Adjuvant potential of metformin with standard anti-seizure medications in persons with active epilepsy: a randomised controlled trial
Abstract
The purpose of this study was to investigate the efficacy and safety of add-on metformin treatment in persons with active epilepsy (a-PWE). This is a single-centric, double-blind, placebo-controlled trial randomised a-PWE (1:1) to receive either metformin (extended-release 500 mg) or matching placebo for 6 months along with background antiseizure medications. Primary outcome was percentage change in seizure frequency/month, and secondary outcomes were 50% responder rate, serum mTOR expression, and serum total antioxidant capacity (TAC), body composition analysis, quality of life (QOL), and safety assessment. Among the randomised a-PWE (n = 60, 30 in each group), no significant difference in percentage change in seizure frequency/month [median (IQR), 5.00 (- 11.25 to 23.45) vs. 0 (- 15.00 to 25.00), median difference (95% CI), 0 (- 18.75 to 12.50), p = 0.687], mTOR expression, TAC, and QOL was noted between metformin and placebo. Compared to baseline, QOL was significantly improved (p = 0.019) in metformin group, but this was not evident in placebo. Body composition analysis revealed a significant increase in percentage-change in BMI (p < 0.001), fat % (p = 0.011), and fat mass (p = 0.004) in placebo compared to metformin. No significant safety concern was observed in metformin group, rather Liverpool adverse event profile (LAEP) score was significantly lower than placebo (p = 0.014). Significant improvement in lipid profile (triglycerides and high-density lipoprotein) and…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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