Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial.

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 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 Ⅲc EOC patients.