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Effect of high-dose N-acetyl cysteine on the clinical outcome of patients with diabetic peripheral neuropathy: a randomized controlled study
Diabetol Metab Syndr
2025 Mar 4;17:79. doi: 10.1186/s13098-025-01624-9
Author
Sherien Mohamed Emara , Sarah Farid Fahmy , Mona Mohamed AbdelSalam , Lamia Mohamed El Wakeel
Author information
1Clinical Pharmacy Department, Faculty of Pharmacy, British University, Cairo, Egypt
2Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt
3Department of Endocrinology, Faculty of Medicine, Ain Shams University Hospitals, Cairo, Egypt
✉Corresponding author.
Article notes
Received 2024 Oct 17; Accepted 2025 Feb 2; Collection date 2025.
Copyright and License information
© The Author(s) 2025
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PMC Copyright notice
PMCID: PMC11881454 PMID: 40038825
Abstract
Background
Methods
A prospective, randomized, parallel, open label, controlled clinical trial. Ninety eligible DPN patients were randomly assigned to either control group receiving standard of care or NAC group receiving standard of care treatment and NAC at a dose of 2400 mg/day for 12 weeks. Glutathione peroxidase (GPx), nuclear factor erythoid-2 related factor (NRF-2) and tumor necrosis factor (TNF) were measured at baseline and after 12 weeks to assess anti-oxidant and anti-inflammatory properties. Michigan neuropathy screening instrument (MNSI), Toronto clinical neuropathy score (TCNS), Diabetic neuropathy score (DNS), Diabetes-39 quality of life questionnaire (DQOL) and pain score were assessed at baseline and after 12 weeks.
Results
NAC group showed a significant increase (p < 0.05) in NRF-2 by 25.3% and GPx by 100% and a decline of 21.45% in TNF-alpha levels versus controls that reported a decline in NRF-2 and GPx and an increase in TNF-alpha. HgbA1C and AST levels significantly decreased in NAC versus controls (7.2 ± 1 vs 8 ± 1.1, p = 0.028 and 29.1 vs 55.4, p = 0.012) respectively. NAC administration resulted in a significant decline in MNSA, TCNS, DNS and pain scores versus controls that showed increase in all scores. The QOL total score and the anxiety and energy and mobility domain scores significantly decreased in the NAC group versus controls, p < 0.001.
Conclusion
High dose NAC administered for 12 weeks modulated inflammation by reducing TNF-alpha and increasing GPx and NRF2 versus controls. NAC improved clinical outcomes of DPN reflected by a decline in neuropathy and pain scores and an improvement in QOL.
Clinical trial registration number
NCT04766450
Keywords: