Abstract
BackgroundChronic Cerebrospinal Venous Insufficiency (CCSVI) has been associated with multiple sclerosis (MS) with a risk ranging from as high as two-hundred-fold to a protective effect. However, not all studies were blinded, and the efficacy of blinding was never assessed.ObjectiveTo evaluate the association of CCSVI with MS in a cross-sectional blinded study and look for any association of CCSVI with the severity of MS.Methodology/Principal FindingsThe Echo-color Doppler examination was carried out in accordance with Zamboni’s five criteria in 68 consecutive MS patients and 68 healthy controls, matched by gender and age (±5 years). Four experienced neurosonologists, blinded to the status of cases and controls, performed the study and were then asked to guess the status (case or control) of each participant. The number of positive CCSVI criteria was similar in the two groups. CCSVI, defined as the presence of two or more criteria, was detected in 21 cases (30.9%) and 23 controls (33.8%), with an OR of 0.9 (95%CL = 0.4–1.8, p = 0.71). The prevalence of CCSVI was related to age in cases (OR increasing from 0.2 to 1.4), but not in controls. CCSVI positive (N = 21) and negative (N = 47) MS patients were similar in clinical type, age at disease onset, disability, and fatigue. Disease duration was longer (16.5±9.8 years) in CCSVI positive than negative patients (11.5±7.4; p = 0.04). The operators correctly guessed 34/68 cases (50%) and 45/68 controls (66%) (p = 0.06), indicating a different success of blinding.Conclusions/SignificanceCCSVI was not associated with MS itself, nor its severity. We cannot rule out the possibility that CCSVI is a consequence of MS or of aging. Blinding of sonographers is a key point in studying CCSVI and its verification should be a requisite of future studies.
Highlights
Association of Chronic Cerebrospinal Venous Insufficiency (CCSVI), a recently proposed vascular condition, with multiple sclerosis (MS) was postulated in a study using extracranial and transcranial color-Doppler sonographic examination [1], whereas subsequent studies have produced conflicting results, and even questioned the existence of CCSVI itself [2]
The mean cross-sectional area (CSA) was always higher in cases than controls, but after Bonferroni’s correction for multiple testing it never reached significance
We found no association of CCSVI with MS in this blinded study
Summary
Association of Chronic Cerebrospinal Venous Insufficiency (CCSVI), a recently proposed vascular condition, with multiple sclerosis (MS) was postulated in a study using extracranial and transcranial color-Doppler sonographic examination [1], whereas subsequent studies have produced conflicting results, and even questioned the existence of CCSVI itself [2]. By contrast with the original report, in which CCSVI was present in all the cases and none of controls, a very uncommon finding for a diagnostic procedure, the results have been amazingly variable with a risk ranging from as high as two-hundred-fold to even a protective effect [3], [4], [5], [6], [7], [8], [9], [10]. Not all studies were blinded, and the efficacy of blinding was never assessed
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Free) 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
