Authors: Michael A. Arata, M.D., Zohara Sternberg, Ph.D., Steven Cen, Ph.D.
Institution: Synergy Health Concepts, Newport Beach, CA
Chronic cerebrospinal venous insufficiency (CCSVI) has been described as a condition resulting from impaired CNS venous drainage in multiple sclerosis (MS) patients. Venous balloon angioplasty (BA) has been performed as a treatment for CCSVI, although a direct link between venous obstruction and CCSVI has not been conclusively demonstrated. In addition, the dysfunction of hypothalamus pituitary adrenal (HPA) axis has been reported in MS patients, correlating with disease activity. Although MS patients undergoing treatment of CCSVI report improvements in quality life, the effect of this intervention on the HPA axis is unknown. The purpose of this study was to determine whether BA induces alterations in the HPA axis, indicated by changes in levels of ACTH and Cortisol.
Material and Methods
Eighty-eight patients underwent treatment of central venous BA for CCSVI correction. Serum samples were taken at baseline and 30 minutes after the completion of the procedure. ACTH and Cortisol were measured using electrochemiluminescence immunoassay. The change in serum ACTH and Cortisol levels was assessed using Wilcoxon signed rank test to determine whether the median differed from 0 using 2-sided test with the α level of 0.05. All statistical analysis was conducted using SAS 9.2.
Central venous BA treatment results in a statistically significant reductions in both ACTH and Cortisol (P<0.01). The distribution in change of ACTH and Cortisol shifted towards negative and significantly away from 0 with median and first, third quartile of -6.15 (-10.25, -2.25) and -4.15 (-6.9, -1.6) respectively. These changes are counter to the stress mediated increase in ACTH and Cortisol levels expected following an invasive procedure.
Reductions in serum ACTH and Cortisol post-BA intervention indicates alterations in the activities of the HPA axis. These hormonal changes can be used as surrogate markers of BA clinical efficacy. This pilot study has potential implications for the treatment of HPA axis dysfunction in pathological states other than MS. Further studies should investigate the long-term endocrine impact of CCSVI treatment.