Page 2 of 3
Posted: Thu Apr 01, 2010 4:40 pm
by ozarkcanoer
A lot of current surgical procedures were perfected during wars on severely wounded men in mash units. No clinical trials there !! Think "M*A*S*H". Think WWI, when they started blood transfusions. Think WWII.
ozarkcanoer
Posted: Thu Apr 01, 2010 5:21 pm
by fogdweller
Surgical procedures are generally compared to other "standard of care" treatment. Often they are applied either simultaneously with the standard of care, i.e. additional care, or on patients where the standard of care is inapproprate. This creates all kinds of difficulties, but is sometimes the best than can be done, and if the effect is strong enough doctors will begin to use it and the new procedure may become the standard of care. The true double blind study is a drug type study, not surgery. Even if someone were the subject of sham surgery, the surgeon would know who was sham and who was real, and some involvement with the surgeion is required.
If it is applied simultaeously with the standard of care, the two might be incompatible. If for example (pure hypothetical) angioplasty on someone taking beta interferon created problems, and beta interferon was the standard of care so it ethically had to be administerd, that would create a clear problem. On the otherhand, if it was only applied to those who for some reason could not or would not take the beta interferon, you clearly would not have a random sample of patients.
The FDA has expert panels that take all this stuff into account when they approve trials, and an FDA approved trial may result in an approved device or drug that doctors can use if they want to, but the "proof" may not be the double blind gold standard. For example Dr. Dake and Dr. Zamboni were willing to apply treatment (antioplasty, or liberation procedure, and sttents respectively). They write articles and publisize their experience, and other doctors can use the procedures if they want.
Off label use of drugs or devices is also common. There are no stents approved by the FDA specifically for veins, I think (I am not too sure) but any doctor is free to use arterial stents on veins as an off label use. Similarly drugs may be used off label. I take tegretol for pain, and in fact that is a common and oft use for that drug. To date I don't think it is FDA approved for that application, but pain doctors are free to prescribe it for that use if they want.
We MSers are reacting a little, I think, to the resistence being voiced by the neurologists that there is no evidence that CCSVI is real, no double blind studies have been done. That is not correct. Ancetodal evidence is, none the less, evidence. Just not as convincing to some people. I think the evidence and the scientific evidence just makes so much sense that doctors who study it will apply treatments as they can. That after all is what Dr. Dake was doing and what Dr. Zamboni was doing, and what all the doctors treating CCSVI are doing.
Please forgive the long rant.
Posted: Thu Apr 01, 2010 5:41 pm
by Lyon
.
Posted: Thu Apr 01, 2010 7:03 pm
by TFau
Are there not limits on the placebo effect? If the effect is caused by endorphins or the like, it must diminish at some point. Why not treat a bunch of people and see if any improvements last, say, 6 months. Surely that would be significantly longer than any placebo effect. I'm sure that my husband would undergo angioplasty even if it meant only 6 months of some relief, even if were a placebo effect.
Posted: Thu Apr 01, 2010 7:45 pm
by Lyon
.
Posted: Thu Apr 01, 2010 8:27 pm
by TFau
Thanks Lyon, I saw Eric's thread after I posted my question on here. It's interesting (to me anyway) - when I was in grad school about 15 years ago I went to a medical-type presentation, and 30% was quoted as the possible efficacy attributed to the placebo effect. It seems to be the accepted number (of the maximum placebo effect observed).
It would be nice if we could compare the CCSVI situation to something that has happened before. It's not the "test the drugs in animals then do a double blind large study in humans and find that the placebo showed a 23% reduction in relapses and the active showed a 30% reduction in relapses, say the efficacy is statistically significant, give it to everyone, and assume it will work (*ahem* copaxone)" scenario. Nor is it a scenario where someone's appendix is about to burst, a doctor takes it out and the person lives - so doctors keep on doing that without needing a rigorous, scientific study to show it's somewhere in between. CCSVI treatment is somewhere in between. Unlike a pharmaceutical which can interact unpredictably with any number of biological in vivo elements, stenosis of the veins can be seen. Opening of the narrowed veins can be seen. Reflux has been observed. And the anecdotal evidence about the benefits of treating CCSVI is piling up.
fogdweller wrote:We MSers are reacting a little, I think, to the resistence being voiced by the neurologists that there is no evidence that CCSVI is real, no double blind studies have been done. That is not correct. Ancetodal evidence is, none the less, evidence. Just not as convincing to some people. I think the evidence and the scientific evidence just makes so much sense that doctors who study it will apply treatments as they can.
I agree with Fogdweller that anecdotal evidence is evidence. It may be weaker than evidence from a double blind study (if one were possible) because (i) the credibility of the evidence has to be considered, (ii) any placebo effect has to be taken into account, and (iii) the percentage of improvements is difficult to assess without a controlled reporting scheme. However, these are not reasons to completely discount the evidence, they are just factors to consider when weighing the evidence. I, for one, have found the reports from other people to be very compelling. I don't think that's being unscientific. Nor do I think vascular surgeons who understand the low risk of angioplasty and are swayed by reports of patients and colleagues on the benefits fo CCSVI treatment are being unscientific or unprofessional.
Sorry for rambling. I was really just interested in knowing if anyone could think of a medical treatment situation from the past that is analogous to this one? It would be interesting to see how it was handled.
If the CCSVI treatment situation is unique, there should be an unique solution for determining whether it can be offered to the masses. It must be unique at least in the sense that a whole new medical field is involved, and the original dominant medical field (neurology) is now essentially in observation mode.
Posted: Thu Apr 01, 2010 9:19 pm
by Cece
TFau wrote:It's interesting (to me anyway) - when I was in grad school about 15 years ago I went to a medical-type presentation, and 30% was quoted as the possible efficacy attributed to the placebo effect. It seems to be the accepted number (of the maximum placebo effect observed).
Isn't the number of people reporting improvements, at least on a self-reported basis here, far greater than 30%? That makes placebo seem less likely...or do I not understand placebo?
TFau wrote:I was really just interested in knowing if anyone could think of a medical treatment situation from the past that is analogous to this one? It would be interesting to see how it was handled.
I'd be interested in this as well, but can't think of anything other than the paradigm-shift of ulcers being caused by bacteria....
Posted: Thu Apr 01, 2010 10:05 pm
by eric593
This is one that comes to my mind:
N Engl J Med. 2002 Jul 11;347(2):81-8.
A controlled trial of arthroscopic surgery for osteoarthritis of the knee.
Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP.
Houston Veterans Affairs Medical Center, Baylor College of Medicine, Houston, TX 77030, USA.
Comment in:
N Engl J Med. 2002 Jul 11;347(2):137-9.
N Engl J Med. 2002 Jul 11;347(2):132-3.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
N Engl J Med. 2002 Nov 21;347(21):1717-9; author reply 1717-9.
J Bone Joint Surg Am. 2003 Feb;85-A(2):387.
ACP J Club. 2003 Mar-Apr;138(2):49.
Curr Womens Health Rep. 2003 Feb;3(1):63-4.
Summary for patients in:
J Fam Pract. 2002 Oct;51(10):813.
BACKGROUND: Many patients report symptomatic relief after undergoing arthroscopy of the knee for osteoarthritis, but it is unclear how the procedure achieves this result. We conducted a randomized, placebo-controlled trial to evaluate the efficacy of arthroscopy for osteoarthritis of the knee.
METHODS: A total of 180 patients with osteoarthritis of the knee were randomly assigned to receive arthroscopic débridement, arthroscopic lavage, or placebo surgery. Patients in the placebo group received skin incisions and underwent a simulated débridement without insertion of the arthroscope. Patients and assessors of outcome were blinded to the treatment-group assignment. Outcomes were assessed at multiple points over a 24-month period with the use of five self-reported scores--three on scales for pain and two on scales for function--and one objective test of walking and stair climbing. A total of 165 patients completed the trial.
RESULTS: At no point did either of the intervention groups report less pain or better function than the placebo group. For example, mean (+/-SD) scores on the Knee-Specific Pain Scale (range, 0 to 100, with higher scores indicating more severe pain) were similar in the placebo, lavage, and débridement groups: 48.9+/-21.9, 54.8+/-19.8, and 51.7+/-22.4, respectively, at one year (P=0.14 for the comparison between placebo and lavage; P=0.51 for the comparison between placebo and débridement) and 51.6+/-23.7, 53.7+/-23.7, and 51.4+/-23.2, respectively, at two years (P=0.64 and P=0.96, respectively). Furthermore, the 95 percent confidence intervals for the differences between the placebo group and the intervention groups exclude any clinically meaningful difference.
CONCLUSIONS: In this controlled trial involving patients with osteoarthritis of the knee, the outcomes after arthroscopic lavage or arthroscopic débridement were no better than those after a placebo procedure.
PMID: 12110735 [PubMed - indexed for MEDLINE]
http://www.ncbi.nlm.nih.gov/pubmed/12110735
Posted: Thu Apr 01, 2010 10:14 pm
by fogdweller
TFau wrote:Sorry for rambling. I was really just interested in knowing if anyone could think of a medical treatment situation from the past that is analogous to this one? It would be interesting to see how it was handled.
I think almost any new surgical procedure is sort of like this.
Keep it simple stupid
Posted: Fri Apr 02, 2010 7:13 am
by MarkW
I guess you have heard of the KISS (Keep It Simple Stupid) principle. It works for me cos I am a simple soul.
Step One show a correlation between CCSVI and MS. BNAC should publish this data later in the month, job done.
Step Two show that balloon venoplasty reverses CCSVI in x% of cases for 3/6/12 months.
This is sufficient to show the procedure may be made available to pwMS.
Finally a study of the impact of CCSVI on a common symptom (fatigue has been suggested already and is cheap to measure). This could be performed against a common treatment for fatigue like mindfulness or CBT. This could not be blinded so a cross over trial would be my suggestion to obtain reliable data.
Like I said KISS, cos mark is stupid.
MarkW
Posted: Fri Apr 02, 2010 7:27 am
by eric593
I'm curious why this cardiac surgeon with MS isn't himself performing venograms and angioplasty on MSer's if he finds it unethical for the medical community not to be "liberating" people?
Posted: Fri Apr 02, 2010 7:40 am
by Lyon
.
Medical specialisms
Posted: Fri Apr 02, 2010 7:46 am
by MarkW
A consultant cardiac surgeon (age 64) has done surgery on the heart and surounding vessels and is an expert on this. It is very different from balloon venoplasty.
MarkW
Posted: Mon Apr 05, 2010 6:54 pm
by Brightspot
Thnaks for posting this link. It is great to be able to paste the link into emails, to help dispell the istaken belief that people seeking screening and treatment for CCSVI are being duped!
why I do not perform liberation procedures myself
Posted: Tue Apr 06, 2010 7:41 am
by GiCi
It seems that I am requested to explain why, as a cardiac surgeon, a MS patient, and a believer in CCSVI, I do not perform the liberation procedure on other patients. The answer is quite simple and rather obvious:
1. I do not have the expertise in endovascular procedures
2. Being a hospital employee I am subjected to the hospital regulations, which prohibit to administer treatments non included in the list of the approved ones.
I hope the above explanation is satisfactory
GiCi