Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial
单位:[1]Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China[2]Department of Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China[3]Department of Graduate School, China Academy of Chinese Medical Sciences, Beijing 100700, China[4]Department of Pain, China-Japan Friendship Hospital, Beijing 100029, China
OBJECTIVE: To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction (YHJD) on patients with advanced epithelial ovarian cancer (EOC). METHODS: All 330 enrolled participants diagnosed with stage III c EOC were randomly divided into two groups that received YHJD or a placebo. The primary end point was health-related quality of life (HRQL) measured by the functional assessment of cancer therapy-ovary cancer (FACT-O) questionnaire. The secondary end point was progression-free survival (PFS). RESULTS: A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups, respectively. After 6 months of treatment, YHJD increased physical wellbeing (PWB), functional wellbeing (FWB), additional concerns (AC), and the trial outcome index (T01) (P < 0.05) by various degrees compared with the baseline. YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB, FWB, AC (P < 0.05), and TOI (P < 0.01). In addition, YHJD had a significant advantage in terms of PFS compared with the placebo (21 vs 18 months, P < 0.05). No adverse events were reported. CONCLUSION: YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stage III c EOC patients. (C) 2020 JTCM. All rights reserved.
基金:
National Natural Science Foundation of China (NSFC)National Natural Science Foundation of China (NSFC) [81473566]
第一作者单位:[1]Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China[2]Department of Graduate School, Beijing University of Chinese Medicine, Beijing 100029, China
通讯作者:
通讯机构:[1]Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China[*1]Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China
推荐引用方式(GB/T 7714):
Li Yifan,Li Juan,Fan Bifa,et al.Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial[J].JOURNAL of TRADITIONAL CHINESE MEDICINE.2020,40(1):103-111.
APA:
Li Yifan,Li Juan,Fan Bifa,Wang Yitong,Jiang Juling...&Lu Wenping.(2020).Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial.JOURNAL of TRADITIONAL CHINESE MEDICINE,40,(1)
MLA:
Li Yifan,et al."Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial".JOURNAL of TRADITIONAL CHINESE MEDICINE 40..1(2020):103-111