September 2014 is the beginning of the school season. Xiao Lei (pseudonym), who was supposed to be in the first year of college, did not have the opportunity to live in college, and came to Beijing from Hohhot to seek treatment for "bipolar disorder". It is a refractory psychiatric disorder characterized by alternating episodes of mania and depression.

Prior to that, he had been treated at Beijing Deshengmen Hospital of Traditional Chinese Medicine for more than a year. It was the second half of 2012, and Xiaolei's father felt that his son had "something wrong with his mental state" and decided to go to Beijing for treatment. After a little search on the Internet, he was "navigated" all the way to Beijing Deshengmen Hospital of Traditional Chinese Medicine.

Xiao Lei's father told the Caixin reporter that the reason why he chose Deshengmen Traditional Chinese Medicine Hospital was because the doctors there told him that "Chinese medicine can go to the roots"; In addition, Deshengmen Hospital of Traditional Chinese Medicine has a diagnosis and treatment instrument - cranial neurotransmitter detector (EFG, E

cephalofluctuog

APH), the effect is amazing.

According to the propaganda of Deshengmen Hospital of Traditional Chinese Medicine, this instrument "has passed the authoritative certification of the US Food and Drug Administration and the China Food and Drug Administration, and has successfully applied for a number of patents in the United States, Japan and the European Union

ld Psychiat

ic Associatio

It is also the designated mental illness testing equipment designated by the Chinese Committee of Experts on Mental Illness."

Xiao Lei's family suddenly became confident. After entering Deshengmen Traditional Chinese Medicine Hospital, the doctor did not ask too much about the condition, that is, he used EFG to conduct a non-invasive test on Xiaolei's head, and generated a "brain fluctuation analysis report", which detected the values of 9 kinds of brain neurotransmitters. The doctor told Lei's father that the numbers proved that there was something wrong with Lei's cranial neurotransmitters. Based on this, the doctor formulated a treatment plan for Xiao Lei, "the high value should be lowered, and the low value should be increased", and hinted that it could be cured.

The next treatment is very expensive. From January to July 2013, Xiao Lei spent nearly 200,000 yuan on treatment at Deshengmen Traditional Chinese Medicine Hospital, but his condition did not improve, but became more serious. My father recalled: "The treatment had no effect. When he was manic, he didn't recognize his relatives and beat people; At the same time as beating us, if you want to kill yourself, you go to hit the wall. ”

One day in July 2013, Xiao Lei committed suicide by taking sleeping pills. The parents wept to dissuade him, and the manic Xiao Lei slashed his mother with a shovel and cut a cut of more than ten centimeters on his father's head. To this day, the long scars on Xiao Lei's father's scalp are still clearly visible.

The helpless father took Xiaolei to Beijing Anding Hospital for treatment. It is a tertiary mental health hospital and one of the important research institutions for the diagnosis and treatment of mental diseases in China.

At the first visit, he told the doctors at Anding Hospital about the neurotransmitter tester. The doctor who received him tactfully told him that the EFG could not be concluded to be ineffective, but that Beijing Anding Hospital had never used such a device; He had only heard about the instrument from advertisements; Moreover, in the past two years, more and more patients have had to be transferred to Beijing Anding Hospital for treatment after receiving EFG diagnosis and treatment in some private hospitals in Beijing, but there is no effect.

"Nearly 30 percent of these patients I first see have had EFG. Not to mention the money spent in vain, the illness was delayed. The psychiatrist, who has more than 20 years of clinical experience, sighed.

EFG mythology

Open the official website of EFG (http://www.efgedu.

et/), a slogan can be seen: "Reshape the spiritual world, create a better life together". The tone of the website is dominated by blue and white, which at first glance is very reminiscent of the official website of the World Health Organization.

However, on EFG's official website, there is no information about the founding organization.

According to the website, the EFG cranial neurotransmitter detector and EFG cranial neurotransmitter immunoregenerative therapy are "the most effective treatment results for insomnia, depression and other mental illnesses successfully developed by 9 international key medical institutions and 192 senior experts including the World Psychiatric Association (WPA), the Asian Sleep Research Society (ASRS), the International Committee for the Prevention and Treatment of Depression (PTD), and the Chinese Association for the Prevention of Mental Disorders after years of scientific research". The instrument can "non-invasively quantitatively detect GABA (γ-aminobutyric acid), Glu (glutamic acid), Ach (acetylcholine), NE (norepinephrine), 5-HT (serotonin), DA (dopamine) six central neurotransmitters", and this technology "has passed the authoritative certification of the US Food and Drug Administration, the China Food and Drug Administration SFDA and the European CE, and has successfully applied for invention patents in China, the United States, Japan, the European Union and other countries".

From the perspective of the development of biomedical technology, it cannot be said that the non-invasive detection of neurotransmitters is unfounded. It should be said that if there is an instrument that can directly measure brain neurotransmitters, it will be of great help to the diagnosis and treatment of mental illness, and it is a blessing for people with mental illness.

Now medicine can prove that there is a correlation between mental illness and the concentration of neurotransmitters in the brain. What are neurotransmitters? To put it simply, when nerve cells in the human brain transmit information to each other, the nerve endings of the previous brain cell release chemicals whose mission is to carry the information, cross the intercellular space, and pass the information on like a postman. These chemicals are called neurotransmitters.

Medical experts told Caixin reporters that there are three main neurotransmitters in the brain: 5-HT, norepinephrine and dopamine. These three neurotransmitters do not function identically. For example, 5-HT governs emotions, desires, and wills; Norepinephrine provides life power; Dopamine transmits happiness. If these three neurotransmitters are out of balance, the signals received by neurons will be weakened or changed, and the human body will experience symptoms such as insomnia, anxiety, obsessive-compulsive, depression, and fear, which are manifested as depression, bipolar disorder, schizophrenia, and other neuropsychiatric disorders.

However, modern medicine can only empirically infer that mental illness is related to neurotransmitter imbalance, and cannot accurately determine which neurotransmitter is deficient in the patient's brain. The reason is that, firstly, the most accurate measurement method of neurotransmitters is to obtain cerebrospinal fluid through craniotomy, and secondly, there are many types of neurotransmitters, the interaction mechanism is 10 points complex, and the precise relationship with mental illness is still being explored.

However, from a market perspective, where there is a need, it is possible. Patients need easy access to testing and a promise of never relapsing, and hospitals need to maximize profits. This is where EFG comes in. It claims to be able to non-invasively detect whether a patient is deficient in neurotransmitters and which neurotransmitter is deficient, so as to prescribe the right medicine. If this were the case, it would be entirely feasible for EFG to write the myth of treating mental illness.

A Caixin reporter typed "cranial neurotransmitter detector" into Baidu Encyclopedia, which claimed that EFG could "provide scientific and accurate examination results for psychiatric experts"; "Under the scientific guidance of the experts, the condition improved significantly after 3 to 7 days of treatment, and the symptoms of headache, insomnia, depression, and psychological disorders basically returned to normal within a month."

Type "EFG cranial neurotransmitter detector" into the Baidu search engine, and there is an overwhelming amount of information about hospitals that advertise the use of the instrument across the country. The claims of EFG are not exactly the same among these hospitals – some claim to treat insomnia, neurasthenia, depression, anxiety, schizophrenia, and some can treat menopausal syndrome, autism, Parkinson's syndrome, Tourette's syndrome, ADHD, and so on.

The same thing is that the design of these websites is similar, and these hospitals are aimed at mental illnesses whose pathogenic mechanisms are yet to be explored and which are difficult to cure in a short period of time. There is a large area of publicity about EFG's miraculous cures on the website, and the "Free Online Consultation" and "Appointment Expert" windows pop up from time to time.

Sounds wonderful. The question is: is all this real?

Detection of a patient

In a remote corner on the fourth floor of Deshengmen Hospital of Traditional Chinese Medicine, a Caixin reporter met Xiaoqin (pseudonym), a 21-year-old female college student from Xinzhou, Shanxi.

Xiaoqin had auditory hallucinations two years ago, and her temperament changed drastically, and she became manic in the past, often suffering from insomnia and throwing things. After seeking medical treatment in many places in Shanxi, Xiaoqin's father did a simple search on the Internet, and the promotional information of Deshengmen Traditional Chinese Medicine Hospital brought them hope. After logging into the dialog box, the "doctor" enthusiastically arranged an appointment for them, and the family traveled from Shanxi to Beijing.

Xiaoqin's father told the Caixin reporter that after a brief consultation, the doctor asked Xiaoqin to do a brain neurotransmitter test. A single test lasts for 10 minutes, and the fee is 680 yuan.

Xiaoqin recalled that this kind of cranial neurotransmitter detection was non-invasive, only a few wires were glued to the scalp, and after about ten minutes, the machine typed out a report with "brain fluctuation analysis report".

Xiaoqin's father showed the report to a Caixin reporter. The data listed above has three more test items than the test items on EFG's official website, which are "Stimulant Transmitter 3", "Excitatory Transmitter 6" and "Inhibition Transmitter 13".

The report concludes that the relative power of GABA and Glu has decreased. dysfunction of cerebral excitatory inhibition".

The doctor glanced at the data and formulated a treatment plan for Xiaoqin for a course of tens of thousands of yuan.

During the test, Xiaoqin's mother said that she had recently gone through menopause and was also unwell. The nurse advised, "Since you've come all the way, you should test it too." ”

Caixin reporter consulted the customer service of Deshengmen Hospital of Traditional Chinese Medicine online and asked about the efficacy of EFG in the treatment of depression and sleep disorders, and the other party replied: "You can rest assured that many patients in our hospital have such conditions every day, as long as they can actively cooperate with the treatment according to the treatment methods of our hospital's experts, they can recover." After years of clinical experience, the cure rate has reached 98%. ”

Through the courteous online service, the Caixin reporter was given the green light all the way and hung up the expert number. At the time of the consultation, the Caixin reporter told the doctor that he had been feeling a lot of pressure and was a little depressed recently. The doctor asked, "Is the initiative low?" "Low interest?" "Low self-esteem?" "It's painful?"

Subsequently, the doctor suggested that the Caixin reporter do an EFG test; The Caixin reporter continued to ask questions, but the doctor refused to answer, citing that "only a test can determine the treatment plan."

"Hospital Money Printing Machine"

EFG's official website claims that "the inspection accuracy can reach more than 97.3%"; The agent used in EFG cranial neurotransmitter immunoregeneration therapy is "made of modern biological gene technology, combined with more than 100 kinds of precious Chinese medicine extraction, concentration and refinement, easy to absorb after taking, quick effect, and the efficacy is more than 30 times that of ordinary drugs, does not contain any hormones, no dependence, no toxic side effects and adverse reactions, and no damage to important organs such as heart, liver, and kidney." ”

Not only that, EFG treatment can also "open up the brain meridians" and "do not rebound after healing".

It is not easy to find out how effective EFG is; However, the cost of testing is expensive, and it is easy to see at a glance.

Prices vary slightly from hospital to hospital. Deshengmen Hospital of Traditional Chinese Medicine charges 680 yuan for each test. When the Caixin reporter consulted the sales representative of EFG cranial neurotransmitter detector as a buyer, he gave a fee suggestion of 150 yuan each time.

This sales representative is Mr. Tian of Shenzhen Kang Li High Technology Co., Ltd. He introduced that the EFG cranial neurotransmitter detector, also known as the brain fluctuation graph, is generally sold in conjunction with the ultra-low frequency transcranial magnetic therapy instrument (a physical instrument used for the treatment of mental diseases, and transcranial magnetic therapy has been used in clinical practice). The transaction amount of the brain fluctuation graph instrument is about 800,000 yuan, the ultra-low frequency transcranial magnetic therapy instrument is about 780,000 yuan, and a set is generally about 1.6 million yuan. "We've been on the market for more than two years, and now we've sold more than 600 sets."

In addition to the 10 hospitals authorized by EFG's official website, there are at least 20 hospitals on the Internet that claim to use EFG's cranial neurotransmitter detector. Among them, there are 8 hospitals in Beijing, including Beijing Deshengmen Hospital of Traditional Chinese Medicine and Beijing Guoji Hospital of Traditional Chinese Medicine.

In addition, according to the promotion materials provided by Shenzhen Kang Li High Technology Co., Ltd., its customer list also includes 40 hospitals and mental health centers across the country.

Mr. Tian told Caixin reporters, "The benefits of it (brain fluctuation chart) are very high. Many deans told us privately that you sent us a money printing machine, which not only solved the clinical needs, but also improved the efficiency of the hospital. ”

Caixin reporters found in Deshengmen Hospital of Traditional Chinese Medicine that patients who came to the psychiatric department for consultation were required to undergo EFG testing. From 9:30 a.m. to 10:30 a.m., five patients entered the EFG testing room. According to this rough calculation, about 35 people are tested every day, and the income from testing alone is 23,800 yuan. If calculated according to the purchase price of 800,000 yuan, the hospital will be able to recover the cost in more than a month.

Treatment options based on EFG test results incur a larger cost of treatment.

The Caixin reporter found that in addition to introducing the EFG cranial neurotransmitter detector, the aforementioned EFG official website also has a lot of space to introduce the supporting EFG cranial neurotransmitter immune regeneration therapy. This kind of "symptomatic treatment, no toxic side effects" therapy is divided into three stages: the first stage, EFG brain neurotransmitter detector detection, 10 minutes to find out the deep cause of mental illness; In the second stage, physical therapy such as ECT, cerebral circulation comprehensive therapy instrument, oxygen therapy instrument + balanced conditioning of traditional Chinese and Western medicine (Chinese main and western auxiliary); The third stage is psychological counseling and rehabilitation.

In this way, with EFG testing as the leader, there is a way to make money: do EFG testing first, and the testing fee is only the beginning; After that, the physiotherapy, massage and acupuncture and traditional Chinese medicine formulated by the doctor based on the test report are the main ones.

After Xiaoqin's EFG test, the doctor diagnosed her with a "mental disorder" that required Chinese medicine and physical therapy. The drugs include 6 boxes of brain tonifying pills and 5 boxes of stone rolling sputum tablets, totaling 1,250 yuan; In addition, two courses of traditional Chinese medicine were arranged, each of which cost 2,000 yuan; In addition, I will do several physical therapy sessions with a course of more than ten days, and a course of treatment is more than 10,000 yuan. It is estimated that after this set of treatments is completed, Xiaoqin will pay nearly 50,000 yuan.

At the same time as Xiaoqin's face-to-face consultation, Xiao Dong, who was waiting outside the door, also held a similar report, but his report was called "Brain Cell Damage Assessment Test Report". He said it cost 800 yuan to do it with the same equipment at another hospital. Although the names of the tests in the two hospitals are different, the test items and even the reference values are exactly the same.

Xiao Dong took out his report and said to the doctor: "I have already done this test (EFG), and I am here to prescribe medicine." He is 29 years old, working in a restaurant in Beijing, and has spent tens of thousands of yuan, but the disease is still not improving, "too difficult to treat".

EFG science

The starting point of the above diagnosis and treatment process is the EFG test report, and all subsequent treatment plans are formulated according to it, which seems to be scientific. But what about the facts?

EFG stands for E

cephalofluctuog

aph。 Many hospitals' official websites or online advertisements have broken this word as "E."

cephal.of.luctuog

aph", in fact, I don't know what to do, there is no "luctuog" in English at all

aph". From the root point of view, the word may be "E."

cephalo-fluctuo-g

aph”，“e

cephalo means "brain", "fluctuo" means "fluctuation", "g

APH is the "image".

This instrument, which has only an abbreviation, has been a commercial success. K-LINK, the company that sells EFG equipment, claims to have sold more than 600 units in two years.

The invention patent certificate provided by K-Link to the Caixin reporter indicates that the invention is a "EEG fluctuation signal analysis device" and the patentee is "Guangzhou Kefu Medical Technology Co., Ltd." There is also relevant literature in the promotional materials to introduce the experiments of the brain fluctuation graph. The manufacturer of the brain fluctuation graph used in the experiment is "Beijing Shupusheng Company". Guangzhou Kefu Medical Technology Co., Ltd. and Beijing Shupson Company have a common legal representative - Xu Jianlan, who is also one of the inventors of the patent.

The paper used in the promotion book mentions, "Xu Jianlan, graduated from Capital Medical University in 1998, master's student, engineer, mainly engaged in neuroscience research".

Xu Jianlan's family did not accept Caixin's reporter's request for an interview with Xu Jianlan, citing health reasons.

It's expensive, but it's still a boon to patients if the results are miraculous. The question is: Is EFG scientific? Does it work?

The Caixin reporter sent EFG-related information to an electroencephalogram expert in China, who said that in terms of measurement principle, EFG is very similar to the EEG equipment commonly used in neuropsychiatry. Its ability to explore the relationship between EEG fluctuations and neurotransmitters is valuable in itself. However, it is not yet marginally available for the detection of neurotransmitters and clinical use.

In the presentation provided by K-LINK, we see a scientific paper by Xu Jianlan, the inventor of the patent, titled "Correlation between Dopamine Levels in the Brain and 11mHz Ultra-Slow Wave Spectrum Power of EEG", which was published in 2009 in Chinese Tissue Engineering Research and Clinical Rehabilitation. The paper explores the relationship between what EFG claims about brain fluctuations and dopamine, one of the neurotransmitters. The conclusion of the paper is that there is a certain relationship between the two, which needs to be further explored. As for the other neurotransmitters mentioned in the EFG test results, there is no literature to support them.

Beijing Anding Hospital represents the first-class level of psychiatry and treatment in China, and Xi Yingjun, the attending physician of the psychiatry department of the hospital, clearly told reporters that Beijing Anding Hospital has never used EFG detectors and has never considered putting it into use in the future.

He found that in the past two years, many patients have been transferred to Deshengmen Hospital of Traditional Chinese Medicine for neurotransmitter testing and a bunch of medicines, "spending a lot of money, but there is no cure." ”

Regarding the EFG test results, Nishi Youngjun said clearly: "I don't look at it at all. In his opinion, "it is irresponsible to promote an examination that has not been confirmed by scientific practice and has not been clearly stated in domestic and foreign textbooks to be extended to clinical practice." It can mislead the patient and make wrong judgments. ”

The attending physician at Beijing Anding Hospital, who treated Xiaolei, also said that he never looked at the EFG test provided by the patient. "The EFG report is meaningless and has no reference value."

The doctor explained to the Caixin reporter that EFG claims to judge mental illness by detecting neurotransmitters, but in fact, cranial neurotransmitters are all interacting and very esoteric and complex, "It is definitely not that EFG can be detected in 10 minutes of extracerebral transmission." "The data is measured by an extracerebral receiver and connected to the scalp with a wire," which is not possible at the moment. ”

Moreover, even if the real data is measured, "it is impossible to express the relationship between depression and clinical practice, and it has no clinical significance." He said.

In response to EFG's miraculous publicity, the doctor said sarcastically: "Even schizophrenia they dare to do it, they are very capable." ”

He felt helpless about the development of Xiao Lei's condition. He told Caixin that the timing of medical appointments is very important for mentally ill patients. Early and timely drug treatment has a certain repair effect on damaged nerve cells, but like Xiao Lei, a delay of one year, missing the best treatment period, or repeated episodes of the disease may lead to irreversible damage to brain nerve cells.

Wang Tao (pseudonym), chief physician of the Wuhan Mental Health Center, once wrote an online article questioning the efficacy of EFG. He pointed out that "all the regular psychiatric hospitals in China do not use cranial neurotransmitter detectors"; In the article, he wrote: "I would like to sincerely warn the patients and their families that before the cause of mental illness is fully understood, any big talk and falsehood that the treatment of mental illness can be effective in a few days, completely cut off from the roots, and have no side effects are all deceptive. ”

During the interview, Wang Tao made a detailed analysis of EFG's main doubts to the Caixin reporter:

First of all, the accurate detection of neurotransmitters must be extracted from the cerebrospinal fluid to have analytical significance, and it is difficult to measure the real data by physical methods.

Second, the neurotransmitter alteration of mental illness is only a scientific hypothesis. That is, the inevitable relationship between neurotransmitters and the treatment of psychiatric disorders cannot be determined;

Thirdly, even if a direct correspondence between neurotransmitters and psychiatric disorders is found, it is meaningless to determine the neurotransmitters at a point in time and in a brain region because the content of neurotransmitters in different brain regions may be different, and this content will continue to change with brain function.

"The non-invasive determination of neurotransmitter content in the human brain remains a huge challenge for the scientific community." Finally, Dr. Wang stressed that the biological indicators of mental illness are not reliable, and at present, it is more dependent on the experience of doctors, "We also hope to have a non-invasive detection method, but it is still a good idea." ”

So, what's going on with those colorful curves and a bunch of complex data on the measurement report? Caixin reporters interviewed a number of brain science researchers, and they didn't understand it, speculating: "It may be automatically generated by the database; It may also be based on a simple linear correspondence. ”

"Tall" coat

Almost all hospitals that use EFG will use the version of EFG's official website to match their own characteristics when they advertise on the hospital's website, but they all start with "certified by the US FDA and other authoritative organizations".

Dr. Wang Tao attended the annual psychiatric meeting in the United States last year, "There are so many international experts together, and the international community has never heard of this kind of cranial neurotransmitter detector." ”

Dr. Xi Yingjun of Beijing Anding Hospital also confirmed to Caixin reporters that "there is no such thing as EFG in authoritative journals and classic and recognized textbooks at home and abroad." ”

Bao Aimin, a professor of neurobiology and doctoral supervisor at Zhejiang University, said sarcastically: "This sounds like the machine we have been waiting for!" I didn't expect it to be born so soon! The Nobel Prize Committee in Stockholm, Sweden should be excited about this! ”

"However," Bao Aimin said, "according to my knowledge, there is no serious SCI journal that has published a single scientific paper on this instrument." ”

Professor Bao Aimin has been engaged in the neuroendocrinological pathogenesis of neurological diseases, psychiatric diseases, and signs and symptoms of endocrine diseases, with a focus on depression, Parkinson's disease, schizophrenia, and gender differences in the human brain in the symptoms of these diseases.

Talking about the diagnosis of mental illness, Bao Aimin said: "At present, the diagnosis of mental illness is basically based on the patient's chief complaint plus symptoms and signs, and compares the standards of the Diagnostic and Statistical Manual of Mental Disorders (DSM), which is flawed by the lack of objective indicators and the dilemma of disagreement among physicians. As a result, scientists are working to overcome this problem, "We are looking forward to figuring out the pattern of neurotransmitter changes, but it will be a long-term, difficult process." ”

Some experts in Taiwan, the United States and other places also expressed doubts about the EFG detector.

Professor Lu Rubin, a leading psychiatrist in Taiwan and with decades of psychiatric research and clinical experience, told Caixin that neuroprotection and nerve regeneration have indeed been very hot topics in the past decade, "but research on nerve regeneration has encountered some bottlenecks in recent years." Because nerve regeneration in the brain is limited to local areas, and if the regenerated nerve cells cannot grow in the original position, they sometimes inhibit each other with the original nerve cells. ”

Regarding the six central neurotransmitters mentioned in EFG's propaganda, Lu Rubin said: "The six major neuronal systems currently known may only account for 5%-10% of the entire brain's neurotransmitters, and there are too many things that are still unknown." ”

Lu Rubin made it clear: "In the world, we have not heard of an EFG tool that can detect the six major neurotransmitters of GABA, Glu, Ach, NE, 5-HT and DA at the same time, and can treat these substances. ”

Ph.D. from Harvard University and Bill Tsa, a Registered Counselor in Massachusetts

He has more than 20 years of clinical experience in the treatment of depression in Hong Kong and the United States. When it comes to EFG testing, Bill says, "I've never heard of it." Regarding the question asked by the doctor when the Caixin reporter visited a hospital, Bill commented: "Very unprofessional. Clinical psychologists or psychiatrists don't ask such questions. ”

The Caixin reporter noticed that there are several "foreign experts" in the "Authorized Doctors" column on EFG's official website. One is "Bee."

s", as a "WHO Hospital Specialist"; One is the "Make.Li", who serves as the "chief expert of the World Psychiatric Society". After verification, the two institutions did not have experts with these two names at all.

According to Caixin reporters, the U.S. Food and Drug Administration and the World Psychiatric Association have never certified or recommended EFG detectors.

Who uses EFG?

On the official website of EFG cranial neurotransmitter detector, the reporter saw 10 authorized hospitals. According to incomplete statistics from Caixin reporters, in Beijing alone, at least 8 hospitals are using EFG testing.

In addition, in the promotional materials provided by EFG manufacturer K-LINK, Caixin reporters found a list of users from 40 hospitals, which was printed with the words "trade secrets, properly kept". There are many tertiary hospitals in the user list.

In addition to the 10 hospitals authorized by EFG's official website and the 40 hospitals on K-LINK's customer list, Caixin reporters searched Google with "EFG", "cranial neurotransmitter detector" and "brain fluctuation grapher" as keywords, and found that at least 20 hospitals were promoting the use of cranial neurotransmitter detectors.

Who are the regulators?

In the official website of EFG, it is stated that EFG "has successfully applied for invention patents in PCT International, China, the United States, Japan, and the European Union".

According to the invention patent certificate provided by the sales representative of Shenzhen K-Link, the Caixin reporter did find the patent "EEG fluctuation analysis device" in the patent search and query system of the State Intellectual Property Office, and the inventors were Zhou Weiping, Xu Jianlan and Liu Enhong. This EEG fluctuation analysis device has also obtained the invention patent certificate in the United States, and the name is "Method.a."

d.appa

atus.fo

.b

ai

.wave.fluctuatio

s.a

alysis”。 The patent exists by verifying through the U.S. Patent Inventions Network.

Does a patent represent a profession? A former staff member of the State Patent Office told reporters: "Chinese people always think that the word 'patent' has a halo, but in fact, it is easy to apply for a patent, and a patent does not mean reliable or professional." ”

A Caixin reporter called the State Intellectual Property Office and received a response that as long as the invention patent meets the three characteristics of inventiveness, novelty and practicability, and meets the laws and regulations required for approval, an invention patent certificate will be issued. As for the social industrialization part, the effect and quality of the products are not under their control, "under the control of other departments such as the General Administration of Quality Supervision, Inspection and Quarantine." ”

In the promotion of EFG's official website and various hospitals, it is also mentioned that EFG's technology "has passed the strict authoritative certification of the US Food and Drug Administration, the China Food and Drug Administration SFDA and the European CE". After investigation, the US FDA and the European CE have not certified it. Similarly, Caixin reporters searched for "EFG" or "cranial neurotransmitters" as keywords in the medical device data query of the State Food and Drug Administration, but there were no query results.

The Caixin reporter used "brain fluctuation" as the keyword and searched for two pieces of information on the "brain fluctuation chart". The registration numbers are "National Food and Drug Administration (Quasi) 2012 No. 3211043", and the production unit is Shenzhen Kangli High Technology Co., Ltd.; and "National Food and Drug Administration (Quasi) 2014 No. 3210879", the production unit is Beijing Laotongren Optoelectronic Technology Center.

On the official website of the Food and Drug Administration, the scope of application of the two registered products is almost the same: "For the research and discussion of the pathogenesis of depression, the auxiliary evaluation of the efficacy of depression, and only for adults." There is no mention of "neurotransmitter testing" or "can be used to detect brain neurotransmitters" in the description.

Caixin reporters repeatedly called and wrote to the Food and Drug Administration, wanting to approve the original registration materials and approval scope of the "brain fluctuation chart", as well as whether it can be used for "brain neurotransmitter detection". Before press time, I finally waited for a reply from the Food and Drug Administration.

Regarding the "testing items and basis" of the brain fluctuation grapher of Shenzhen Kangli High Technology Co., Ltd., the Food and Drug Administration replied that "there is currently no corresponding national standard and industry standard for this product".

The FDA's response also said that the main role of the product is to "provide indicators of neurotransmitter function in the brain by analyzing the ultra-slow signals of EEG signals...... to provide supporting information for the diagnosis and evaluation of efficacy of the corresponding disease".

Regarding the "clinical effect", the reply of the Food and Drug Administration mentioned that "the product is only for patients with depression to carry out clinical trials", and the scope of application is standardized as "research and discussion on the pathogenesis of depression, auxiliary evaluation of the efficacy of depression, and only for adults".

An industry insider told Caixin that even if clinical trials can be done according to the reply, there are still two important questions involved: Is EFG beyond the scope of use? Is the clinical data falsified?

"The Food and Drug Administration should be asked to disclose the clinical trial unit, person in charge, and data." The insider suggested.

Behind the grafting

A search for formal information about EFG reveals a description of the scope of its use, all of which include the word "auxiliary". This means that the EFG test report alone cannot be relied upon for diagnosis, let alone a treatment plan. In fact, there is a complete process for diagnosing mental illness.

The Caixin reporter also noted that all the patented materials called it a "brain fluctuation chart"; In the actual sales process, manufacturers are willing to describe it as a "brain fluctuation graph (brain neurotransmitter detector)"; When it was finally used in a primary hospital, the hospital directly claimed to the patient that it was a "neurotransmitter detector".

This series of grafts is accompanied by a gradual exaggeration of the scope of application and efficacy. An exploratory invention has evolved into an artifact that effectively cures many mental illnesses, and the cost of detection is naturally much higher than that of a simple electroencephalogram; What's more, it caters to patients' eagerness for a cure, which willingly falls into the expensive trap behind the medical "myths."

When you search for "Beijing depression" on Baidu, the first few search results are all hospitals that use EFG.

The patients contacted by Caixin reporters who came to a hospital for treatment, without exception, were first searched on Baidu and then directed here.

Xiao Lei's patient Xiao Wei is 19 years old and the only daughter in the family. After the symptoms of bipolar disorder appeared, he was also treated in a hospital, costing hundreds of thousands of yuan. In the end, his condition deteriorated, his emotions were completely out of control, he became manic, and he beat his parents at home. Xiaowei's mother choked up with Caixin reporters and said that she didn't want to recall her daughter's experience of being treated in a hospital, "It was too painful." ”

Advertisements for neurotransmitter detectors are still popping up on the go. A Caixin reporter once stumbled upon a sign of "a certain hospital" at the intersection of Beijing's Beitucheng roundabout, which is still a few kilometers away from a hospital, guiding a large number of patients with mental illness to receive EFG treatment every day.

The small online advertisements of "cranial neurotransmitter detector" are even more pervasive, and can be easily found in the advertising positions or pop-ups of many web pages. Words such as "the condition has improved significantly in 3 to 7 days", "symptoms such as headache, insomnia, depression, and psychological disorders have basically returned to normal within a month", and "the cure rate has reached 98%" have brought hope to those patients and their families who are in deep pain.

What awaits them is greater disappointment, even despair.

(This article was originally published in Caixin's New Century Weekly, Issue 37, 2014; Written by Zhang Jin and Zhao Han)