Efficacy of Oral Mixed Tocotrienols in Diabetic Peripheral Neuropathy
| Autor: | Ching Ee Loo, Michelle M. Samy, Hong Chin Wee, Yi Loon Tye, Fatimah Abu Bakar, Normala Wahid, Irene Looi, Wai-Yee Fung, Wai Yee Choon, Li Ying Kam, Hock Aun Ang, Loke Meng Ong, Yusnita Yusof, Chee Kin Yoon, Su-Way Sim, Najihah Idris, Kelvin Khai Meng Beh, Syed Azhar Syed Sulaiman, Jia Woei Wong, Nurzalina Abdul Karim Khan, Pei Yeing Teoh, Bee Yen Ooi, Alan Swee Hock Ch’ng, Hoon Ngoh Ong, Hadzlinda Zainal, Dy Win Low, Wei Shuong Tang, Kah Hay Yuen, Jayasumithra T. Ganapathy, Shalini C. Sree Dharan, Hoon Lang Teh, Luen Hui Lim, Chin Aun Yeoh, Ibrahim Lutfi Shuaib, Yusmawati Mohd Yusof, Chee Peng Hor, Adlina Bakar, Suriani Saaidin, Sheau Chin Lim |
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| Rok vydání: | 2018 |
| Předmět: |
Male
Hyperhomocysteinemia medicine.medical_specialty medicine.medical_treatment Administration Oral 030209 endocrinology & metabolism Placebo Antioxidants law.invention 03 medical and health sciences 0302 clinical medicine Diabetic Neuropathies Double-Blind Method Randomized controlled trial law Internal medicine Diabetes mellitus Outcome Assessment Health Care medicine Humans Homocysteine Original Investigation Aged Retrospective Studies business.industry Tocotrienols Vitamin E Middle Aged medicine.disease Symptomatic relief Peripheral neuropathy Methylcobalamin Patient Compliance Female Neurology (clinical) business 030217 neurology & neurosurgery Follow-Up Studies medicine.drug |
| Zdroj: | JAMA Neurology. 75:444 |
| ISSN: | 2168-6149 |
| DOI: | 10.1001/jamaneurol.2017.4609 |
| Popis: | Management of painful diabetic peripheral neuropathy remains challenging. Most therapies provide symptomatic relief with varying degrees of efficacy. Tocotrienols have modulatory effects on the neuropathy pathway and may reduce neuropathic symptoms with their antioxidative and anti-inflammatory activities.To evaluate the efficacy of oral mixed tocotrienols for patients with diabetic peripheral neuropathy.The Vitamin E in Neuroprotection Study (VENUS) was a parallel, double-blind, placebo-controlled trial that recruited participants from January 30, 2011, to December 7, 2014, with 12 months of follow-up. This trial screened 14 289 patients with diabetes from 6 health clinics and ambulatory care units from 5 public hospitals in Malaysia. A total of 391 patients who reported neuropathic symptoms were further assessed with Total Symptom Score (TSS) and Neuropathy Impairment Score (NIS). Patients 20 years or older with a TSS of 3 or higher and an NIS of 2 or higher were recruited.Patients were randomized to receive 200 mg of mixed tocotrienols twice daily or matching placebo for 12 months. Patients with hyperhomocysteinemia (homocysteine level ≥2.03 mg/L) received oral folic acid, 5 mg once daily, and methylcobalamin, 500 μg thrice daily, in both groups.The primary outcome was patient-reported neuropathy TSS (lancinating pain, burning pain, paresthesia, and asleep numbness) changes at 12 months. The secondary outcomes were NIS and sensory nerve conduction test result.Of 391 eligible patients, 300 were recruited (130 [43.3%] male; mean [SD] age, 57.6 [8.9] years; mean [SD] duration of diabetes, 11.4 [7.8] years) and 229 (76.3%) completed the trial. The TSS changes between the tocotrienols and placebo groups at 12 months (-0.30; 95% CI, -1.16 to 0.56; P = .49) were similar. No significant differences in NIS (0.60; 95% CI, -1.37 to 2.65; P = .53) and sensory nerve conduction test assessments were found between both groups. In post hoc subgroup analyses, tocotrienols reduced lancinating pain among patients with hemoglobin A1C levels greater than 8% (P = .03) and normohomocysteinemia (homocysteine level2.03 mg/L; P = .008) at 1 year. Serious adverse events in both groups were similar, except more infections were observed in the tocotrienols group (6.7% vs 0.7%, P = .04). Results reported were of modified intention-to-treat analyses.Supplementation of oral mixed tocotrienols, 400 mg/d for 1 year, did not improve overall neuropathic symptoms. The preliminary observations on lancinating pain among subsets of patients require further exploration.National Medical Research Registry Identifier: NMRR-10-948-7327 and clinicaltrials.gov Identifier: NCT01973400. |
| Databáze: | OpenAIRE |
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