Abstract
Oxidative stress is a major mechanism contributing to the progression of β-thalassemia. To assess the effect of vitamin E and N-acetyl cysteine (NAC) as antioxidant agents on total oxidative stress (TOS) status and total antioxidant capacity (TAC) in patients with transfusion-dependent β-thalassemia (TDT). In this open-label randomized controlled trial, from May to August 2019, 78 eligible patients with TDT over the age of 18 were enrolled. All patients were registered at the Thalassemia Clinic of Shiraz University of Medical Sciences in Southern Iran. Patients were randomly allocated to the NAC group (10 mg/kg/day, orally), vitamin E group (10 U/kg/day, orally), and control group. The duration of the study was 3 months. The mean age of the participants was 28.5 ± 5.1 (range: 18–41) years. At the end of the study, TOS significantly decreased only in the vitamin E group (mean difference (MD), 95% confidence interval (CI): 0.27 (0.03–0.50), P = 0.026). TAC significantly decreased in both supplemented groups at the 3rd month of treatment (NAC group: MD (95% CI): 0.11 (0.04–0.18), P = 0.002 and vitamin E group: 0.09 (0.01–0.16), P = 0.022 respectively). Hemoglobin did not significantly change at the end of the study in each group (P > 0.05). Mild transient adverse events occurred in 4 patients of the NAC group and 5 patients of the vitamin E group with no need to discontinue the treatment. Vitamin E can be a safe and effective supplement in improving oxidative stress in patients with TDT. Moreover, it seems that a longer duration of using antioxidant supplements needs to make clinical hematologic improvement in TDT patients.
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The methodology is listed in detail in the “Material and methods” section of the manuscript. All data are available upon request.
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Acknowledgments
The authors would like to thank the Research Vice-Chancellor of Shiraz University of Medical Sciences for their approval and financial support. Also, they would like to express great thanks to the patients for their respectable cooperation in this study.
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Research Vice-Chancellor of Shiraz University of Medical Sciences supported this work financially.
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SH developed the concept of the manuscript, conducted data analysis, and drafted and revised the manuscript. ORZ drafted and critically revised the manuscript. NK, MB, MK, SZ, and AB drafted and revised the manuscript. MM, AA, and SAZF conducted laboratory investigations. SS performed the enrollment of participants, data gathering, and drafted the manuscript. All authors read and approved the final manuscript.
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Data were analyzed by the Statistical Package for the Social Sciences (SPSS) software, version 23 (SPSS Inc., Chicago, IL, USA).
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Haghpanah, S., Cohan, N., Bordbar, M. et al. Effects of three months of treatment with vitamin E and N-acetyl cysteine on the oxidative balance in patients with transfusion-dependent β-thalassemia. Ann Hematol 100, 635–644 (2021). https://doi.org/10.1007/s00277-020-04346-2
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DOI: https://doi.org/10.1007/s00277-020-04346-2