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The effect of vitamin K2-7 in peripheral neuropathy due to Vitamin B12 deficiency and/or diabetes mellitus: A Preliminary Study
Abstract
Objective: 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 Methods: An open labeled clinical study was conducted in 30 patients presenting with peripheral neuropathy and suffering from either megaloblastic anaemia (viamin 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) was 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. Results: 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. Conclusion: 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. However, the therapeutic efficacy needs to be evaluated further in a larger sample size, with a placebo controlled randomised double blind trial.
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Objective To study, the safety, tolerability and therapeutic activity of Vitamin K 2-7(MK7) in a series of patients with idiopathic muscle cramps-systremma Material and Method An open-labelled ambulant trial was conducted in 19 patients presenting with muscle cramps. Vitamin K 2-7 (100µg/Capsule/ Day) was given orally for 3 months. Patients on regular anti-coagulant treatment were excluded from the study. Patients kept the record of frequency, duration and intensity of their cramps during the baseline period of 7 days and throughout the study. They were divided in two groups A and B as per the frequency of cramps. The intensity of cramps was assessed with a Visual Analogue Scale (VAS). They were followed up in the fourth month for recurrence of any cramps. Blood biochemistry and organ function tests were studied at the baseline and at the end of therapy for safety. Prior to the study EC permission and informed consent from patients were obtained. Results Patients from Group A (n=9) had 1-2 cramps/day to 5 /day with severity of 2-9 on the VAS and duration of 1min to 10 min. Patients from Group B (n=10) had lesser frequency of 2-4/wk to at least once a week. Duration of cramps varied from less than 1 min to 10 min with a severity of 2-8 on the VAS. Patients from both the groups experienced a reduction in the frequency. In the Group A, it reduced from 1-2 cramps/day and 5 /day to no cramps or 2-3/ month and in the Group B, from 2-4/wk the frequency reduced to no cramps-1/month. There was also a reduction in the duration as well as severity recorded as 0-3 on VAS as compared to the baseline 2-9 in the Group A. Intensity of cramps was also reduced in the group B from 2-8 VAS decreasing to 0-2 score. Vitamin K 2-7 was well tolerated clinically and found to be safe on the organ function in all the patients. No severe adverse events were reported during the period of therapy. Conclusion Vitamin K 2-7 at a dose of 100 µg /day for 3 months was found to be well tolerated and safe with a therapeutic relief of muscle cramps. The therapeutic activity needs to be evaluated in a larger sample size, with a placebo-randomized cross-over double blind trial to ascertain the efficacy. (The Ind. Pract. 2010; 63(5):287-291)
In clinical practice, the finding of an elevated mean corpuscular volume (MCV), macrocytic anaemia or specific neurological symptoms is often the reason to test for vitamin B12 (B12) deficiency. Use of the MCV as a test for the detection or exclusion of B12 deficiency is only justified if the diagnostic accuracy is sufficiently high. However, the sensitivity and specificity are not well known. We performed a systematic review of the diagnostic value of an elevated MCV for B12 deficiency in both anaemic and non-anaemic patients. Of approximately 3500 titles and/or abstracts that were screened, 37 original papers contained usable data. The population under study proved to be the characteristic of major influence on the study outcome. Pooling of data from different studies was performed in subsets of the data corresponding to the different populations studied. The cut-off levels of both MCV and serum B12 had a significant influence on the study outcomes. The data, however, were pooled without taking these cut-off levels into account. The pooled estimates should be interpreted with this limitation in mind. The reference standards were (1) a low serum B12 concentration and (2) a B12 deficiency confirmed by low serum B12 combined with additional diagnostic investigations. In the population that was randomly screened for low serum B12, the sensitivity of the MCV for B12 deficiency was 17%, whereas the sensitivity was 30% for B12 deficiency in patients with anaemia. When measurement of serum B12 was ordered to exclude B12 deficiency as part of the patients' treatment, the sensitivity was 30% for low serum B12 concentration, 58% for B12 deficiency and 75% for B12 deficiency in patients with anaemia. In the population with pernicious anaemia, the sensitivity was far from perfect (77%). In the five studies that reported data on the positive predictive value of the MCV for B12 deficiency, this ranged from 0% (0/6) to 55% (11/20). This systematic review shows that a considerable number of B12-deficient patients will remain unnoticed when the MCV is used to rule in patients for further evaluation. Depending on the population studied, up to 84% of cases will than be missed. The MCV can be used to make the diagnosis of B12 deficiency more--or less--probable. An elevated MCV justifies the measurement of serum B12. The MCV should not be used as the only parameter ruling out the diagnosis of B12 deficiency.
Treatment of Human Disease Conditions and Disorders using Vitamin K analogues and Derivatives
- B Vaidya Ashok
Vaidya Ashok B, et al. Treatment of Human
Disease Conditions and Disorders using
Vitamin K analogues and Derivatives. PCT/
IN2008/000465, Jul. 2008.