Double Blind Trials ???????????

Everyday living
1

Could someone clarify; in ‘New Pathways’ it states in an Italian study has found 76% of MS patients compared to 16% of controls had CCSVI published in BMC Neurology February 2013.

While the MSS state: First results from key NMSS-funded CCSVI studies

Published date: 15 Mar 2013 at 10:20AM

The first of seven CCSVI studies funded by the National MS Society and the MS Society of Canada has published its results, which showed no increase in prevalence of CCSVI in people with MS.

Researchers from the University of Texas Health Science Centre at Houston used sonography techniques to measure blood outflow from the brain to establish whether any of the participants in the study fulfilled the criteria for CCSVI.

276 people were assessed for CCSVI (206 with MS and 70 without). The researchers found that CCSVI was present in 3.88% of people with MS and 7.14% of people without MS. These results showed no significant differences in blood flow rates between people with MS and people without.

The results were published in the journal Annals of Neurology.

Questions arise from these reports but mainly how can two completely different trials have findings so different? I personally have no interest in CCSVI (Snake Venom is my forte) but it does seem to ridicule double blind studies.

George

2

The answer to your question, George, is that the two studies do not appear to be comparable in any way.

The UTexas study seems to present everything that a well conducted study should. The abstract is so clear that the study could be repeated on the information in the abstract alone, and the statistics are absolutely clear as to the findings. The methods used to determine blood-flow are clearly identified. And, most importantly, UTexas at Houston does not have a vested interest in CCSVI.

The study in New Pathways is exactly the opposite. As a journal, it is noted for being pro-CCSVI and pro-vitamin supplements (and not much else). The actual study has not yet been published (as far as I can determine) but the Headline results have been released to a number of pro-CCSVI sources. No meaningful statistics have been given, and the researchers have a vested interest in CCSVI, as they carry out the procedure at their clinic. It is not clear if any measures to determine blood-flow were used, only a measure of constriction in the relevant blood vessel(s).

In a nut-shell, it would be like comparing maximum speed of a Ferrari, with the miles-per-gallon of a Smart-car. Not really a lot of use. What could be more interesting (and informative) would be to compare all the published results of studies into CCSVI and see how many of them broadly agree, and how many were anomalous.

Geoff

3

I have been watching the studies into CCSVI for some time and so far as I can see there is little similarity between the results and they are so different that they give little assistance to anyone in coming to a conclusion if it is something people who have a diagnoses of MS should do.
There are a number of vested interests involved.
People make money out of providing treatment for CCSVI.
Neurologists make money out of treating MS and would lose some of that money if people with MS found benefit from having CCSVI treated. However there is also a professional pride issue with neurologists, imagine them having to admit most of what they had said about MS was garbage.
The drug industry would lose a lot of money if people with MS dropped drugs in favour of treatment for CCSVI.
However all that would be equally true if other treatment options were considered. you mention snake venom, same story there really vested interests in the supply of it and vested interests about drug sales if snake venom became universally accepted.
Till science become the driving force behind clinical trials rather than vested interests then I see them as virtually useless to the layman to make decisions on concerning any treatment.

4

Thank you both for your comments. I have no idea about how much regard the publications each journal these statistics are.

I presume the MS-UK (MSRC) information states the BMC Neurology (BMC I presume stands for British Medical Council?). The MSS info was from Pub Med that I know is well respected.

I think I’ll stick with my Snake Venom that costs me about £60 for 4 years supply. No one is ripping me off and before someone say’s there’s nothing in it; I don’t think a Placebo would last 32 years even if it did I’m happy.

I thought Dr. Gilhooly was a marvellous advocator for LDN until I saw him in an interview about CCSVI and wondered where his horse was as he came over as a cowboy; why oh why do people do it?

Obviously eventually science WILL find the cure for MS; let’s face it they have not come far since Charcot first discovered MS as a distinct disease in 1860.

George

5

No I do not think placebo is the general reason for unapproved treatments working, I think you need a reasonable number of reports to eleminate placebo as a possibility. As for CCSVI ithink I would give it a go if I had MS and could afford it, the big issue is that it needs repeating every now and then so it depends how often in your case i.e. if they block after a week or two as can happen then it’s probably not viable to repeat it once a month but if it last a year or so then maybe it is worth giving it another go.

6

George, pubmed is one of several databases that list the same academic publications and conference procedings. (Alternatives are web of knowledge, sciencedirect, etc.) Finding something on one of these databases is no guarantee of how good it is though.

Most good research is published as an article in a journal. If something is not published, it may simply be too soon and the researchers are still writing it up, but not being published is often a sign that the research is “not of publishable quality” (in other words, it sucks).

How good a journal is depends on a number of things, not least of which is how good the quality of research needs to be to get into that journal. For example, to get published in the journal “Science”, a paper normally needs to be groundbreaking and of internationally acknowledged high standards because Science has a very high standard to maintain. But, notwithstanding the “not of publishable quality” comment above, almost anyone can get a mediocre or even poor study published in some journal or other that has an editor who isn’t as fussy and is much more desperate to fill an issue (which probably has damn all readers!). [Watch out for research published as a letter - it’s sometimes used to get something published when the research isn’t good enough to warrant it!]

So not all journals are equal.

Sometimes, a really good piece of research ends up being published in a lesser known journal, but on the whole, better research gets published in better journals. And all research is absolutely, definitely not equal.

So, two key things: quality of the source (typically a journal) and quality of the research.

Telling the quality of research takes years of training. On the whole, large scale studies, tight controls, double blinding, transparent methodology and analyses, and clear measures agreed up front are good signs. If you consider these (and other) factors, it is relatively easy to see which CCSVI trials are worth listening to. The U of Texas trial is.

Unfortunately, some people find it impossible to read research papers with any objectivity, instead choosing to believe the studies that fit with their own beliefs and dismiss the studies that do not. Some even resort to disbelieving the whole system because it’s not telling them what they want to hear - a sure sign of narrow-minded ignorance :frowning:

Karen x

PS Where were you the other Sunday? You keep missing lunch at The Wheatsheaf!

7

Easy to say, David, when you don’t have MS.

8

Let’s add a bit to Karen’s comments.

George, BMC does not stand for British Medical Council. It stands for BioMedCentral.
BioMedCentral are British based, but owned by the German Springer organisation. They claim to host 250 online journals, and they charge an “Article-processing Charge” for each article published, and authors get to nominate their own reviewers.

The Article-processing Charge is around £1500 (if you have the readies, you can even start your own journal) so it is a good place to go if there is something not quite so good about your paper. See Karen’s comments, above.

And, of course, you guessed it, there are one or two things about that particular article that would raise an eyebrow or two.
Two things leap out as you read it:

  • One of the authors was also the person who carried out the scans. Hence, it could not have been a true double-blind study.
  • The statistics section reveals what is normally called a “Shotgun” approach. This term is used when researcher subject their data to every statistical test that they can find, in the hope that the result will be significant. The end result is that some “highly significant results” (those with a probability value with 2 or more zeros after the decimal point) are not identified as being obtained by any specified statistical test. If an undergraduate tried this on in a term paper, the resultant mark would be very low indeed.

In short - trust the UTexas paper, do not place any value on the BioMedCentral one.

The CCSVI/ Dr Gilhooly isue is something else altogether. Back last year when EJC was promoting an “interesting” dentist, there was a comment in one thread that the Essential Health Clinic were getting better results with TMJ (and hence the dental approach) than with CCSVI. I have noted that one of the supporters of that particular dentist has also appeared with Dr Gilhooly at a so-called CCSVI conference recently.

Geoff

9

Thank you Karen and the good doctor; puts it in perspective; the power of the press eh! I hope there’s something in Leveson that will stop this type of reporting but methinks perhaps that is asking too much.

Many moons ago when I was diagnosed there were no MRI; no different types you either had MS or did not. Although I said in my last message; “not much progress since Charcot” one can’t help but feel in the air Stem Cells will be the cure without the cause known.

As far as the Wheatsheaf definitely be at next one. Apart from meeting old Mark and very old Val nice to see you and your O/H.

George