Double-blind, randomized placebo-controlled study of efficiency and safety of complex acetyl-L-carnitine, L-carnitine fumarate and alpha-lipoic acid (Spermactin® Forte) for treatment of male infertility

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.

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Oral Alpha Lipoic Acid Treatment for Symptomatic Diabetic Peripheral Neuropathy: A Randomized Double-Blinded Placebo-Controlled Study

Endocrine Metabolic & Immune Disorders - Drug Targets ◽

10.2174/1871530320666200506081407 ◽

2020 ◽

Vol 20 (9) ◽

pp. 1531-1534 ◽

Cited By ~ 1

Author(s):

Mamdouh R. El-Nahas ◽

Ghada Elkannishy ◽

Hala Abdelhafez ◽

Enas T. Elkhamisy ◽

Amr A. El-Sehrawy

Keyword(s):

Peripheral Neuropathy ◽

Lipoic Acid ◽

Diabetic Peripheral Neuropathy ◽

Study Groups ◽

Controlled Study ◽

Alpha Lipoic Acid ◽

Disability Score ◽

Perception Threshold ◽

Outcome Parameters ◽

Double Blinded

Background: Alpha-lipoic acid (ALA) was used in the treatment of diabetic peripheral neuropathy (DPN) using different routes, doses and treatment durations. The aim of this work is to assess the efficacy of oral 600mg ALA twice daily over 6 months in the treatment of patients with DPN. Methods: This is a prospective, single-center, double-blinded, placebo-controlled study conducted at the outpatient clinic of Mansoura Specialized Hospital, Mansoura University. A total of 200 patients with DPN were randomly assigned to add on treatment with either oral 600mg twice daily ALA (n=100) or placebo (n=100) for 6 months. Treatment outcome was assessed using vibration perception threshold (VPT), neurological symptom score (NSS), neurological disability score (NDS), and visual analog scale (VAS) for pain at baseline and at each visit (1, 3 and 6 months) after the start of treatment. Results: Comparison between the study groups regarding the baseline data revealed no statistically significant differences. with respect to the outcome parameters, no significant differences were found between the studied groups at baseline. However, in subsequent visits, ALA-treated patients had significantly better results regarding almost all the outcome parameters (NSS, NDS, VAS, VPT). Mild nausea was reported in 6 patients. None of the studied patients discontinued treatment. Conclusions: Oral 600mg ALA twice-daily treatment for DPN over 6 months is effective, safe and tolerable.

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The effect of alpha lipoic acid supplementation on sperm functions in idiopathic asthenozoospermic patients: a case-controlled study

Human Fertility ◽

10.1080/14647273.2021.2025271 ◽

2022 ◽

pp. 1-9

Author(s):

Yahya M. Hodeeb ◽

Emad M. El-Rewiny ◽

Abdullah M. Gaafar ◽

Ahmed N. Zayed ◽

Mohamed S. Hasan ◽

...

Keyword(s):

Lipoic Acid ◽

Controlled Study ◽

Alpha Lipoic Acid ◽

Acid Supplementation ◽

Sperm Functions

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Protective effect of alpha lipoic acid on diabetic nephropathy in rats

Mansoura Veterinary Medical Journal ◽

10.35943/mvmj.2019.23.204 ◽

2019 ◽

Vol 20 (3) ◽

pp. 19-23

Author(s):

Samar Yabes ◽

Mohamed EL-Adl ◽

Mohamed Hamed ◽

Gehad El-Sayed

Keyword(s):

Diabetic Nephropathy ◽

Lipoic Acid ◽

Nitrosative Stress ◽

Acid Group ◽

Controlled Study ◽

Alpha Lipoic Acid ◽

Sprague Dawley ◽

Glycemic Status ◽

Oxidative And Nitrosative Stress ◽

Tissue Samples

Objective: To evaluate the protective role of alpha lipoic acid in rats affected with experimentally-induced diabetes and secondarily complicated with nephropathy. Design: Randomized controlled study. Animals: Forty-eight Sprague Dawley rats. Procedures: Rats were allocated randomly into four groups (12 each); Control rats (Group 1); alpha lipoic acid (ALA) supplemented rats (Group 2); rats with induced diabetic nephropathy (Group 3), and rats with diabetic nephropathy and supplemented with alpha lipoic acid (Group 4). After one month of experimental induction, serum, plasma and renal tissue samples were harvested to determine glycemic status, renal damage markers, antioxidant status, oxidative and nitrosative stress markers, apoptotic marker and histopathology of kidney tissues. Results: In comparison with non-supplemented diabetic rats, alpha lipoic acid reduced renal malondialdehyde (5.74± 0.26 vs 11.3± 1.96 nmol/g. tissue) and renal nitric oxide (30.06± 2.07 vs 36.6± 1.07 nmol/g. tissue). ALA significantly improved the antioxidant enzyme activity (catalase and reduced glutathione), glycemic status, and decreased caspase 3 concentration (P<0.05). Conclusion and clinical relevance: Alpha lipoic acid may be an alternative intervention to alleviate nephropathy as a complication of diabetes. Further studies need to be done in naturally occurring cases.

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