NIH Stops or Continues to Fund Xiao Procedure Trial?

By xysergroup | 8月 4, 2013

According to the recent update made by Beaumont Hospitals on Aug. 1, 2013, the NIH funded clinic trial “Nerve Rerouting Treatment for Neurogenic Bladder in Spina Bifida” “has been withdrawn prior to enrollment” for the reason that “protocol as presented by investigator was not approved by the NIDDK”. Here we record the reactions from Fang Zhouzi and Xiao Chuanguo.

[1] Translation of Fang Zhouzi’s micro blog.

2013-8-3 09:00

The U.S. National Institutes of Health (NIH) has withdrawn the “Xiao Procedure” clinic trial, the reason is that “protocol as presented by investigator was not approved by the NIDDK (the funding agency)” The Xiao Procedure trial in the U.S. comes to a dead end. Not long ago, Xiao Chuanguo still bragged on Southern Metropolis Daily that “the Xiao Procedure has been carried out in several universities in the U.S., with very good results. this is the only one surgery learned by U.S. from China.”

[2] Translation of Xu Peiyang’s blog (deleted under the pressure from Xiao Chuanguo)
National Institutes of Health (NIH) Withdrew “Xiao Procedure” Clinic Study

2013-8-3 09:23
On Aug. 1, 2013, National Institutes of Health (NIH) Withdrew the “Xiao Procedure” clinic study. The reason is “protocol as presented by investigator was not approved by the NIDDK.”

[3] Translation of Xiao Chuanguo’s blog (ranked the top most of the Hottest ScienceNet Blogs, recommended by 44 persons)

The NIH Extends the Inclusion Criteria to Further Assess the Effectiveness of Xiao Procedure, Continues to Fund the Xiao Procedure Study

2013-8-3 13:54

Thanks Xu Peiyang for removing the blog post containing misleading information. I was at first reluctant to waste time to talk about it before the US results being officially published.

The truth is:

1. The NIH has determined that Xiao Procedure is safe, therefore the safety assessment of the original study [translator’s note: from the context, “the original study” refers to NIH sponsored NCT01096459] would no longer be needed.

2. The NIH has determined that, so far the amount of SB cases and the results of Xiao Procedure can sufficiently draw statistical conclusions, so that this study does not need to increase the number of cases (otherwise there would be another 3 years of delay to complete the study). Therefore, the NIH has withdrawn the original plan funding 15 more cases, but instead continues to proceed and to fund the study in the name of the current title and contents [translator’s note: from the context, “the current title and contents” refers to that of 2006 study NCT00378664].

3. The NIH has determined in principle the efficacy of Xiao Procedure on the bowel and bladder disorders caused by spina bifida, and requires the new study [translator’s note: from the context, “the new study” refers to NCT00378664] to add research to further assess the level of improvement of Xiao Procedure on urinary incontinence caused by SCI and other diseases. (level of improvement, note: not to assess whether or not effective, but the level of improvement)

It’s realy funny to look at those clowns and Fang Zhouzi barking on the “withdraw”. After I first saw this on the microblog this morning, I deliberately waited for and finally saw Fang Zhouzi jumped into the mud :-) This Dr. Plagiarism who lives on Baidu [translator’s note: the predominate Chinese search engine], actually too stupid to understand even basic medical search.

[translator’s note: omitted the following the screen shot of the NCT00378664 web page]

Topics: Xiao Chuanguo, Nerve rerouting |

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