Abstract: 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 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).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(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 vs18 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 Ⅲc EOC patients.

Key words: Ovarian neoplasms, Quality of life, Disease-free survival, Yiqi Huoxue Jiedu decoction, Randomized controlled trial