Clinical Efficacy of a Topical Polyherbal Formulation in the Management of Fluorouracil -Associated Hand-Foot Syndrome Publisher



Karimi E¹ ; Gharib B² ; Rostami N³ ; Navidpour L⁴ ; Afshar M¹ Show Affiliations
Source: Journal of Herbal Medicine Published:2019

Abstract

Aim: Hand foot syndrome (HFS) is a common side effect following administration of fluoropyrimidine drugs like capecitabine and 5-flourouracil in cancer patients. This syndrome is not life threatening. However, it is the main reason for dose reduction or temporary discontinuation of these drugs. The aim of this study was evaluating the efficacy of a standardized topical polyherbal hydrogel (E.gel) containing Calendula officinalis L., Matricaria recutita L. and Salvia officinalis L. for the management of Hand Foot Syndrome (HFS) in cancer patients following administration of fluoropyrimidine drugs. Methods: In the present survey, 27 patients suffering from HFS were randomized to receive the E.gel and the placebo four times a day for 2 weeks. At the baseline and at the end of trial HFS grades were determined. Results: No serious adverse events occurred. Among the patients who have completed the study, 71% had a significant improvement compared to the placebo (p-value = 0.039). In 5% of the patients no changes were observed in the treatment group, while the side effects had worsened in the placebo group. Moreover, in 10% of the patients both treatment and placebo groups showed improvement and in 14% no changes were observed in both groups. Conclusion: This study shows that patients receiving the polyherbal hydrogel experienced less complications and symptoms associated with HFS. In summary, it seems that the use of the prepared polyherbal hydrogel was beneficial for cancer patients administered fluorouracil-chemotherapeutic agents. © 2019