羽矢

——评所谓“国际学术同仁声援肖传国医生的公开信”

受肖传国欺骗而开展肖氏手术临床试验的肖的国外支持者，在所谓“国际学术同仁声援肖传国医生的公开信”中为肖传国开脱，不惜歪曲、捏造有关肖氏反射弧手术的事实，包括：

1. 为混淆手术“成功”的定义而称“不能把手术的成功定义为大小便功能恢复正常”，不顾肖传国本人、神源医院、肖传国任主编的学术杂志网站、华中科技大学等在院士申请材料、鉴定资料、广告宣传中声称的“85％的患者大小便已恢复正常”、“术后与常人无异，大小便能够自控”、“像正常孩子一样排尿”、“获得控尿和自主排尿功能……大便功能也转为正常”等等。实际上，即便在美国进行临床试验的Beaumont医院的新闻发布会上，他们也自称“（术后一年，Beaumont医院的）大多数患者大脑能够接管并控制正常排尿”（in most patients the brain was able to take over and control urination normally.）。（见《肖氏手术的“成功”、“治愈”、“有效”(XYS20101014)》）

2. 谎称肖传国在美国经过动物研究、结果发表并经同行验证后才“走出了勇敢的一步”、在中国进行人体临床试验。实际上，肖传国在中国
开始人体试验时，其大鼠实验结果期刊论文刚刚发表一年、获得猫实验研究资金刚刚半年。人体试验开始四年后，猫实验结果期刊论文才发表。（见《肖传国的美国猫实验与中国人试验同步进行(XYS20101005)》）

3. 信中谎称“Beaumont医院先期试验的数据是支持肖氏手术的”，不顾其所遭到的其结果“首次挑战了（肖传国）先前发表的成功率超过85%的优异结果”、“临床疗效与肖此前所报告的截然不同”、“没有一个能完全自主排尿，这一事实令人困扰”等强烈质疑。（见《国外同行专家对美国肖氏手术临床试验结果的评价(XYS20100930)》）

31位国际学术同仁声援肖传国医生的公开信：
不能把手术的成功定义为大小便功能恢复正常
one cannot expect normalization of bladder and bowel function to be the definition of success

Beaumont医院新闻发布会
（Beaumont医院的）大多数患者大脑能够接管并正常控制排尿。
in most patients the brain was able to take over and control urination normally.

Beaumont医院NIH资助试验材料
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.
Our preliminary data are very promising, and with 9 subjects now 12 months post procedure, 7/9 subjects are voiding either voluntarily or by stimulating the new reflex mechanism.

华中科技大学官方新闻
协和医院“人工反射弧”原理和技术顺利通过鉴定
发布时间:2004-9-2
2000 年至今，协和医院治疗脊髓脊膜膨出患者 62例，绝大部分取得了显著效果。在术后已获系统随访两年以上的20例（其中14例为无反射性膀胱，6例为高反射性膀胱合并逼尿肌－尿道外扩约肌协同失调）患者中，17例手术后8－12月获得控尿和自主排尿功能，85.7％的无反射性膀胱患者的膀胱容量由117.28毫升增加到208.71毫升，平均最大逼尿肌压由18.35升高到32.57厘米水柱；6例高反射性膀胱患者中，5例术后一年左右恢复可控协同排尿，逼尿肌－尿道外扩约肌协同失调消失，膀胱容量由94.33毫升增加至177.83毫升，平均残余尿量由70.17毫升减少至23.67毫升。所有获得排尿功能者大便功能也转为正常，并同时获得了膀胱/直肠感觉功能（即便意）。在其余42例中，已经进行尿动力学随访的21例（术后6－12个月），膀胱功能已改善者达71％，其余21例因术后时间少 6于个月，正在恢复中。
在鉴定会上，著名神经科学家、中国科学院韩济生院士、鞠躬院士、陈宜张院士，著名外科学专家王正国院士、刘允怡院士、顾玉东院士、金锡御教授、裘法祖院士鉴定后

国内宣传：
肖传国任主编的《中国临床泌尿外科杂志》网站：
http://www.cjcu.com.cn/showart.aspx?artid=3187
患者接受手术后，只需挠挠大腿内侧，就可以自主控制排尿，甩掉尿袋子。目前，这一技术在国内已经得到广泛临床应用。而在美国，肖传国教授也已将该技术进行了临床推广，迄今已成功治疗脊髓损伤患者、脊柱裂脊膜膨出患儿和脊髓其他病变所致大小便失控90余例。
http://www.cjcu.com.cn/showbt.aspx?artid=1988
发布时间：2007-6-8 1:15:38
2006 年8月13日上午，小善善躺在郑州大学神经泌尿外科研究中心的无影灯下……术后6个月，他大便恢复了正常。现在小善善已经能像正常孩子一样排尿，甩掉了伴他4年来的“尿不湿”和导尿管。看着小善善能痛快地撒尿，肾盂不再积水、发炎，小善善的父母就像从一场噩梦中醒来，高兴得流泪了。
http://www.cjcu.com.cn/showbt.aspx?artid=1979
为什么反射弧建立了善善撒尿还要用力才能尿出？高晓群教授告诉记者，撒尿的行为是神经支配尿道括约肌收缩的结果，善善的神经虽然恢复了正常，但由于善善的括约肌从出生以来都没有使用过，所以已经出现了退化，必须经过康复训练才能逐渐恢复，数月之后，小善善将完全恢复正常。“可以确定，我们为小善善建立的人工反射弧已经百分之百成功了！”高晓群肯定地说。
http://www.cjcu.com.cn/showart.aspx?artid=940
1995年，在美国潜心攻关10多年发明了“人工反射弧”的肖传国教授回到祖国，首次成功的为一批截瘫患者进行了神奇的“人工反射弧”手术，术后约一年患者获得了自我控制排尿功能，

神源宣传：
迄今为止，已有近400例患者接受了这一手术，其中80%的患者获得治愈，彻底解决了大小便失禁问题。

肖氏反射弧专治大小便失禁
2009年12月01日 17:39 来源:大河健康报
目前为止，此类手术已成功开展1000多例，包括截瘫在内的有脊髓损伤的患者，手术后唯一要做的就是每次排尿前挠挠大腿，像拉开关一样，通过生理刺激激活反射活动，引起排尿。像小勇这样的患有脊柱裂脊髓脊膜膨出的病人，术后与常人无异，大小便能够自控。

肖传国2007年申报院士证明
证明
郑州大学神经泌尿外科研究中心，自2006年1月开始应用肖传国教授发明的“人工体神经－内脏神经反射弧”技术，治疗脊柱裂、脊髓脊膜膨出所致的神经原性膀胱患者117例，术后随访8个月以上60例，85％的患者大小便已恢复正常。
特此证明
2007年2月28日
郑州大学神经泌尿外科研究中心

应用证明
华中科技大学同济医学院附属梨园医院
我院从2000年起应用人工建立体神经—内脏神经反射弧手术治疗脊柱裂脊膜膨出大小便失禁患者15例，治愈率为80%(12/15)。

应用证明
上海市虹口区妇幼保健院
我院从2006年4月起应用肖传国教授发明的人工反射弧理论和技术，为12例先天性脊柱裂和3例脊髓损伤所致大小便失禁患儿手术。已获随访10例，8例有效，治愈率80%，能自主控制大小便。

肖传国及其课题组论文
苏秋棉 杨荆艳 郭峻 杜茂信  人工体神经-内脏神经反射弧恢复脊髓损伤致神经源性膀胱病人的护理 护理研究2002年9月第16卷第9期
目前能完全自控者24例，症状明显改善者5例，无改变者2例，有效率93.5%。

肖传国, 杜茂信, 刘钊, 李兵, 陈朝晖, 程平, 陈敏. 人工体神经-内脏神经反射弧治疗脊髓脊膜膨出患者大小便功能障碍. 临床泌尿外科杂志2003年11月第18卷第11期7例无反射型患者中4例获得控尿和自主排尿功能，尿失禁消失；6例高反射型患者全部于术后1年左右恢复可控排尿……充盈性尿失禁消失。
结论：人工反射弧能安全有效地治愈先天性脊髓脊膜膨出所致大小便失禁。
我们应用人工反射弧原理和手术方式在国际上首次成功治愈了这类患者的大小便失禁，效果显著。

美国Beaumont医院试验结果论文中，声称9名患者中有7人建立了反射弧。肖传国的“国际学术同仁”及其他支持者试图以此7/9作为肖氏手术“成功” 的标志。但此“成功”显然与国内宣传报道、肖的院士申报材料、肖的论文等所声称的“成功”不同。对该结果作出强烈质疑的同行专家、国内受欺骗的病人显然也不买账。

让数据说话：Beaumont论文Table2（见http://xysblogs.org/wp-content/blogs/107/uploads/tab12a.gif）表明，术后12月病人尿动力学数据（膀胱容量capacity、是否排尿voiding）的改变，与反射弧是否建立不相关：

是否排尿：
2个无反射者，从“否”转为“是”
7个有反射者，3个从“否”转为“是”，2个为“否”不变，2个为“是”不变。
膀胱容量:
2个无反射者，膀胱容量1增1减
7个有反射者，膀胱容量4增3减

这就是编辑评论中所说的“One of the most curious findings”：“本试验最古怪的发现是尿动力数据和主观评估之间的矛盾。有位患者膀胱容量减小、反射弧未建立，但他竟然主观上报告大小便功能改善！”

以上数据宣布了肖氏反射弧在实际疗效上的失败：部分病人的状况得以某种程度的改善，并非由“反射弧”引起的。更可能的原因则是国内外专家指出的：自愈、缺陷修补术、栓系松解术、骶神经根切断术等。

其中，栓系松解术是治疗脊柱裂的常规手术，由于不切断神经，所以不会造成肖氏手术的下肢严重后遗症。为了排除解栓术的效果，美国ACH医院2009年3月开始的7例脊柱裂试验有对照：治疗组“肖弧”+栓系松解术，对照组仅栓系松解术。而肖传国为了牟利而大规模推广应用了2000多例，却从未做过对照试验以排除其他因素对手术效果的影响。

肖传国践踏人伦，将美国的猫实验与中国的人试验同步进行。肖传国在中国开始人体试验时，其大鼠实验结果期刊论文刚刚发表一年、获得狗实验研究资金刚刚半年。人体试验开始四年后，猫实验结果期刊论文才发表。狗实验结果从未发表。

肖传国借助1989年至1992年间获得的总额不到9万美元的3项小额研究资金，于1990年和1992年分别发表两篇关于鼠[1]、猫[2]实验的会议摘要，并于1994年发表大鼠试验结果期刊论文[3]。借此，肖传国获得美国NIH一项21万美元的大额研究资金[4]，用于进一步的犬类动物实验。首批资金于1994年11月9日发放。

仅仅过了半年之后的1995年5月，“被武汉协和医院请回，委以泌尿外科主任的重任”[5]的肖传国，就想出了“一个大胆的计划”[6]、“走出了勇敢的一步”[12]，在平顶山矿工身上开始了人体试验[6,7]。其初步结果会议摘要于1998年发表[8]。该会议摘要注明由NIH和PVA资助，而此前唯一的NIH资助是犬类动物实验【4】。

肖从未发表NIH资助的犬类动物实验结果，而是于1999年才发表猫实验结果期刊论文[9]，注明由NIH资金[4]资助，这是在人体试验开始4年、人体试验结果发表1年之后！

在这篇论文中，肖传国竟然声称：“如果本神经外科技术能在较大型动物中得以完善，本技术可以最终用于患者。”（If this neurosurgical technique … can be further perfected in larger animals, it may eventually be applied to patients）也就是说，平顶山矿工们在毫无人性的肖传国眼里，居然连“较大型动物”都不如！

借平顶山矿工人体试验，肖传国登上了所谓的“人生的珠穆朗玛”（肖传国博客语）。此后，数千名国内外患者被其残害，沦为其谋取暴利、博取名望的工具。

从以下资料，我们可以看到肖传国是如何践踏人伦、将猫实验与人试验同步进行的，以及其国外合作者（所谓“国际学术同仁”们）在论文[10]、网站评论[11]和为其辩护的“公开信”[12]中是如何扭曲事实的。

[1] 1990年发表大鼠试验结果会议摘要
A possible new reflex pathway for micturition after spinal cord injury. J Urol 1990; 143:356A.

[2] 1992年发表猫试验结果会议摘要
Skin CNS Bladder reflex pathway for micturition after SCI in cat. J. Urol. 1992 146:437A.

[3] 1994年5月发表大鼠试验结果期刊论文
A possible new reflex pathway for micturition after spinal cord injury. Paraplegia. 1994 May;32(5):300-7.
In order to restore bladder function after spinal cord injury, a controllable new reflex pathway has been established in rats.

[4] 1994年获NIH科研动物实验研究资金（资金号R01DK44877）21万美元
http://taggs.hhs.gov/AwardDetail.cfm?s_Award_Num=R01DK44877&n_Prog_Office_Code=119
Issue Date: 11-09-1994（资金发放日期1994年9月11日）

[5] 华中科技大学《“打飞的上下班”的肖传国教授》
1995年，肖教授被武汉协和医院请回，委以泌尿外科主任的重任……。在协和，“肖氏原理”很快用于临床。这一转化，比他在美国的同项进程早了近5年。（http://xyh.hust.edu.cn/old/xyzc/20021/c2.htm）

[6] 黄普磊《无数截瘫病人因他看到了生活的曙光》
1995年5月16日，平顶山矿务局总医院骨科，美国州立大学长岛医学院医学博士肖传国正和该科主任杜茂信商量一个大胆的计划。……将这个动物实验成功的手术用于人类……(http://www.westking.com/html/xbcf/2007/12/19/20071219112128.html)

[7] 南方周末《“有望获诺贝尔奖的手术”？》
1995年，肖传国开始做临床应用研究。他选择的第一站是河南平顶山煤业集团总医院，之所以没有首先在美国做，是因为“在美国申请基金非常慢，最快也要等一年半到两年。而且美国对做临床研究审批很严……”
……肖传国给南方周末记者提供了两名当年做肖氏手术的矿工，记者电话咨询时，其中一名史姓矿工表示有效，只是脚趾的功能受影响（该病人腰部有损伤，尚能行走）。另一名樊姓矿工则表示“不理想”。据他介绍，与其同批手术的其他四人也没啥效果。

[8] 1998年发表人体试验结果会议摘要
A new procedure to restore bladder functions after spinal cord injury: Preliminary report on 14 patients. J Urol. 1998 May; 159 (5):304A

[9] 1999年发表猫试验结果期刊论文，由R01DK44877资金资助（”Supported by grant R01DK44877-01″）
“Skin-CNS-bladder” reflex pathway for micturition after spinal cord injury and its underlying mechanisms. J Urol. 1999 Sep;162(3 Pt 1):936-42.

[10] 美国Beaumont医院遭到强烈质疑的临床试验结果论文
Beaumont’s paper:
Initial studies done in rats involved microanastomosis of the left L4 ventral root to the left L6 ventral root.[2,3] After scratching the skin surface afferent information travels through the intact L4 DR and initiates the reflex. Further studies have established this technique in higher taxonomic species,[4] and recently have been brought from bench to clinical practice in humans, involving microsurgical anastomosis of the L5 and S2/3 ventral roots.[5,6]
最开始的大鼠实验引入了左L4到L6腹侧神经根的显微吻合术[2,3]【注：肖1990年大鼠摘要和1994大鼠论文】。骚挠皮肤后，传入信息通过未切断的L4背侧神经根引起反射。在更高级生物物种【注：指猫】中的进一步研究确立了这一技术[4]【注：肖1999年猫论文】。最近，（该技术）已经从实验室走上人的临床应用……[5,6]【注：肖2003年脊髓损伤试验结果论文和2005年脊柱裂试验结果论文】。
【注：猫与人在肖传国眼里是同等级的生物物种。论文作者或者不知道、或者有意颠倒了真正的试验顺序】

[11] 美国试验主持者之一、Beaumont儿童医院儿科泌尿主任在美国《科学》网站的评论
Evan Kass MD Chief of Pediatric Urology Beaumont Children’s Hospital
Sep. 25, 2010. 10:43:49 AM
The scientific basis for his surgical procedure was initially developed in the animal laboratory and the results published in peer reviewed journals. Only after years of research was it applied to humans.
肖传国的外科手术的科学基础最初是在动物实验中奠定的，其结果发表在同行评议的学术期刊上。经过了多年的研究之后，该手术才应用于人类。

[12] 肖传国的国外合作者为其开脱的《国际学术同仁声援肖传国医生的公开信》
Open letter in support of Chuan-Guo Xiao
Dr. Xiao performed groundbreaking animal research in the United States…. The results of his studies were published in peer-reviewed journals and other scientists have replicated Xiao’s findings confirming these results. Dr. Xiao eventually took the courageous step of moving from animal research to human studies and began performing the rerouting procedure on patients with spinal cord injury and spina bifida in China.
肖传国医生在美国进行了开创性的动物实验研究……研究结果发表在同行评议的期刊，其他科学家已经重复了肖的发现、证实了其结果【注：肖传国动物实验结果几乎无人引用，更别提“重复”、“证实”了】。肖医生最终走出了勇敢的一步，从动物研究转移到人类临床试验，开始在中国的脊柱损伤和脊柱裂病人身上开展神经重建手术。

德国Tubingen大学于2005年9月开始实施实施6例脊髓损伤患者手术。该大学在2005年9月7日宣布临床试验开始的新闻稿中，除了引用肖传国“成功”病例外，还声称：

“迄今已有13名患者在美国做了手术。自术后六个月起，膀胱功能明显得以迅速恢复，成功率约80%，（与肖传国所报告的成功率）几乎完全相同。”

肖传国谎称“肖氏手术在中国是常规手术”，并利用引自子虚乌有的会议报告中的“92名脊髓损伤患者中的88%、110名患者中的87%恢复膀胱功能”这一谎言，欺骗国外一些机构开展临床试验。反过来，又谎称这些临床试验为临床应用，以此在国内做广告欺骗国内患者；同时又借国外合作者之口，引诱国外患者来中国做手术（见《“肖氏术”何以在美国开始临床试验(XYS20100227)》），以此获取巨额暴利。

而Tubingen大学所述13名患者的美国手术，明显是肖传国的又一谎言。事实上，美国NIH从1999年起曾资助肖传国240万美元，在纽约大学开展了治疗脊髓损伤的试验（基金号5R01DK053063），但仅做了两例，迄今未出正式结果，仅在一份会议摘要中报告了两个病例，数据远逊于肖传国自己的结果（例如，报告中平均余尿为200毫升，而肖传国最初15个脊髓损伤病例为31毫升）。纽约大学此后不再继续该项试验。而美国新一轮有12名患者参加的试验，由Beaumont医院于2006年12月启动，其中，3例脊髓损伤患者“手术无助”，9例脊柱裂“无一例患者能完全自主排尿”。

Tubingen大学的6例手术结果是：全部失败，“仅两例有些改善”。这是肖传国在上海SIU 2009学术会议上透露的。

不过，6例手术全部失败没有妨碍Tubingen大学试验主持者Karl-Dietrich Sievert出面签署所谓《31位国际学术同仁声援肖传国医生的公开信》（信中谎称“Beaumont医院先期试验的数据是支持肖氏手术的”、“已经证实了肖传国以前发表的结果”，不顾其所遭到的“临床疗效与肖此前所报告的截然不同”的强烈质疑）。原因是什么？因为试验失败后，肖传国又向他们撒谎了：“病人选得不对、术后护理不当”。

【更新：德国Tubingen大学2010年3月报告其肖氏手术临床试验失败，8名脊髓损伤患者无一能通过刺激皮肤引发排尿。试验主持者承认，他们始终未能重复肖传国的结果、患者无一达到自主排尿的试验目标。见《泌尿学时报》报道德国肖氏手术临床试验失败】

参见：

德国Tubingen大学2005年9月7日新闻稿
http://www.uni-protokolle.de/nachrichten/id/105332/
13 Patienten wurden bisher in den USA versorgt und wiesen eine deutlich schnellere Regeneration der Blasenfunktion von sechs Monaten auf, mit einer annahernd gleich bleibenden Erfolgswahrscheinlichkeit von 80 Prozent.

English translation:
So far, 13 patients had been treated in the U.S. and it showed a noticeably fast recovery of bladder function from six months, with an almost the same constant 80% success rate (as Dr. Xiao previously reported).

2. 肖传国上海SIU 2009演讲：
http://xysblogs.org/wp-content/blogs/107/uploads//s80.jpg
http://webcasts.prous.com/netadmin/webcast_viewer/Preview.aspx?type=0&lid=10196&pv=2

受肖传国“肖氏手术在中国是常规手术、成功率85%”的谎言所欺骗，一些国外机构陆续开展了肖氏手术临床试验。其中德国Tubingen大学最早于2005年9月实施了第一例手术，共实施6例脊髓损伤患者。据肖传国在上海SIU 2009学术会议上的演讲，德国的6例全部失败，“仅两例有些改善”。美国Beaumont医院于2006年12月开始，首批实施了12例手术。据美国媒体报道，其中全部3名脊髓损伤患者“手术无助”。其他机构的临床试验正准备实施，或刚开始不久、结果尚未公布。

最近，美国首批12名患者中的9名脊柱裂患者的临床试验一年随访结果，在美国《泌尿学杂志》2010年第8期正式发表。该杂志同时在社论和编辑评论中刊载同行的严厉批评和质疑，指出该试验缺乏对照组，结果自相矛盾且无统计意义，疗效与肖传国此前报告的截然不同，认为是对肖先前结果的挑战，怀疑肖先前论据和数据的可靠性，推测某些患者的改善并非肖氏手术本身的效果，并警告冒然推广应用此手术会有极大危险。

去年底，国内“肖氏手术”无一成功、反而致残的黑幕被揭开，实施该手术的郑州神源医院关闭，受害患者开始起诉该医院。肖传国不但面临学术上的破产，其发财之路也被断绝。国外同行对美国试验结果的批评和质疑，更使肖传国陷入困境。我们注意到，美国临床试验结果论文和评论于6月19日在线发表，6月24日方玄昌遇袭，8月29日方舟子遇袭。

肖传国落网后，其国外合作者于9月29日发布由美国首批临床试验领导者Kenneth Peters撰写的所谓《31位国际学术同仁声援肖传国医生的公开信》。这些国外利益相关者以“国际科学界”自居，试图以肖传国的所谓成就为其开脱，并向中国政府和警方施加压力。该《公开信》声称，“其他科学家已经重复了肖传国的发现、证实了肖传国以前发表的结果”，发表在《泌尿学杂志》的结果“证明神经重建确实发生了，这个成绩是了不起的，肖医生应该得到嘉奖。……该先期试验的数据是支持肖氏手术的”。

现将《泌尿学杂志》发表的论文摘要部分以及三篇评论翻译如下，让我们看看无利益相关的国外同行专家是如何评价美国肖氏手术临床试验结果的。

论文：

腰——骶神经重建治疗脊柱裂的试验结果（摘要）

目的：通过重建腰——骶神经通路，建立皮肤——中枢神经系统——膀胱反射弧，恢复脊柱裂患者的大小便功能。据报告，中国的成功率为87%。现报告我们北美首批神经重建临床试验的结果。

材料与方法：9例受试者加入该研究。施行了硬膜内腰——骶神经重建术。对受试者进行经皮肤刺激的尿动力学测试和认真的神经学随访。密切监控了出现的不利情况以及大小便功能的改变。

结果：术后1年，7例(78％)患者经刺激皮肤产生可重复观察到的膀胱压增大【注：膀胱压增大有助于排尿。国内专家研究了肖传国论文中的尿动力学图后指出，膀胱压增大可能是由腹压而不是由逼尿肌收缩引起的，而后者才是反射弧建立的标志】。2例患者能够停用导尿术，全部患者安全地停用了抗毒蕈碱药物【注：其中4例从未用过该膀胱肌肉松弛药物】。无一例患者能完全自主排尿。大多数患者称肠道功能有改善。1例患者在术前就能控制大便，4例患者在术后1年能控制大便。术后1个月，89%的患者出现不同程度的下肢肌肉群无力。1例患儿出现持久性足下垂，其他患者在12个月内恢复到术前水平。

结论：术后1年时，大多数患者经刺激适当皮区可观察到新的反射弧。观察到大小便功能的改善。下肢无力主要是自限性的，仅1例出现持续足下垂。本手术需要更多病例和更久随访，以评估这一新疗法的风险/效益率。

评论一：

本期杂志发表的Peters等人的神经重建研究结果，首次挑战了（肖传国）先前发表的成功率超过85%的优异结果。虽然有证据表明，神经重建能建立新反射弧、引起逼尿肌收缩，但该研究组发现，术后一年，9例患者中，无一例患者能自主排尿，且仅有两例能停用导尿术。尽管停用了抗毒蕈碱治疗，从膀胱顺应性以及膀胱内压测量得到的膀胱容量来看，结果引人注意【注：另一专家认为“微小的膀胱顺应性的改变，可能不具有统计学意义”。按论文中给出的数据，9名患者平均膀胱容量从术前211ml仅增加到术后一年的253ml，离散程度非常大，且5人增加、4人减少。另据文献资料，随年龄增长，正常儿童膀胱每年增容约15ml。论文未列出顺从度个体数据，只给出平均术前为16.1 ml/cm H2O（6.6至28.6）、术后提高到21.8 ml/cm H2O（7.8至53.8），也非常离散。这两项重要指标的改善程度远远小于肖传国公布的结果：术后提高到术前的约两倍。另外，Beaumont医院的患者状况比肖所报告的患者要好得多，其术前指标甚至比肖的术后指标还要好】。对于运动机能已经缺失的孩子来说，持久性足下垂不应视为轻微并发症。该研究虽然有潜力，但也警告我们，在更常规地应用该手术前，需要进行进一步有对照的研究。

比利时根特大学泌尿系Piet Hoebeke

评论二：

本文作者提供了北美首批腰——骶神经重建术治疗脊柱裂患者的结果。本研究及肖传国先前的动物和临床研究的结果，清楚表明了神经重建术可建立经刺激下肢皮肤的体神经——自主神经（或皮肤——膀胱）反射弧。同样清楚的是，该手术的临床疗效与（肖传国）此前所报告的截然不同。

虽然作者出色地对患者进行了术后追踪、描绘了其术后变化，但在缺乏严格监控的对照样本的情况下，研究结果难以验证。特别是大便功能的改善和微小的膀胱顺应性的改变，可能不具有统计学意义。按肖传国的报告，110个脊柱裂患儿中有87%获得成功，而（美国试验的）大多数患者仍然需要间歇性清洁导尿，没有一个能完全自主排尿，这一事实令人困扰。这些孩子中的大多数不能自主排尿、不能利用新生的皮肤反射弧，在这种情况下，我们不得不怀疑神经移植在这个手术中所起的作用。膀胱顺应性和控尿情况的改善，有没有可能其实是以前一系列大量的临床试验中已经报道过的腹侧S3运动神经单侧神经切断术导致的？【注：这一判断与国内专家一致，即部分患者的改善可能是选择性骶神经切断术而非肖氏手术本身的疗效。另外，国内专家还指出，与肖氏手术同时做的栓系松解术本身就是治疗脊柱裂的常规手术，而神源医院的广告就是“修补+松解+反射弧重建省时省力省钱”、“脊髓脊膜膨出——做两个手术花一样钱”】

我祝贺作者接受这项挑战。我希望，本研究能使神经源性大肠和神经源性膀胱的神经外科疗法得以起死回生、重获关注【注：与“肖氏反射弧”手术类似的神经重建术很早就有人提出，但从未获得成功】。我强烈赞同本文作者意见：此手术应当只能停留在研究框架内【注：指不能临床应用】。

加州大学戴维斯医院儿童泌尿科Eric Kurzrock

评论三：

本试验最古怪的发现是尿动力数据和主观评估之间的矛盾。有位患者膀胱容量减小、反射弧未建立，但他竟然主观上报告大小便功能改善！考虑到这个患者术前的压力性尿失禁，我实在忍不住地猜测，他术后排尿只不过是因为腹内压力施加到扩张了的膀胱颈而导致膀胱排空而已【注：国内专家也作出过相同判断，并认为长期靠腹压排尿会导致膀胱输尿管反流、肾脏反流（肖传国最近透露，小善善就存在这个问题），最终损害肾功能】。肖传国报告说，他的110名患者1年内有超过87%的患者获得了尿感和控尿。相比之下，在肖亲自帮助下做同样手术的这9位患者，却只在客观尿动力学数据和主观报告中表现出不怎么大的改善。除非该手术的发明者拿出可靠的论据和数据证明手术的有效性，不适当地、仓促地在患者身上和医疗界推广应用此手术会有极大危险。

密歇根大学医学院泌尿系John Park

论文见：
Outcomes of Lumbar to Sacral Nerve Rerouting for Spina Bifida.
J Urol. 2010 Aug;184(2):702-7. Epub 2010 Jun 19.
Peters KM, Girdler B, Turzewski C, Trock G, Feber K, Nantau W, Bush B, Gonzalez J, Kass E, de Benito J, Diokno A.
Department of Urology, William Beaumont Hospital, Royal Oak, Michigan, USA.
评论见：
J Urol. 2010 Aug;184(2):417-8.
J Urol. 2010 Aug;184(2):708; discussion 708.
J Urol. 2010 Aug;184(2):707; discussion 708.
国内专家评论见：
2009年12月8日北京科技报《调查神源医院》
科学新闻2009年第23期《众说“肖氏反射弧”》

上月底，肖传国在其科学网博客上发布消息，回应前一阶段《科学新闻》、《中国新闻周刊》、《南方周末》等对其“肖氏手术”的揭露。继三年多前“著名的病人”小善善表演撒尿后，肖传国这次又亮出了小善善当众表演撒尿的照片。

以蹭会议餐度日的八卦骗子陈宽据此造谣，称“方舟子感到穷途末路，只好于两天后自编自导一场电影”，诬陷方舟子遇袭“是一场骗局”。此谎言又经《东莞时报》改编后刊登。

那么，真实情况又如何呢？让我们看看肖传国的描述和照片。

上次小善善表演撒尿是这样的：

2007-05-23 10:40:22　来源: 大河报
“用力，用力！”善善妈妈鼓励说，“咦——”善善叫着用力，又一股尿流了出来。

专家是这么说的：

（科学新闻）泌尿外科医生一看就明白，这是典型的腹压排尿。用力，用力！善善妈妈鼓励说，这就是要善善增加腹压嘛，膀胱的活动我们是不能主观控制的，只有通过增加腹压来帮助膀胱排尿。

这次，不知有没有喊口号“用力，用力！”，但从照片上看，大人帮着压肚子，孩子额头、腮帮、颈静脉鼓涨。

当年，“一遇到媒体来采访，医生就会给善善喝很多水”：

（北京科技报）2006 年8月，善善妈妈带他在河南神源医院接受了“肖氏反射弧”手术。“手术以后，善善觉得排尿时不痛了。但是医生要借助电刺激来辅助善善排尿。当时，有很多媒体报道善善的手术，而一遇到媒体来采访，医生就会给善善喝很多水。医生嘱咐我，由于神经是刚接好的，善善像刚出生的婴儿一样，排尿时需要别人教。”回到海南后，善善总是在妈妈的指导下，尝试用力排尿。但即使让他坐得再久，他也不能排完。同年，小善善回到河南神源医院接受复查。“当时，善善的情况仍然没有好转。医院给我们的回复就是慢慢来。”

这次，肖教授是不是把喝饮料与撒尿的顺序搞错了？

（肖传国博客）小善善排尿后，我特意让护士买了各种饮料，让他想喝什么就喝什么，尽量多喝；同时检查其他病人、并向小善善的爸爸了解了很多情况并和他商量了小善善进一步的治疗。在其后的两个多小时里，小善善一滴尿也没漏，裤子干干的。我告诉小善善的爸爸：不需要再让小善善穿纸尿裤上学了。小善善治疗好啦。

这父母是怎么当的嘛，连小善善不再需要纸尿裤都注意不到，竟然忍心让孩子成年累月甚至在大热天穿厚厚的纸尿裤，还需要肖教授提醒？当然，这可能正是肖壶的神奇之处：一见肖教授就立马有效，“一滴尿也没漏”。

不过，三年多前不是早就“结硕果”、“甩掉了”吗？

“肖氏反射弧”结硕果 海南患儿甩掉尿袋子
2007年05月23日 15:12 来源:郑州大学
术后6个月，大便已恢复正常。不到10个月，现在小善善已能象正常孩子一样排尿，从此甩掉了伴他4年的“尿不湿”和导尿管。

三年多前，肖教授不是早就在论坛上声称小善善“完全好了”吗？

肖传国和他的国内外病人们:让朋友们高兴哈,让敌人们难受哈:-)
送交者: 搬运工 于 2007-04-22 01:13:22
顺便通知jxh一下:谢谢你对河南/海南那小善善的关心.老肖上周让河南医院把他接回免费复查:那小孩大小便已完全好了

既然三年多前“完全好了”，那么，肖教授这次描述的膀胱输尿管反流、肾脏反流怎么会是手术前残留的呢？

（肖传国博客）小善善父子坐车2小时来到海南医学院见我，不出所料:大小便基本恢复正常了，膀胱也慢慢发育了：容量变大，排尿有力，不用做膀胱扩大手术了。唯一残留问题是手术前的膀胱输尿管反流还存在，这导致排尿时部分尿往肾脏反流、二次排尿，但这只需一个非常小的抗反流手术就马上纠正了。

膀胱输尿管反流、肾脏反流真是这么轻描淡写吗？莫非正是专家猜测的，是上次“完全好了”之后长期腹压排尿的造成的恶果？

（科学新闻）做了肖氏手术之后，如果没有效，还是用膀胱压，腹压来排尿，久了之后，对上尿路（对输尿管、肾脏）是有损害的。他要借助巨大的膀胱压力，而不是逼尿肌的压力，久而久之，就可能产生膀胱输尿管反流，肾脏的积水，输尿管的积水会增加，对肾功能是有损害的，危害也是在这个地方。

关于小善善膀胱的容量，肖教授写此博客时，一定忘了他自己三个多月前在科学网博客上是怎么说的：

术前膀胱发炎太厉害导致膀胱疤痕挛缩容量小（100毫升）……现在大小便完全自解，泌尿系完全不再发炎，肾积水消失，肾功能正常。唯一一点是膀胱增大不明显，仍然只能装100毫升左右尿，所以上课要戴纸尿裤，以免万一膀胱满了憋不住。

漫长的四年过去了，小善善膀胱容量从术前的“100毫升”到三个多月前的“增大不明显……100毫升左右”。短短的三个多月又过去了，神奇的反射弧终于显神效，迅速使得“膀胱也慢慢发育了：容量变大”：“小善善自己拉了几百毫升尿”。肖教授，几个月增加到几倍容量，你就不怕吹爆了？【新语丝网友anti代答：“这个是根据需要来的：为了解释戴纸尿裤， 就说膀胱小。为了说拉尿拉的多， 就说膀胱大。”】

这肖壶还有更神奇的：截断了一根神经的手术侧左下肢居然“次要”受影响。这一点如果能被证实，恐怕肖教授就不仅不用“院士暂时不当”，诺贝尔奖都可以“暂时想想”：

（肖传国博客）大家注意：小善善现在主要是右下肢发育和功能受影响，而肖氏手术取用神经的左下肢基本正常。

术后病人下肢到底怎么“受影响”呢？神源医院说得很清楚：

因分离神经术后可能出现相应神经支配区（如：会阴部、下肢）麻木，肌力减退，造成很多病人不敢让受影响的肢体负重，而相应地使对侧肢体代偿其负重任务。久而久之，代偿肢体肌丝增粗，而不敢负重的肢体则变得细弱无力。

彭剑等律师和记者的调查显示，该手术致残率高达39%。而在肖传国等人公开的学术报告中，最严重的一例，发表在近期美国《泌尿学杂志》上，是美国Beaumont医院的9名病人之一，持久性足下垂。这种后遗症肖传国本人此前从未报告过，而是轻描淡写。对此，专家在《泌尿学杂志》的评论中指出：

对于运动机能已经残疾的孩子来说，持久性足下垂不能视为轻微并发症。（Persistent foot drop cannot be considered a minor complication in children who are already motor disabled.）

专家在《泌尿学杂志》上还严厉指出：

除非肖氏手术的发明者拿出可靠的论据和数据证明手术的有效性，不适当地、仓促地在病人身上和医疗界推广应用此手术具有极大的危险。（Unless the innovators provide a sound argument and data for the validity of the procedure, there is a great danger of its improper and rapid adaptation by patients and the medical community at large）

肖教授，你已经在国内搞了十余年、对两千余例病人下过手了，怎么至今连“可靠的论据和数据”都拿不出，只会拿小善善这样的个例来说事？更可笑的是，连这个神源医院唯一的“成功”个例也被你和不良媒体说的漏洞百出！

本文链接：http://xysblogs.org/yush/archives/8136
另见：
“著名的病人小善善找不到了？”——“肖氏反射弧”的虚假宣传和无耻谎言(XYS20091117)
著名的病人小善善找到了！——评肖传国们丧尽天良的虚假宣传(XYS20091210)
新语丝志愿者举报“肖氏术”的公开信(XYS20100301)：
http://xysblogs.org/wp-content/blogs/107/uploads/xpletterc.html

美国《泌尿学杂志》刊登编辑评论，以严厉措辞质疑“肖氏手术”在美国Beaumont医院的试验结果，而Beaumont医院的论文作者在回复中无力辩解。随后，居然有个别反方人士、肖传国追随者仍在反方论坛试图辩解。例如，该论坛版主称：

俺估计有两个可能的原因
送交者: Amalgamator 于 2010-08-11 01:33:42
1、老昏和他的团队的技术要高，就是学习曲线的问题。国外作的还有像老昏说的接着吃使膀胱扩张的药那样让他“哭笑不得”的事情。
2、国内做的多是潜在成功可能高的患者，美国这面看报道至少有些希望不大的患者也作了。

此人还引用肖传国曾多次为国外手术失败而找的借口，称：

记得老昏说过，有些长期使用使膀胱扩张药物的患者（就是抗毒蕈碱？），不适合作反射弧手术，因为新的反射通路可以建立起来，但是膀胱功能已经不行了。还说他为这些患者想了另外的办法。

这是胡扯。

1. 肖传国最初的20个脊柱裂病例，“成功率”都能达到85%。省却了“白手起家”这个“学习曲线”、在肖传国有了上千例经验后亲自指导Beaumont医院，得到的结果竟然与以前的结果“根本不一样”（《泌尿学杂志》编辑评论：”not at all similar to previous reports”）。

2. Beaumont医院并非选了“希望不大的患者”。实际情况恰恰相反。

Peters等在论文中首次公布了其病人尿动力学具体数据（在其一年和两年报告摘要中没有公布），包括平均膀胱容量和平均膀胱顺从度（bladder compliance）：
术前膀胱容量211ml，膀胱顺从度16.1 ml/cm H2O
术后膀胱容量253ml，膀胱顺从度21.8 ml/cm H2O

肖最早的20个脊柱裂病例：
areflexic bladder：
术前膀胱容量117.28ml
术后膀胱容量208.71ml
hyperreflexic bladder：
术前膀胱容量94.33ml
术后膀胱容量177.83ml

肖在上海SIU 2009公布的506个脊柱裂病例：
Non Contractile Bladder：
术前膀胱容量129.1ml，膀胱顺从度6 ml/cm H2O
术后膀胱容量269.9ml，膀胱顺从度12.8 ml/cm H2O
Hyper-reflexic Bladder：
术前膀胱容量72.6ml，膀胱顺从度3.7 ml/cm H2O
术后膀胱容量136.2ml，膀胱顺从度8.96 ml/cm H2O

从术前膀胱容量和顺从度这两项重要的尿动力学指标来看，Beaumont医院选的病人，其状况比肖的病人要好得多，其术前数据甚至比肖的术后数据还要好。这还真说明了，他们的病人确实如其一年报告摘要所言，经过了“广泛的术前病人评估”（“extensive preoperative evaluation”）。

3. 按Peters等的试验结果论文，病人在术后9个月之前就停用了膀胱肌肉麻痹剂（“Antimuscarinics were stopped by 9 months”），其中，9名病人中有4人从来就没有使用过。而且，据Beaumont医院曾大肆宣传但后来失败了的脊柱损伤病人的母亲透露，病人术前即停止或逐步停止使用肌肉麻痹剂（“He was not taking any Ditropan, etc., before the surgery. But the other 2 patients were. They were asked to cut it by 1/3 a week prior to surgery, they will cut again in 3 months and completely stop at 6.”）

更重要的是，按Peters等在论文中公布的膀胱容量数据，使用过膀胱肌肉麻痹剂的5名病人，膀胱容量并未过度扩张；而且，从未使用过的4名病人，反倒比使用过的5名病人术后“效果”更差，前者平均膀胱容量术后一年只比术前增加了10ml，而后者增加了68ml。（注：9名病人中，术后膀胱容量增加的有5人、减少的有4人，且离散程度非常大。另据文献资料，随年龄增长，正常儿童膀胱容量每年增加约15ml。）

将国外手术失败归咎于膀胱肌肉麻痹剂，这其实肖的“老”诡辩。不幸的是，Peters等在论文中公布了具体数据，这个诡辩破产了。怪不得《泌尿学杂志》专家评论认为，“Peters等人的研究首次挑战了肖传国先前发表的85%成功率这个杰出结果”呢（the study by Peters et al (page 702) are the first to challenge the excellent, previously published results of nerve rerouting that showed up to 85% success）。

无论如何，Peters等人并没有采用反方人士的辩解，显然他们心知肚明，知道这样的辩解瞒不过去。所以，他们只好在回复质疑时，指望其三年结果能带来些希望（“Hopefully our 36-month data will shed more light on the clinical usefulness of this innovative procedure.”）。当然，其三年结果如何，可想而知。

肖传国在反方论坛或其博客上曾多次诅咒：“欺骗、利用、残害病人必遭天谴”、“误导欺骗病人必遭天谴”。

现在，“肖氏手术”在国内已被记者、律师及专家彻底揭露，证明是一场残害病人、谋取暴利的骗局。但肖传国及其追随者在国内仍大肆欺骗、残害病人，迄今已加害两千余，每人谋取三万余元。同时又利用国内外信息不畅，欺骗国外医院和研究机构，利用虚假信息招徕病人做试验，且引诱病人来国内做手术，每人收取两万美元，据称至2009年6月“已成功治疗”90余例美国病人。

因此，肖传国的诅咒，应当转送给肖传国本人及其追随者。

【补充】

肖曾于2009年在上海SIU 2009学术会议的演讲中提到德国的“6名患者，仅两例有些改善。可能的原因：病人选得不对？术后护理不当？”，并解释说：“我想，他们选择病人时尿动力学没做对，我想，他们没停用ditropan，如果膀胱代谢失调、容量大到1200毫升，怎么能做这手术呢？”事实上，据德国试验者公布的尿动力学数据，患者术前膀胱容量为346毫升（标准差140），甚至稍小于肖传国最初15例患者的364毫升，更别提什么“大到 1200毫升”了，这表明德国患者并未因肌肉麻痹剂（ditropan）的使用导致膀胱失调扩张。

身为前神源医院股东和郑州大学神经泌尿外科研究中心主任的肖传国，2007年申报中国科学院院士时，提供了一份落款 2007年2月28日的治愈率假证明[1]，声称神源医院自2006年1月开始应用肖氏术治疗患者 117例，“术后随访8个月以上60例，85％的患者大小便已恢复正常”。实际上，根据媒体报道和郑州大学领导的讲话，神源医院直到2006年8月才成立，并于8月13日才对“著名病人”小善善实施了第一例手术，根本不可能“60例病人随访8个月以上”[2]。

假证明被方舟子揭露后，肖传国在论坛发贴[3]辱骂揭露他的中国新闻周刊记者蔡如鹏时，谎称“证明材料在4月底最后上报审核时我发现日期不对，已改过来了”。可惜无论“改”哪个日期都圆不了谎。这次接受南方周末采访[4]，又谎称“神源医院实际成立时间早于8月，小善善也并非第一例，在小善善之前已经做过两三个病人”。可惜这谎言太低级，记者不买账。

肖传国告诉南方周末记者：“如果没有方舟子，我应该早就是院士了。”果真如此，则这是对方舟子学术打假业绩的最大的肯定。不过也难说。说不定科学院偶尔明察秋毫，早发现了这份证明是假的呢。

肖传国吹牛成瘾、谎话连篇，由提供假证明并一再圆谎之事可见一斑。令人惊讶的是，此人居然妄称“欢迎科技界同仁和全国媒体逐条核查方舟子在新语丝网站上发表的对我的所有指控，查到一条属实，奖金五万”。

可笑至极。

参考资料：

[1]肖传国2007年申报院士证明

http://xysblogs.org/wp-content/blogs/107/uploads/shenyuan.jpg
证明
郑州大学神经泌尿外科研究中心，自2006年1月开始应用肖传国教授发明的“人工体神经－内脏神经反射弧”技术，治疗脊柱裂、脊髓脊膜膨出所致的神经原性膀胱患者117例，术后随访8个月以上60例，85％的患者大小便已恢复正常。
特此证明
2007年2月28日
郑州大学神经泌尿外科研究中心

http://xysblogs.org/wp-content/blogs/107/uploads/liyuan.jpg
华中科技大学同济医学院附属梨园医院
我院从2000年起应用人工建立体神经—内脏神经反射弧手术治疗脊柱裂脊膜膨出大小便失禁患者15例，治愈率为80%(12/15)。

http://xysblogs.org/wp-content/blogs/107/uploads/fuyou.jpg
应用证明
上海市虹口区妇幼保健院
我院从2006年4月起应用肖传国教授发明的人工反射弧理论和技术，为12例先天性脊柱裂和3例脊髓损伤所致大小便失禁患儿手术。已获随访10例，8例有效，治愈率80%，能自主控制大小便。

[2]方舟子《“肖氏反射弧手术”治愈率的假证明）(XYS20091029)

[3]肖传国网帖
这蔡如鹏倒是只在这点科学问题上菜了一下，但主要是德性
Posted by: CG
Date: November 11, 2009 09:25PM
有份卫生部的鉴定他想复印，当时又下班啦，就把装订成册的报院士原始材料初稿给他了，让他带走复印完寄来，这狗日的却拿去交给方叉，这不就挑到神源医院那应用证明的日期。我质问他，他发誓没有。可是他不知道这份证明材料在4月底最后上报审核时我发现日期不对，已改过来了。

[4]“有望获诺贝尔奖的手术”？
记者：柴会群
南方周末 2010-04-15

然而此证明却被方舟子的支持者指为造假，因为证明出具的时间是2007年2月，郑州大学神经泌尿外科研究中心（即神源医院）2006年8月才做第一例手术，不可能有随访8个月的病人。更不用说有60例。

肖传国对南方周末记者解释说，神源医院实际成立时间早于8月，小善善也并非第一例，在小善善之前已经做过两三个病人。但此说法仍无法解释证明中“60例病人随访8个月”的提法。

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.