'Clinically proven' - what should it mean?

I recently came across information about a cooling mat for dogs and cats. AniMat Cool Gel Mat™ (AnimAlarm®, http://theanimalarm.com/animat-cool-gel-mat/) which the company says “uses a unique patented gel that stays cool automatically with no activation”. Well of course this pricked my interest because I started to think about ways in which we could use this in the clinic.

For example let’s say we have satisfactorily implemented active cooling* in a heat stroke or hyperthermic seizure patient, could the patient then be kept on such a cooling mat for a while – we do recommend they are kept on a surface that will allow further conductive heat loss, why not this mat? Or in practices in which the environmental temperature control is not great, could this mat help with keeping in-patients cool? Can you think of other scenarios?

[* On a tangent…Although I am not aware of any kind of randomised controlled veterinary trial, current recommendation is to employ evaporative cooling by soaking the patient in cool but not cold water and then applying an effective fan, topping up the wetting as necessary; no spirit on pads, no ice packs; stop active cooling before temperature normalises to avoid rebound hypothermia.]

Naturally I then visited the website looking for more information and hopefully some kind of evidence of efficacy. On the website it says:

“Clinically proven to lower a pet’s temperature by direct touch, the AniMat will keep your pet cool and comfortable for hours, reducing the risk of potentially life threatening effects of over heating from heat-stroke, stress, dehydration,lethargy and loss of appetite.”

So I emailed the company keen to find out what the evidence is for this product being ‘clinically proven’. And this is the reply I received from a Director of Animaware Ltd:

“In answer to your question, both the manufacturer has tested the mats and we have also done our own trials with dogs with them, we have had very positive results. We are in the process of putting all the information together in a proper format which we can send you on completion, this will include our trials and thermal images. (We have trialled them with dogs with a high temperature, their temperature has returned to normal within 20 minutes.)”.

Now I think we can be pretty sure that by robust evidence-based (EBVM) principles the information available will fall short – I might be wrong but I doubt it, how far short remains to be seen. Nevertheless I look forward to receiving it.

According to the promotional piece “[the mat] uses gel technology that has previously been used in cooling bedding and pads for humans”. In the context of cooling hyperthermic humans, cooling blankets have been evaluated but these have either water or air circulating through them which helps to remove the heat from the body. Some are gel-coated but they are still circulating-type blankets.

In fairness the company here have not so far tried to promote this cooling mat to vets as a treatment for heat stroke (to my knowledge they haven’t anyway) and I probably would not have given the whole thing much more thought had it not been for those two words ‘clinically proven’ – not that I am slightly transfixed on the need for evidence or anything!

By what criteria can a product/therapy be said to be ‘clinically proven’?

Should one be able to say a product is ‘clinically proven’ without first producing the evidence for review by an appropriate body/committee/organisation?

Of course this is going to take us down a whole other path in terms of freedom on the internet and even in promotional material but it is something that caught my attention.

What do you think? Am I being unreasonably critical?