Efficacy and safety of resveratrol, an oral hemoglobin F-augmenting agent, in patients with beta-thalassemia intermedia
- 321 Downloads
Recently, resveratrol showed induction of γ-globin mRNA synthesis in human erythroid precursors and reducing oxidative stress in red cells of thalassemia patients in many in vitro studies. We aimed to investigate the efficacy and safety of resveratrol, for the first time, in non-transfusion-dependent beta-thalassemia intermedia (B-TI) in Southern Iran. In this double-blind randomized clinical trial, 54 patients with B-TI were investigated during 6 months between October 2016 and March 2017. Patients were randomly allocated into three groups by simple randomization method. Group 1 (hydroxyurea (HU) and placebo, 18 patients), group 2 (resveratrol/piperine and placebo, 16 patients), and group 3(HU and resveratrol/piperine, 20 patients). Primary end point was considered as change in hemoglobin (Hb) levels and need for blood transfusion. Drug safety was considered as a secondary end point. Mean age of the patients was 28.2 ± 5.6 (18–42) years. Response rate was not significantly different among the three groups (P > 0.05). Higher percentages of adverse events were detected in groups 2 (31.3%) and 3 (25%) compared to group 1 (5.6%). However, the difference was not statistically significant (P > 0.05). All reported adverse events were gastrointestinal symptoms. Resveratrol showed a similar efficacy with HU in the small population of non-transfusion B-TI patients during a 6-month follow-up. Complications, mostly gastrointestinal, were observed more frequently in resveratrol groups compared to the HU group. Although it was not statistically significant, more attention should be given to safety and efficacy of resveratrol as an oral HbF-augmenting agent.
KeywordsAugmenting Beta thalassemia Hemoglobin F Resveratrol
The authors would like to thank Shiraz University of Medical Sciences for financial and approval (approval code 7691, and ethics committee code IR.sums.REC.1394.16), and patients who participated in the study. The author wish to thank Mr. H. Argasi at the Research Consultation Center (RCC) at Shiraz University of Medical Sciences for his invaluable assistance in editing this manuscript.
Compliance with ethical standards
The study protocol was approved by the local Ethics Committee of Shiraz University of Medical Sciences (approval code 7691, and Ethics Committee code IR.sums.REC.1394.16). Prior to start of the study, details were explained to each patient, and a written informed consent was obtained from all patients.
Conflict of interest
The authors declare that they have no conflict of interest.
- 2.Franco SS, De Falco L, Ghaffari S, Brugnara C, Sinclair DA, Mattè A, Iolascon A, Mohandas N, Bertoldi M, An X (2013) Resveratrol accelerates erythroid maturation by activation of FoxO3 and ameliorates anemia in beta-thalassemic mice. Haematologica:Haematol 2013:090076Google Scholar
- 15.Fibach E, Prus E, Bianchi N, Zuccato C, Breveglieri G, Salvatori F, Finotti A, Lipucci M, Paola D, Brognara E (2012) Resveratrol: antioxidant activity and induction of fetal hemoglobin in erythroid cells from normal donors and β-thalassemia patients. Int J Mol Med 29(6):974–982PubMedPubMedCentralGoogle Scholar
- 35.Boocock DJ, Faust GE, Patel KR, Schinas AM, Brown VA, Ducharme MP, Booth TD, Crowell JA, Perloff M, Gescher AJ (2007) Phase I dose escalation pharmacokinetic study in healthy volunteers of resveratrol, a potential cancer chemopreventive agent. Cancer Epidemiol Prev Biomarkers 16(6):1246–1252CrossRefGoogle Scholar
- 36.Brown VA, Patel KR, Viskaduraki M, Crowell JA, Perloff M, Booth TD, Vasilinin G, Sen A, Schinas AM, Piccirilli G (2010) Repeat dose study of the cancer chemopreventive agent resveratrol in healthy volunteers: safety, pharmacokinetics, and effect on the insulin-like growth factor axis. Cancer Res 70(22):9003–9011CrossRefGoogle Scholar
- 37.Gardner Z, McGuffin M (2013) American Herbal Products Association’s botanical safety handbook, second edn. CRC press, Boca RatonGoogle Scholar