Sudden cardiac death and Myocardial Infarction (MI) are major causes of death in both developed and developing countries. The Autonomic Nervous System (ANS) plays an important role in the pathophysiology of conduction system of heart and thus a major disturbance in ANS can result in sudden cardiac death. The current available treatment modalities are based on the correction in the autonomic dysfunction. While doing so most of these drugs themselves produce serious side effects such as prolongation of QT interval. Such QT change is reason for the recall of several drugs . There is need for safe intervention in these serious life threatening conditions. It was observed that vitamin K2-7, shows promising result in the correction of sympathovagal balance.
ANS is characterized by its ability to more precisely regulate a tissue's function. The balance between these two systems is critical in maintaining the homeostasis in proper state.
Role of vitamin K2-7 in correcting sympathovagal imbalance :
In an observational pilot study to determine the effect of vitamin K2-7 on sympathovagal balance on male volunteers using ANSiscopeTM, it was observed that after 2 months of therapy 350 µg/day with vitamin K2-7, there was a marked normalization in the sympathetic activity which was initially elevated, with little effect on parasympathetic activity. No effect on QT interval was observed.This study provides window for the use of MK-7 in maintaining sympathovagal balance and can also be used as protective and preventive in cardiovascular diseases.
FIG 1. ANS Activity Indices at day 0, M/32, 77 kg> Result: 25 % Late Autonomic Dysfunction Level 25 % + 0 % age related
FIG 2. ANS Activity Indices at day 58, M/32, 77 kg Result: 21 % Early Autonomic Dysfunction Level 25 % + 0 % age related
To study the effect of vitamin K2-7 on cardiac output in rats, Isoproterenol (ISO) induced cardiac model was selected for the study.
Effect on cardiac output
It was observed that ISO induced decrease in cardiac output was found to be reversed in 90 µg/kg & 450 µg/kg dose of vitamin K2-7 test drug administered ISO injected rats. This effect was non-linear and was enhanced in 900 µg/kg dose.
Effect on left cardiac work:
It was observed that administration of ISO leads to marked decrease in left cardiac work when measured 48 hrs after ISO injection in comparison to pre ISO level i.e. control. This ISO induced left cardiac work decrease was found to be reversed to a great extent at all dose levels i.e. at 90 µg/kg, 450 µg/kg and 900 µg/kg with ISO injected rats in comparison to ISO control. It was found that at the dose level of 900 µg/kg decrease in reversal was higher than other treatment group.
Healthy male, 50 yrs, was accessed for ANS activity. The percentage of dysfunction was 61%. It was considered as a baseline reading. On 3rd day of baseline reading he was put on 350 µg/g vitamin K2-7 for 2 months. After 2 months his percentage of ANS dysfunction was changed from 61% to 31%. He was feeling more energetic and even work for longer time without any tiredness.
Healthy male, 32 yrs, was assessed for ANS activity. The percentage of dysfunction was 25%. It was considered as a baseline reading. On 3rd day of baseline reading he was put on 350 µg/g vitamin K2-7 for 2 months. After 2 months his percentage of ANS dysfunction was changed from 25% to 21%.
Peripheral Neuropathy, causes & symptoms:
Peripheral neuropathy; damage to nerves of peripheral nervous system, is a common problem faced by a large number of patients. It can be caused by multiple etiological factors. The commonest amongst these are vitamin deficiencies like vitamin B12, folate and diabetes mellitus with symptoms of sensory and motor defects.
Persistence of neuropathy symptoms despite routine treatment is a well identified unmet medical need. Despite good glycaemic control and correction of vitamin B12 through supplements, yet there remain symptoms of neuropathy. It is termed as residual neuropathy.
K2-7 in Peripheral Neuropathy
A study  was designed to identify patients with residual neuropathy and to study the effect of vitamin K2-7 in relieving the symptoms of peripheral neuropathy. The therapeutic impact of vitamin K2-7 was identified by considerable relief in the symptoms of patients with residual neuropathy by a validated Visual Analogue Scale (VAS).
Vitamin K2-7 was found to be well tolerated and has a potential for relief of symptoms of peripheral neuropathy in case of megaloblastic anemia & diabetes mellitus.
The effect of vitamin K2-7 in peripheral neuropathy due to diabetes mellitus and / or megaloblastic anaemia has indicated therapeutic potential of vitamin K2-7 in these two conditions.
The effect of vitamin K2-7 in peripheral neuropathy due to vitamin B12 deficiency and diabetes mellitus: A Preliminary Study.
To evaluate the activity and tolerability of vitamin K2-7 (MK-7) in a series of patients with peripheral neuropathy due to vitamin B12 deficiency and / or diabetes mellitus.
Material and Method :
An open labeled clinical study was conducted in 30 patients presenting with peripheral neuropathy and suffering from either megaloblastic anemia (vitamin B12 deficient) and/ or diabetes mellitus. Vitamin B12 levels in blood were estimated at baseline and during therapy. Vitamin K2-7 capsules (100 mcg / capsule, twice a day) were given orally for 8 weeks. Patients kept a regular record of the intensity of the symptoms during the baseline and throughout the study. Symptoms included tingling and numbness along with weakness, fatigue and cramps. The intensity of the symptoms was assessed on a Visual Analog Scale (VAS). They were followed up to 8 weeks. Blood biochemical and organ function tests were studied at the baseline, at the fourth week and at the end of the eight week. Prior to the study Ethics Committee Approval was obtained from the Ethics Committee of T. N. M. C. & B. Y. L. Nair Ch. Hospital. The trial was registered with Clinical Trial Registry of India (CTRI). (CTRI/2012/08/002930). Informed written consent was obtained from the patients before enrolment.
Depending on the basal VAS score the patients were divided in a moderate group and a severe group. The moderate group had VAS score of 6-8 and the severe group had a VAS score of 8-9. By the end of eight week, the VAS score in both the groups was reduced to 1-2. The intensity specifically of tingling and numbness has reduced to a much greater extent. It was of interest to observe that ten out of 23 patients of vitamin B12 deficiency group had residual neuropathic symptoms in-spite of adequate levels of vitamin B12 following vitamin B12 administration. The residual neuropathic symptom score reduced following vitamin K2-7 therapy. Vitamin K2-7 was well tolerated clinically and found to be safe as per the organ functions in all the patients. No adverse events were reported during the period of therapy.
This preliminary study has shown that vitamin K2-7 at a dose of 100 mcg twice a day for 8 weeks was well tolerated and safe with a therapeutic activity for the symptoms of peripheral neuropathy.
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