Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized, Double-Blinded, Placebo-Controlled Trial
Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized, Double-Blinded, Placebo-Controlled Trial作者机构:Center of Science and TechnologyChina-Japan Friendship HospitalBeijing 100029China Integrative Oncology Department of Chinese Medicine and Western MedicineChina-Japan Friendship HospitalBeijing 100029China
出 版 物:《Chinese Journal of Integrative Medicine》 (中国结合医学杂志(英文版))
年 卷 期:2022年第28卷第7期
页 面:579-585页
核心收录:
学科分类:1002[医学-临床医学] 100214[医学-肿瘤学] 10[医学]
基 金:Supported by Capital’s Funds for Health Improvement and Research (No. 2018-2-40610)
主 题:peripheral neuropathy chemotherapy target therapy Chinese medicine Wen-Luo-Tong randomized controlled trial
摘 要:Objective: To evaluate the efficacy of Wen-Luo-Tong Granules(WLT) local administration in the treatment of patients with peripheral neuropathy(PN) induced by chemotherapy or target therapy. Methods: This study is a randomized, double-blinded, and placebo-controlled trial. Seventy-eight patients with PN induced by chemotherapy or target therapy were enrolled from China-Japan Friendship Hospital between July 2019 and January 2020. They were randomly assigned to WLT(39 cases) and control groups(39 cases) using a block randomization method. The WLT group received WLT(hand and foot bath) plus oral Mecobalamin for 1 week, while the control group received placebo plus oral Mecobalamin. The primary endpoint was PN grade evaluated by the National Cancer Institute-Common Toxicity Criteria for Adverse Events(NCI-CTCAE). The secondary endpoints included quantitative touch-detection threshold, neuropathy symptoms, Quality of Life QuestionnaireChemotherapy Induced Peripheral Neuropathy(QLQ-CIPN20), and Quality of Life Questionnaire-Core30(QLQ-C30). Results: After treatment, the PN grade in the WLT group was significantly lower than that in the control group(1.00±0.29 vs. 1.75±0.68, P0.01). The total effective rate in the WLT group was significantly higher than that in the control group(82.05% vs. 51.28%, P0.01). Compared with the control group, the touchdetection thresholds at fingertips, neuropathy symptom score, QLQ-CIPN 20(sensory scale, motor scale, autonomic scale, and sum score), and QLQ-C30(physical functioning, role functioning, emotional functioning, and global health) in the WLT group significantly improved after treatment(P0.01 or P0.05). Conclusion: WLT local administration was significantly effective in the treatment of patients with PN induced by chemotherapy or target therapy.(Trial registration No. ChiCTR1900023862)