Effects of a Three-Month-Antioxidant Therapy on the Oxidative Balance in Beta-Thalassemia Patients

Background and aim: Beta-thalassemia is one of the most common single-gene disorders worldwide. Depending on the amount of genetic defect, patients may present with mild to severe clinical phenotype. Precipitation of excess α-chains induces the production of free radicals and reactive oxygen species. Antioxidants play an important role in reducing oxidative damage. This prospective, interventional case-control clinical trial investigated the impact of a three-month antioxidant therapy regimen, consisting of vitamin E and N-acetylcysteine (NAC), on oxidative balance in patients with transfusion-dependent Beta-thalassemia (TDT). The primary aim was to evaluate changes in oxidative stress biomarkers—total antioxidant capacity (TAC), total oxidant status (TOS), and oxidative stress index (OSI)—alongside secondary outcomes, such as hematological parameters, serum ferritin and organ-function parameters. Patients and Methods: The study was conducted at Al-Hussein University Hospital and El-Obour Hospital, Kafr El-Sheikh Governorate, during the period from November 2022 to November 2023, the study included 88 TDT patients, aged 5–18 years, divided by systematic random method into a case group (n=48) receiving antioxidants alongside standard treatment and a control group (n=40) receiving only standard treatment. Eligible patients underwent a comprehensive baseline assessment which included medical history, physical examination and laboratory investigations (CBC, serum ferritin, organ-function tests, and oxidative stress biomarkers). At the end of the three-month period, a repeat comprehensive follow up assessment was conducted. Post-treatment, the case group exhibited a highly significant increase in TAC, decrease in TOS and reduction in OSI. Significant improvements were noted in serum ferritin and organ-function parameters reflecting reduced oxidative damage to these organs. Conclusion: A three-month regimen of vitamin E and NAC significantly improved oxidative damage in TDT patients, as evidenced by increased TAC, reduced TOS and OSI, lower serum ferritin, and better renal and liver functions. While it does not directly ameliorate anemia, the therapy offers a protective effect against oxidative damage, supporting its potential inclusion in TDT patients’ management protocols.