurs. Apparently, therefore, the placebo effect is more often determined in chronically current diseases, as well as anxiety and pain syndrome.
Do mental factors alone determine the placebo effect?
One study compared placebo effects in 70 patients in the treatment of three anxiety disorders. Patient responses to and expectations of treatment were studied in three randomized controlled trials. As a result, it was found that patients with obsessive-compulsive disorders responded much less to placebo than those with generalized social phobia or panic disorder. These data cannot be explained by different patient expectations.
A placebo effect study was conducted in individuals 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 by the condition of the patients, as well as by the results of encephalographic studies characterizing the activity of various parts of the brain. Significant improvement was noted in 13 patients (52%) treated with medication and 10 patients in the placebo group (38%). This effect was accompanied by fundamentally different changes in brain activity. Thus, antidepressants predominantly activated the prefrontal area of the brain responsible for the emotional state of a person, and the placebo had only a general stimulating effect on the brain, that is, it did not so much relieve depression as it contributed to a general increase in mental activity. “Physicians have known for years that even sham treatment improves patient outcomes,” said Edru Leichter, lead researcher. “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 number of publications have concluded that natural opioids (endofins) play a significant role in placebo-induced analgesia. It has been found that placebo-induced analgesia is partially reduced after 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 the transmission of pain signals from one nerve cell to another. We examined 14 healthy male volunteers who were injected with saline solution in the jaw. For 20 minutes, the participants had to record how severe the pain was every 15 seconds, estimating it on a scale of 100. They recorded their feelings of pain, and then summed up the scores. In randomized trials, some volunteers were given 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 endorphin system of the body. There was activity in four permanent brain regions, however, activity in other brain regions also matched the volunteers' description of pain. For example, activity in the dorsolateral prefrontal cortex correlated well with expectations of a drug's analgesic effect. Placebo participants reported a reduction in pain. Using positron emission tomography, it was shown that after taking the placebo pill, the human 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 a physical basis. We saw firsthand how the endorphin system activated in pain-related areas of the brain. Similar activity was noted when the volunteer was told that he had received pain medication. However, the response of people who were switched from real drugs to placebos was not always the same. The researchers divided the patients into "little reactive" and "very reactive" (in whom pain was reduced by more than 20%). “What determines such a different response is not yet clear, 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 quality of the brain - self-regulation, which is most likely short-term.
In another study, researchers at the University of Texas demonstrated the existence of a placebo effect in depressed men who took Prozac or placebo for 6 weeks. Comparing positron emission tomography scans of the patients' brains, they found that in both groups there was an increase in activity in the cerebral cortex - in the "thinking" part, while it was observed in the limbic part that controls emotions. In 15 people, there was an improvement in neurological symptoms, and 8 of them took a placebo. The differences in the responses of the compared groups of patients that took place were that changes in both the brainstem and the hippocampus were observed in those taking Prozac. The authors suggest that reduced metabolic activity in the brainstem and hippocampus probably maintains positive cortical or limbic changes, contributing to a longer lasting effect of the drug.
The placebo activates the function of the cerebral cortex, and this, in turn, stimulates the endocrine system and the production of hormones of the adrenal cortex, which have pronounced anti-stress and anti-inflammatory effects.
As you know, Parkinson's disease is associated with a reduced level of dopamine in the blood, and drugs that stimulate the production of this substance are used to treat it. However, when the six patients began to receive injections of a simple saline solution instead of medicine, their health continued to improve, as before. As the tests showed, as a result of the procedure, the level of dopamine in the blood of these patients increased by more than two times. Of course, the patients themselves did not know anything 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 Stoysle and 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 introduction of saline causes the same effect as the introduction 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 the expectation appears, the brain launches other mechanisms that target the focus of the disease. This confirms the fact that the patient is able to transform the hope for healing into tangible biochemical reactions.
Placebo therapy. Researchers of the placebo effect quite reasonably had a question: if placebo pills for some diseases are not much inferior in effectiveness to a real drug, is it not better to use it? However, is it ethical? An article published in the British Medical Journal that Israeli doctors use (and not without effect) placebos could not help but attract attention. It turned out that about 60% of doctors, in order to satisfy the "unjustified" demands of patients, use in their medical practice substances that have nothing to do with a drug in the usual sense. Therefore, one can resort to a placebo in order to “not withhold help” and not harm with an unnecessary drug. A placebo is used, so to speak, for a diagnostic purpose: “it will help” means that the disease is imaginary.
Published research results indicate a high frequency of cases of cure with placebo: headache - 62%, colds - 45%, rheumatism - 49%, motion sickness - 58%, intestinal disorders - 58% of cases. However, there were also low cure rates: sleep disturbances - 7% of cases, bronchial asthma - 5%, epilepsy - 0%, mental disorders - 0%. This indicates that the medicinal properties of drugs are actually much lower than commonly believed, since their testing did not take into account the placebo effect.
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 articles on placebos. These trials showed that a placebo can act like a drug (sometimes even a potent drug) and also cause changes in the reactions that take place in the body.
The placebo effect occupies a special place in the treatment of mental and psychosomatic diseases.
There is no unified theory of the occurrence of psychosomatic diseases. Diseases of this kind are considered the result of the devastating effects of stress. At the same time, the stressful state is fixed in long-term memory, that is, it is able to remind 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 come even without touching the magnets he used to treat (once he simply forgot them at home).
The significance of the impression that 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 his consultations with wealthy patients. After the examination, the professor, alone in a special darkened room, pondered the diagnosis and treatment. At this time, complete silence was to be observed in the house. From such a consultation, the impression made on the patient and his relatives was favorably reflected in 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 physicians known to him admitted that in his practice "he used more bread-balls, drops of colored water, and powdered ash than other remedies combined." Without judging the doctor in the slightest, the president called the practice "a good lie."
I would like to recall the famous therapist of the 19th century 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, cured many diseases. After the death of the doctor, it turned out that they included well-ground chalk. The delight and joy with which the patients took these "medicines" was more useful than the drugs themselves. The great practitioner of placebo therapy wrote: “The art of the doctor lies in creating a “soulful” medicine that would comfort the angry, calm the impatient, stop the mad, frighten the impudent, make the timid bold, the frank - hidden, trustworthy - desperate.
Trust in the doctor is an essential component of the placebo effect. When the patient is afraid of something or something hurts, his senses are heightened. Meanwhile, the discussion continues among physicians who consider it unethical to deceive the patient, and among those who rely on Plato, according to whom "lying does not benefit the gods, but is useful to people as a medicine." It should be noted that even a non-specialist, resorting to placebo-type effects, can act as a healer.
White lie, placebo effect - the basis of "shamanic medicine" - so say the opponents of the use of placebo in medical practice. Proponents of placebo therapy are no less categorical: in a number of diseases, a “dummy” can successfully replace drugs, and if we take into account the growing high cost of new drugs, then placebo is economically beneficial. However, there is a golden mean; adherents of this position believe that placebo is an interesting field of medicine that requires attention and study.
Critical views on the placebo effect. Some authors have expressed doubts about the existence of the placebo effect. There have been numerous discussions on this topic, which continue to this day.
Employees of the University of Copenhagen and the International Medical Center, which specializes in assessing the quality of clinical experiments, analyzed the results of 114 published studies, which involved 7500 patients suffering from 40 different diseases, including arterial hypertension, asthma, pain syndrome, depression, schizophrenia, epilepsy. They concluded that placebo has no significant effect on secondary administration and may have little subjective benefit in long-term treatment of the disease. Scientists have not found substantiated evidence for the generally accepted notion that, on average, the condition of one in three patients who are given pseudo-drugs improves after taking them. The researchers became interested in where this figure came from, and it turned out that the authors of all the articles in which she met, refer to the work of G. Beecher. After analyzing the data of this work, they found a number of shortcomings. First, the range of disorders in which the placebo effect was confirmed by the results of studies was limited only to various types of pain syndromes (after surgery, with headache, angina pectoris and osteoarthritis). Only one study found to support placebo efficacy for coughs, colds, motion sickness, and anxiety. Second, 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 of the studies, 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 misinterpretation of statistical data. The fact is that in many diseases the condition of patients in itself either improves or worsens, and these fluctuations are erroneously attributed to the action of a placebo. Success from a placebo may coincide with the natural (positive) course of the disease. This fact, well known to physicians 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 upon the return of its periods, one in comparison with the other, they happen daily, or every other day, or after a long time.”
Studies comparing treatment outcomes not only with placebo but also with no treatment at all have shown that placebo and no treatment at all often have almost the same effect on patients.
Medical statisticians at the Houston Cancer Center backed the Copenhagen researchers because of the well-known statistical observation that a patient who feels terrible today will almost always feel better the next day, no matter what doctors do. Agree with the results of the Danish study and scientists at the Center for Biomedical Ethics at the University of Virginia, who consider placebo effects a medical legend.
At the same time, other medical statisticians do not find this work convincing enough, since the statistical method of meta-analysis used by the Danes can give erroneous results. The placebo efficacy may have been exaggerated quantitatively, but in many cases it was still quite significant. D. Evans notes that if they had carefully analyzed the data, they would have found that the effect when using a placebo was not statistically significant only according to the results of studies that used a binary scale (the presence of a positive or negative effect). On the contrary, in those studies that used a continuous scale with placebo, there was a pronounced statistically significant positive effect. The range of states studied in the mentioned test was very wide - their number was estimated at four dozen. Particularly indicative is the fact that the placebo acts differently in different diseases, that is, it is not a panacea, not a universal medicine.
The Copenhagen researchers acknowledged that in some cases they also noted a weak placebo effect, manifested, in particular, in patients' subjective judgments of the pain they had experienced, but rated it as insignificant and almost imperceptible. Most likely, these are subjective delusions: some patients instinctively want to answer the interviewing doctor that they feel like they are 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 a placebo based on scientific data. Such a study is quite difficult to conduct, since the use of a placebo is difficult to separate from the accompanying actions of medical personnel. Therefore, the placebo effect is usually identified with the totality of conditions that accompany 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% after a certain time compared to those who were prescribed a placebo. At the same time, those who took a placebo had a 200% improvement compared to patients who were on a waiting list and received no treatment at all. According to the authors, about 25% of the severity of the effect of antidepressants is due to spontaneous remission, 50% - to the placebo effect, and only 25% - to the pharmacological action of the drugs. However, if an additional 25%, which gives the actual effect of antidepressants, lead to the fact that the condition of patients begins to be characterized not by an average, but by a slight severity of functional disorders, then the effect of pharmacotherapy is very important.
A study was made of the significance of the so-called positive and negative consultations in persons with functional pathology. In the first case, the patient was told 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, one patient was given a placebo, while the other was given no medication. Recovery occurred much more often and faster in the first group; in both groups, there was no difference in treatment effect between placebo and no drug participants. From this 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 opponents of placebo. Thus, Tad Kapchuk, a professor at Harvard University who has participated in many clinical studies using placebo, states: "Although inert pills have shown little effectiveness in relieving pain, I see no justification for using them outside of clinical trials." He insists that in future studies, the placebo effect should be compared not only with the effect of real drugs, but also with no treatment at all.
What effect the imitation of the therapeutic effect - "dummy" has, is practically unknown today, because there are very few studies comparing the state 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 without intervention in modern conditions, since not a single ethical committee will agree to conduct such studies.
Placebo in clinical trials. In the 19th century, medicine was dominated by the practice of evaluating the effectiveness of treatments on the basis of pathophysiological theories and the physician's "impression" that the drug or treatment was helping the patient. Already in the 30s of the last century, Bradford Hill introduced a randomized selection of patients both in the main group and in the control (comparison) group in determining the effectiveness of the test drug. Decisive was the decision of the US Food and Drug Administration (FDA), adopted in 1962, that new drugs should be subjected to clinical trials before their widespread use. Evidence of efficacy subsequently began to be obtained through randomized placebo-controlled trials, placebo control became the gold standard for clinical drug trials.
In recent decades, evidence-based decision making, which combines individual experience with the results of clinical research, has become widely accepted in clinical practice. The rapid development of evidence-based medicine methods also introduced physicians to the term "placebo", used in clinical trials of drugs as indispensable evidence that the test drug is better than "dummy".
Clinical studies of new drugs usually compare two groups of patients in whom the natural course of the disease and the nonspecific effects of therapy would be approximately equivalent. When active treatment is given to one group and placebo to the other, the differences are attributed to the specific effect of the therapy. Over the past 40 years, using this method, high results have been achieved in evaluating the effectiveness of many drugs.
Since the 1970s, placebo and double-blind trials have been mandatory for evaluating the efficacy of new drugs, testing the efficacy of established drugs, and comparing similar drugs. A distinction is made between an open method, when the drug is known to all participants in the treatment or trial, and a simple blind method, when the patient does not know which medicine he is taking. In a double-blind method, a test drug is compared with its placebo counterpart, but neither the test subjects nor the experimenters know which of these drugs is used for protocol studies. Patients should not be aware of this because their expectations affect the outcome of treatment; doctors - because they can involuntarily influence the well-being of the subjects, who catch the slightest change in the behavior of the doctor. Only a third party has complete information. The double-blind method eliminates the effect of bias on the results of treatment, since the doctor cannot have a psychological impact on the patient and it is not enough to objectively assess the effect of therapy. The effect of a medicinal substance is considered to be scientifically confirmed if the difference between the measurements of the effects of the study drug and its counterpart reaches a statistically significant value. Medicine as a science is gradually replacing medicine as an art. That is why it is necessary to apply treatment, the effectiveness of which has been proven by objective data.
However, the use of a placebo as a comparator to prove the benefit of a new drug creates a number of problems in itself. For example, can a placebo be used in a drug trial 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, known effective drug to another? Based on this, the ethical committees of European countries are very exacting in the design of clinical trials, requiring that the use of a placebo be irreproachably justified. Thus, according to the Declaration of Helsinki, in any medical research (including clinical trials), all patients, in particular those included in the control group, must be properly examined and receive appropriate treatment. Refusal in some pathological conditions from the use of placebo, when patients (from the control group) cannot be left without treatment, should be considered ethically justified. If the effectiveness of the drug is already established, a placebo-controlled trial should not be carried out even if required by the 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 the trial, also include the informed consent of the patient. However, the latter, as some studies show, can affect the outcome of the test. If a worsening condition occurs after placebo, the patient should be withdrawn from the study or switched to active treatment in the same trial. There are strong arguments for the fact that participants in clinical trials in many cases are aware that they are prescribed a "pacifier". They make similar conclusions based on the absence of side effects. So, in one clinical study comparing the outcomes of the use of two antidepressants and placebo, 78% of patients and 87% of doctors correctly identified who took the drugs and who - their imitation. In other data, in 23 of 26 studies, the identification of patients treated with active and inactive drug 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 feel one of the often developing side effects - dry mouth, and it will seem to them that they are receiving a specific treatment.
Conclusion. The placebo problem seems to be somewhat broader than the actual clinical trials. There seems to always be a component of expectation of the effect in the positive effect of this or that drug, as in the case of taking a placebo. This component of expectation, hope for an effect depends not only on whether an outwardly inert, indifferent substance is similar to a real medicine in color, shape, smell. In anticipation of the effect, a large role belongs to the doctor himself, his relationship with the patient.
There are still more questions than answers about the placebo mechanism of action. Although it is generally accepted that the secret of the placebo lies in autosuggestion, this assumption does not explain many of the oddities of its action. Already now there are many systems that are based only on the effect of faith. However, the task of scientists is to learn how to use the mechanisms of self-healing without taking a placebo. Research in this area is still ahead. Irving Kirsch, a psychiatrist who has studied the placebo effect for many years, said, "The only thing we can say for sure is that we don't know anything about it."
Placebo is an extremely interesting medical phenomenon. It is likely that the essence of placebo in the future 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 because they are inert,” writes Daniel Moerman, a thirty-year placebo researcher.
In recent years, interest in studying the placebo problem has revived somewhat. Thus, the decision of the US National Institutes of Health in the budget year approved 14 new clinical studies aimed at studying the mechanisms of placebo effects on the patient's body.
Based on the data accumulated to date, it can be assumed that the placebo effect is present in any treatment intervention and its importance should not be underestimated. This is stated by Ann Arrington, a professor at Harvard University and author of The Placebo Effect.
So, based on our own many years of experience in studying the general principles of pharmacotherapy, we propose to single out the following body responses to the effects of a drug:
1. Psychosomatic (if there is a placebo effect).
2. Pharmacological (pharmacodynamic).
3. Metabolic (associated with the metabolism of the drug in the body).
4. Response-nonspecific (non-specific reaction in response to the introduction of a foreign substance).
5. Response-physiological (for any change in pathophysiological processes in the body, a reverse specific reaction occurs).
The features of the manifestation of these reactions depend on the dose of the drug (strength of exposure), 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 impact and respond to it .
All these questions require deep fundamental study. At the same time, modern medicine has a theoretical justification for the practical use of only pharmacological effects and does not take into account the entire versatility of the body's response to it.In medicine, cases have been recorded when patients recovered due to taking drugs whose effectiveness has not been proven. Moreover, clinical studies confirm that the medicinal value is approaching zero. In this case, there is a placebo effect - curing yourself with almost the power of thought.
Placebo: what is it
Almost two hundred and fifty years ago, doctors described the facts of the recovery of patients after taking substances that are not drugs, but passed off as such.
In simple words, we can say that the patient receives a "dummy" that imitates a tablet, capsule, injection. There are no medicinal components in its composition and, logically, it should not “work”. But in reality, it turns out that the patient receives “treatment” and recovers.
The phenomenon was called "placebo" and was subjected to repeated study by psychologists and physicians.
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 drugs, and which - their imitation.
Example 1 Psychiatry
A doctor in a psychiatric clinic located in one of the cities of the United States treated patients suffering from violent attacks. Their behavior was aggressive, threatening the life and health of others.
At the initial stages, most patients of the clinic were kept in conditions of deprivation of activity - in straitjackets.
The management of the clinic went on an experiment in which, by prior arrangement, Dr. Medel's patients began to receive a new, hitherto unknown, but very effective medicine. This medicine allowed to stabilize and socialize violent crazy 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.
Patients talked, smiled, and the doctor was able to abandon the guard, which he had not parted with before.
Imagine his surprise when he learned the results of the test treatment. None of the insane asylum patients received medication, all took a placebo.
The therapy paid off because neither side of the experiment (neither the doctor nor the patients) knew who was receiving the medicine. Patients believed that a drug had been found that would help overcome their problems. And so it happened.
The doctor wanted with all his might to see the results, changes in the behavior and consciousness of his wards. He really "saw" them, thereby unwittingly influencing the sick.
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 have not yet invented a medicine capable of defeating the disease, and mortality was extremely high.
Taking a risk, the medical staff informed the patients about the admission to the hospital of a rare, very effective and equally expensive drug that could overcome the disease within a month. The mentioned characteristics of the drug were important: new, effective, expensive.
Under the guise of know-how, patients received acetylsalicylic acid. But the belief in the effectiveness of a new drug delivered to the hospital specifically for them, potential suicide bombers, made it possible to cure 80% of patients.
Example 3 Pediatrics
In the United States, placebo drugs are widely used in pediatrics. American doctors are deeply and unshakably convinced that children should not be stuffed with medicines unless absolutely necessary.
Not only children, but also their parents often need a "magic" pill. Therefore, drugs of this kind are sold in pharmacies and consist of safe components that are allowed even for small children.
Pills "from laziness", "from fear", from diseases developing against a background of uncertainty, phobias are very popular. What is most surprising is that they bear fruit.
List of drugs considered placebo
The list of drugs marked as "dummy" is quite large. According to the Russian Academy of Medical Sciences, about a third of drugs on the modern pharmacological market are “dummy”. Many of them have a high cost and are popular with both doctors and patients.
- Medicines to improve blood circulation, microcirculation - actovegin, cerebrolysin, solcoseryl;
- Immunomodulatory drugs;
- "Heart" drugs - ATP, cocarboxylase, riboxin;
- and (linex, bifidumbacterin, bifidoc, hilak forte and others);
- Means for improving cerebral circulation - piracetam, nootropil, tenoten, phenibut, pantogam, aminalon, tanakan, preductal;
- Mildronate, mexidol;
- Bioparox;
- Polyoxidonium, grippol, gromecin;
- Chondroprotectors - chondrosamine, glucosamine, chondroitin;
- Valocordin, valoserdin, novopassitis;
- Antithrombotic drug thrombovazim;
- Essentiale N, mezim forte.
What enhances the placebo effect
Pharmaceutical companies that produce certain groups of drugs know the marketing moves. These methods increase not only the popularity (and hence the level of sales) of dummy drugs. They also help patients, despite the absence of the active substance in the composition of the drug:
- Patients like large, brightly colored tablets more than small, faded, colorless ones. Patients subconsciously develop confidence in outwardly visible drugs;
- A pronounced therapeutic effect is manifested in patients after taking drugs from well-known manufacturers compared to modest competitors, even if the composition contains the same active substance;
- Expensive medicines “treat” faster, more efficiently, and there is more confidence in them than in cheap analogues;
- After the end or interruption of the placebo "treatment" course, 5% of patients experience a withdrawal syndrome with pronounced symptoms;
- From 5 to 10% of patients experience the claimed side effects, although there are no substances that can cause them in the medicine;
Placebo has a better effect on people with a 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, checking any information “by the tooth”, are less amenable to the influence of a 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 the treatment with pacifiers.
Types of placebo
Placebo treatment is not limited to banal pills with a magical effect. There are several types of placebo:
Preparations
The most popular and extensive group. Under the influence of "powerful" pacifiers, migraines disappear, blood pressure normalizes, bleeding stops, even tumors, including malignant ones, dissolve.
There are many such examples described in the medical literature. In each case, the effectiveness is recorded and cannot be explained only by the impact on the consciousness and subconsciousness.
Imaginary surgical interventions
Surgeons use the placebo effect, replacing the real operation with a sham one, and achieve the same result as with a real intervention.
Surgeon David Callmes has been practicing spinal surgery for many years after severe injuries and fractures. He decided on an experiment, during which some of the patients were actually operated on. The other part was informed about the operation, although in fact there was none.
But what really happened was the reliable preparatory work with patients, the identical surroundings in the operating room.
As a result of a well-played performance, the well-being of patients improved. At the same time, pain disappeared and functions were restored. This means that somewhat different regeneration mechanisms come into play.
Placebo - acupuncture and homeopathy
Instilling faith in the patient in the possibility of getting rid of a serious illness by inserting needles into the skin and taking homeopathic medicines makes it possible to achieve tremendous success in the treatment of mental and somatic diseases.
And yet, how does it work?
In psychology, the placebo effect is used not only to correct personal qualities, but also for training and education, development, and stabilization at any age. Placebo is based on suggestion. Properly executed suggestion triggers hidden mechanisms in the human body. This allows you to mobilize your own resources and defeat the disease.
Every doctor knows that there are patients for whom the attention of a medical worker is already a treatment. Suspicious, suggestible people, ready to believe in a magic pill, a unique procedure, rejuvenating apples and living-dead water, easily succumb to the temptation 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 treatment, gives the necessary commands.
For this category of patients, a good doctor is the one who prescribes drugs, will treat, and will not explain how to do without them. Just in such cases, the placebo contributes to the treatment, does not harm the body, causing, most likely, damage only to the wallet.
It has long been known that faith works miracles. Placebo - belief in the possibility of becoming healthy again despite predictions and possible negative options.
