Sunday, May 18, 2008

I cannot find any evidences that the ReBuilder actually works

I have had more people ask me about the ReBuilder. It claim itself as the new treatment for peripheral neuropathy. Here is the claim on the home page of the company:

The ReBuilder®
The company knows the suffering of people with peripheral neuropathy and this list is directly targeted at the PNers. They have promised to Relieves your pain and numbness, and that goes together with to Restores the feeling in your feet and hands and to Help you sleep all night. They know lots of PNers have impaired balance and mobility, so they promise to Restores your balance and mobility. The consequence of pain reduction should lead to another promise and to Reduces or eliminates pain medications. It is very nice of them to throw in some specifics, such as to Eases nerve pain from shingles & sciatica. And if you Used with the footbath, toenail fungus is eliminated. It is also FDA Approved.

I have searched their websites, I did not find any hard research evidence for anything they said the device will do. They have a long monologue on the site and trying to prove this thing really should work. But, "should work" is a long way from it actually works.

About the FDA approved statement, I have found the following sentences on their website:
"It is registered under the 510K basis as both a TENS and an EMS, (which is the only two categories that the FDA offers). The FDA does not approve any medical device, the FDA only 'approves' pharmaceuticals." Well, I wonder what they meant when they typed the words "FDA Approved" on the front page of their website.

The company is conducting an "ReBuilder Evaluation Study". I have found the "Enrollment Form" on their page. But be aware if you want to enroll yourself in the study. You need to sign the form and declared that "I have not been promised any particular clinical outcome". And also be aware that any credible clinical study should randomly enrolled and conducted with a double blind experiment design. I cannot find any approval for human subject protection, which is federal mandate for research involves human subjects.

The bottom line is this product promise a lot. It has no scientific evidence to prove its effectiveness. It "FDA approval" is a lie, said so by their own statements. If it had worked for 16 years as the company claimed, I encourage them to conduct serious clinical trials to prove its effectiveness, as many other medical devises have gone through.

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