Therapeutic value of black seed oil in methotrexate hepatotoxicity in Egyptian children with acute lymphoblastic leukemia

Infect Disord Drug Targets. 2015;15(1):64-71. doi: 10.2174/1871526515666150320161440.


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 80 mg/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 ' 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 methotrexate therapy.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adolescent
  • Antimetabolites, Antineoplastic / adverse effects*
  • Antimetabolites, Antineoplastic / therapeutic use
  • Chemical and Drug Induced Liver Injury / prevention & control*
  • Child
  • Child, Preschool
  • Cuminum / chemistry*
  • Female
  • Humans
  • Infant
  • Leucovorin / administration & dosage
  • Liver / drug effects*
  • Liver / metabolism
  • Male
  • Methotrexate / adverse effects*
  • Methotrexate / therapeutic use
  • Plant Oils / administration & dosage
  • Plant Oils / chemistry
  • Plant Oils / therapeutic use*
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / complications
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma / drug therapy*
  • Prognosis
  • Seeds / chemistry


  • Antimetabolites, Antineoplastic
  • Plant Oils
  • Leucovorin
  • Methotrexate