Kipp et al. British Columbia chronic cerebrospinal venous insufficiency (CCSVI) registry: early self-reported benefits are not sustained at follow-up interview. ECTRIMS 2013 Thursday, October 03, 2013, 15:45 – 17:00.
Background: Venoplasty with or without intravascular stents (the
“liberation” treatment) has been proposed as a treatment for multiple
sclerosis (MS) patients with radiologic findings suggestive of Chronic
Cerebrospinal Venous Insufficiency (CCSVI). The purpose of the British
Columbia (BC) CCSVI Registry is to gather information on safety and
efficacy from MS patients in BC, Canada who have received the
“liberation” treatment abroad.
Methods: A standardized telephone survey is used to interview
volunteer MS patients up to 4 times – initial, 6-month, 12-month and
24-month follow-up. Participants are asked to rate their general health
(GH), fatigue level (FL), mobility (M), exercise level (EL) and
procedure rating (PR) on a scale of 5 (1= much better, 2= somewhat
better, 3= same, 4= somewhat worse and 5= much worse).
Results: As of
April 23, 2013, 76 patients completed the first 2 interviews.
Patient-reported outcomes at initial interview (average 15.5 months
post-treatment) and 6-month follow-up (average 21.5 months
post-treatment) will be presented.
Conclusions: The majority of participants’ self-reported benefits in
general health, fatigue level, mobility and exercise level following
CCSVI “liberation” treatment are short term and decline the longer the
time period from treatment. Interestingly, while this self perception
of impact of the therapy declines over time, this perception is less
true when patients are asked to rate the overall procedure (PR). This
may reflect psychosocial and interpersonal issues rather than be a true
measure of treatment outcome.
This study is to be presented next week at ECTRIMS and proably we should not comment until then but it has slipped out.
This short term benefit has been a consistent feature of reports, but it is not sustained. Therefore as the trials are much longer term the chances of finding a success is reduced. If we look at some of the the placebo effects in some trials, this lasts around three months.
You have been pressing Prof G on his beliefs about this aspect of MS, but if you take a step-back and look at the accumulating data.
This is the suggestion as far as I read it.
The original idea that there is 100% concordance of CCSVI and MS and that it is causal in MS is not supported. Therefore, the original view was fundamentally flawed.
Arguments that more recent studies can not support this because they are not using the right new methods of detection seem like goalpost shifting and the original view was not based on newer methods of detection.
Where the radiographic markers attributed to CCSVI are found.
- It does not occurring all MSers.
- It occurs in non-MSers.
- However they occur in more MSers than non-MSers
- The markers of CCSVI increase with disease duration and is therefore likely to be a consequence rather than a cause…
- Many neurologists are sceptical about the validity of the outcome measure. Non-CCSVI protagonists find no evidence of the condition.
What is the therapeutic effect?
- People claim remarkable improvements on social media.
- Remarkable improvements are not universal and no effect is not uncommon.
Therefore if the effect was so obvious it would be easy to detect in small well-controlled studies. Trials would be halted because of the obvious benefit. However so far it appears
- Short term-benefit from venoplasty may be gained but it is often not sustained. Is it a placebo effect? However, there are many testimonies on the web.
- Class I evidence or the value of treatment is lacking
- One clinical US trial (by CCSVI protagonists) was stopped due to apparent worsening
- Second trial halted due to lack of interest (this reason is unbelievable)
- Three other trials ongoing reporting hopefully Soon.
If CCSVI was working I would say great it matters not to me. I would dust myself down and try to move on. If MS is cured, which I hope it will be, there are plenty of neurological problems to adapt ones skill set to
If something dramatic changes, we can change our world view but until then, sceptical is the order of the day.
This is what the weight of data is saying to me, so there you have it. You asked and pushed for opinions and one has now been given, it may be wrong, if it is, I am big enough (literally) to accept this,you may not like it but it is, what it is.
You may have your head in another worldview..but I say “show me the evidence”