A clinical study to determine metformin as a cause of serum vitamin B12 decrease and effect of combination of metformin and mecobalamin on serum vitamin B12 levels in type 2 diabetics

Background: Several evidences show metformin decreases vitamin B12. Diabetics are also at the risk of developing neuropathy which is treated with vitamin B12. metformin being initial therapy for diabetic patients, it becomes all the more important to know the extent of this decrease. The study was designed with the objective to compare the levels of vitamin B12 in patients on metformin vis-à-vis on antidiabetic drugs other than metformin and to evaluate the increase in vitamin B12 levels after prescribing a combination of metformin and mecobalamin, in T2DM patients.Methods: Of 500 enrolled, 321 patients completed the study for duration of 6 months, divided in two periods of 3 months each. At the end first period of 3 months the vitamin B12 levels were compared form Metformin vs. that of other antidiabetics. In second period of 3 months a combination of metformin and mecobalamin was given instead of plain metformin and vitamin B12 levels were repeated at the end of this period.Results: There was reduction in vitamin B12 levels with metformin with levels of 272.5pg/ml compared to 714.6pg/ml with other antidiabetics at the end of first period. The levels increased from 272.5pg/ml to 615.9 pg/ml at the end of second period after receiving the combination of metformin and mecobalamin.Conclusions: T2DM patients being treated with metformin had a greater risk of reduction in vitamin B12 levels and addition of vitamin B12 in the form of mecobalamin would decrease the reduction in vitamin B12 levels associated with Metformin therapy

Efficacy and safety of a fixed dose combination of paracetamol, chlorpheniramine maleate and phenylephrine in treatment of common cold: a phase IV, open-labelled, multi-centric study

Background: Acute coryza or common cold affects the upper airways, sometimes in association with low-grade fever and systemic symptoms, and usually presents with at least two of the following symptoms: cough, dysphonia, throat discomfort, sore throat, nasal congestion, rhinorrhoea, sneezing, headaches, myalgia and fever. A triple combination of analgesics, decongestants and antihistamines provides better relief for multiple symptoms in common cold and allergic rhinitis according to various studies. A combination of Paracetamol as an analgesic, anti-inflammatory and antipyretic, Chlorpheniramine maleate, an anti-histaminic and Phenylephrine as a nasal decongestant is popular in the treatment of common cold. Hence the present study was planned to evaluate efficacy and safety of this combination in treatment of common cold.Methods: This was a phase IV, open-labelled, multicentric study in 159 patients. Efficacy assessment was done by analyzing the reduction in mean TSS at each follow-up visit and safety assessment was done by analyzing the adverse events during the study.Results: There was reduction in mean TSS from 6.62 (day 1) to 3.56 (day 3) and 0.69 (day 5). Most of the patients had >50% reduction in total symptom score at visit 3 and 58.49% patients had complete relief from the symptoms at the end of study. Out of 159 patients, 26 i.e. 16.36% experienced adverse events. Sedation and drowsiness (6.29%) were the most common adverse event seen in patients.Conclusions: A fixed dose combination of Chlorpheniramine maleate, Paracetamol, and Phenylephrine is safe and effective in the treatment of common cold