After all, we have been quite vocal about the fact that we are not treating MS.
Let's get that one out of the way first. You are so.
The test for efficacy: I think you should use something out of the variety of MS symptoms, and use that as an end point for this treatment. Something that most or many MS people have, like clonus or numbness. Admit to everyone and yourself that you are treating MS by treatment of veinous insufficiency, because you believe that much anecdotal, and significant experimental evidence is now available, enough to justify further experimentation. Be honest, because if you're only treating CCSVI, you'll have to limit yourself to things like pressure, flow, and diameter.
If you want a hint, I get twitchy, jumping legs when *they* (my legs) are physically hot. A hot blanket, a hot laptop, it doesn't take much. Bet I share this with quite a few.
For testing, why not just open your practice to first-come, first-served treatments, and make your control someone some way down the list. Test them before the treatment of the ones ahead of them in the list, so they can act as controls, and test them again before their treatment to see how they compare to the first test.
You don't even need to use the same people as controls all the way through, you can select another control and treat the previous one. As long as the number of controls (plus maybe sex and age) stays the same. I don't even think their MS status matters, but keep them all the same if you want.
Shouldn't you even be able to extrapolate or average them or something so time they spent as a control doesn't have to be fixed?
The controls can continue their existing medication or start a new one, just as long as it doesn't change after their randomization counterpart is treated. Or would that invalidate stats?
I don't think it should matter what other medication they are on, but if you want you could probably get a matched pair of those too. There are a lot of us who would probably sign up, especially, if it means they don't have to fly to Poland.
You have said yourself you are comfortable with the association having been established, haven't you?
As far as placebo goes, I am so happy this is being discussed. I really feel strongly about it myself, but there are probably others here, who are more qualified and/or have better ideas. All I have is unfortunate experience.
The written material on this topic (even the Cochrane studies used placebo as a control) has to meet scientific standards as strict as the ones we hold ourselves to, but it is starting to come out of the woodwork.
Thanks, everybody, for working on this problem. It's important.