Wednesday, November 25, 2009

The Cure Rate of "Xiao's Procedure": 85% or 0%?

A New Thread netter, "lightman", has translated a report on the Chinese magazine Science News into English. With permission, here is the English version. The original Chinese version can be read here.

The cure rate of "Xiao procedure": 85% or 0%?

Di Li-hui, Science News (Chinese) Vol. 22, Nov. 23, 2009

Scinece News Editor: In Volume 20, Oct. 28, this magazine reported the "Xiao reflex arc", the controversial surgical procedure, in article "Who will evaluate Xiao Chuan-guo?". After the article was published, our reporters have learned more information about this procedure.

Peng Jian, a pro bono lawyer, continues his busy work of collecting and collating evidence from different sources. Previously on Oct. 16, the mothers of the two children with spina bifida filed lawsuits against Henan Shen Yuan Urologic Surgery Hospital. At present, the court has set the date for hearing on Oct. 28. Peng Jian revealed that, before the end of the year, it was expected that about twenty more patients (or their kins) would bring their cases to the court.

Investigation restarted

"I realized, for this case, the only effective way was for many patients to come forwards together, especially those who took the operation during the same period." Peng Jian told Science News that he started the effort to collect the names of the patients since 2006 - in this year, Fang Zhou-zi lost a case that was brought forward by Xiao Chuan-guo, for his harsh questioning on the validity of the theory of "Xiao reflex arc", as well as the academic credentials of Xiao, its inventor.

In the summer of 2007, when the names on his list had totaled a few dozens, Peng Jian arranged interns to start interviewing the patients over the phone. "At that time, we successfully got through to more than forty people, and learned that the outcomes of their operations were very bad. In most cases there was virtually no improvement. Some (operations) even led to disability." Liu Lin, who took part in the phone interviews, told Science News.

Further investigation, however, was hindered by difficulties. The main one was the lack of financial support. Although several non-profit organizations expressed the intention to provide supports, none materialized in the end. Yet in the meantime, patients continuously visited the law firm where Peng Jian works, hoping to "accelerate the process of legal aid".

In September 2009, when financial resources became less of a constraint, the investigation was started again. This time, among the 150 plus contacts obtained through the exchanges between the patients, more than eighty successful phone interviews were made, and fifteen were interviewed in person. Peng Jian said, "Now the 'number' is still increasing; we receive at least two, even as many as three or four calls each day, that provide supporting evidence for the case."

Among the patients who have received the "Xiao procedure" and have been contacted so far, the survey finds no example of complete success. The percentage of patients with evident improvements is also low - This is in sheer contrast with the "85% cure rate" advertised by the hospital.

More contradictions

Peng Jian, the lawyer, also found another inexplicable contradiction.

The Neuro-urologic Surgery Research Center at Zhengzhou University issued a certificate to Xiao Chuan-guo on Feb. 28th, 2007, for his application to academian. The certificate claimed: Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University had applied the "artificial somato-autonomic reflex arc" technique invented by Professor Xiao Chuan-guo 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 obtained bowel movement and urination completely continent.

Peng Jian found out, however, that it was reported on Aug. 14 of 2006 by Da He Bao:"Yesterday, little Shan-shan received the operation at Zhengzhou Shen Yuan Urological Surgery Hospital ...... the operation for little Shan-shan was the first case in Henan ...... Dong Zi-ming, from Zhengzhou University and the dean of Fundamental Medical College, said: Shan-shan's operation made a Henan record - the first 'Artificial reflex arc' in Henan. And Zhengzhou Shen Yuan 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 practices in Zhengzhou University."

In other words, the center conducted the first "Xiao reflex arc" operation as late as Aug. 13th of 2006. It was merely six and a half months away from the time when the center provided the certificate of cure rate for Xiao Chuan-guo, 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 Shen Yuan Urological Surgery Hospital between Aug. 2006 and the first six months of 2007. They found no case of bowel movement and urination completely continent. 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 obtained bowel movement and urination completely continent".

"Let the patients speak out - it is the most objective way"

It is perhaps too shocking to believe the conclusion of the investigation that the cure rate is close to 0% - Is it related to the bias caused by the questions designed by people who are not medical professionals, such as Peng Jian?

"The statistical results obtained through amateur methods, although reviewing is needed prior to official publication, have already shed light on some issues." Professor Liao Li-min at Beijing Bo Ai Hospital commented in this way, "At present, only when the patients speak out can we expose the problems. Justice can be served only through the patients. If the operation succeeds, the patients are the biggest beneficiary; if it fails, the patients are the hardest-hit victims. Let the patients speak out - it is the most objective way."

To Peng Jian, spending money and man-power to interview the patients one by one is the most direct and, perhaps, the only viable way to collect evidence. "Peer review, is possible in theory, but impossible in reality. The current evaluation of the procedure was all made by the 'authorities', including the evaluation of some scientific achievements. Isn't it very difficult to find other experts to draw a different conclusion? Moreover, I find that, the experts in the field are trying to stay away," Peng Jian said.

What Peng Jian said was acknowledged by experts in the field. "We experts don't want to get involved, although we do not like to see what the patients have turned out to be." A well-known expert in urological surgery told Science News, "It is not that we are not willing to (speak out), but that what we say probably won't have any effects. He can say we know nothing. So-called experts and colleagues, or anybody, in his eyes, can be dismissed as worthless."

Comments from peers

Nevertheless, there are experts who, in the end, are brave enough to speak out.

"I use two sentences to describe (my opinion): first, this procedure is absolutely not like what he described, that it has solved the problem of neurogenic bladder; second, the procedure may be effective for some patients, because there are some pertinent indications. Some patients can be treated with this (procedure), but absolutely not all." Professor Song Bo at the Chong Qing the Third Military Medical University held this opinion.

Song Bo indicated that he did not agree to blindly gloss over or promote this type of procedures, because, after all, it was not a business activity. "I am all against the statement that it has solved the problem of neurogenic bladder; I did not really agree with its application for the National Prize for Progress in Science and Technology either." In the meantime, he believes there has not enough evidence so far to assert that the procedure is completely useless. "But his research is not finished yet. What are the indications for the procedure, ultimately, is not even clear. It is unfounded at this stage to say things like a grand problem has been solved." Song Bo said.

"He applied the (neuro-surgical) techniques to urological surgeries. We could see very few clinical patients, and we did not observe his operations either. We simply were not able to make any comments. They brought the patients in. I did not watch the operation. He had no publication at that time. We knew even less about the international evaluation on his procedure. Everything was based on his own words. We could not see any comments from other countries. He said we would not be able to conduct the operation, but why they themselves were not able to popularize it either? We are also wondering." Guo Ying-lu, a professor at the Beijing Medical University and an academian of China Engineering Academy, told Science News.

"When doing science, we should allow mistakes, exploration, and all kinds of efforts. But we should not allow claims such as what has been solved and what has been created, when there is no complete scientific evidence, nor a large amount of evidence-based medical data. They are not scientific statements. I oppose these statements." Song Bo summed up.

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