Korean J Pain.  2018 Jul;31(3):183-190. 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 A
• Kumar H
• Mondal RD
• Anand SS
• Ghosal A
• Datta A
• Sawant SV
• Kapatkar V
• Kadhe G
• Rao S

• KMID: 2417956
• DOI: http://doi.org/10.3344/kjp.2018.31.3.183

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.

Keyword

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

MeSH Terms

Clinical Protocols
Dose-Response Relationship, Drug
Healthy Volunteers
Humans
Injections, Intramuscular
Lower Extremity
Neuralgia
Peripheral Nerves
Peripheral Nervous System Diseases*
Prospective Studies
Sensation
Vitamin B 12 Deficiency
Vitamin B 12*
Vitamin B 12

Figure

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  Fig. 1 Study disposition chart.

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  Fig. 2 Changes in serum cobalamin levels in patients and healthy volunteers.

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