Effect of Oral Silymarin Administration on Prevention of Radiotherapy Induced Mucositis: A Randomized, Double‐Blinded, Placebo‐Controlled Clinical Trial

Abstract

Mucositis is a frequent severe complication of radiation therapy in patient with head and neck cancer. Silymarin is a polyphenolic flavonoid extracted from the milk thistle that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluate silymarin efficacy in prevention of radiotherapy induced mucositis in patients with head and neck cancer, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of oral silymarin 420 mg daily in three divided doses starting at the first day of radiotherapy for 6 weeks, on oral mucositis occurrence was assessed. Twenty-seven patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization and National Cancer Institute-Common Terminology Criteria oral mucositis grading scale scores were recorded at baseline and weekly during these 6 weeks. The median World Health Organization and National Cancer Institute Common Terminology Criteria scores were significantly lower in silymarin group at the end of the first to sixth week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during radiotherapy, but there was a delay for mucositis development and progression in silymarin group. Prophylactic administration of conventional form of silymarin tablets could significantly reduce the severity of radiotherapy induced mucositis and delay its occurrence in patients with head and neck cancer. Copyright © 2016 John Wiley & Sons, Ltd.

Dietary Supplements Commonly Used by Cancer Survivors: Are There Any Benefits?

“…In 1 trial of 50 pediatric patients undergoing treatment for acute lymphoblastic leukemia with chemotherapy‐induced hepatotoxicity, participants receiving silymarin had a significant lowering of liver enzymes when compared with a placebo 167 . In a randomized controlled trial, the administration of oral silymarin (420 mg/d) significantly reduced the severity of radiotherapy‐induced mucositis and delayed its occurrence 168 . In another study, women undergoing radiation therapy for breast cancer who used a silymarin‐based cream (Leviaderm) showed lower incidence and intensity of acute skin reactions 169 …”

Milk Thistle (Silybum Marianum) as a Supportive Phytotherapeutic Agent in Oncology

“…Radioprotektivní účinek silymarinu při vývoji orální mukozitidy byl zkoumán v klinické, dvojitě zaslepené a placebem kontrolované studii na 30 pa cientech s nádorem hlavy a krku léčených radioterapií. Silymarin (420 mg/ den ve třech dávkách) byl pa cientům v experimentální skupině podáván per os a výsled-kem byl pozdější nástup zánětu a jeho nižší závažnost [53].…”

Silymarin content in Silybum marianum extracts as a biomarker for the quality of commercial tinctures

“…In vitro anti-inflammatory, anti-arthritic, antioxidant and anti-carcinogenic properties have also been documented (Gupta et al, 2000;Pendry et al, 2006;Shaker et al, 2010;Zhao et al, 2011;Agarwal et al, 2013) as well as clinical trials testing silymarin in cancer therapy (Invernizzi et al, 1993;Schrӧder, F.H. et al, 2005;Greenlee, H. et al, 2007;Shahbazi, F. et al, 2015;Elyasi, S. et al, 2016).…”