Background: ‘Acute lymphoblastic leukemia is the most common childhood malignancy’.
Adding methotrexate to treatment protocols increased survival rate in children with leukemia.
Methotrexate efficacy is limited by its hepatotoxicity. Aim of the study: To assess the therapeutic value
of Black seed oil in ‘methotrexate induced hepatotoxicity in Egyptian children with acute lymphoblastic
leukemia’. Subjects and methods: This study was conducted on 40 children with acute lymphoblastic
leukemia’ including 20 patients under methotrexate therapy and Black seeds 80mg/kg/day for one
week after each methotrexate dose [Group II] and 20 patients under methotrexate therapy and placebo
[Group III]. This study included also ‘20 healthy children of matched age and sex as a control group’
[Group I]. All patients were subjected to complete blood picture, bone marrow aspiration and liver functions. Results: No
significant differences in liver functions between group II and III before therapy were observed. There were nonsignificant
increase in total, direct and indirect serum bilirubin, serum ALT, AST, and alkaline phosphatase levels and
prothrombin time in group II after methotrexate and Black seed oil therapy but there was significant increase in group III
after treatment with methotrexate and placebo with ‘significant differences between group II and III ʼ after therapy. There
were significant differences in prognosis regarding remission, relapse, death and ‘disease free survival but no significant
difference in overall survival between group II and III’. Conclusion: Black cumin seeds decreased MTX hepatotoxicity
and improved survival in children with ALL and can be recommended as adjuvant drug in patients with ALL under
Keywords: Acute lymphoblastic leukemia, black seed oil, hepatotoxicity, methotrexate.
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