Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial

摘要

Background: LC09 is composed with 5 kinds of traditional Chinese herbal medicines (Astragalus membranaceus,flowers carthami, lithospermum, geranium wilfordii, and radix angelicae) which are used in China and developedover several thousand years. Aim: To assess the effectiveness and safety of herbal compound LC09 on patients withcapecitabine-associated hand-foot syndrome (HFS). Materials and Methods: In this randomized, double-blind, andparallel-controlled study, 156 patients that diagnosed with HFS were randomly assigned to a treatment group (n =78) or control group (n = 78). Patients were evaluated every week by the National Cancer Institute (NCI) grade andNumerical Rating Scale (NRS) pain scores. The Dermatology Life Quality Index (DLQI) scale and Instrumental Activityof Daily Living (IADL) scale were used to assess the quality of life before the treatment, and at 1 week and after thetreatment of 2 cycles. Results: At the baseline, no significant differences were observed between the 2 groups. Aftertreatment, significant differences in NCI grade and NRS pain scores were observed between the 2 groups (P .01).In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group comparedwith the control group (P .01). Furthermore, the chemotherapy completion rate between 2 groups was significantlydifferent (P = .002). In addition, no adverse reactions were observed in either LC09 or control group. Conclusion:LC09 can decrease NCI grade and significantly alleviate pain in HFS patients. Besides, it can also increase chemotherapycompletion rate.