Experts’ Opinions on Xiao Procedure

By xysergroup | 8月 18, 2010

The Xiao Procedure has been questioned by top experts in China. Below are the experts’ opinions excerpted and translated from Chinese media reports.

Who will evaluate Xiao Chuanguo?
Science News. Oct 28, 2009

Gong Ju, who is engaged in basic neurology research, said frankly on the other hand that the basic research done by Xiao Chuanguo at the very beginning was not convincing enough, for example the tissue slice performed by using an electronic microscope; moreover, Xiao had drawn a scheme of reflex, but the middle part is not correct in neuroanatomy. “The reason is, the nerve reflections stimulated by scratching skin cannot reach motoneurons directly to form a reflex arc, as he had drawn. Such kind of reflex arc reaches muscle directly, which is only possible to reach the anterior horn of the spinal cord through an interneuron instead of to reach by skin-sense. He missed a connection, but he just drew in his way; he never concerned other’s arguments, but insisted that it is very correct”, said Gong Ju, “I don’t like such kind of things.”

Professor Jin Xiyu of the Third Military Medical University in Chong Qing was a specialist in urological surgery….During the evaluation, Xiao Chuanguo specially brought several patients to the panel to show the effects of the procedure. A non-specialist would see that the patients started to urinate normally after their lower abdomens being slightly pressed. But Jin Xiyu, being an expert in urodynamics, suggested that it could imply that the urination was caused mainly by the pressure (applied to abdomens), rather than the recovery of neurological functions.

“Artificial Reflex Arc”, Who can explain it?
China News Weekly. Nov 11, 2009

In the evaluation report, the reporter noticed it also mentioned, “The spinal continuity of this type of children patients is not broken. A functioning healthy somatic motor nerve bundle must be sacrificed in order to construct an artificial reflex arc to control the bladder, which carries very high risks.”

About this potential risk, Xiao provided an explanation, “There were indeed 4 or 5 children having some problems among the initial 20 cases. This is like ‘robbing Peter to pay Paul’. There is very little side effect to lower limbs, which may have a little weakness. But now we have solved it. Only a third of the nerve bundle, at most a half, is used, and it will fully recover after a year. So this is not a problem any more.”

If the Xiao procedure has 85% success rate, why cannot it be popularized in any major hospitals?

To find out the answer, we interviewed several experts in urological surgery. “We also have this concern!”, said Guo Yinglu, the honorary director of the Institute of Urological Surgery at Peking University and the only Academician in urological surgery in Chinese Academy of Engineering. Guo said, “It makes some sense in the theory of the Xiao procedure. But not for all the patients can it achieve nerve reconnection”. He then took the case of SCI patients as an example. “The injury of spinal cord happens at different levels. Only for those at lower levels, their bladder nerve may be reconnected, and you can only do this when you are able to find the nerve”. Guo continued to say, “So, it means that even if he (Xiao) is correct, the effectiveness (of the procedure) is limited”. Guo said that he was not aware of the situation of implementing the Xiao procedure to spina bifida, and he did not have much contact with Xiao in person.

Most of the urosurgical experts interviewed were not willing to talk much about Xiao’s reflex arc procedure. They all said that this technique needs to face the evaluation along the time. “If it is proven to be effective, it would gain extensive clinical implementation, because the needs from the affected patient population are overwhelming.”

But there are doctors expressed doubt on the Xiao procedure. Dr. Ji Xiaolong, director of the Pathology Department of the Armed Police General Hospital, said that the healing of nerves remains a big challenge in medical field. “It’s hard (for nerve) to grow into one piece. Imagine that each nerve is like a telephone cable with many contacts in it. Only when every contact is connected, can we say it is healed. No current technique in any microscopic surgery can achieve this. Leaving the two nerve stumps searching for each other (for reconnecting), it involves uncertainty”.

The cure rate of “Xiao procedure”: 85% or 0%?
Science News. Nov 23, 2009

“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 Third Military Medical University in Chongqing 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 surgery. 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 Yinglu, a professor at the Beijing Medical University and an academician 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.

An investigation of Shenyuan Hospital
Beijing Sci-Tech Weekly. Dec 08, 2009

Former president of Henan Shenyuan Hospital Gao Xiaoqun told the Weekly, the conventional treatment of spinda bifida is detethering a tethered cord…. As for the Xiao Reflex Arc, doctors also perform detethering in addition to never rerouting….

In August 2004, a panel was formed by seven academicians and a professor, including top experts Qiu Fazu from Tongji Medical College and Han Jisheng from Beijing University Medical School. The panel concluded that Xiao’s achievement had “important implications and outstanding novelty” on solving the urinary and fecal incontinence caused by congenital spinal meningocele。

Han Jisheng, academician of the Chinese Academy of Sciences and professor of Peking University Medical School, told the Weekly, experts of the evaluation panel only witnessed the postoperative situation of two patients. One urinated after scratching the leg; another discharged both urine and stool with the help of electrical stimulation. “I cannot remember exactly how much the cure rate was. we did not see all the successful cases, we believed that this technique feasible in theory,” Han said, now that the cure rate of this technique has been questioned, I think that Xiao really needs to provide more successful cases to substantiate his statement.

Another expert of the evaluation panel also recalled that Xiao only presented the panel with partial selective information of seven or eight patients. The panel did not see all of the data of the 20 patients that Xiao claimed he had done.

Guo Yinglu, the honorary director of the Institute of Urosurgery at Peking University and the only Academician on Urosurgery in the Chinese Academy of Engineering, commented that, “It makes some sense in the theory of the Xiao procedure. But not for all the patients can it achieve nerve reconnection, and you can only do this when you are able to find the nerve”. Guo said, “So, it means that even if he (Xiao) is correct, the effectiveness (of the procedure) is limited”.

Dr. Ji Xiaolong, director of the Pathology Department of the Armed Police General Hospital, said that the healing of nerves remains a big challenge in medical field. “It’s hard for nerve to grow into one piece. Imagine that each nerve is like a telephone cable with many contacts in it. Only when every contact is connected, can we say it is healed. But current technique in any microscopic surgery can’t achieve this point but leaving the two nerve stumps searching for each other (for reconnecting), this procedure involves uncertainty”.

“I specialize in the research of nerve regeneration. I believe that this idea is simply nonsense”. Yu Yanbing, director of Neurosurgery of China-Japan Friendship Hospital, told Beijing Sci-Tech, that the standard surgical procedure for congenital spina bifida is detethering, which has a success rate of 50% to 70%. The mechanism of Xiao procedure is said to regenerate the rerouted central nerves, but it is basically impossible to regenerate the central nerves. An organ is under an integrated control of multiple nerves and it is extremely difficult to find out those that control a specific organ. If you make a wrong connection or damage the original nerve, the surgery may compromise the original function of the organ without the intended recovery.

Opinions on Xiao’s Reflex Arc
Science News. Dec 8, 2009

An Letter from an anonymous expert

So far, concerns over the Xiao Procedure are as follows.

First, no control group has been set up. Selective sacral neurectomy has been used for treatment of neurogenic bladders. Even the artificial reflex arc itself doesn’t work at all, the surgery may have some effect as it denervates S2 and S3 nerves. Such effect at the early stage is not caused by the reflex arc. Without a control group, we cannot tell whether the effect is the result of selective sacral neurectomy or of the reflex arc.

Second, the urodynamic data contradict themselves. One of Xiao’s paper titled “Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida” was published on Eur Urol, 2006 Jan;49(1):22-8. The figures reveal the truth inside the reflec arc. The postoperative urodynamic studies in Fig. 3B and Fig. 4B clearly show that the patients urinated by intra-abdominal pressure. But Xiao explained that it is reflex arc to cause the urination. The flaw was ignored by editors. The evidence is that the intra-abdominal pressure (Pabd) is as same as intravesical pressure (Pves). And the detrusor pressure (Pdel) is very low (a flat line), nearly zero. Voiding happened only when intra-abdominal pressure existed.

Third, other reports by Xiao et al on the reflex arc have showed no effect either. A web post, “Comparison of clinical outcomes of the Xiao reflex arc procedure in domestic and foreign cases”, summarized the 2 cases in the U.S.A: the max flow rate was 8cc/s and post-void residual was 200cc/s. “At last follow-up (15 months) L5 stimulation caused a detrusor contraction of 59cm H20, a Q max of 8 cc/sec and no DESD. Voided volume was 150cc and post-void residual was 200 cc’s. (AUA 2005). Urologists know that the normal value of the max flow rate is ≥ 20 ml/s for male, and ≥ 25ml/s for female. If the max flow rate is ≤ 10ml/s, it should be considered as abnormal results due to lower ureteral obstruction or neurogenic bladder. (See Urosurgery, by Jieping Wu, p804). These 2 cases have the max flow rate of 8cc/s and residual of 200ml. How could those results show efficacy?

Conclusion: The reflex arc itself does not take effect. The improvement in some patients is the efficacy of selective sacral neurectomy. Since the reflex arc procedure transects limited number of nerve roots, its efficacy is less than that of selective sacral neurectomy.

Expert’s opinion
(by a member of the expert panel who evaluated the Xiao Procedure orginized by the Ministry of Health of China)

The above-mentioned urodynamic studies obviously show that it is intra-abdominal pressure that causes voiding. The maximum flow rate 8cc/s and post-void residual 200cc Obviously indicate there is no effect.

Last October, Xiao was invited to give a presentation on the 30th anniversary of the Institute of Urological Surgery at the Peking University. He showed his video which was more like a commercial to me. In the video, a patient’s mother from the US told a story after the operation. It was not a scientific presentation.

He once got a fairly large amount of grant in the US, and wanted to study 40 cases. We have not seen his final report till 2009. His AUA report was an abstract, which tell us little.

The urological community in China do not well accept the Xiao Procedure. Otherwise, we have already popularized the procedure long time ago. About two years ago in Kunming, in a national conference on urology, Xiao Chuanguo gave a presentation. Song Bo commented afterwards, made some rather objective remarks on the procedure. We run into each other on all kinds of occasions, so it is hard to comment in a direct manner, we do not want to corner him, so that Song Bo refrained himself in the conference. The author of the above letter specializes in neurology, he gives a relatively objective comment. He is sure of that there is no establishment of the reflex arc, and the reflex arc procedure has no effect at all.

In case the procedure has no effect, to void using intra-abdominal pressure instead of detrusor contraction would harm upper urinary tract in the long run, result in vesicoureteral reflux leading to hydronephrosis and hydroureter, and eventually damage the kidney.

Besides, after the denervation of normal nerve, there are questions such as whether it would lead to ED, or how the erectile function is affected, after the children grow up. For these reasons, the procedure is very controversial.

Topics: Xiao Chuanguo, Nerve rerouting |

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