Xiao Procedure Trials in SCI outside China
By xysergroup | 3月 13, 2010
Listed below we summarize the facts regarding the clinical trials of the Xiao Procedure in patients with spinal cord injury (SCI) in the US and Germany. Some of the facts have already been included in the Open Letter of Complaint against the Xiao Procedure, others were recently found. We note that the SCI cases conducted by third parties all failed.
1. According to Dr. Xiao, he has “dedicated my live to SCI research since 1976″ [1]. His first animal studies on rats [2] and cats [3], as well as his first clinical trial of 15 patients [4] are all for SCI.
2. Dr. Xiao’s papers on SCI were published “in highly regarded western journals” in 1999 and 2003, co-authored with Dr. de Groat, “the most respected name in bladder physiology” [5]. We note that, in his recent reviews [6, 7] on bladder function recovery after SCI, Dr. de Groat gave no word to Dr. Xiao’s work.
3. From 1999 to 2007, the NIH awarded Dr. Xiao more than 2.4 million dollars for the clinical trial in SCI at New York University (NYU) [8]. It was said that 40 SCI patients had been involved with an 80% response rate [9], but so far no official results have been released, except for a conference abstract [10] that reported two cases with much worse urodynamic results than Dr. Xiao’s first 15 SCI patients in China [4]. Nevertheless, NYU discontinued its clinical study after running out of the multi-million dollar funding after several years of extension.
4. In December 2006, William Beaumont Hospitals started the clinical trial [11] in both SCI and spina bifida (SB). The key data of the trial, such as the success rate and the occurrence rate of the complications, can be traced back to Dr. Xiao’s unpublished report [12] (see “How Xiao Procedure Trials Started in U.S.”). The trial was also believed to be based on false information regarding the acceptance of the procedure in China, which was exposed by Dr. Xiao when he was interviewed by the meida [13] and was confirmed by Dr. Wise Young on the CareCure forums [14].
5. No SCI case was reported in Beaumont’s one-year clinical outcomes [15]. We know from media [16] that “the three with spinal cord injuries were not helped by the procedure”. More over, in May 2009, the mother of one of the Beaumont’s first SCI patients asked for help to buy catheters for her son [17]. Furthermore, in the most recent presentation on the trial results by Dr. Peters of Beaumont [18], no SCI case was presented either.
6. In December 2009, Beaumont obtained a grant from the NIH for the clinical trial in SB [19]. The current trial no longer includes SCI, even though Dr. Peters recently said “need to further explore this technique in spinal cord injury” in his presentation [18].
7. All of the 6 SCI cases in Tubingen, Germany have failed, “only 2 showed some improvement” [20].
8. Dr. Xiao blamed the failure of SCI cases to “incorrect patient selection” and “inappropriate postoperative care” [20]. In his several posts on Chinese forums [21, 22, 23], he further blamed the misuse of Ditropan and catheters. But according to the mother of the patient [24], the patients at Beaumont had already been required to quit Ditropan.
References
[1] http://sci.rutgers.edu/forum/showpost.php?p=1183019&postcount=36
[2] Xiao CG, Godec CJ. A possible new reflex pathway for micturition after SCI. Paraplegia. 32(5):300-307, 1994
[3] Xiao CG, de Groat WC, Godec CJ, Dai C and Xiao Q. “Skin-CNS-bladder” reflex pathway for micturition after spinal cord injury and its underlying mechanisms. J Urol 162: 936-42.
[4] Xiao CG, Du MX, Dai C, Li B, Nitti VW and de Groat WC (2003). An artificial somatic-central nervous system-autonomic reflex pathway for controllable micturition after spinal cord injury: preliminary results in 15 patients. J Urol 170: 1237-41.
[5] http://sci.rutgers.edu/forum/showpost.php?p=1118680&postcount=33
[6] de Groat WC, Yoshimura N. Mechanisms underlying the recovery of lower urinary tract function following spinal cord injury. Progress in Brain Research. 2006;152:59-84.
[7] Fowler CJ, Griffiths D, de Groat WC. The neural control of micturition. Nature Reviews Neuroscience. 2008 Jun;9(6):453-66.
[8] http://projectreporter.nih.gov/project_info_description.cfm?aid=6698512
[9] Blount JP and Tuite G. Xiao Procedure. Pediatric ShortCuts Newsletter. Spring 2009
http://www.neurosurgery.org/xiaoS09.asp
Note: Dr. Tuite is one of the neurosurgeons who lead the clinical trial at All Children’s Hospital in Fla., see:
http://www.wctv.tv/medicalminute/interviewheadlines/47870982.html
[10] http://www.urotoday.com/264/conference_reports/selected_abstracts/female_urology__part_10.html
[11] http://www.clinicaltrials.gov/ct/show/NCT00378664
[12] 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. Proceedings of the International Conference of Urology; Shanghai, July 2-4, Shanghai, China; 2005.
[13] http://xy*****logs.org/wp-content/blogs/107/uploads/xpletter.html#nw3
[14] http://sci.rutgers.edu/forum/showpost.php?p=1180817&postcount=53
[15] http://linkinghub.elsevier.com/retrieve/pii/S0022534709608843
[16] http://www.tampabay.com/features/humaninterest/article984049.ece
[17] http://sci.rutgers.edu/forum/showthread.php?t=118791
[18] http://www.glsuna.com/PetersGLSUNA2010.pdf
[19] http://projectreporter.nih.gov/project_info_description.cfm?aid=7696321
[20] http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=10196&pv=2
[21] http://www.chinagonet.com/main/view_post.php?pid=2251853
[22] http://www.starlakeporch.net/bbs/read.php?1,52103,52175#msg-52175
[23 http://www.starlakeporch.net/bbs/read.php?1,53199,53199#msg-53199
[24] http://sci.rutgers.edu/forum/showpost.php?p=586207&postcount=34
Topics: Xiao Chuanguo |
