Efficacy of a traditional persian fruit infusion (Naqu Fawakeh) versus silymarin in reducing chemotherapy-induced hepatotoxicity in pediatric ALL: A triple-blind randomized clinical trial

Abstract

Maintenance-phase Chemotherapy-induced hepatotoxicity is concerned in pediatric Acute Lymphoblastic Leukemia (ALL). Traditional Persian Medicine (TPM) recommends Naqu Fawakeh, a fruit-based infusion, for liver inflammation. This study compare the effect of Naqu Fawakeh and silymarin on Chemotherapy side effects.

In this triple-blind, randomized clinical trial, 82 children aged 5–17 years received either Naqu Fawakeh (n = 44) or silymarin (n = 38) for eight weeks. Both groups were administered by 5 mL (<30 kg body weight) and 10 mL (≥30 kg), three times daily after meals. Liver enzymes (AST, ALT) and chemotherapy-related symptoms (nausea, vomiting, constipation, thirst) were assessed before and after the intervention. No placebo group was included due to ethical considerations.

Both interventions significantly reduced liver enzyme levels, with a greater effect in the Naqu Fawakeh group. The mean difference between groups was significant for ALT (P = 0.029). ALT decreased significantly in the Naqu Fawakeh group (P < 0.001) and in the silymarin group (P = 0.005); AST also decreased in both groups (Naqu Fawakeh: P = 0.005; silymarin: P = 0.011). Both treatments reduced nausea and vomiting within and after 24 h, as well as thirst, though the between-group mean difference was significant only for thirst (P = 0.001). Reductions in nausea and thirst were consistently greater in the Naqu Fawakeh group. No adverse renal or hematologic effects were observed.

Therfore Naqu Fawakeh, as a safe and supportive therapy, is more effective than silymarin in reducing liver enzyme. Further studies are confirmed findings.