The clinical trials on the so called “Xiao Procedure” are currently undergoing in the U.S. [a, b], despite of the fact that the procedure has long been questioned in China and recently found by Chinese lawyers and reporters to be ineffective and risky. We thus raise the question: how could the clinical trials have started in the U.S.? We find the answer after thoroughly examining the information from different sources: Dr. Xiao Chuanguo provided false or dubious information regarding his procedure, and some hospitals in the U.S. accepted Dr. Xiao’s self-claim without discrimination.
Dr. Xiao published a review article [c] in the European Urology, in which he claims by citing his conference report [25]
By the end of 2004, a total of 92 SCI patients with hyper reflexic or acontractile bladder in our hospital have been treated with the somatic and autonomic reflex arc procedure and 81 of them regained bladder control one year postoperatively [25].
…Up to date, we have performed the procedure for bladder and bowel control safely on 110 children with spina bifida [25]. The rate of success at the one year follow-up is 87%, compared to the 85% for the first 20 cases reported.
…Occurrence rate of partial loss of the left L4 or L5 motor function after surgery, the only complication for 25% of the first 20 cases, has been dramatically reduced to 5% with only slighter and recoverable muscular weakness by using only half of the lumbar ventral root [25].
Dr. Xiao’s report [25] cited by the review [c] provides so far the best rate of success, the least rate of risk, and the largest number of patients among his publications. These data have logically become the major reference of the U.S. trials (see the ClinicalTrials.gov registry [a] and the project description at the NIH grant website [b]), and have been frequently cited by William Beaumont Hospitals in various occasions, such as its press release [d], the department description [e], and the one-year clinical report [f].
Unfortunately, these critical data are very suspicious.
A piece of material [g] dated on August 28, 2004 from the Propaganda Department of Dr. Xiao’s hospital reveals: “since 2000 … 62 patients with spina bifida have been treated in Xiehe Hospital,” including Dr. Xiao’s very first 20 patients that were followed up “over two years”. In contrast, the report [25] dated on July 2-4, 2005 gives a total of 110 children with spina bifida who had been followed up for one year with 87% success rate, excluding the first 20 patients.
Another piece of news of March 2006 [h] from Dr. Xiao’s university says: “up to date, 218 “artificial reflex arc” operations have been carried out in China; the rate of effectiveness is as high as 80%.” However, there are total 237 cases reviewed in the article [c] (92 SCI and 110 spina bifida in the report [25], and 15 SCI and 20 spina bifida cases in Xiao’s previous papers), and all these cases should have been followed up for one year by the end of 2004. By doing a simple math, we can find that there are 174 effective cases in the 2006 news [h], whereas there are total 206 successful cases in the 2005 review article [c] (81 + 110×87% in the report [25] and 15×80% + 20×85% in the previous papers).
Dr. Xiao’s institute has no reason to play down its professor’s achievement. The contradiction in the number of patients and success or effective rate can only be explained in such a way that the data in Dr. Xiao’s article were either exaggerated or fabricated.
In fact, even the data from Dr. Xiao himself are also inconsistent. In a TV program [i] on March 29, 2009, Dr. Xiao admitted “the success rate is nearly 80%”. Several months later in his presentation [j] at the SIU 2009 Congress, the rate dramatically increased to 86.2%. Moreover, in his presentation, he claimed that 506 cases were followed up for 12 months at Shenyuan Hospital, and presented the statistics of the urodynamic data of the 506 cases. Several days later, he said a slip of the tongue in his web post [k] that “only about 400 of the patients were followed up with urodynamic study”.
Finally, the conference report [25] does not exist in the literature. There indeed exists an International Conference of Urology in Shanghai on July 2-4, 2005, which was solely sponsored by the Chinese Journal of Clinical Urology, Dr. Xiao being the Editor-in-Chief; there indeed exists a proceeding of the conference in the literature database, but Xiao’s report disappeared.
Unfortunately, this is not the only case that Dr. Xiao manipulated clinical data.
On February 28, 2007, the Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University signed an official document [l] for Dr. Xiao, the Director of the Center, for his bid for the membership of the Chinese Academy of Sciences (CAS). The Academician is the most honorable title for a scientist in China to pursue. In this supporting document, it was claimed that, starting from January 2006, the Center had applied the procedure to 117 patients, “Sixty cases were followed up for more than eight months. 85% of the patients have regained normal bladder and bowel functions.”
What was claimed in the supporting document is anything but truth. The Center did not come into existence until August 2006 and conducted its first operation on August 13. Ridiculously, less than 7 months later, the Center produced the document for its Director stating that they have conducted “more than 8 months” follow-ups on 60 patients. This ridiculous incident could not be the result of mistakenly dating the document, because the deadline for submitting application package was April 30, 2007 as required by the CAS.
In fact, Dr. Xiao has a long history of telling lies. Just to mention a few. He lied about winning the America Urological Association (AUA) Achievement Award in his resume [m]. The original copy of the resume disappeared from the internet after Dr. Fang Zhouzi exposed the fact along with Dr. Xiao’s other misconducts, but the claim of winning the award can still be found on the internet, such as at Ho Leung Ho Lee Foundation’s website [n]. Another example is that the expert panel who once evaluated the Xiao Procedure were told that the procedure was well recognized internationally. What they were not told was that Dr. Xiao’s publications were seldom cited by peers; and at the time, his work was not recognized even by his employer, who “discriminated against him … by terminating his employment as a research director; by forcing him to work in a laboratory that was used for the storage of paint, tiles, and windows”, as disclosed in a summary order from a U.S. Court of Appeals [o].
Now that Dr. Xiao dared to fabricate an official document for the most honorable academic title in China, lie about his award and his work, why could not he play the same trick in his paper for it to be published in a prestigious urology journal in Europe, and in turn to deceive the top institutions in the U.S.?
Dr. Xiao failed in his application for the Academician in China, three times in row every two years. His procedure was not recognized at all in China. Ironically, clinical trials of his procedure have started in the U.S..
The question is: could the top institutions in the U.S., such as the National Institutes of Health, Beaumont Hospitals and All Children’s Hospital, be so naive to be deceived and rashly start clinical trials based on suspicious data?
The answer is definitely YES.
“The procedure has not gained widespread acceptance outside of China,” Beaumont’s one year clinical report [f] implies the Xiao Procedure’s widespread acceptance “inside” of China. In at least three responses [p, q, r] to patients’ inquiries, Beaumont team said explicitly:
In China, this procedure is now standard of care. Dr. Xiao has taught this procedure to surgeon’s at all the major hospitals in China.
……
>> This surgery is now standard of care in China. Dr. Xiao has taught this procedure to surgeons all over China. It is done everyday in hospitals in China. If you really want to have this procedure done on your son, we would suggest going to China. … If you are at all interested in going to China, I would be happy to forward your information to Dr. Xiao. I have done this with other families.
Beaumont’s words regarding the acceptance of the procedure are absolutely not reflecting the truth, whose source apparently can be traced back to Dr. Xiao.
Xiao Procedure is not standard of care in China. Dr. Xiao has failed to teach this procedure to surgeons in China, as he admitted in an interview with China News Weekly, and his team is the only one who has the ability to perform this procedure. Moreover, no major hospital except a couple of affiliated hospitals of the university, where Dr. Xiao is the director of Urology Department, did it before mid-2006, and only one local private for-profit hospital, Shenyuan, where Dr. Xiao owns 30% of its shares, did it after August 2006.
The procedure has never been performed by surgeons in China other than Dr. Xiao’s team, let alone being widely accepted in China, either by critics, or by doctors and patients. It has been questioned by Dr. Fang and the readers of the New Threads since 2005. Dr. Fang hereby faced nearly 10 libel lawsuits filed by Dr. Xiao and lost one case in a local court in Dr. Xiao’s hometown, based on the following court findings, which became a joke teeming Chinese internet forums: “the defendant Fang could not find the plaintiff’s name on the list of award winners cannot deny the fact that the plaintiff won the award. Therefore, it is an established fact that the plaintiff has won the AUA Award.” Recently, some top experts, in defiance of Dr. Xiao’s potential legal action, finally expressed their concerns over the lack of scientific basis of the Xiao Procedure and unethical for-profit practice of this questionable procedure without adequate and proper clinical trials. Those experts include the one and only Academician in urologic surgery, directors from departments of urology in major hospitals, and even members of the expert panel who once evaluated this procedure. In addition, the procedure has long been infamous across Chinese internet forums where there are full of complaints from patients who received this procedure; no single success case can be found from patients’ posts. The only places where the procedure gets popular are the more than 50 (by the end of 2007) online advertising websites, where spamming posts from Shenyuan Hospital flood along with those of cures for cancer and diabetes.
Beaumont team took and further propagated the lie of so called widespread acceptance. What’s worse, they based their trial at least partially on this lie, citing the lie in their one year report as the evidence. What’s the worst, in at least two of their responses, they suggested the patients (and they “have done this with other families”) to go to China for the surgery, in spite of the fact that the surgery “much is still unknown” [b] to them and the “results are too immature to report yet” [q].
Because of the unknowns, “if a parent walked into my office and stuck $50,000 in my face, I’d have to say no.” Dr. Kenneth Peters, Chairman of Urology Department who leads the trial at Beaumont, once told St. Petersburg Times [s] before he would “emphasize caution” at the First World Conference on Spina Bifida Research, “Do the benefits outweigh the risks? I’m not ready to say that.”
But, what has Beaumont team actually already done with patients who are “desperate for help [s]” from them?
Thanks to Beaumont’s effort of spreading the lie, there were more than 90 U.S. patients that had been “successfully treated” by the procedure, as announced by the website of Dr. Xiao’s Chinese Journal of Clinical Urology, after Dr. Xiao was interviewed by CNN [t]. We have noticed that each foreign patient is charged about 20,000 USD, whereas each local patient 30,000 CNY (4,400 USD).
What would be the destinies of the 90 U.S. patients, along with 9 patients with SB and 3 patients with SCI (”were not helped by the procedure” [s]) at Beaumont, 8 children at All Children’s Hospital (”may eventually involve 100 children” [s]), as well as 6 SCI patients (”only 2 showed some improvement” [j]) in Germany?
On the same occasion, Dr. Peters told St. Petersburg Times: “I was wowed in China when I saw Dr. Xiao’s data.” [s]
Thus, the final question is: what data did Dr. Peters really see, or in other words, what data was Beaumont’s trial based on? the suspicious data from the non-existent report [25]? or the data similar to what Dr. Xiao created out of thin air then presented to the CAS? the widespread acceptance of the Xiao Procedure in China where it has never been accepted? the so called international recognition that Dr. Xiao told the expert panel while at the time he was fired by his U.S. employer? or the lightly mentioned “dramatically decreased incidence of these complications” [c, d], “small risk of some foot weakness” [t] or the later “cautious findings in Beaumont” that need to be “emphasized” and “prompted intense debate at All Children’s” [s]?
The answer to this final question is exactly to the very first question: how could the clinical trials have started in the U.S.?
REFERENCES
[a] Lumbar to Sacral Ventral Nerve Re-Routing.
Identifier: NCT00378664
http://www.clinicaltrials.gov/ct/show/NCT00378664
[b] Safety and Efficacy of Nerve Rerouting for Treating Neurogenic Bladder in Spina Bifida.
Project Number: 1R01DK084034-01
http://projectreporter.nih.gov/project_info_description.cfm?aid=7696321
He has reported that in 92 SCI patients, 88% regained bladder control within one year after the nerve rerouting surgery and in 110 children with spina bifida, reported success in 87% at one year. However, in China rigorous follow up is challenging….
[c] Xiao CG. Reinnervation for neurogenic bladder: historic review and introduction of a somatic-autonomic reflex pathway procedure for patients with spinal cord injury or spina bifida. Eur Urol. 2006 Jan;49(1):22-8; discussion 28-9. Epub 2005 Nov 2.
http://www.ncbi.nlm.nih.gov/pubmed/16314037
[25] Xiao CG. A somatic-autonomic reflex pathway procedure for neurogenic bladder and bowel: results on 92 patients with SCI and 110 children with spina bifida. . In: Proceedings of the International Conference of Urology; Shanghai, July 2-4, Shanghai, China; 2005.
[d] Beaumont Hospitals’ press release.
Beaumont sees results in nation’s 1st urinary nerve rewiring surgeries for spina bifida patients. 04/17/2008.
https://www.beaumonthospitals.com/news-story-beaumont-results-urinary-nerve-rewiring-surgeries-spina-bifida-patients
Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate….Possible side effects of the surgery include mild postoperative spinal fluid leakage, lower extremity weakness and headache. Recent changes in the surgical technique have dramatically decreased the incidence of these complications. Standard risks associated with any surgery may include bleeding and infection.
[e] Beaumont Hospitals’ Research by Department, Urology.
https://www.beaumonthospitals.com/research-institute-research-by-department-urology
Beaumont Hospitals launched a research study to “rewire” nerves in the spinal cord in the hope of giving bladder control to people with spinal cord injury or spina bifida who otherwise depend on self-catheterization to urinate. The first procedure garnered national attention and appeared in more than 160 news outlets including U.S. News & World Report, The Washington Post and Forbes.
…Chuan-Guo Xiao, M.D., reports an almost 90-percent success rate.
[f] Beaumont Hospitals’ one-year clinical report.
http://linkinghub.elsevier.com/retrieve/pii/S0022534709608843
Despite a reported success rate as high as 87% at one year, the procedure has not gained widespread acceptance outside of China.
[g] New Technique Helps Children with Spina Bifida.
Propaganda Department of the Party Committee of Wuhan Xiehe Hospital, August 28, 2004
http://www.xys.org/forum/db/176/44.html
http://www.cnhan.com/gb/content/2004-08/29/content_380330.htm
Since 2000, 62 patients with spina bifida have been treated in Xiehe Hospital, most of them have obtained remarkable effects. Among the 20 patients who were followed up systematically over two years after surgery, 17 patients obtained bladder control and voluntary voiding functions in 8-12 months after surgery…. Among the rest 42 patients, the bladder functions of 71% of 21 patients who underwent urodynamics examination (6-12 months after surgery) have improved; the other 21 patients are still to recover, since it is less than 6 months after surgery.
[h] Wuhan Xiehe Hospital “Exports” Surgery Technique.
Huazhong University of Science and Technology Weekly, Issue 205, March 2006
http://weekly.hustnews.com/text/show.aspx?id=6428
In 1995, Xiao Chuanguo, who invented “artificial reflex arc” after over 10 years of concentration, returned to China, and successfully performed the magic “artificial reflex arc” operation on a group of paraplegic patients for the first time. The patients obtained voluntary voiding function in about one year after operation. ???? Up to date, 218 “artificial reflex arc” operations have been carried out in China; the rate of effectiveness is as high as 80%.
[i] The Wonder of “Magic Reflex Arc”: Scratching Thigh to Cure Incontinence.
Hubei Provincial Broadcast and Television, News Channel, News at Six, March 29, 2009
http://news.hbtv.com.cn/content/2009-03/29/content_1614131.htm
Xiao Chuanguo: “We have solved the big problem that has not been solved in hundreds of years. We have done 1500 cases, the success rate is nearly 80%.”
At first, foreign experts were skeptical that how the problem for hundreds of years could be so easily solved by Xiao Chuanguo. Xiao did not argue, instead he went to the U.S. himself last year, and did 12 around-the-clock surgeries in the presence of experts from the world. All surgeries completely succeeded, astonishing the international medical communities. Experts around the world began to come to Wuhan on their own expense to learn the Xiao Procedure.
[j] Xiao Chuanguo’s presentation at the 30th Congress of SIU (SIU 2009)
Shanghai, China, November 1-5, 2009.
http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=10196&pv=2
Slide 56: Xiao Procedure for Spina bifida
1406 cases since 2006 in Henan Center, of the 506 follow-up at 12 month post-surgery, 435 gained bladder control
Slide 57: Comparison of urodynamic data in spina bifida patients
Effective Rate: 435/506=85.9% Pre & Post Surgery(1yr)
Slide 80: Tubingen Experience, Germany
6 SCI patients, only 2 showed some improvement. Possible causes: incorrect patient selection? inappropriate postoperative care?
[k] Xiao Chuanguo’s web post.
http://www.rainbowplan.org/bbs/topic.php?topic=103290
Posted by: WWWW 2009-11-15 01:22:52
The intention to support to set up the (Shenyuan) Hospital was more effectively doing follow-up and scientific research, but (the doctors) were all busy doing surgeries. So nearly 1500 cases have been done in more than 2 years, but only about 400 of the patients were followed up with urodynamic study.
[l] Certificate for Xiao Chuanguo’s CAS application
Neuro-Urologic Surgery Research Center (a.k.a Shenyuan Hospital) at Zhengzhou University, February 28, 2007
Starting from Jan. of 2006, the Neuro-urological Surgery Research Center at Zhengzhou University has 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 regained normal bladder and bowel functions.
[m] Xiao Chuanguo’s resume claiming he won AUA Achievement Award
http://xysblogs.org/wp-content/blogs/107/uploads/041210_cgxiao_cv.doc
[n] Ho Leung Ho Lee Foundation’s website showing Xiao Chuanguo won AUA Achievement Award
http://www.hlhl.org.cn/english/showsub.asp?id=476
Dr. Xiao has been awarded … America Urological Association Achievement Award (2000)
[o] Summary order from US Court of Appeals for the Second Circuit
http://vlex.com/vid/chuan-guo-xiao-continuum-18536135
[p] Patients’ posts regarding Beaumont Hospitals’ responses.
http://spinabifidaconnection.com/showpost.php?p=2350&postcount=1
http://spinabifidaconnection.com/showpost.php?p=3209&postcount=3
http://spinabifidaconnection.com/showpost.php?p=3888&postcount=8
[q] Patients’ post regarding Beaumont Hospitals’ responses.
http://sci.rutgers.edu/forum/showpost.php?p=878421&postcount=44
our results are too immature to report yet in the spinal cord injury, …Dr. Xiao in China who developed the surgery may be able to perform this on you there.
[r] Letter from Beaumont Hospital on Xiao Procedure.
http://ronandmelissa.com/wp/?p=52
[s] Experimental Surgery Helps Relieve Kids with Spina Bifida and Spinal Injuries
By John Barry, Times Staff Writer, March 15, 2009
http://www.tampabay.com/features/humaninterest/article984049.ece
[t] CNN Interviews “Xiao Reflex Arc”
Chinese Journal of Clinical Urology, June 12, 2009
http://www.cjcu.com.cn/showart.aspx?artid=3187
In the U.S. Professor Xiao Chuanguo has conducted the clinical implementation of this technique, and so far has successfully treated more than 90 cases of incontinence caused by spinal cord injury, spina bifida and other spinal cord diseases.
[u] Surgery Might Aid Bladder Control after Spine Surgery
http://www.nctimes.com/lifestyles/health-med-fit/article_8b6c668a-94bb-59fc-b7d3-266bef6ecbe3.html
Lauran Neergaard, Associated Press, February 18, 2007
There are some risks, Peters cautioned, including general anesthesia and wound infections. For children with spina bifida who can walk, rerouting the thigh nerve causes a small risk of some foot weakness.
