Evaluation of oral nano-silymarin formulation efficacy on prevention of radiotherapy induced mucositis: A randomized, double-blinded, placebo-controlled clinical trial
2021
Hosseini, Sare | Rezaei, Sina | Moghaddam, Mohammad Reza Niazi | Elyasi, Sepideh | Karimi, Gholamreza
Most of the patients with head and neck cancer who undergo radiotherapy experience some degrees of mucositis. Silymarin is a polyphenolic flavonoid that exhibits strong anti-inflammatory activity but has low oral bioavailability. In this research, we evaluated the effect of nano-formulation of silymarin on prevention of radiotherapy induced mucositis in patients with head and neck cancer.Thirty-one patients who fulfilled the inclusion criteria randomly assigned to medicine (n = 16) or placebo (n = 15) group and received 5 mL nano-silymarin solution (70 mg/5 mL) or placebo solution three times daily for 6 weeks started from the first day of radiotherapy. European Organization for Research and Treatment of Cancer (EORTC) mucositis grading scores were recorded at baseline and weekly during 6 weeks of radiotherapy.The median EORTC scores were not significantly different between silymarin and placebo groups at the end of the sixth week (p > 0.05). Moreover, the scores increased significantly in both groups during radiotherapy. However, after 4 weeks of treatment with silymarin, the scores had a non-significant decreasing trend in contrast to placebo group.It seems that increasing the duration of treatment and modification of nano-formulation could improve its efficacy in prevention of radiotherapy induced mucositis.
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