Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
, 31 (3), 183-190

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

Affiliations

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

Amrita Sil et al. Korean J Pain.

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 µg injection intramuscularly three times a week) and group B (methylcobalamin 1500 µg 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 ± 234.50) as compared with group B (1438.5 ± 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 µg methylcobalamin thrice weekly regime is more effective in increasing the serum cobalamin levels as compared to the 1500 µg 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.

Conflict of interest statement

CONFLICT OF INTEREST: The authors received a research grant in the form of an “Investigator initiated study” for conduct of the study from Wockhardt India Pvt. Ltd. None of the authors or any first degree relative of the authors have any financial interest in the subject matter discussed. The study was purely academic in nature.

Figures

Fig. 1
Fig. 1. Study disposition chart.
Fig. 2
Fig. 2. Changes in serum cobalamin levels in patients and healthy volunteers.

Similar articles

See all similar articles

Cited by 1 PubMed Central articles

References

    1. 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.
    1. Briani C, Dalla Torre C, Citton V, Manara R, Pompanin S, Binotto G, et al. Cobalamin deficiency: clinical picture and radiological findings. Nutrients. 2013;5:4521–4539. - PMC - PubMed
    1. Oh R, Brown DL. Vitamin B12 deficiency. Am Fam Physician. 2003;67:979–986. - PubMed
    1. 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;60:1057–1063. - PMC - PubMed
    1. Healton EB, Savage DG, Brust JC, Garrett TJ, Lindenbaum J. Neurologic aspects of cobalamin deficiency. Medicine (Baltimore) 1991;70:229–245. - PubMed

LinkOut - more resources

Feedback