Efficacy of Wen-Luo-Tong on Peripheral Neuropathy Induced by Chemotherapy or Target Therapy: A Randomized, Double-Blinded, Placebo-Controlled Trial.
10.1007/s11655-022-3575-y
- Author:
Bo DENG
1
;
Li-Qun JIA
2
;
Dong-Gui WAN
3
;
Bao-Yi WANG
3
;
Zhi-Qiang CHENG
3
;
Chao DENG
3
Author Information
1. Center of Science and Technology, China-Japan Friendship Hospital, Beijing, 100029, China.
2. Integrative Oncology Department of Chinese Medicine and Western Medicine, China-Japan Friendship Hospital, Beijing, 100029, China. liqun-jia@hotmail.com.
3. Integrative Oncology Department of Chinese Medicine and Western Medicine, China-Japan Friendship Hospital, Beijing, 100029, China.
- Publication Type:Randomized Controlled Trial
- Keywords:
Chinese medicine;
Wen-Luo-Tong;
chemotherapy;
peripheral neuropathy;
randomized controlled trial;
target therapy
- MeSH:
Antineoplastic Agents/adverse effects*;
China;
Humans;
Japan;
Peripheral Nervous System Diseases/drug therapy*;
Quality of Life/psychology*;
Surveys and Questionnaires
- From:
Chinese journal of integrative medicine
2022;28(7):579-585
- CountryChina
- Language:English
-
Abstract:
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 Questionnaire-Chemotherapy 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, P<0.01). The total effective rate in the WLT group was significantly higher than that in the control group (82.05% vs. 51.28%, P<0.01). Compared with the control group, the touch-detection 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 (P<0.01 or P<0.05).
CONCLUSION:WLT local administration was significantly effective in the treatment of patients with PN induced by chemotherapy or target therapy. (Trial registration No. ChiCTR1900023862).
