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Article

Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy

1
Diabetes Center, 1st Propaedeutic Department of Internal Medicine, Medical School, University General Hospital of Thessaloniki AHEPA, Aristotle University of Thessaloniki, 54636 Thessaloniki, Greece
2
Department of Nutrition and Dietetics, University General Hospital of Thessaloniki AHEPA, 54636 Thessaloniki, Greece
3
Department of Internal Medicine IV, Division of Endocrinology, Diabetology and Nephrology, University of Tübingen, 72076 Tübingen, Germany
4
Institute for Diabetes Research and Metabolic Diseases (IDM) of the Helmholtz Centre Munich at the University of Tübingen, 72076 Tübingen, Germany
5
German Center for Diabetes Research (DZD), 72076 Tübingen, Germany
*
Author to whom correspondence should be addressed.
Nutrients 2020, 12(11), 3254; https://doi.org/10.3390/nu12113254
Received: 3 October 2020 / Revised: 18 October 2020 / Accepted: 20 October 2020 / Published: 23 October 2020
(This article belongs to the Special Issue Dietary Intake and Diabetes)
Aim: To investigate the efficacy of Superoxide Dismutase, Alpha Lipoic Acid, Acetyl L-Carnitine, and Vitamin B12 (B12) in one tablet in Diabetic Neuropathy (DN). Patients–methods: In this prospective, double-blind, placebo-controlled study, 85 patients with Diabetes Mellitus Type 2 (DMT2) were randomly assigned, either to receive the combination of four elements (active group, n = 43), or placebo (n = 42) for 12 months. We used the Michigan Neuropathy Screening Instrument Questionnaire and Examination (MNSIQ and MNSIE), measured the vibration perception threshold (BIO), and Cardiovascular Autonomic Reflex Tests (CARTs). Nerve function was assessed by DPN Check [sural nerve conduction velocity (SNCV) and amplitude (SNAP)]. Pain (PS) and quality of life (QL) questionnaires were administered. Results: At follow-up, BIO, MNSIQ, QL, PAIN, and SNCV, SNAP, and B12 levels had significantly improved inactive group (p < 0.001, p < 0.001, p < 0.001, p < 0.001, p = 0.027, p = 0.031, and p < 0.001 respectively), whereas the inplacebo group MCR (mean circular resultant) and PAIN deteriorated (p < 0.001, p < 0.001). The changes in MNSIQ, QL, SNCV, BIO, and PAIN differed significantly between groups (p < 0.001, p < 0.001, p = 0.031, p < 0.001, and p < 0.001 respectively). Conclusions: The combination of the four elements in one tablet for 12 months in patients with DMT2 improved all indices of peripheral neuropathy, including SNAP and SNCV, pain, and Quality of Life perception, except CARTs and MNSIE. View Full-Text
Keywords: measurement; peripheral neuropathy; diabetes mellitus; neurometrix measurement; peripheral neuropathy; diabetes mellitus; neurometrix
MDPI and ACS Style

Didangelos, T.; Karlafti, E.; Kotzakioulafi, E.; Kontoninas, Z.; Margaritidis, C.; Giannoulaki, P.; Kantartzis, K. Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy. Nutrients 2020, 12, 3254. https://doi.org/10.3390/nu12113254

AMA Style

Didangelos T, Karlafti E, Kotzakioulafi E, Kontoninas Z, Margaritidis C, Giannoulaki P, Kantartzis K. Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy. Nutrients. 2020; 12(11):3254. https://doi.org/10.3390/nu12113254

Chicago/Turabian Style

Didangelos, Triantafyllos, Eleni Karlafti, Evangelia Kotzakioulafi, Zisis Kontoninas, Charalampos Margaritidis, Parthena Giannoulaki, and Konstantinos Kantartzis. 2020. "Efficacy and Safety of the Combination of Superoxide Dismutase, Alpha Lipoic Acid, Vitamin B12, and Carnitine for 12 Months in Patients with Diabetic Neuropathy" Nutrients 12, no. 11: 3254. https://doi.org/10.3390/nu12113254

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