Thread: exciting news!
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Old 08-14-2014, 07:55 PM
Neurochic Neurochic is offline
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Join Date: Sep 2011
Posts: 246
10 yr Member
Neurochic Neurochic is offline
Member
 
Join Date: Sep 2011
Posts: 246
10 yr Member
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I'm not going to reignite the calmare debate because its just not worth it. There are few things on this board in the 6 years I have been reading and posting here which have caused so much argument. I will try and explain why you are likely to have lots of problems getting any insurer to fund this "therapy".

The FDA formal approval (which is the only reason it can be legally used or sold as a medical device in the USA) that was given for this "therapy" is for a simple TENS machine. The FDA approval it has is only granted based on the fact that the manufacturer has stated that it is the same as existing, listed models of TENS machines already on the market. That is how they get round having to do years worth of clinical trials which are necessary if a manufacturer is trying to licence a genuinely novel medical device. There documents are all filed and publicly available so you can go to the FDA database and check them out for yourself if you are interested. People will argue endlessly that it's not a TENS machine but the facts, as filed with the FDA by the inventor/manufacturer themselves, are irrefutable.

There is extremely poor evidence that it works. People who believe in it will point you to all sorts of articles but none of these are the properly conducted, peer reviewed, published clinical trials demonstrating any efficacy. There are also issues of bias or financial interest attached to most if not all of these. Properly conducted, robust, published clinical trials patients are the are the kind of evidence that doctors and medical insurers look for to determine efficacy, safety and value for (their) money. You will see anecdotal stories from people who think Calmare cured or helped them but anecdotal stories are not the same as an objective, reproducible, evidence base.

There are now, however, a number of published, peer reviewed clinical trials which have been carried out using ketamine in CRPS patients. Certain protocols using ketamine are no longer regarded as experimental in mainland Europe where it is now regarded as a standard form of treatment for those CRPS patients who don't sufficiently respond to other treatments. The largest issue with the clinical trials to date is that it's not possible to "blind" a ketamine trial because it is always obvious whether a patient is receiving ketamine or a placebo.

Ketamine has the additional advantage that it is a drug that has been used in humans and animals for decades utilising an intravenous delivery system so its actions and safety profile is already extremely well known. It is a cheap drug and whilst patients need to be monitored whilst it is delivered, it is relatively uncomplicated, especially at lower doses so the potential risks and claims that insurers need to factor in are limited. In the last 6 years US insurers have increasingly been prepared to fund various protocols involving ketamine for CRPS patients so it has shifted from being regarded as purely experimental.
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"Thanks for this!" says:
eevo61 (08-14-2014), Jimking (08-19-2014), KetamineCoordinator (10-04-2014), RSD ME (08-22-2014)