Manuka combinations with nigella sativa and hydroxyurea in treating iron overload of pediatric β-thalassemia major, randomized clinical trial.

Autor:	Gamaleldin MM; Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.; Department of Pharmacy Practice & Science, R. K. Coit College of Pharmacy, University of Arizona, Tucson, AZ, USA.; Department of Pharmaceutical Sciences (Pharm-D Program), Fakeeh College for Medical Sciences, Jeddah, Saudi Arabia., Abraham IL; Department of Pharmacy Practice & Science, R. K. Coit College of Pharmacy, University of Arizona, Tucson, AZ, USA.; Department of Family and Community Medicine, College of Medicine, University of Arizona, Tucson, AZ, USA.; Clinical Translational Sciences, University of Arizona Health Sciences, Arizona, USA., Meabed MH; Department of Pediatrics, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt., Elberry AA; Department of Clinical Pharmacology, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.; Department of Pharmacy Practice, Pharmacy Program, Batterjee Medical College, Jeddah, Saudi Arabia., Abdelhalim SM; Department of Pharmaceutical Sciences (Pharm-D Program), Fakeeh College for Medical Sciences, Jeddah, Saudi Arabia., Mahmoud Hussein AF; Beni-Suef Health Insurance Hospital, Beni-Suef, Egypt., Hussein RRS; Department of Clinical Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.
Jazyk:	angličtina
Zdroj:	Heliyon [Heliyon] 2024 Jun 26; Vol. 10 (13), pp. e33707. Date of Electronic Publication: 2024 Jun 26 (Print Publication: 2024).
DOI:	10.1016/j.heliyon.2024.e33707
Abstrakt:	Background: β-thalassemia major is microcytic hypochromic anemia disorder inherited from parents, resulting from a mutation in the β-globin locus. As a result, a quantitative defective hemoglobin synthesis and relative excess in α-globin is occurred. As such, frequent blood transfusion is required, that leads to iron overload. Iron overload results in several pathological complications, including cell death, tissue injury, organ dysfunction, and liver fibrosis. The present study examined the effectiveness of nigella Sativa and manuka honey combination or manuka honey alone to the conventional therapy (Deferasirox + blood transfusion) used for preventing and managing iron overload in pediatric β-thalassemia major patients. Methods: One hundred sixty-five patients participated in this randomized, double-blind, standard therapy-controlled, parallel-design multisite trial. The patients were randomly allocated into three groups, receiving either 500 mg nigella sativa oil combined with manuka honey lozenge (344 mg) daily or manuka honey alone plus the conventional therapy for ten treatment months. Ferritin level, serum iron, transferrin saturation, total iron binding capacity, alanine transaminase, and aspartate transaminase were determined at baseline and month 10. Results: Eventually, serum ferritin and iron were decreased significantly in the nigella sativa + manuka honey group as compared with the control group. Other clinical parameters were significantly impacted. The level of alanine transaminase and aspartate transaminase were significantly decreased in the nigella sativa plus manuka honey group compared with the control group. Conclusion: Results showed that nigella sativa plus manuka honey was more effective than manuka alone or the conventional treatment alone in managing iron overload of β-thalassemia major patients. Competing Interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. (© 2024 The Authors. Published by Elsevier Ltd.)
Databáze:	MEDLINE
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