Effects of three months of treatment with vitamin E and N-acetyl cysteine on the oxidative balance in patients with transfusion-dependent β-thalassemia.

2020-11-20
Annals of hematology 100(3)
- Sezaneh Haghpanah
- Nader Cohan
- Mohammadreza Bordbar
- Asghar Bazrafshan
- Mehran Karimi
- Soheila Zareifar
- Sanaz Safaei
- Azam Aramesh
- Mohamad Moghadam
- Saeid Amiri Zadeh Fard
- Omid Reza Zekavat

PubMed: 33216196
DOI: 10.1007/s00277-020-04346-2

Study Design

Type: Randomized Controlled Trial (RCT)
Population: 78 eligible patients with transfusion-dependent β-thalassemia (TDT) over the age of 18
Methods: open-label randomized controlled trial, from May to August 2019; patients randomly allocated to NAC group (10 mg/kg/day, orally), vitamin E group (10 U/kg/day, orally), and control group
Blinding: Open-label
Duration: 3 months

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.

Research Insights

N-Acetyl Cysteine→Increased Hemoglobin Levels
Hemoglobin did not significantly change at the end of the study in each group (P > 0.05).
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally
N-Acetyl Cysteine→Reduced Total Antioxidant Capacity
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 ...
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally
N-Acetyl Cysteine→Reduced Total Oxidative Stress
At the end of the study, TOS significantly decreased only in the vitamin E group ... TOS significantly decreased only in the vitamin E group
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally
Vitamin E→Increased Hemoglobin Levels
Hemoglobin did not significantly change at the end of the study in each group (P > 0.05).
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally
Vitamin E→Reduced Total Antioxidant Capacity
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 ...
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally
Vitamin E→Reduced Total Oxidative Stress
At the end of the study, TOS significantly decreased only in the vitamin E group ... TOS significantly decreased only in the vitamin E group
Effect
Neutral
Effect size
Small
Dose
10 mg/kg/day, orally

Adverse Events Reported

N-Acetyl Cysteine→Overall tolerability
Mild transient adverse events occurred in 4 patients of the NAC group
Finding
Reported
Grade
mild
Vitamin E→Overall tolerability
Mild transient adverse events occurred in 5 patients of the vitamin E group
Finding
Reported
Grade
mild