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Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial.
Phytother Res 2017; 31(9):1323-1329PR

Abstract

Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed. Forty patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization HFS grading scale scores were recorded at baseline and every 3 weeks during these 9 weeks. The median WHO HFS scores were significantly lower in silymarin group at the end of the 9th week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during chemotherapy, but there was a delay for HFS development and progression in silymarin group. Prophylactic administration of silymarin topical formulation could significantly reduce the severity of capecitabine-induced HFS and delays its occurrence in patients with gastrointestinal cancer after 9 weeks of application. Copyright © 2017 John Wiley & Sons, Ltd.

Authors+Show Affiliations

Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.Department of Clinical Pharmacy, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.Hematology-Oncology Department, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.Pharmaceutical Research Center, Faculty of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

28635153

Citation

Elyasi, Sepideh, et al. "Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial." Phytotherapy Research : PTR, vol. 31, no. 9, 2017, pp. 1323-1329.
Elyasi S, Shojaee FSR, Allahyari A, et al. Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Phytother Res. 2017;31(9):1323-1329.
Elyasi, S., Shojaee, F. S. R., Allahyari, A., & Karimi, G. (2017). Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Phytotherapy Research : PTR, 31(9), pp. 1323-1329. doi:10.1002/ptr.5857.
Elyasi S, et al. Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: a Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. Phytother Res. 2017;31(9):1323-1329. PubMed PMID: 28635153.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Topical Silymarin Administration for Prevention of Capecitabine-Induced Hand-Foot Syndrome: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial. AU - Elyasi,Sepideh, AU - Shojaee,Farzaneh Sadat Rezazadeh, AU - Allahyari,Abolghasem, AU - Karimi,Gholamreza, Y1 - 2017/06/21/ PY - 2017/04/27/received PY - 2017/05/31/revised PY - 2017/06/01/accepted PY - 2017/6/22/pubmed PY - 2017/9/26/medline PY - 2017/6/22/entrez KW - capecitabine KW - gastrointestinal cancers KW - hand-foot syndrome KW - silymarin SP - 1323 EP - 1329 JF - Phytotherapy research : PTR JO - Phytother Res VL - 31 IS - 9 N2 - Hand-foot syndrome (HFS) is a frequent dose-limiting adverse reaction of capecitabine in patient with gastrointestinal cancers. Silymarin is a polyphenolic flavonoid extracted from the Silybum marianum that exhibits strong antioxidant and antiinflammatory activities. In this study, we evaluated silymarin efficacy in prevention of capecitabine-induced HFS in patients with gastrointestinal cancers, as the first human study. During this pilot, randomized, double-blinded, placebo-controlled clinical trial, the effect of silymarin gel 1%, which is applied on the palms and soles twice daily starting at the first day of chemotherapy for 9 weeks, on HFS occurrence was assessed. Forty patients fulfilled the inclusion criteria assigned to the silymarin or placebo group. World Health Organization HFS grading scale scores were recorded at baseline and every 3 weeks during these 9 weeks. The median WHO HFS scores were significantly lower in silymarin group at the end of the 9th week (p < 0.05). The scores increased significantly in both placebo and silymarin groups during chemotherapy, but there was a delay for HFS development and progression in silymarin group. Prophylactic administration of silymarin topical formulation could significantly reduce the severity of capecitabine-induced HFS and delays its occurrence in patients with gastrointestinal cancer after 9 weeks of application. Copyright © 2017 John Wiley & Sons, Ltd. SN - 1099-1573 UR - https://www.unboundmedicine.com/medline/citation/28635153/Topical_Silymarin_Administration_for_Prevention_of_Capecitabine_Induced_Hand_Foot_Syndrome:_A_Randomized_Double_Blinded_Placebo_Controlled_Clinical_Trial_ L2 - https://doi.org/10.1002/ptr.5857 DB - PRIME DP - Unbound Medicine ER -