Hungarian to English translation
European radiologists: a lot of controversy about the CCSVI
2010th December 01, Wednesday
Intervention by the European Society of Radiology (CIRS) has recently published a commentary in the official cerebrospinal chronic venous insufficiency (CCSVI) scientific position. Below is a complete communication CIRS original Hungarian translation available.
The clerk professionals commentary:
JAReekers Dept of Radiology, AMC, University of Amsterdam, The Netherlands.
MJLee Department of Academic Radiology, Beaumont Hospital, Dublin, Ireland.
A. M. Belli. Department of Radiology, St. George's Hospital, London
F Barkhof Department of Radiology, MS Center Amsterdam, VU University Medical Center, Amsterdam, The Netherlands
Chronic venous insufficiency or cerebrospinal CCSVI some people suspected by the new theory, which is a direct causal relationship with this vein, with symptom of multiple sclerosis (MS). (1) The core of the theory that the jugular vein and / or narrowing of the azygos vein in the brain due to inadequate venous drainage. They claim that this specific ultrasound criteria (which venous insufficiency hemodynamic severity score - VHISS - called) is characterized by abnormal blood flow within the venous drainage of the brain disorder or vérelfolyási problem, which is the deposits in the area around the ventricles. (2) CCSVI The theory is that they are very similar to the deposition of the lower limb veins around the depositions of iron, which occurs in chronic deep vein thrombosis. Dr. Zamboni, the first tuple of this new theory, balloon dilatation of the blood flow treat this disorder, thus curing the CCSVI and this proportion is - according to some accounts - alleviating the symptoms caused by MS. However, this theory does not fit into the pathophysiology of MS is now generally accepted scientific data on the weights.
At the same time increasing the CCSVI balloon angioplasty and related acceptance around the world, ignoring the fact that the procedure is not supported by scientific evidence. Further argument against is that most information comes from a single source. The treatment is a treatment called liberation and the results can be viewed on YouTube. There are well-documented reports that according to this improved quality of life of MS patients after treatment. However, there are no data in patients in whom treatment was unsuccessful, although this would provide a much more balanced picture. It seems that the CCSVI and thus the successful treatment of MS in the current forum is the Internet. The CIRS office in Amsterdam and the Centre of SM-20 receives a request about 10 months. CIRS is a lot of intervention radiologist turns to for advice. A multi-center world perform balloon dilatation of stent surgery, with or without due CCSVI. So far, no currently available test data and no randomized clinical trial (RCT) process. This new treatment for patients based on anecdotal evidence and available on the Internet "testimony" is based on the reports. The CIRS feel that this is not a good basis for the adoption of a new treatment for possible complications of the procedure, an often desperate patients.
The inconsistency is more than the argument
The CIRS believes that the CCSVI theory in its current form poses a number of contradictions. First: this is the essence of the new theory CCSVI syndrome, ie, abnormal venous drainage from the brain. The head of the anatomical variations of venous drainage of many shows, which is not very well cataloged in most textbooks. The head and neck veins on the keyboard also show great variability. Those in the intervention radiologists who practiced in the parathyroid samples, well aware of the enormous anatomical diversity of veins. In addition, the jugular vein of the great variability in addition to the two known natural narrowing, as well as other prominent theory CCSVI vein, the vena azygosnak no role in venous blood draining from the head. The azygos venous blood, leading to the spinal cord, but not alone, as many intercostal vein also provides the same function.
In addition, this imaging test done supine position, which affects blood flow and image interpretation. A recent randomized comparative studies have been carried out so-called venous constriction in patients with MS and not MS. (3-4) both studies show that there is no difference in the incidence of venous congestion between the two groups. This seems a very strong argument against the existence of CCSVI. However, the doctors who handle CCSVI pointed out that these studies have been carried out in the venous hemodynamic insufficiency severity score (VHISS) tests. Another part of the theory that the venous obstruction should be treated. However, where there is a real hemodynamic venous obstruction, there should be pressures, which should result in the gradient disappears after successful balloon dilatation. It has been demonstrated, and balloon dilations CCSVI because investigators have confirmed that the so-called never stenosisnál no measurable pressure. The process is carried out so they say, it's not the pressure gradient, but the pattern changes caused by the narrowing of the outflow, and this mintaváltás pathological entity.
Really, this success is what to say?
There is still a matter of successful anecdotal treatments. Undoubtedly there are patients whose symptoms subsided after treatment with the CCSVI, but could easily be that it's just placebo effect, as we used to see in this case. A lot of medical treatment, the success of the foundation, or assisted in the placebo effect. There is nothing wrong per se with the placebo effect, as long as we are aware that this plays a role. It is also known that the more invasive treatment, and the more the physician considers that the treatment is effective, the greater the placebo effect. In addition, the SM from the emotional impact may be factors. Anyway, the characteristics of the disease relapses and spontaneous improvement. It is therefore difficult to collect the scientific evidence supporting the theory CCSVI-t RCT without proof.
The dilemma now is that by being promoted to the new treatment procedure, the success of some pioneering early szétkürtölte the popular press, and also reduced the chances of a properly conducted investigation, because of concern, may be unethical, if not offered to the patient, this new and promising treatment. The doctor, however, the primary task of "Do not harm" so as not to damage. We believe that the damage can occur if a certain treatment is offered, without any scientific evidence of the effectiveness of the procedure would be available. A pseudo-arguments like "There's nothing else." or "Do you know how much you paid for a kezelésekért, which is not six?" may not be truly valid and they are not scientific arguments.
Without research, there is no evidence
Faced with these contradictions, and because the effectiveness of the treatment CCSVI for lack of evidence, some of the pioneers of treatment of MS patients with their work is called phase 1 study. However, a phase 1 study protocol, the medical ethics committee approval, leaflet, consent, or without the supervision of the safety committee is not appropriate. The CIRS believes that a properly conducted investigation and scientific rigor to solve this dilemma. We believe that there is a need for prospective randomized "placebo" arm examination. Independent company to monitor this investigation, for example. Intervention by the European Society of Radiology (CIRS) and / or the European Society of neurologists would be ideal.
As physicians and interventional radiologists, would certainly hope that all the anecdotal reports, which reported an improvement in the quality of life, and confirmed that patients will benefit from this new treatment. We, the public has long been used radiologists pioneered treatments which have proven very beneficial for patients over the past 30 years. Fibroid embolization is the latest in the vertebral and carotid artery stent surgery plastica is already well proven procedures in a randomized study. We believe that the CCSVI treatment should be assessed in this way. Furthermore, we believe that as long as there is no real scientific data on the t-CCSVI and dilation of the balloon, this treatment is not recommended for the treatment of MS patients outside of a well-designed clinical trials.
(Translated by dr. Klotild Matthias)
1: Zamboni Fri The big idea: iron-dependent Inflammation in venous disease and multiple sclerosis in Proposed Parallels. J R Soc Med 2006; 99:589-93.
2: Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, et al. The severity of chronic venous insufficiency in cerebrospinal Patients with multiple sclerosis is related to Altered cerebrospinal fluid dynamics. Func Neurol. 2009; 24:133-8.
3: Krogias C, Schröder A, Wiendl H, Hohlfeld R, Gold R. Chronic cerebrospinal venous insufficiency "and multiple sclerosis: critical analysis and first-Observation in an unselected cohort of MS Patients. Nervenarzt. 2010; 81:740-6
4: Doepp F, Paul M, Valdueza JM, Schmierer K, Schreiber SJ. No cerebrocervical venous congestion in Patients with multiple sclerosis. Ann Neurol. 2010; 68:173-83.