DrSclafani answers some questions

[PCakes]

wow Cece...thanks!.. great research and it makes sense.. at my age my internal thermometer has lost it's mind and my research on that topic turned up similar...

[Cece]

thanks pcakes...my thermostat is whacked and I'm not of that certain age!

I'll make a separate thread for this, but I wanted to post one more thing here, also to consolidate some of this:

"Any changes in body temperature will be picked up by two different sets of thermoreceptors: central receptors and peripheral receptors. Central thermoreceptors are located within the hypothalamus, and are thus “central” to the thermoregulatory system. Central thermoreceptors monitor the temperature of the blood as it circulates throughout the brain. The central receptors are sensitive to temperature changes as little as .018°F."
http://www.abcbodybuilding.com/magazine ... lation.htm

So the concise question is: what effect does the slowed perfusion in MS have on the temperature of that blood and, if there is an effect, how does it affect the central thermoregulatory function in the hypothalamus?

[FlashHack]

So the concise question is: what effect does the slowed perfusion in MS have on the temperature of that blood and, if there is an effect, how does it affect the central thermoregulatory function in the hypothalamus?

For us hot-heads, that is a question to which we already know the answer!

[fogdweller]

Dr Sclafani, I am wondering how such studies could be/will be or have already been started to be performed? Catheter vengography applied to all and for the placebo-group then just not apply the dilatation/ballooning? Without them knowing that it has been done or not? For how long would the improvements be compared in such a study (and by which criteria), and for how long would the placebo group not know it was placebo? Is this a realistic and necessary direction the neurologists are pushing us to go for? Placebo treatments without applying venoplasty?

This is the closest I've come to finding a similar sham surgery:

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

Thankl-you Eric593. I am very interested in how one can ethically do "sham" surgery. Whether informed consent is sufficient for the risks of the incision and insertion of the catheter is interesting to me. In angioplasty, though, the level of sedation is very low, and although not painful, I think you can feel the catheter moving in the body, so merely numbing the insertion site and sheilding the patient's eyes would not be sufficient. Plus the follow-up requires a warfarin regime, and a patient would know ilf they were receiving a placebo and not the anti-clotting drug. The anti-clotting drug is a risky thing. Those following the CCSVI history know that the one death that happened was due to the anti-clotting drugs that were part of the post-stenting procedure.

I have heard, but do not know first hand that Stanford is planning to insert the catheter into all subjects but in the placebo arm, not inflate the balloon. I have no idea what they would plan to do about the warfarin regiment.

If I find out the accurate trial plan, I will post itl

[eric593]

fogdweller,

I don't think there's any issue with comparing warfarin use to giving a placebo in place of it.

Have you seen the % of placebo patients in the Rebif trial that experienced the same side effects as the active drug group?

http://www.rxlist.com/rebif-drug.htm

(page 3 chart)


There doesn't seem to be any issue with a patient figuring out if they're on the active or placebo drug as the placebo group had a very high % of the same side effects as the active drug group.

[Niceflow]

Thanks L. for your explanation regarding metal implants & MRI. I did ask my dentist about the material used and here is his answer:

"The bridge is made of a gold and platinum alloy for teeth numbers 13 - 23. It is not an actual implant. This bridge has been glued onto natural teeth and is visible from the outside. It has no intra-osteo metallic components."

Any more comments would be appreciated.

[L]

Thanks L. for your explanation regarding metal implants & MRI. I did ask my dentist about the material used and here is his answer:

"The bridge is made of a gold and platinum alloy for teeth numbers 13 - 23. It is not an actual implant. This bridge has been glued onto natural teeth and is visible from the outside. It has no intra-osteo metallic components."

Any more comments would be appreciated.

Unfortunately gold is an excellent conductor, gold/platinum alloy is efficient too. So this could potentially rule MR out. Try Johns Hopkins though since the size and shape of an implant is important in deciding whether or not MR can take place.. But as Dr Sclafani said in response to my question, the MRV can be skipped and you can go straight to a venogram.

[pegmegrund]

Thanks L. for your explanation regarding metal implants & MRI. I did ask my dentist about the material used and here is his answer:

"The bridge is made of a gold and platinum alloy for teeth numbers 13 - 23. It is not an actual implant. This bridge has been glued onto natural teeth and is visible from the outside. It has no intra-osteo metallic components."

Any more comments would be appreciated.

Unfortunately gold is an excellent conductor, gold/platinum alloy is efficient too. So this could potentially rule MR out. Try Johns Hopkins though since the size and shape of an implant is important in deciding whether or not MR can take place.. But as Dr Sclafani said in response to my question, the MRV can be skipped and you can go straight to a venogram.

I realize that this could be a completely different situation and combination of metals, but I have a gold crown on a tooth, and have had many MRIs with no problem. Hope that helps-

[drsclafani]

The circulation in the hands and feet is affected by the autonomic nervous system in ms. this leads to purple feet and hands.

somehow, relieving the venous outflow improved autonomic nerve function

Is it safe to say that if you have a jugular vein valve issue ..good chance you'll find the same in other areas.. ? Many of the symptoms listed below are also known as MS symptoms?

Symptoms of Venous Insufficiency..signs and symptoms mentioned in various sources for Venous Insufficiency includes the 12 symptoms listed below:
Throbbing leg
Cramping
Burning sensation in leg
Leg fatigue
Nonhealing ulcers in foot
Swollen limb
Thickened skin on affected limb
Shiny skin on affected limb
Discolored skin on affected limb
Leg heaviness
Leg redness
Varicose veins

Thank you again..

i am not aware of any proven association between ccsvsi and other venous valve problems.

[jr5646]

Dr. Sclafani,

I just had an MRV done at Buffalo (BNAC-selfpay option) and wanted to see if you think this image shows treatable stenosis/narrowing? Is this something common you've seen? Is this area too high to be reached? Below is a direct quote from the report which I can't really make heads or tails of.. Also, I only presented with one of the five Zamboni criteria via doppler.. #2 - Reflux propagted upward to the Deep Cranial Veins (DCV's) and/or from the White Matter (WM) to the Subcortical Gray Matter (SCGM). Perhaps a bunch of clollateral veins too? Possible lower right IJV valve issue (sticky valve?) and Iron measures very high (higher than the avg. MS Pt.)

From the report: "MR VENOGRAM FINDINGS: The superior sagittal sinus with appears to drain predomininatly on the right. The transverse sinuses are relavetly symmetric in size. The sigmoid sinuses and jugular bulbs are relatively symmetric in size. At the base of the brain, the internal jugular veins are well visualized. At the level of the cranical/cervical junction junction on the right, the internal jugular on the right takes on a flattened morphology with respect to flow charactists. This segment is small in size being less than 10mm. Throughout the neck, the internal jugular veins have an ellipsoid morphology. The junction of the internal jugular veins with the subclavian veins is normal in apperance. There is slight asymmetry of the internal juglar veins with the right being larger than the left."

I'm not quite sure if or how this correlates, but my very first two presenting symptoms showed up on the left side. Left arm/hand numbness (still have it approx. 10 yrs later and left eye Optic Neuritis 2002 - complete, but temporary blindness that resolved in about 3 mths with steroids..

Anyway, the rest of the report comments on the arterial side.. all good



Thanks again for all your help.. I decided on investing the $4500 to hopefully get some answers and further research, but would really rather give it to someone who needs it more than I do instead..

[MS_mama]

Dr. Sclafani, I was wondering how high you think the risk of thrombosis is post-angioplasty, considering that other doctors are not prescribing anticoagulants after the procedure unless stents are involved. I am considering if the risk is high enough if I should request it anyway, even though its not part of their protocol. What are your thoughts and what regimen do you prescribe after the angioplasty?

[Johnson]

Thanks L. for your explanation regarding metal implants & MRI. I did ask my dentist about the material used and here is his answer:

"The bridge is made of a gold and platinum alloy for teeth numbers 13 - 23. It is not an actual implant. This bridge has been glued onto natural teeth and is visible from the outside. It has no intra-osteo metallic components."

Any more comments would be appreciated.

Unfortunately gold is an excellent conductor, gold/platinum alloy is efficient too. So this could potentially rule MR out. Try Johns Hopkins though since the size and shape of an implant is important in deciding whether or not MR can take place.. But as Dr Sclafani said in response to my question, the MRV can be skipped and you can go straight to a venogram.

Although gold is an excellent conductor of electricity (arguably the best conductor metal), it is non-ferrous (non-magnetic), and would not be subject to the heating that ferrous metals would be. I have a very large gold crown, and have had many MRIs with it in my mouth. The only real problem is that it tends to cause a "black hole" on the images.

[fogdweller]

There doesn't seem to be any issue with a patient figuring out if they're on the active or placebo drug as the placebo group had a very high % of the same side effects as the active drug group.

But I did not see any indication that the patients KNEW they were on the placebo. If they did it wouldn't be a blinded trial.

If you have known anyone on anti-clotting therapy, you can tell very easily if you skratch yourself and it is very hard to stop the bleeding. I sincerely doubt that a placebo drug would produce this side effect. Maybe it does but I doubt it. The patient's would almost certainly know if they were on placebo or the real deal, and the trial would no longer be blinded.

If it is virtually impossible to blind the study, you can still divide the group into random --treatment arm--non-treatment arms, and compare. If you use MRI findings and CSF fluid and the like that are not as subjective as reported effects, that would be better than nothing.

[Donnchadh]

Dr. Sclafani, I was wondering how high you think the risk of thrombosis is post-angioplasty, considering that other doctors are not prescribing anticoagulants after the procedure unless stents are involved. I am considering if the risk is high enough if I should request it anyway, even though its not part of their protocol. What are your thoughts and what regimen do you prescribe after the angioplasty?

While I cannot speak about others, my IR prescribed 75mg Plavik for 30 days starting on the day of the balloon procedure.

Using an anticoagulant is a standard part of Dr. Zamboni's protocol.

Donnchadh

[Cece]

MS_mama, maybe check the thread index, he does use an anti-clotting regimen but I forget what & how long...whenever he tells a story about "his very first patient," it's memorable...in regards to thrombosis, his very first CCSVI patient had a beautiful initial result and then clotted over and it could not be salvaged.