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Randomized Controlled Trial
Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial.
- Yifan Li, Juan Li, Bifa Fan, Yitong Wang, Juling Jiang, Zhenhua Zhang, Xinxing Wang, and Wenping Lu.
- Department of Oncology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
- J Tradit Chin Med. 2020 Feb 1; 40 (1): 103-111.
ObjectiveTo further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction (YHJD) on patients with advanced epithelial ovarian cancer (EOC).MethodsAll 330 enrolled participants diagnosed with stage Ⅲc 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).ResultsA 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 (TOI) (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.ConclusionYHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stage Ⅲc EOC patients.
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