Eficacia de complejo B en la corrección de la deficiencia de vitamina B12 en pacientes mexicanos con diabetes tipo 2 en tratamiento prolongado con metformina: estudio clínico de fase IV

Background and objective

Prolonged use of metformin can cause side effects such as vitamin B12 deficiency. The objective of this study was to evaluate the safety and efficacy of intramuscular B-complex to improve serum vitamin B12 levels in patients with prolonged use of metformin and suboptimal vitamin B12 levels.

Materials and methods

This Phase IV study included adults with type 2 diabetes treated with metformin (≥3 years) and serum vitamin B12 levels below 300 pg/ml. The intervention consisted of intramuscular injections of B-complex, with face-to-face and telephone follow-up.

Results

Of the 201 patients evaluated, 40 patients at the initial visit had cobalamin deficiency (19.9%), and of these, only 33 (82%) completed the 6-week follow-up. A statistically significant change was observed when comparing baseline vitamin B12 levels with final levels (p < 0.001) in 99.5% of the patients. No significant changes were observed in signs and symptoms of neuropathy, except for leg cramps and general weakness. Anemia symptoms remained unchanged in most patients. No adverse effects were reported.

Conclusions

Intramuscular administration of B-complex is safe and effective in increasing serum vitamin B12 levels in patients with type 2 diabetes and prolonged use of metformin. No significant improvements were observed in neuropathy or anemia symptoms. The treatment was well tolerated, and no adverse effects were reported.