To investigate the efficacy of a new combination of four elements (Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, Vit. B12) contained in one pill in Diabetic Neuropathy (DN).
In current prospective, double-blind, placebo-controlled, age In current prospective, double-blind, placebo-controlled, age-matched study, 85 patients with Diabetes Mellitus Type 2 (DMT2), randomized in two groups: group A: n=43 received the pill with the combination of the four elements (SOD, ALA, B12, ACL) and group B: n=42 received placebo. The following methods for detecting DN and Autonomic Neuropathy (DAN) used: MNSI, Cardiovascular Autonomic Reflex Tests (CARTS). We measured using DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. We used a pain (PS) and a quality of life (QL) questionnaire, also.
All values of laboratory tests and indices of measurements between the two groups did not differ at baseline A vs B including HbA1c (7.2±1.2 vs 6.8±1.2% p=0.207, Vit.B12 263±100 vs 299±155 pmol/L p=0.268). The following indices improved significantly in group A (baseline vs final): MNSIQ 6.6±1.6 vs 6.0±1.7 (p=0.003), QL 39.8±10.8 vs 36.2±9.8 (p<0.001), PAIN 20.6±7.9 vs 17.4±7.0 (p<0.001) and SNCV 32.5±23.8 vs 39.4±22.8 m/s (p=0.027), SNAP 6.2±5.1 vs 7.5±6.5 uV (p=0.031) improved significantly. Vit. B12 increased in group A (p<0.001) and was unchanged in group B.
In the current study after 12 months from the administration of the combination with the four elements in one pill in patients with DMT2 (group A), we observed an improvement in all indices of peripheral neuropathy including neurophysiological parameters, Pain and QL except for CARTS.