The ability to pee on your own is something we take for granted. But for a large group of people, this is only a dream for them. They are the patients with spinal cord injuries and those born with spinal bifida. A widely reported surgery procedure, Xiao procedure, named after its inventor Dr. Chuan-Guo Xiao of China, is claimed to offer a cure. But does it really work?
Dr. Xiao invented this procedure while working in the US with a grant from the NIH, but he was not able to run a full clinical trial of his procedure in the US. From 1999 to 2006, after spending $2.4 million of NIH grant (Grant Number: 5R01DK053063-05), he was only able to report on two patients in a preliminary report in 2005. We never heard anything more about that study.
The largely unregulated Chinese health care market gave him a much better opportunity. In 1995 Dr. Xiao found support from the leaders of the Pingdingshan Coal Mine Hospital in Henan province. According to an article in China News Weekly, "'Artificial Reflex Arc', Who can explain it?" (in Chinese),
In 1995, Xiao began the clinical research. His first choice was the Pingdingshan Coal Mine Hospital in Henan province. The reason that he did not first do the trial in the US, was because that "in the US application for grants is very slow, at least one and a half to two years. In addition, the US has much stricter approval process for clinical trials. Even for oral drugs you would need truckloads of paperwork. It's much harder for surgical procedures. Further, I am a foreigner, it would be even more difficult."
"At that time, the head of Pingdingshan Coal Mine Health Bureau was visiting the US. He heard that I was working on this, so invited me to their hospital. I went and visited them. The biggest advantage the hospital offered was that all the patients were miners so we could keep long term follow-up on them."
According to Xiao, the clinical study at Pingdingshan Hospital "did not require approval from the Ministry of Health, only needed approval from the hospital's ethics committee."
Clearly, the motivation for Dr. Xiao to move back to China was the lack of regulation and oversight. Dr. Xiao operated on 15 paralyzed patients there in the two years starting from 1999, and claimed success on 10 patients, a nearly 70% success rate.
Things snowballed from that point on. Dr. Xiao opened a privately run hospital, Shenyuan Hospital, in Henan province with the sole purpose of carrying out this operation. According to some of the doctors, the Xiao procedure have been operated on over ten thousand patients (not all of them at that hospital). Some of them were desperate Americans who traveled to China and paid $30k to $40k for the operation. Dr. Xiao claims over 80% success rate for these operations. The hospital has since been closed but the operations by Dr. Xiao are continued at Tongji Medical School in Wuhan.
Today, two hospitals in the US, the Beaumont Hospitals in Michigan, and the All Children's Hospital in Florida, are conducting clinical trials on children based on the data from China provided by Dr. Xiao. Several other hospitals are also considering starting their own trials. According to Dr. Xiao, the benefit of the surgery will not be seen until about a year after the surgery. Some patients may take even longer.
Recent news reports out of China, however, have cast some serious doubts on the reliability of the clinical data there. Two mothers of the children who had the surgeries at Shenyuan Hospital filed lawsuits against the hospital. According to this Science News report (in Chinese),
With the help from her parents, Little Fang (pseudonym) comes into the room with her crippled legs.
She is one of the patients who have had the surgeries of "Xiao's Artificial Reflex Arc Procedure". Her situation was not improved even got worse after she received this procedure one and a half years ago. Thus now, she came to Beijing and is looking for further treatment.
Little Fang is not the only victim of the Xiao procedure. On October 16, the mothers of other two children with spina bifida filed lawsuits against Henan Shenyuan Urological Surgery Hospital. They complained that the incontinence of their children were not improved three years after the Xiao procedure. Moreover, none of the patients who underwent the same surgery during the same period were cured either, which is much different to the success rate of 85% claimed by the hospital in their propaganda. The worst is that the procedure resulted in serious complications: the two children got atrophy and deformity in the left legs.
The lawyer working for the plaintiffs reported more problems (link in Chinese):
Peng Jian, the lawyer, also found another inexplicable contradiction.
The Neuro-urologic Surgery Research Center at Zhengzhou University issued a certificate to Xiao Chuanguo on Feb. 28, 2007, for his application to academician. The certificate claimed: Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University had applied the "artificial somatic-autonomic reflex arc" technique invented by Professor Xiao Chuanguo to 117 patients with neurogenic bladder caused by spina bifida or meningomyelocele. Sixty cases were followed up for more than eight months. 85% of the patients have recovered normal bladder and bowel functions.
Peng Jian found out, however, that it was reported on Aug. 14 of 2006 by Dahe Newspaper, "Yesterday, Little Shanshan received the operation at Zhengzhou Shenyuan Urological Surgery Hospital ...... the operation for Little Shanshan was the first case in Henan ...... Dong Ziming, from Zhengzhou University and the dean of Fundamental Medical School, said: Shanshan's operation made a Henan record -- the first 'artificial reflex arc' in Henan. And Zhengzhou Shenyuan Hospital made a national record -- this was the first, in our nation, interdisciplinary neuro-urological surgery hospital. It was a creation resulted from the effort to integrate research and clinical practice in Zhengzhou University."
In other words, the center conducted the first "Xiao reflex arc" operation as late as Aug. 13, 2006. It was merely six and a half months away from the time when the center provided the certificate of cure rate for Xiao Chuanguo, which evidently contradicted with its claim that "Sixty cases were followed up for more than eight months".
Peng Jian and others sought out and visited more than a hundred patients who took the "Xiao reflex arc" operation at Zhengzhou Shenyuan Urological Surgery Hospital between Aug. 2006 and the first six months of 2007. They found no case regained the bladder and bowel control. Instead, the conditions of many patients deteriorated after the operation. Judging from the times of their operations, these patients should at least count for a considerable portion of the "117 cases" mentioned in the certificate issued by the center. This calls into serious question the hospital's claim that "85% of the patients have recovered the bladder and bowel control".
One reporter investigating the case traveled to rural counties spanning several provinces to see firsthand the results of the operation on patients. What she found was shocking (link in Chinese).
The boy patient in Meishan county could still walk by himself and even climbed stairs in the hospital before his surgery, in spite of a bit of deformity in his legs. But after having the Xiao procedure in Sep. 2007, his legs with parts of nerves cut off started to fester. Two years later, both of his legs had to be amputated at a local hospital of Meishan.
The parents of this boy cherished great hope before the surgery because the hospital had promised them a success rate of 85%, which means most of the patients could get cured. They trusted the doctors because the doctors were kind and looked very trustful. After the boy was already on the operation bed, the parents were asked to sign a consent form right before the surgery, as if it were just a routine procedure. No explanation was offered, so they signed the form without understanding the risk of serious complications at all.
The second child in Shanxi province could walk as well before the surgery, but is disabled now. After the surgery, the muscles of his feet and legs started to atrophy and now his lower extremities are apparently deformed. One year ago before the surgery, it costed 1000 Chinese Yuan a year to buy diapers for his incontinence. But now, not only his legs are disabled, but also his previous incontinence gets more severe. In 2008, he had a medical examination in Jishuitan hospital in Beijing, and was told by the doctor that it was impossible to restore to the same status as before by performing any further surgery on his legs.
The third kid in Deyang County was thought being lucky by his mother initially after the Xiao procedure. The kid was still very young and the case was not very severe before surgery. She was happy that the disease seemed to be cured a little and at least did not get worse as others after surgeries. But half a year later, the leg which was operated started to atrophy and became thinner.
......
The last one in Shanxi province, his father was a coal miner and is laid-off now. This family is living in the cave of a mountain and has no heating in this cold winter. His father raises 30 pigs and needs to save the heating for the piggy cubs, otherwise they will get sick in the cold. He has finished high school and wanted to make the justice to be done as well. These patients are preparing for suing the hospital who misleads them for the Xiao procedure with misleading and false statements on the surgical risks and effectiveness.
The English translation of all the reports are collected here.
Do we want that kind of health care in the US?