Abstract
Diabetic peripheral neuropathy (DPN) is the most common microvascular complication of diabetes that affects approximately half of the diabetic population. Up to 53% of DPN patients experience neuropathic pain, which leads to a reduction in the quality of life and work productivity. Tocotrienols have been shown to possess antioxidant, anti-inflammatory, and neuroprotective properties in preclinical and clinical studies. This study aimed to investigate the effects of tocotrienol-rich vitamin E (Tocovid SuprabioTM) on nerve conduction parameters and serum biomarkers among patients with type 2 diabetes mellitus (T2DM). A total of 88 patients were randomized to receive 200 mg of Tocovid twice daily, or a matching placebo for 12 months. Fasting blood samples were collected for measurements of HbA1c, renal profile, lipid profile, and biomarkers. A nerve conduction study (NCS) was performed on all patients at baseline and subsequently at 2, 6, 12 months. Patients were reassessed after 6 months of washout. After 12 months of supplementation, patients in the Tocovid group exhibited highly significant improvements in conduction velocity (CV) of both median and sural sensory nerves as compared to those in the placebo group. The between-intervention-group differences (treatment effects) in CV were 1.60 m/s (95% CI: 0.70, 2.40) for the median nerve and 2.10 m/s (95% CI: 1.50, 2.90) for the sural nerve. A significant difference in peak velocity (PV) was also observed in the sural nerve (2.10 m/s; 95% CI: 1.00, 3.20) after 12 months. Significant improvements in CV were only observed up to 6 months in the tibial motor nerve, 1.30 m/s (95% CI: 0.60, 2.20). There were no significant changes in serum biomarkers, transforming growth factor beta-1 (TGFβ-1), or vascular endothelial growth factor A (VEGF-A). After 6 months of washout, there were no significant differences from baseline between groups in nerve conduction parameters of all three nerves. Tocovid at 400 mg/day significantly improve tibial motor nerve CV up to 6 months, but median and sural sensory nerve CV in up to 12 months of supplementation. All improvements diminished after 6 months of washout.
Highlights
Most (70 of 88) participants completed study treatment for 12 months, because 8 of them were lost at follow-up, 3 withdrew due to adverse events, 1 was unable to return for the end-of-study visit due to personal reasons, and 6 were unable to return for the last follow-up due to movement control orders implemented by the Malaysian government as a measure against the COVID19 pandemic
Five out of the six who failed to return for the final follow-up visit due to COVID-19 returned for the washout visit
72 participants were included in the washout analysis
Summary
Diabetic peripheral neuropathy (DPN) is one of the most common microvascular complications of diabetes that affects roughly 50% of the type 2 diabetic population [1]. It is the most common cause of foot ulcers [2] and is involved in 50–75% of non-traumatic amputations [3]. Up to 25% of patients with DPN will eventually develop foot ulcers during their lifetime [3]. Diabetic neuropathic pain is hard to identify and treat because its pathophysiological mechanism is not yet fully understood. Up to 53% of patients with DPN experience neuropathic pain, reducing their quality of life and work productivity [4]. Neuropathic pain generally responds poorly to traditional painkillers [5,6]
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