The Indian Practitioner

V. K. Kulkarni ¹, D. U. Upase ², Y. A. Dound ³, S. S. Jadhav ³, A. A. Bhave ⁴, D. S. Mehta ³, A. D. B. Vaidya ⁴

Affiliations
1 Department of Haematology, B. Y. L. Nair Ch. Hospital, Dr. A. L. Nair Road, Mumbai Central, 7, Shefalee, Makarand Society, Veer Savarkar Marg, Mahim, Mumbai - 400016, IN
2 Department of Haematology, B. Y. L. Nair Ch. Hospital, Dr. A. L. Nair Road, Mumbai Central, Mumbai, IN
3 Viridis BioPharma Pvt. Ltd., V. N. Purav Marg, Chunabhatti, Mumbai, IN
4 ICMR Advance Centre of Reverse Pharmacology in Traditional Medicine, Medical Research Center-Kasturba Health Society, Mumbai, IN

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. 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 enrollment.

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.

Keywords

Vitamin K2-7, Diabetes Mellitus, Megaloblastic Anaemia, Peripheral Neuropathy, Reverse Pharmacology.

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