Assessment of complementary treatment with Yiqi Fumai lyophilized injection on acute decompensated ischemic heart failure (ACT-ADIHF): a multicenter randomized controlled trial

Background To evaluate the efficacy and safety of Yiqi Fumai lyophilized injection in treating acute decompensated ischemic heart failure (ADIHF). Methods 666 patients with ADIHF from 37 clinical research centers in China were randomly allocated to the treatment group (n = 332) and the control group (n = 334). The control group was treated with standardized western medicine. The treatment group received intravenously 5.2g Yiqi Fumai lyophilized injection based on standardized western medicine for 7 days. Results There was no statistically significant difference in baseline characteristics between the two groups (P > 0.05). After treatment, the BNP level in the treatment group was significantly lower than that in the control group (8 days: 465.0 pg/ml vs. 533.6 pg/ml, P < 0.05; 60 ± 3 days: 398.0 pg/ml vs. 464.0 pg/ml, P < 0.01). The percentage of BNP level reduced by more than 30% compared to baseline was significantly higher in the treatment group than that in the control group (P < 0.01). And the improvement of LVEF, NYHA cardiac functional classification, MLHFQ score, and TCM four diagnosis information score were better in the treatment group than those in the control group at 60 ± 3 days after enrollment (P < 0.05 or P < 0.01). There were no statistically significant differences in the incidence of composite endpoint events and adverse events (P > 0.05). Conclusion Based on standardized western medicine, using Yiqi Fumai lyophilized injection can further reduce the plasma BNP level, improve cardiac function, alleviate clinical symptoms, improve the quality of life in patients with ADIHF, and it is safe.