New Vitamin B12 Buccal Films in Patients with Liver Cirrhosis Adjuvant with Diabetes Mellitus

Objective: To determine prospectively plasma levels of vitamin B12 in diabetic patients with liver cirrhosis before and 3 months after vitamin administration and its effects on nutritional state of patients. Additionally study a new dosage form of vitamin B12 (buccal film) in compare to traditional one as intramuscular injection. Methods: 120 blood samples were collected from 60 adult cirrhotic patients for estimation of vitamin B12 levels before and after vitamin administration. Additionally there was an estimation of other biochemical parameters to study the effect of B12 level changes on them. The most changeable parameters were hemoglobin, AST, ALT, and Transferrin levels. The rate of change in vitamin B12 levels and other biochemical parameters was significant before and after treatment with vitamin, adds to the difference in levels between the two different dosage forms groups. Vitamin B12 levels were measured by ElISA, before and after 3 months from the completion of treatment. Results: Vitamin B12 serum concentrations did not show any significant differences among the two groups before treatment. There was a significant increase in vitamin B12 serum concentrations after four weeks of B12 treatment in the two groups (35 ± 26_ 141 ± 49.3 vs. 53.8 ± 45.9_ 172.2 ± 52.8 pg/dL,) group I and group II respectively. Paired analysis in each group showed a significant increase for vitamin B12 in the two groups. Statistically significant differences were found for some biochemical parameters as hemoglobin, AST, ALT, and Transferrin concentrations before and four weeks after treatment. Conclusions: Patients with symptomatic infection by liver cirrhosis and diabetic have a lower vitamin B12 levels than normal. This could reflect a more need for vitamin B12 treatment for those patients for long time. These results could present the opportunity to treat these cases and to use vitamin B12 supplementation. There are many dosage forms for B12 in the markets; here we introduced a new competitor dosage form that was buccal films.