Browse > Article
http://dx.doi.org/10.3344/kjp.2018.31.3.183

A randomized, open labeled study comparing the serum levels of cobalamin after three doses of 500 mcg vs. a single dose methylcobalamin of 1500 mcg in patients with peripheral neuropathy  

Sil, Amrita (Department of Pharmacology, IPGME&R)
Kumar, Hrishikesh (Department of Neuromedicine, Institute of Neurosciences)
Mondal, Rahul Deb (Department of Neuromedicine, Institute of Neurosciences)
Anand, Sidharth Sankar (Department of Neuromedicine, Institute of Neurosciences)
Ghosal, Anirban (Department of Neuromedicine, Institute of Neurosciences)
Datta, Ashis (Department of Neuromedicine, Institute of Neurosciences)
Sawant, Sandesh V (Wockhardt Limited)
Kapatkar, Vaibhavi (Wockhardt Limited)
Kadhe, Ganesh (Wockhardt Limited)
Rao, Sameer (Wockhardt Limited)
Publication Information
The Korean Journal of Pain / v.31, no.3, 2018 , pp. 183-190 More about this Journal
Abstract
Background: Vitamin B12 deficiency has been associated with peripheral neuropathy, loss of sensation in the peripheral nerves, and weakness in the lower extremities. Methylcobalamin is the most effective analogue of vitamin B12 used to treat or prevent the complications associated with vitamin B12 deficiency. The current study aimed to compare the serum cobalamin levels after administration of two different regimes of methylcobalamin in peripheral neuropathy patients. Methods: The present study was a prospective, randomized, comparative study. The study consisted of two parallel groups, group A (methylcobalamin $500{\mu}g$ injection intramuscularly three times a week) and group B (methylcobalamin $1500{\mu}g$ injection intramuscularly once a week). A control group of healthy volunteers was also included. Results: A total of 24 patients (12 in each group) were included in the study. Five healthy volunteers were also included as a control in each group. At the end of treatment, serum cobalamin levels were significantly (P = 0.028) higher in group A ($1892.08{\pm}234.50$) as compared with group B ($1438.5{\pm}460.32$). The serum cobalamin levels in Group A healthy volunteers were also two times higher than that of group B (P = 0.056). Both the LANSS scale and DN4 questionnaire reported similar results at end of treatment. Conclusions: The $500{\mu}g$ methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the $1500{\mu}g$ methylcobalamin once weekly regime.
Keywords
Clinical protocols; Cobalamin (vitamin B12); Drug dose-response relationship; Intramuscular injection; Methylcobalamin; Neuropathic pain; Peripheral neuropathy; Prospective studies; Randomized controlled clinical trials; Survey and questionnaire; Vitamin B12 deficiency;
Citations & Related Records
Times Cited By KSCI : 1  (Citation Analysis)
연도 인용수 순위
1 Yamazaki K, Oda K, Endo C, Kikuchi T, Wakabayashi T. Methylcobalamin (methyl-B12) promotes regeneration of motor nerve terminals degenerating in anterior gracile muscle of gracile axonal dystrophy (GAD) mutant mouse. Neurosci Lett 1994; 170: 195-7.   DOI
2 Naik SU, Sonawane DV. Methylcobalamin is effective in peripheral neuropathies. Eur J Clin Nutr 2015; 69: 530.   DOI
3 Monograph. Altern Med Rev 1998; 3: 461-3.
4 Methylcobalamin (Vitamin B-12) Injection [Internet]. Tampa (FL): Defy Medical; [cited 2016 Sep 9]. Available at http://www.defymedical.com/services/12-services/89-met hylcobalamin-vitamin-b-12-injection.
5 Sweetman SC. Martindale: the complete drug reference. 36th ed. London, Pharmaceutical Press. 2009.
6 Zagar BR, Longyhore DS. Evaluating the association between vitamin B12 deficiency and peripheral neuropathy in patients with diabetes. Int J Med Pharm 2014; 2: 1-10.
7 Briani C, Dalla Torre C, Citton V, Manara R, Pompanin S, Binotto G, et al. Cobalamin deficiency: clinical picture and radiological findings. Nutrients 2013; 5: 4521-39.   DOI
8 Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician 2003; 67: 979-86.
9 Leishear K, Boudreau RM, Studenski SA, Ferrucci L, Rosano C, de Rekeneire N, et al. Relationship between vitamin B12 and sensory and motor peripheral nerve function in older adults. J Am Geriatr Soc 2012; 60: 1057-63.   DOI
10 Healton EB, Savage DG, Brust JC, Garrett TJ, Lindenbaum J. Neurologic aspects of cobalamin deficiency. Medicine (Baltimore) 1991; 70: 229-45.   DOI
11 Soneji N, Peng PW. Ultrasound-guided pain interventions - a review of techniques for peripheral nerves. Korean J Pain 2013; 26: 111-24.   DOI
12 Gupta JK. A review on hyperhomocysteinemia and its risk factors. Innovare J Med Sci 2016; 4: 11-4.
13 McCombe PA, McLeod JG. The peripheral neuropathy of vitamin B12 deficiency. J Neurol Sci 1984; 66: 117-26.   DOI
14 Amador N. Vitamin B12 replacement therapy and its rehabilitative effects on psychiatric and neurologic symptoms. Nutrition Bytes 1998; 4.
15 Aaron S, Kumar S, Vijayan J, Jacob J, Alexander M, Gnanamuthu C. Clinical and laboratory features and response to treatment in patients presenting with vitamin B12 deficiency-related neurological syndromes. Neurol India 2005; 53: 55-8.   DOI
16 Mizukami H, Ogasawara S, Yamagishi S, Takahashi K, Yagihashi S. Methylcobalamin effects on diabetic neuropathy and nerve protein kinase C in rats. Eur J Clin Invest 2011; 41: 442-50.   DOI
17 Mutiawati E, Meliala L, Aji D, Wasito W, Muchlisin ZA. A preliminary study on the effect of methylcobalamin application on reducing neuropathic pain. HVM Bioflux 2015; 7: 101-3.
18 Yaqub BA, Siddique A, Sulimani R. Effects of methylcobalamin on diabetic neuropathy. Clin Neurol Neurosurg 1992; 94: 105-11.   DOI
19 Chatterjee S, Dureja GP, Kadhe G, Mane A, Phansalkar AA, Sawant S, et al. Cross-sectional study for prevalence of non-steroidal anti-inflammatory drug-induced gastrointestinal, cardiac and renal complications in India: interim report. Gastroenterol Res 2015; 8: 216-21.   DOI
20 Yamane K, Usui T, Yamamoto T, Tsukamoto T, Soma Y, Yoshimura N, et al. Clinical efficacy of intravenous plus oral mecobalamin in patients with peripheral neuropathy using vibration perception thresholds as an indicator of improvement. Curr Ther Res Clin Exp 1995; 56: 656-70.   DOI
21 Bennett M. The LANSS Pain Scale: the leeds assessment of neuropathic symptoms and signs. Pain 2001; 92: 147-57.   DOI
22 Scalabrino G, Corsi MM, Veber D, Buccellato FR, Pravettoni G, Manfridi A, et al. Cobalamin (vitamin B(12)) positively regulates interleukin-6 levels in rat cerebrospinal fluid. J Neuroimmunol 2002; 127: 37-43.   DOI
23 Bouhassira D, Attal N, Alchaar H, Boureau F, Brochet B, Bruxelle J, et al. Comparison of pain syndromes associated with nervous or somatic lesions and development of a new neuropathic pain diagnostic questionnaire (DN4). Pain 2005; 114: 29-36.   DOI
24 Kennedy DO. B vitamins and the brain: Mechanisms, dose and efficacy-A review. Nutrients 2016;8:68.   DOI
25 Scalabrino G, Buccellato FR, Veber D, Mutti E. New basis of the neurotrophic action of vitamin B12. Clin Chem Lab Med 2003; 41: 1435-7.
26 Institute of Medicine. Food and Nutrition Board. Dietary Reference Intakes: Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline. Washington, DC, National Academy Press, 1998.
27 Kuwabara S, Nakazawa R, Azuma N, Suzuki M, Miyajima K, Fukutake T, et al. Intravenous methylcobalamin treatment for uremic and diabetic neuropathy in chronic hemodialysis patients. Intern Med 1999; 38: 472-5.   DOI
28 Okada K, Tanaka H, Temporin K, Okamoto M, Kuroda Y, Moritomo H, et al. Methylcobalamin increases Erk1/2 and Akt activities through the methylation cycle and promotes nerve regeneration in a rat sciatic nerve injury model. Exp Neurol 2010; 222: 191-203.   DOI
29 Package insert template for mecobalamin tablet & capsule [Internet]. Petaling Jaya, Malaysia: Idaman Pharma; 2013 [cited 2016 Sep 5]. Available at http://npra.moh.gov.my/ images/reg-and-noti/PI/non-poison/Mecobalamin-Templat e-oral-Website.pdf.
30 Watanabe T, Kaji R, Oka N, Bara W, Kimura J. Ultra-high dose methylcobalamin promotes nerve regeneration in experimental acrylamide neuropathy. J Neurol Sci 1994; 122: 140-3.   DOI
31 Yagihashi S, Tokui A, Kashiwamura H, Takagi S, Imamura K. In vivo effect of methylcobalamin on the peripheral nerve structure in streptozotocin diabetic rats. Horm Metab Res 1982; 14: 10-3.   DOI
32 Minauchi Y, Tokunaga H, Suzuki M. Leprous neuralgic pain--its therapy and pathogenesis. Nihon Rai Gakkai Zasshi 1986; 55: 210-7.   DOI
33 Sato Y, Honda Y, Iwamoto J, Kanoko T, Satoh K. Amelioration by mecobalamin of subclinical carpal tunnel syndrome involving unaffected limbs in stroke patients. J Neurol Sci 2005; 231: 13-8.   DOI