A widely used and expensive mental illness treatment that many patients have turned to for help is in the spotlight due to suggestions it offers little help.
A college student name Xiaolei and his father travelled more than 500 kilometers from the northern region of Inner Mongolia to Beijing in late 2012 to seek treatment for Xiaolei, who was diagnosed with a mental disorder characterized by depression and mania.
Xiaolei saw an online advertisement for Beijing Deshengmen Hospital, a small public facility specializing in traditional Chinese medicine, which is using a new treatment involving a system called an encephalofluctuograph (EFG). It is a computer whose makers say can scan the release of chemicals in the brain using wires attached to the head.
The hospital said in its ads that the computer and traditional Chinese medical treatments would produce amazing results, the father said.
The ads also said that the EFG is certified by drug regulators in China and the United States; holds patents in the United States, Japan, and the European Union; and is designated by the World Psychiatric Association (WPA) as a testing and treatment instrument for mental illness. It causes little pain, the ad said, but had a high rate of cures. There would be no relapses, the ads vowed.
However, after spending 200,000 yuan (US $32,680) from January to July 2013 at Deshengmen Hospital, Xiaolei's disease got worse. Sometimes he was violent.
In July 2013, after trying to kill himself and hurting his mother, Xiaolei was sent to Beijing Anding Hospital, a well-respected facility that specializes in mental disorders. A doctor examined Xiaolei and told his father that he heard about the EFG treatment, but his hospital never used it because its effectiveness has not been proven by experts. A growing number of patients had come to him after receiving the EFG treatment, the doctor said.
In an interview with Caixin, the doctor, who has over 20 years of experience treating mental illnesses, said that about 30 percent of the patients he received recently have received EFG treatments in other hospitals.
"It is not only a waste of money but also a delay of treatment," the doctor said.
The EFG 'Miracle'
A website called efgedu.net describes the EFG as advanced technology for curing depression, insomnia, and other mental illness that was developed by 192 experts from nine prominent medical institutions, including the WPA, the Asian Sleep Research Society, and the International Committee for the Prevention and Treatment of Depression. The site says the computer offers the most effective treatment for a variety of mental illnesses by accurately detecting neurotransmitter secretion. No clear information about who owns the company making the EFG is included on the website.
Neurotransmitters are chemicals released by the brain that send signals across a synapse from one brain cell to another. They communicate information throughout the brain and body.
A medical expert said that neurotransmitters affect human emotions and feelings, and an imbalance of neurotransmitter secretion may cause depression, insomnia, and other mental disorders.
Modern medical research has proven the link between mental disorders and neurotransmitter imbalances, but has not established the role played by individual neurotransmitters in mental illnesses due to the huge diversity and complicated functions of the chemicals.
Despite this, many hospitals in China have started to advertise the EFG treatment based on the theory, fanning patients' expectations that their disorders can be cured.
A Cash Cow
A 21-year-old university student named Xiaoqin had an experience similar to Xiaolei's at Beijing Deshengmen Hospital. In 2012, Xiaoqin started to show symptoms of auditory hallucinations, insomnia, and mania. She was treated in her hometown in the northern province of Shanxi, but did not improve. Her parents then saw ads for the EFG system online and took her to Deshengmen Hospital in the capital.
Xiaoqin's father said she underwent a test costing 680 yuan (US $111) and the result showed that her brain "failed to suppress excitement." A doctor suggested Xiaoqin undergo a treatment plan costing more than 50,000 yuan (US $8,170).
An EFG equipment sales agent told Caixin that the EFG computer is usually sold as a set with a "transcranial magnetic therapy device" for about 1.6 million yuan (US $261,459).
"Since it arrived on the market two years ago, we have sold more than 600 sets," the agent said.
A client list provided by the agent and information found online shows that at least 70 hospitals across the country have bought or been offering EFG testing, including eight in Beijing.
"Its profitability is very high," the agent said of the system. "Many hospital heads told us that we offered a great product that meets clinical demand while boosting the hospital's profits."
Behind the EFG
Shenzhen Cornley Hi-Tech Co., the EFG seller that the agent Caixin spoke to works for, said the patent for the EFG belongs to Guangzhou Kefu Medical Technology Co. The manufacturer is Beijing Shupusheng Industry and Trade Co. Both companies' legal person is registered as Xu Jianlan, who is also one of the developers of the patent.
Documents provided by Cornley show that Xu graduated in 1998 with a master's degree from Beijing Capital Medical University, where he specialized in neuroscience. Caixin tried to contact Xu but could not reach him.
Xi Yingjun, a psychiatrist at Beijing Anding Hospital, said that he has seen an increasing number of patients who underwent EFG treatment.
"They spent lots of money but saw little effect," Xi said. "The [EFG] testing hasn't been proven by either scientific practice or theory. It is irresponsible to promote it in clinical treatment because it may mislead patients."
The promotional material for the EFG says the equipment can test the levels of six kinds of neurotransmitters, but Lu Rubin, a psychiatric expert from Taiwan, said there is no evidence that six kinds of neurotransmitters can be monitored at the same time. He adds that the six chemicals listed on the EFG material account for less than 10 percent of neurotransmitters that brain releases.
"There are so many things that remain unknown," Lu said.
Regulatory Loophole
The EFG website also says the equipment and treatment have been authorized by the U.S. FDA and the WPA, but no such records of the system can be found in those organizations' databases.
Documents provided by Cornley said the EFG involves a patent developed by Xu Jianlan, Liu Enhong, and Zhou Weiping. The patent involves methods and apparatuses for analyzing brain waves, and the registration records for the patent can be found in both China and the United States.
But an official at the State Intellectual Property Office said that having a patent does not necessarily mean a device is reliable and professional. The office said in an email that a patent can be granted to inventions that are "innovative, creative, and practical," but that the effectiveness and quality of a product are subject to the supervision of the quality watchdog and other government agencies.
In registration records with the China Food and Drug Administration, EFG instruments are described as equipment used for research on the causes of depression and to assist in therapy for depression. There is no mention of neurotransmitters.
The drug administration said in an email that the EFG instruments are used for clinical experiments for depression treatments, and there is no national or industry standard for this kind of product.
Meanwhile, Xiaolei's doctor at Anding Hospital said that early treatment is very important to the recovery of mental illness patients. He said that since Xiaolei spent a year receiving EFG treatment, that window is closed for her.