I repeat, these clinical trials are underway in the USA right now, and SpraGel is expected to be proven and approved for use in the USA by the end of this year.
Regards, Clare
At Thu, 9 Jan 2003, Dr.Moore wrote:
>
>Man, I do have a lot of free time on my hands.
>
>First of all, I left something out in my previous postings- I do think
>you need surgery if the adhesions cause bowel obstruction. You can die
>from a bowel obstruction, especially if it perforates.
>
>As far as Dr. K, he could easily prove that the Spraygel works. Why is
>he not on the Spraygel website as one of the clinical investigators? It
>sounds like he has more than enough patients and experience. What you
>need in medicine to prove something works is a "randomized, prospective,
>double-blind study with a placebo control." This is the gold standard
>for medical studies. Let me try and explain what this is by breaking
>down each part. The overall idea is to take a large number of subjects
>(preferably people, not rats) and randomly split them in half. One half
>of the group gets one treatment (say in this case Spraygel squirted on a
>surgical site) and the other gets placebo (in this case maybe saline).
>Neither the doctor or patient can know which arm of the study they are
>in (ie "double-blind"). Then you have to have a way to measure results
>(maybe do a second look laparoscopy and have an independent observer
>measure the amount of adhesions before and after). The prospective part
>means that you have to plan this in advance and not "retrospectively"
>look at the data. I know this is confusing- again, whole college
>classes are taught on how to read medical journals.
>
>And some of you may be saying, "These studies are impossible- no one
>would agree to such a study." The simple fact is that these studies
>happen all the time and change medicine all the time. The most recent
>example of a beautifully designed and executed study is the WHI (Women's
>Health Initiative) Study on hormones. 16,000 women took part in a
>double-blind, placebo control study for 5+years.