[논문]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; Kumar, Hrishikesh; Mondal, Rahul Deb; Anand, Sidharth Sankar; Ghosal, Anirban; Datta, Ashis; Sawant, Sandesh V; Kapatkar, Vaibhavi; Kadhe, Ganesh; Rao, Sameer

doi: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 원문보기

The Korean journal of pain, v.31 no.3, 2018년, pp.183 - 190

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)

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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.

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문제 정의

The authors acknowledge the cooperation of the director, consultants, nursing staff and students of The Institute of Neurosciences for their co-operation during conduct of the study. The authors acknowledge Knowledge Isotopes Pvt.

제안 방법

The primary outcome measure (serum cobalamin) was evaluated at baseline (BL), on Day 8, and at the end of treatment (ET), i.e., Day 15. Patients were asked to report at 10 AM, and the blood samples were collected at 11 AM.
The study population was categorized into two parallel groups, Group A (methylcobalamin 500 mcg injection intramuscularly thrice weekly) and Group B (methylcobalamin 1500 mcg injection intramuscularly once a week). The study medication ampoules were stored in a cool, dark place away from light.

대상 데이터

A total of 24 patients with neuropathic pain and 10 healthy volunteers were included in the study (Fig. 1). Both the groups, A and B consisted of 12 patients each having a mean age of 61.
Consenting patients of either gender diagnosed with peripheral neuropathy, aged 18 years or above, and attending the Neurology out-patients’ department (OPD) of the Institute of Neurosciences, Kolkata, were included in the study.

데이터처리

Intra-group changes of cobalamin were done using Friedman’s ANOVA, followed by a post hoc Dunn’s test.
The clinico-demographic parameters were analyzed by chi-square/Fishers (for categorical data) or Student's t-test (for numerical data).
The parameters between groups were analyzed using the Mann-Whitney U test. Intra-group changes of cobalamin were done using Friedman’s ANOVA, followed by a post hoc Dunn’s test.

이론/모형

32 program. Allocation concealment was done by the sequentially numbered opaque sealed envelope (SNOSE) technique. All the patients were followed up for 2 weeks (Fig 1).
Continuous data was reported as mean ± standard deviation (SD) and categorical as percentage (%). The normality analysis was performed using the Kolmogorov-Smirnov (K-S) test. The clinico-demographic parameters were analyzed by chi-square/Fishers (for categorical data) or Student's t-test (for numerical data).

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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 원문보기

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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 원문보기

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