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I'm not sure why all of these trials should be designed to see if treating CCSVI stops progression. I would think it would be enough to initially open up veins to help alleviate fatigue. That way the end points would be shorter and the treatment would be available much sooner. Following treated patients over the long term to assess levels of progression and number of relapses could just be built into the study.

If an endpoint of, eg, 3 months was set and significantly reduced fatigue was found in the tested group, it would unethical to not treat the control group. Almost all MS patients have some fatigue, don't they?

As part of our writing campaign, perhaps we should strongly suggest shorter endpoints as well the longer endpoints. Maybe that's already part of the plan.

Just wondering what everyone else thinks about this.

Theresa

seems like the drug trials are not required to prove a cure - just a reduction in relapse rate (with minimal undesireable side effects).

Drug trials set endpoints. It just seems that setting fatigue reduction as an endpoint would make the treatment available faster, at least in Canada.

I think you are absolutely right, TFau. Reduction of fatigue is huge, I'd consider it worthy of being an endpoint in itself...I earlier suggested that warm feet could be an endpoint! But I wonder if fatigue is considered not significant enough, by someone designing a study who has never experienced m.s. fatigue (just like someone who says, "Oh, I'm depressed," without much understanding how true depression feels.) I suppose it could also be harder to trust the measurement of fatigue given by the patients, as opposed to lesions that are measurable and verifiable.

Cece,
I would be a new woman with warm feet, hands and nose and yes, no debilitating fatigue!!! Just controlling those symptoms themselves would be huge!

All I realy want out of my CCSVI treatment is to rid me of the fatigue and to stop any further progressions. I am not saying this is a cure but a really big fix of devastating symptoms.

val

Cece wrote:I think you are absolutely right, TFau. Reduction of fatigue is huge, I'd consider it worthy of being an endpoint in itself...I earlier suggested that warm feet could be an endpoint! But I wonder if fatigue is considered not significant enough, by someone designing a study who has never experienced m.s. fatigue (just like someone who says, "Oh, I'm depressed," without much understanding how true depression feels.) I suppose it could also be harder to trust the measurement of fatigue given by the patients, as opposed to lesions that are measurable and verifiable.

I thought that I read somewhere that fatigue is the number one debilitating symptom of MS - both in the number of people who have it and the disability it causes. Isn't it the biggest reason why pwms have to stop working? Is there a rating scale for fatigue, like the EDSS? For my husband, who has ppms, we never consider fatigue as being his worse symptom, but it is definitely there.

I just can't stand the thought of having to wait for 3 years for a trial to tell us if treating CCSVI actually alters progression before the treatment is offered. While it will be great if and when that is proven, at this point it seems more like intellectual curiousity considering that many people have noted immediate relief of symptoms.

TFau, I think you have a really good idea here. I think one reason the drug trials never look at fatigue as an endpoint is that the drugs never address fatigue as a symptom. I think Zamboni called fatigue an "orphaned" symptom because no treatment has ever had an effect on it.

My fatigue was totally related to thyroid. I finally had a smart Dr. that ran a full thyroid panel and discovered that I had virtually no T3 in my system... my TSH was always fine, but I was not converting T4 to T-3 properly. Being on the right medication turned my life around as far as the fatigue,, and now I have learned that the thyroid is the first to be affected by iron overload... I don't think they are doing anywhere near enough investigation on metabolic problems before proceeding with CCSVI

My husband has PPMS. We raised the head of our bed as per Andrew Fletchers instructions 4 weeks ago today so that the head was about 7 inches higher than the foot. From the 3rd day my husband had warm, pink feet, where normally they have been purple, puffy and freezing cold. We are hoping/noticing other small changes too, however too early to say definitely that they are here to stay. Didn't cost us anything to do and that in this age is definitely saying something!

I would say fatigue can be one of the most debilitating aspects of this disease. Some days I have very little fatigue. But others it can come on all of a sudden and so severe that I think I'm going to pass out. When I first was diagnosed and read about fatigue. I thought to myself ok I'll be tired so I'll need to rest more. But I didn't think that it can be so awful. I mean so bad I feel physically ill. Feeling tired and feeling MS fatigue is two completely different things.

Tired and MS fatigue are definitely 2 different things. People will say to me "I feel tired too" I respond that this is way past tired. It is like I get up from a night's sleep and feel like I haven't slept in a month.

Val

It kind of rings hollow when one reports the number one improvement post-op, to be siginificant fatigue reduction, but wanted to echo that yes, indeed, it IS a significant, overarching symptom that affects every waking moment on a daily basis, some days better than others, but no days can be considered zero-fatigue days either. That's my POV only.

Post op, my days are measured by how little time I have to get things done, that's 180 from this time last year, where I sought to engage as few activities as possible, ostensibly to "conserve energy", which as most here are aware, is a lose-lose proposition, for if this paradigm is correct, and I presume most of us consider it at a minimum to be highly relevant, resting can in fact exacerbate the problem, all discussion of inversion type therapies aside for now.

Naps, why bother? Feeling worse or only a tiny bit better on waking, means that hours are wasted for nothing. Best to slog one's way through the day and do what you can do.

If I had to rate my own reduction in fatigue, I would put it at 75-90% depending on the day, and that is without any significant lifestyle changes whatsoever, which may very well easily cover the remaining 10-25%, and of course factoring in that I'm 40 not 18, and raising 3 small children.


Yes, this is anecdotal, cannot be measured in any way (fatigue that is), other than a self assessment, which means that we'll have to go with what the majority of patients have attested to in this regards.

I outrun my 3 and 7 year old, put them to bed at night, wake them up in the morning, feed them, clothe them, play with them, juggled all of that plus extracurricular stuff, while having child number 3 a few weeks ago in a hospital 35 miles from home, and never missed a beat, got lost, forgot a name, used a post-it-note, or failed to enjoy every moment of our last child, my son....

And to that, I give my stented veins all the credit....

Mark

CureIous,
I got tired just from reading what you do!
Glad you're the energizer bunny!
keep it up!

COngratulation... for your new born curious! I'm very happy for you now that you can fully appreciate every moments...

I'm gratefull to you, because you took time of yours to buit the new alliance for ccsvi!


barbara