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Lihui Di, Science News (Chinese) Vol.22, Nov 23, 2009

Editor: We report a controversial surgery in “Who judges Chuanguo Xiao” on Vol. 20, Oct 28. Since the news, reporters got more information about this surgery.

Jian Peng, a pro bono lawyer, engages in evidence collection. On Oct 16, two mothers of children with spina bifida accused Henan Shenyuan Urological Hospital. The court trial will be started on Dec 28. Jian Peng revealed that around twenty more patients (their parents) would bring lawsuit in the end of this year.

Restart of investigation

“I realize that, the only effective way for this case is that plenty of patients bring accusation together, especially those who took the surgery in the same period.” Jian Peng told Science News that he started to collect information about patients on 2006. At the same year, Zhouzi Fang (a famous freelance in China) seriously questioned academic level of Chuanguo Xiao, who develops an artificial reflex pathway. Fang subsequently lost the lawsuit which Xiao filed.

In the summer of 2007, as the number of patients on the list increased to dozens, Jian had interns make telephone interview. “We got through to more than 40 patients. And we found that outcomes of those cases were not good at all. Almost all patients don’t have any improvements. Some were even worse, suffering from mobility impairment after surgery.” Lin Liu, one of whom conducted interviews told Science News.

But investigation stagnated since then. The major problem is lack of finance. Although a few of pro bono organizations expressed intention to provide financial help, nothing came into being. Meanwhile, patients visited Jian Peng lawyer office frequently to ask for legal aid.

Not until September 2009, was the investigation restarted as finance allows. From more than 150 patients who left contacts in patient-to-patient communication, they got through to 80 persons on phone, and 15 persons in person. Jian Peng said: “the number is increasing. We usually get calls twice every day, sometimes as many as 4 calls to provide more proof.

The interview shows that none of patients who taken the ‘Xiao procedure’ surgery makes complete recovery so far. The percentage of patients with the clear improvement is extremely low, in a marked contrast with “85% of cure rate” as the hospital claims.

More contradictions

Jian Peng also found another tricky contradiction.

Neurourology Surgery Research Center in Zhengzhou University provided a certification on Feb 28, 2007 for Xiao’s application for fellowship of China Academy Society. It claims that the center provided the revolutionary surgery to construct an artificial somatic-central nervous system-autonomic reflex pathway, which Chuanguo Xiao developed, for 117 patients with neurogenic bladder dysfunction caused by spina bifida or meningomyelocele. The more than 8-month post operative visit on 60 patients shows that 85% patients restore bladder/bowel continence.

But Jian Peng found that it was reported by Dahebao on Aug 14 of 2006: “Yesterday, little Shanshan received surgery at Zhenzhou Shenyuan Urological Hospital…the surgery on little Shanshan is the first case in Henan province…Ziming Dong as dean of the basic medicine school of Zhengzhou University said: the surgery on Shanshan is the first case of ‘artificial reflex arc’ in Henan province. And Zhenzhou Shenyuan hospital also makes national record – it is the first multiple-specialty neurourological hospital in China, which is also a product of the combination of science research and clinics in Zhenzhou University.”

In other words, the first case which the center offers the new treatment was as late as Aug 13, 2006. It was only 6 and half months prior to the center providing certification of the cure rate, which contradicts the statements that “we made 8-month post operative visits on 60 patients”.

Jian Peng and his colleagues contacted more than 100 patients underwent ‘Xiao procedure’ in Zhenzhou Shenyuan Urological Hospital between August 2006 and the first half of 2007. No case shows the full recovery of bladder and bowel function. Instead, condition of many patients deteriorated after the surgery.  Given the time of surgeries, those cases should make up a large part of 117 cases which the certification from the research center asserted. So it raises the question of the statement that 85% patients get full recovery of bladder and bowel function.

“Let patients speak out. It is most objective”

As the investigation concludes the cure rate being close to 0%, the result is too astonished – is it related to non-medical professional conducting inquiry? For instance, inaccuracy introduced by Jian Peng during the investigation.

“The folk statistics methodology and results need be reviewed before formal publication. But data may figure out something”  Prof Limin Liao of Beijing Boai hospital comments “so far, only words from patients can address the issue. To restore the justice, patients should stand out. If surgery gets success, the patient is the biggest beneficiary. If surgery gets failed, he/she is the biggest victim. Let patients speak out. It is most objective”

It is the most direct and probably the only feasible way for Jian Peng to obtain evidence by using financial resource and man power to interview patients one by one. “Holding a peer review, is theoretically possible but not in the reality. There are assessments on this surgery, and its related scientific achievements, which made by ‘authorities’ in the field. If we invite experts to make a different assessment, isn’t it too difficult? And in any case, I find that the experts in the same field intentionally skirt around” Jian Peng said.

Jian Peng’s points were confirmed by the peer. “All experts are not willing to be involved in even although we do not want to see the current situation of patients” a famous urology expert told Science News, “It is not true that we don’t want to do something at all. But what we say cannot bring any effect. He could say that we do not know anything. Peers or anybody, from his eyes, could be nothing else.”

Peer review

Nevertheless, some experts dare speak out

“I use two sentences to comment: first, this surgery is absolutely not as effective as what he said, to solve the problem of neurogenic bladder dysfunction. Second, it may be effective for a part of patients. There may be indications. Some patients should take the surgery. But not all of them”. Professor Bo Song from the Third Military Medical University at Chongqing said.

Bo Song also said that he opposed to excessive boast or propaganda over such kind of surgery because it should not be commercial activity. “If they claim to solve the problem of neurogenic bladder dysfunction, I totally disagree. If they apply for the prize for the progress of science and technology, I would unlikely endorse it.” But meanwhile he admits that for the present the evidence is not enough to conclude the surgery is of no avail. “And his research is not finished. We do not know what indications are. If they claim that it solves the big problem, it is unfounded”. Bo Song said.

“He borrows techniques in neurology to urology. But we haven’t seen a few patients in clinics. We haven’t watched the actual surgery either. So we were not able to make any comments. The patients were brought only for demo. I haven’t watched their surgeries. He had few publications then. We even know less about assessment international peers gave on him. Almost all information is what he said. I haven’t seen assessment international peers gave on this kind of surgery. He said that we were unable to perform this surgery. But why not they promote using the surgery themselves? It is our doubt” Yinglu Guo, Professor of Peking University First Hospital, fellow of China Engineering Academy, told Science News.

“In the course of science research, we should allow mistakes, trials and all kinds of efforts. But without complete scientific evidence, or enough proof within evidence-based medicine, scientists are not allowed to claim solving a big problem or creating a new thing. That is unscientific statement. I disagree such kind of statement” Bo Song finally summarized.