Clinical Study Of The Neuroprotective Effects Of Palm Vitamin E Tocotrienols In Peripheral Neuropathy Of Type 1 And Type 2 Diabetes Mellitus
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Date
2016-12
Authors
Sim, June Su-Way
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Publisher
Universiti Sains Malaysia
Abstract
This clinical study investigated the palm tocotrienols’ neuroprotective effect in diabetic peripheral neuropathy (DPN). The characteristics of patients with DPN were studied in 300 diabetic patients recruited from 13 outpatient clinics and hospitals in the north-west region of peninsular Malaysia. Neuropathy assessments performed on the patients were the Total Symptoms Score (TSS) and Neuropathy Impairment Score (NIS). It was found that the most common symptom experienced by the patients was numbness, followed by other painful symptoms. In addition, abnormal signs were mostly seen in the lower limbs compared to the upper limbs, and were symmetrical on both sides of body. The following part of the study investigated the neuroprotective effect of palm vitamin E in a randomized, double-blind, and placebo controlled clinical trial. The 300 patients with DPN were randomized to either tocotrienols or placebo group. TSS and NIS were carried out at baseline, the 6th and 12th month. The per-protocol analysis showed that lancinating pain in the tocotrienols treated group had a significant improvement by mean score change (SD) of -0.58 (1.41) at the 6th month (p=0.047) and borderline improvement of -0.64 (1.32) at the 12th month (p=0.053) compared to that of the placebo group [-0.20 (1.46), and -0.29 (1.43) respectively]. The study on the DPN impairments did not see any significant difference in the mean changes from baseline for NIS and subscores in the lower limbs at both 6th and 12th month between the two treatment groups in the per-protocol population which could be because neuropathy in the large fibers takes more time for recovering compared to the small fibers. Lastly, the nerve conduction studies (NCS) were carried out to monitor the neurophysiological changes in sensory and motor nerves at pre- and post-treatment. The results showed small mean changes in most of the sensory and motor nerves physiology which were only less than 10% of the baseline values and the mean changes between the two groups at post-treatment were not significantly different. A longer period for NCS may be required to observe any possible neuroprotective effect of tocotrienols on the sensory and motor nerves in DPN. In conclusion, the findings from the current study suggest that supplementation of tocotrienols up to a twelve months period was able to significantly improve lancinating pain in DPN symptoms compared to patients who were not treated with tocotrienols. Nevertheless, the effects of tocotrienols in DPN impairments and neurophysiology are still uncertain and warrant further investigations to determine its usefulness in the clinical practice for the management of DPN.
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Keywords
Palm tocotrienols’ neuroprotective effect , in diabetic peripheral neuropathy